ガイドライン

(旧版)EBMに基づく 胃潰瘍診療ガイドライン 第2版 −H. pylori二次除菌保険適用対応−

書誌情報
第2部 胃潰瘍診療ガイドライン―解説―

 
参考文献
1.フローチャート概説とグレードレベルの解説
1) 科学的根拠(evidence)に基づく胃潰瘍診療ガイドラインの策定に関する研究班 編:EBMに基づく胃潰瘍診療ガイドライン.じほう,2003
2) 日本ヘリコバクター学会ガイドライン作成委員会:Helicobacter pylori 感染の診断と治療のガイドライン.日本ヘリコバクター学会誌,2(suppl):2-12,2000 (Helicobacter Research, 4:444-54,2000にも同じ内容が転載されている)
3) Asaka M, et al: Guidelines in the management of Helicobacter pylori infection in Japan. Helicobacter, 6:177-86,2001

2.出血性潰瘍診療指針
・内視鏡的治療

出血性潰瘍,内視鏡的治療の定まった検索式により導かれた文献中,検討内容に則した100文献が見出された。そのうち,メタアナリシスは4文献(レベル I),ランダム化比較試験(RCT)は68文献であった。ガイドラインによる診療指針ではメタアナリシスの4文献,メタアナリシスのために用いたRCT36文献,他に6文献と改変Forrest分類の出典1文献(検索式外文献)の計47文献を採用した。
1) O'Brien JD, et al: Controlled trial of small bipolar probe in bleeding peptic ulcers. Lancet, 1(8479):464-7,1986 (レベル II)
2) Moretó M, et al: Efficacy of monopolar electrocoagulation in the treatment of bleeding gastric ulcer: a controlled trial. Endoscopy, 19:54-6,1987 (レベル III)
3) Vallon AG, et al: Randomized trial of endoscopic argon laser photocoagulation in bleeding peptic ulcers. Gut, 22:228-33,1981 (レベル II)
4) MacLeod IA, et al: Neodymium yttrium aluminium garnet laser photocoagulation for major haemorrhage from peptic ulcers and single vessels: a single blind controlled study. Br Med J (Clin Res Ed), 286:345-8,1983 (レベル II)
5) Swain CP, et al: Controlled trial of Nd-YAG laser photocoagulation in bleeding peptic ulcers. Lancet, 17:1113-7,1986 (レベル III)
6) Matthewson K, et al: Randomized comparison of Nd YAG laser, heater probe, and no endoscopic therapy for bleeding peptic ulcers. Gastroenterology, 98:1239-44,1990 (レベル III)
7) Krejs GJ, et al: Laser photocoagulation for the treatment of acute peptic-ulcer bleeding. A randomized controlled clinical trial. N Engl J Med, 316:1618-21,1987 (レベル III)
8) Jaramillo JL, et al: Efficacy of the heater probe in peptic ulcer with a non-bleeding visible vessel. A controlled, randomized study. Gut, 34:1502-6,1993 (レベル III)
9) Gralnek IM, et al: An economic analysis of patients with active arterial peptic ulcer hemorrhage treated with endoscopic heater probe, injection sclerosis, or surgery in a prospective, randomized trial. Gastrointest Endosc, 46:105-12,1997 (レベル III)
10) Tekant Y, et al: Combination therapy using adrenaline and heater probe to reduce rebleeding in patients with peptic ulcer haemorrhage: a prospective randomized trial. Br J Surg, 82:223-6,1995 (レベル II)
11) Goh P, et al: Endoscopic hemostasis of bleeding peptic ulcers. Dig Dis, 11:216-27,1993 (レベル II)
12) Panés J, et al: Controlled trial of endoscopic sclerosis in bleeding peptic ulcers. Lancet, 2(8571):1292-4,1987 (レベル II)
13) Balanzó J, et al: Endoscopic hemostasis by local injection of epinephrine and polidocanol in bleeding ulcer. A prospective randomized trial. Endoscopy, 20:289-91,1988 (レベル II)
14) Sung JJ, et al: The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison. Ann Intern Med, 139:237-43,2003 (レベル II)
15) Bleau BL, et al: Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized stydy comparing endoscopic treatment with medical therapy. Gastrointest Endosc, 56:1-6,2002 (レベル III)
16) Jensen DM, et al: Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots. Gastroenterology, 123:407-13,2002 (レベル III)
17) Kohler B, et al: Upper GI-bleeding--value and consequences of emergency endoscopic treatment. Hepatogastroenterology, 38:198-200,1991 (検索式外文献)
18) Sofia C, et al: Endoscopic injection therapy vs. multipolar electrocoagulation vs. laser vs. injection + octreotide vs. injection + omeprazole in the treatment of bleeding peptic ulcers. A prospective randomized study. Hepatogastroenterology, 47:1332-6,2000 (レベル II)
19) Pulanić R, et al: Comparison of injection sclerotherapy and laser photocoagulation. Endoscopy, 27:291-7,1995 (レベル III)
20) Yang S, et al: Laser photocoagulation versus ethanol injection therapy after preinjection with epinephrine in the treatment of bleeding peptic ulcers. Digestive Endoscopy, 5:213-7,1993 (レベル II)
21) Chung SC, et al: Injection or heat probe for bleeding ulcer. Gastroenterology, 100:33-7,1991 (レベル III)
22) Sollano JD, et al: Endoscopic hemostasis of bleeding peptic ulcers: 1:10000 adrenalin injection vs. 1:10000 adrenalin +1% aethoxysclerol injection vs. heater probe. Gastroenterol Jpn, 26 Suppl 3:83-5,1991 (レベル II)
23) Laine L: Multipolar electrocoagulation versus injection therapy in the treatment of bleeding peptic ulcers. A prospective, randomized trial. Gastroenterology, 99:1303-6,1990 (レベル II)
24) Chung SC, et al: Adding a sclerosant to endoscopic epinephrine injection in actively bleeding ulcers: a randomized trial. Gastrointest Endosc, 39:611-5,1993 (レベル III)
25) Chung SC, et al: Epinephrine or epinephrine plus alcohol for injection of bleeding ulcers: a prospective randomized trial. Gastrointest Endosc, 43:591-5,1996 (レベル III)
26) Chung SS, et al: Randomized comparison between adrenaline injection alone and adrenaline injection plus heat probe treatment for actively bleeding ulcers. BMJ, 314:1307-11,1997 (レベル III)
27) Balanzó J, et al: Injection therapy of bleeding peptic ulcer. A prospective, randomized trial using epinephrine and thrombin. Endoscopy, 22:157-9,1990 (レベル II)
28) Park CH, et al: A prospective, randomized trial comparing mechanical methods of hemostasis plus epinephrine injection to epinephrine injection alone for bleeding peptic ulcer. Gastrointest Endosc, 60:173-9,2004 (レベル III)
29) Loizou LA, et al: Endoscopic treatment for bleeding peptic ulcers: randomised comparison of adrenaline injection and adrenaline injection + Nd: YAG laser photocoagulation. Gut, 32:1100-3,1991 (レベル III)
30) Chung IK, et al: Comparison of the hemostatic efficacy of the endoscopic hemoclip method with hypertonic saline-epinephrine injection and a combination of the two for the management of bleeding peptic ulcers. Gastrointest Endosc, 49:13-8,1999 (レベル III)
31) Cipolletta L, et al: Endoclips versus heater probe in preventing early recurrent bleeding from peptic ulcer: a prospective and randomized trial. Gastrointest Endosc, 53:147-51,2001 (レベル III)
32) Shimoda R, et al: Evaluation of endoscopic hemostasis with metallic hemoclips for bleeding gastric ulcer: comparison with endoscopic injection of absolute ethanol in a prospective. randomized study. Am J Gastroenterol, 98:2198-202,2003 (レベル II)
33) Chou YC, et al: A prospective, randomized trial of endoscopic hemoclip placement and distilled water injection for treatment of high-risk bleeding ulcers. Gastrointest Endosc, 57:324-8,2003 (レベル III)
34) Lin HJ, et al: A prospective, randomized trial of endoscopic hemoclip versus heater probe thermocoagulation for peptic ulcer bleeding. Am J Gastroenterul, 97:2250-4,2002 (レベル III)
35) Fullarton GM, et al: Controlled trial of heater probe treatment in bleeding peptic ulcers. Br J Surg, 76:541-4,1989 (レベル III)
36) Chung SC, et al: Endoscopic injection of adrenaline for actively bleeding ulcers: a randomized trial. Br Med J (Clin Res Ed), 296:1631-3,1988 (レベル III)
37) Hui WM, et al: A randomized comparative study of laser photocoagulation, heater probe, and bipolar electrocoagulation in the treatment of actively bleeding ulcers. Gastrointest Endosc, 37:299-304,1991 (レベル III)
38) Rutgeerts P, et al: Neodymium-YAG laser photocoagulation versus multipolar electrocoagulation for treatment of severely bleeding ulcer: a randomized comparison. Gastrointest Endosc, 33:199-202,1987 (レベル III)
39) Cipolletta L, et al: Prospective comparison of argon plasma coagulator and heater probe in the endoscopic treatment of major peptic ulcer bleeding. Gastrointest Endosc, 48:191-5,1998 (レベル III)
40) Koyama T, et al: Prevention of recurrent bleeding from gastric ulcer with a nonbleeding visible vessel by endoscopic injection of absolute ethanol: a prospective, controlled trial. Gastrointest Endosc, 42:128-31,1995 (レベル II)
41) Lee KJ, et al: Randomized trial of N-Butyl-2-Cyanoacrylate compared with injection of hypertonic saline-epinephrine in the endoscopic treatment of bleeding peptic ulcers. Endoscopy, 32:505-11,2000 (レベル III)
42) Sacks HS, et al: Endoscopic hemostasis. An effective therapy for bleeding peptic ulcers. JAMA, 264:494-9,1990 (レベル I)
43) Kahi CJ, et al: Endoscopic therapy versus medical therapy for bleeding peptic ulcer with adherent clot: a meta-analysis. Gastroenterology. 129:855-62,2005 (レベル I)
44) Calvet X, et al: Addition of a second endoscopic treatment following epinephrine injection improves outcome in high-risk bleeding ulcers. Gastroenterology, 126:441-50,2004 (レベル I)
45) Marmo R, et al: Outcome of endoscopic treatment for peptic ulcer bleeding: Is a second look necessary? A meta-analysis. Gastrointest Endosc, 57:62-7,2003 (レベル I)
46) Wong SK, et al: Prediction of therapeutic failure after adrenaline injection plus heater probe treatment in patients with bleeding peptic ulcer. Gut, 50:322-5,2002 (レベル III)
47) Morris DL, et al: Optimal timing of operation for bleeding peptic ulcer: prospective randomized trial. Br Med J (Clin Res Ed), 288:1277-80,1984 (レベル III)

・内科的治療
検索式で検索された文献のうち,最終的な採用文献数は計24編(英文23編,その他(フランス語)1編)となった。
1) Wong SK, Yu LM, Lau JY, et al: Prediction of therapeutic failure after adrenaline injection plus heater probe treatment in patients with bleeding peptic ulcer. Gut, 50:322-5,2002 (レベル II)
2) Collins R, Langman M: Treatment with histamine H2 antagonists in acute upper gastrointestinal hemorrhage. Implications of randomized trials. N Engl J Med, 313:660-6,1985 (レベル I)
3) Barer D, Ogilvie A, Henry D, et al: Cimetidine and tranexamic acid in the treatment of acute upper-gastrointestinal-tract bleeding. N Engl J Med, 308:1571-5,1983 (レベル II)
4) Gray BN, De Zwart J, Andrewarthur L, et al: Controlled clinical trial of ranitidine in bleeding peptic ulcer. Aust N Z J Surg, 56:723-7,1986 (レベル II)
5) Lau JY, Sung JJ, Lee KK, et al: Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. N Engl J Med, 343:310-6,2000 (レベル II)
6) Lin HJ, Lo WC, Lee FY, et al: A prospective randomized comparative trial showing that omeprazole prevents rebleeding in patients with bleeding peptic ulcer after successful endoscopic therapy. Arch Intern Med, 158:54-8,1998 (レベル II)
7) Daneshmend TK, Hawkey CJ, Langman MJ, et al: Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial. BMJ, 304:143-7,1992 (レベル II)
8) Villanueva C, Balanzó J, Torras X, et al: Omeprazole versus ranitidine as adjunct therapy to endoscopic injection in actively bleeding ulcers: a prospective and randomized study. Endoscopy, 27:308-12,1995 (レベル II)
9) Leontiadis GI, Sharma VK, Howden CW: Systematic review and meta-analysis: proton-pump inhibitor treatment for ulcer bleeding reduces transfusion requirements and hospital stay--results from the Cochrane Collaboration. Aliment Pharmacol Ther, 22:169-74,2005 (レベル I)
10) Bardou M, Toubouti Y, Benhaberou-Brun D, et al: Meta-analysis: proton-pump inhibition in high-risk patients with acute peptic ulcer bleeding. Aliment Pharmacol Ther, 21:677-86,2005 (レベル I)
11) Leontiadis GI, Sharma VK, Howden CW: Systematic review and meta-analysis of proton-pomp inhibitor therapy in peptic ulcer bleeding. BMJ, 330:568,2005 (レベル I)
12) Khuroo MS, Khuroo MS, Farahat KL, et al: Treatment with proton pump inhibitors in acute non-bariceal upper gastrointestinal bleeding: a meta-analysis. J Gastroenterol Hepatol, 20:11-25,2005 (レベル I)
13) Levine JE, Leontiadis GI, Sharma VK, et al: Meta-analysis: the efficacy of intravenous H2-receptor antagonists in bleeding peptic ulcer. Aliment Pharmacol Ther, 16:1137-42,2002 (レベル I)
14) Yang CC, Shin JS, Lin XZ, et al: The natural history (fading time) of stigmata of recent hemorrhage in peptic ulcer disease. Gastrointest Endosc, 40:562-6,1994 (レベル II)
15) Hsu PI, Lai KH, Lin XZ, et al: When to discharge patients with bleeding peptic ulcers: a prospective study of residual risk of rebleeding. Gastrointest Endosc, 44:382-7,1996 (レベル II)
16) de Lédinghen V, Beau P, Mannant PR, et al: When should patients with bleeding peptic ulcer resume oral intake? A randomized controlled study. Gastroenterol Clin Biol, 22:282-5,1998 (レベル II)
17) Riemann JF, Schilling D, Schauwecker P, et al, Cure with omeprazole plus amoxicillin versus long-term ranitidine therapy in Helicobacter pylori-associated peptic ulcer bleeding. Gastrointest Endosc, 46:299-304,1997 (レベル II)
18) Sung JJ, Leung WK, Suen R, et al: One-week antibiotics versus maintenance acid suppression therapy for Helicobacter pylori-associated peptic ulcer bleeding. Dig Dis Sci, 42:2524-8,1997 (レベル II)
19) Rokkas T, Karameris A, Mavrogeorgis A, et al: Eradication of Helicobacter pylori reduces the possibility of rebleeding in peptic ulcer disease. Gastrointest Endosc, 41:1-4,1995 (レベル II)
20) Jaspersen D, Koerner T, Schorr W, et al: Helicobacter pylori eradication reduces the rate of rebleeding in ulcer hemorrhage. Gastrointest Endosc, 41:5-7,1995 (レベル II)
21) Lai KC, Hui WM, Wong WM, et al: Treatment of Helicobacter pylori in patients with duodenal ulcer hemorrhage--a long-term randomized, controlled study. Am J Gasteoenterol, 95:2225-32,2000 (レベル II)
22) Sharma VK, Sahai AV, Corder FA, et al: Helicobacter pylori eradication is superior to ulcer healing with or without maintenance therapy to prevent further ulcer hemorrhage. Aliment Pharmacol Ther, 15:1939-47,2001 (レベル I)
23) Gisbert JP, Khorrami S, Carballo F, et al: H. pylori eradication therapy vs. antisecretory non-eradication therapy (with or without long-term maintenance antisecretory therapy) for the prevention of recurrent bleeding from peptic ulcer. Cochrane Database Syst Rev, (2):CD004062,2004 (レベル I)
24) Rørbaek-Madsen M, Fischer L, Thomsen H, et al: Late outcome of bleeding gastric ulcer. Five to eight years' follow-up. Scand J Gastroenterol, 29:983-7,1994 (レベル IV)

3.内視鏡的粘膜切除術後の潰瘍
内視鏡的粘膜切除術後の潰瘍の検索式で検索された総文献数は126編でランダム化比較試験(RCT)は4編認められ,臨床的検討が行われていたRCTの2編を採択した。
1) Yamaguchi Y, et al: A prospective randomized trial of either famotidine or omeprazole for the prevention of bleeding after endoscopic mucosal resection and the healing of endoscopic mucosal resection-induced ulceration. Aliment Pharmacol Ther, 21:111-5,2005 (レベル II)
2) Lee SY, et al: Healing rate of EMR-induced ulcer in relation to the duration of treatment with omeprazole. Gastrointest Endosc, 60:213-7,2004 (レベル II)

4.H. pylori 除菌治療
・初期治療

検索式で検索された総文献数から,研究班により選択された論文は計261編(今回14編追加)であった。最終的な採用文献数は18編であった。除外された理由は,対象疾患が明確でない,内容が今回の目的と異なる等である。
1) Sung JJ, Chung SC, Ling TK, Yung MY, Leung VK, Ng EK, Li MK, Cheng AF, Li AK: Antibacterial treatment of gastric ulcers associated with Helicobacter pylori. N Engl J Med, 332(3):139-42,1995 (レベル II)
2) Bayerdörffer E, Miehlke S, Lehn N, Mannes GA, Höchter W, Weingart J, Klann H, Sommer A, Heldwein W, Hatz R, Simon T, Bolle KH, Bästlein E, Meining A, Ruckdeschel G, Stolte M: Cure of gastric ulcer disease after cure of Helicobacter pylori infection--German Gastric Ulcer Study. Eur J Gastroenterol Hepatol, 8(4):343-9,1996 (レベル II)
3) Tatsuta M, Ishikawa H, Iishi H, Okuda S, Yokota Y: Reduction of gastric ulcer recurrence after suppression of Helicobacter pylori by cefixime. Gut, 31(9):973-6,1990 (レベル II)
4) Furuta T, Futami H, Arai H, Hanai H, Kaneko E: Effects of lansoprazole with or without amoxicillin on ulcer healing: relation to eradication of Helicobacter pylori. J Clin Gastroenterol, 20 Suppl 2:S107-11,1995 (レベル II)
5) Fukuda Y, Yamamoto I, Okui M, Tonokatsu Y, Shimoyama T: Combination therapies with a proton pump inhibitor for Helicobacter pylori-infected gastric ulcer patients. J Clin Gastroenterol, 20 Suppl 2:S132-5,1995 (レベル III)
6) Kohli Y, Kato T, Azuma T, Ito S, Hirai M: Lansoprazole treatment of Helicobacter pylori-positive peptic ulcers. J Clin Gastroenterol, 20 Suppl 1:S48-51,1995 (レベル III)
7) Kato M, Asaka M, Kudo M, Sukegawa M, Katagiri M, Koshiyama T, Kagaya H, Nishikawa K, HokariK, Takeda H, Sugiyama T: Effects of lansoprazole plus amoxycillin on the cure of Helicobacter pylori infection in Japanese peptic ulcer patients. Aliment Pharmacol Ther, 10(5):821-7,1996 (レベル II)
8) Lazzaroni M, Perego M, Bargiggia S, Maconi G, Fiocca R, Solcia E, Franceschi M, Cesana B, Bianchi Porro G: Helicobacter pylori eradication in the healing and recurrence of benign gastric ulcer: a two-year, double-blind, placebo controlled study. Ital J Gastroenterol Hepatol, 29(3):220-7,1997 (レベル II)
9) Axon AT, O'Moráin CA, Bardhan KD, Crowe JP, Beattie AD, Thompson RP, Smith PM, Hollanders FD, Baron JH, Lynch DA, Dixon MF, Tompkins DS, Birrell H, Gillon KR: Randomised double blind controlled study of recurrence of gastric ulcer after treatment for eradication of Helicobacter pylori infection. BMJ, 314(7080):565-68,1997 (レベル II)
10) Meining A, Höchter W, Weingart J, Sommer A, Klann H, Simon T, Huber F, Bolle KH, Hatz R, Fischer G, Lehn N, Stolte M, Bayerdörffer E: Double-blind trial of omeprazole and amoxicillin in the cure of Helicobacter pylori infection in gastric ulcer patients. The Ulcer Study Group, Germany. Scand J Gastroenterol, 33(1):49-54,1998 (レベル II)
11) Malfertheiner P, Bayerdörffer E, Diete U, Gil J, Lind T, Misiuna P, O'Morain C, Sipponen P, Spiller RC, Stasiewicz J, Treichel H, Ujszászy L, Unge P, Zanten SJ, Zeijlon L: The GU-MACH study: the effect of 1-week omeprazole triple therapy on Helicobacter pylori infection in patients with gastric ulcer.Aliment Pharmacol Ther, 13(6):703-12,1999 (レベル II)
12) Asaka M, Sugiyama T, Kato M, Satoh K, Kuwayama H, Fukuda Y, Fujioka T, Takemoto T, Kimura K,Shimoyama T, Shimizu K, Kobayashi S: A multicenter, double-blind study on triple therapy with lansoprazole, amoxicillin and clarithromycin for eradication of Helicobacter pylori in Japanese peptic ulcer patients. Helicobacter, 6:254-61,2001 (レベル II)
13) Befrits R, Sjöstedt S, Tour R, Leijonmarck CE, Hedenborg L, Backman M; Stockholm United Study Group for Helicobacter Pylori: Long-term effects of eradication of Helicobacter pylori on relapse and histology in gastric ulcer patients: a two-year follow-up study. Scand J Gastroenterol, 39(11):1066-72,2004 (レベル II)
14) Malfertheiner P, Kirchner T, Kist M, Leodolter A, Peitz U, Strobel S, Bohuschke M, Gatz G; BYK Advanced Gastric Ulcer Study Group: Helicobacter pylori eradication and gastric ulcer healing-comparison of three pantoprazole-based triple therapies. Aliment Pharmacol Ther, 17(9):1125-35,2003 (レベル II)
15) Higuchi K, Fujiwara Y, Tominaga K, Watanabe T, Shiba M, Nakamura S, Oshitani N, Matsumoto T, Arakawa T: Is eradication sufficient to heal gastric ulcers in patients infected with Helicobacter pylori? A randomized, controlled, prospective study. Aliment Pharmacol Ther, 17(1):111-7,2003 (レベル II)
16) Ford AC, Delaney BC, Forman D, Moayyedi P: Eradication therapy in Helicobacter pylori positive peptic ulcer disease: systematic review and economic analysis. Am J Gastroenterol, 99(9):1833-55,2004 (レベル I)
17) Ford A, Delaney B, Forman D, Moayyedi P: Eradication therapy for peptic ulcer disease in Helicobacter pylori positive patients. Cochrane Database Syst Rev, (4):CD003840,2004 (レベル I)
18) Treiber G, Lambert JR: The impact of Helicobacter pylori eradication on peptic ulcer healing. Am J Gastroenterol, 93:1080-4,1998 (レベル I)

・レジメン
検索式で検索された総文献数は計1,621編(うち英文1,068編,和文553編)で,研究班により選択された文献数は計476編(うち英文397編,和文79編)であった。最終的な採用文献数は計26編(英文26編,和文0編)となった。
1) Meining A, et al: Double-blind trial of omeprazole and amoxicillin in the cure of Helicobacter pylori infection in gastric ulcer patients. The Ulcer Study Group, Germany. Scand J Gastroenterol, 33:49-54,1998 (レベル II)
2) Lazzaroni M, et al: Helicobacter pylori eradication in the healing and recurrence of benign gastric ulcer: a two-year, double-blind, placebo controlled study. Ital J Gastroenterol Hepatol, 29:220-7,1997 (レベル II)
3) Axon AT, et al: Randomized double blind controlled study of recurrence of gastric ulcer after treatment for eradication of Helicobacter pylori infection. BMJ, 314:565-8,1997 (レベル II)
4) Kato M, et al: Effects of lansoprazole plus amoxycillin on the cure of Helicobacter pylori infection in Japanese peptic ulcer patients. Aliment Pharmacol Ther, 10:821-7,1996 (レベル II)
5) Katoh M, et al: Clinical efficacy of lansoprazole in eradication of Helicobacter pylori. J Clin Gastroenterol, 20 Suppl 2:S112-4,1995 (レベル II)
6) Carvalho AF, et al: Addition of bismuth subnitrate to omeprazole plus amoxycillin improves eradication of Helicobacter pylori. Aliment Pharmacol Ther, 12:557-61,1998 (レベル II)
7) Habu Y, et al: Triple therapy with omeprazole, amoxicillin and clarithromycin is effective against Helicobacter pylori infection in gastric ulcer patients as well as in duodenal ulcer patients. Results of a randomized controlled trial in Japan. Digestion, 59:321-5,1998 (レベル II)
8) Koizumi W, et al: A prospective randomized study of amoxycillin and opmeprazole with and without metronidazole in the eradication treatment of Helicobacter pylori. J Gastroenterol Hepatol, 13:301-4,1998 (レベル II)
9) Chu KM, et al: A prospective randomized trial comparing the use of omeprazole-based dual and triple therapy for eradication of Helicobacter pylori. Am J Gastroenterol, 93:1436-42,1998 (レベル II)
10) Gschwantler M, et al: Famotidine versus omeprazole in combination with clarithromycin and metronidazole for eradication of Helicobacter pylori--a randomized, controlled trial. Aliment Pharmacol Ther, 13:1063-9,1999 (レベル II)
11) Malfertheiner P, et al: The GU-MACH study: the effect of 1-week omeprazole triple therapy on Helicobacter pylori infection in patients with gastric ulcer. Aliment Pharmacol Ther, 13:703-12,1999 (レベル II)
12) Lerang F, et al: Highly effective twice-daily triple therapies for Helicobacter pylori infection and peptic ulcer disease: does in vitro metronidazole resistance have any clinical relevance? Am J Gastroenterol, 92:248-53,1997 (レベル II)
13) Gisbert JP, et al: Meta-analysis: proton pump inhibitors vs. H2-receptor antagonists--their efficacy with antibiotics in Helicobacter pylori eradication. Aliment Pharmacol Ther, 18:757-66,2003 (レベル I)
14) Cammarota G, et al: Three-day antibiotic therapy with azithromycin and tinidazole plus lansoprazole or pantoprazole to cure Helicobacter pylori infection: a pilot study. Eur J Gastroenterol Hepatol, 11:247-50,1999 (レベル II)
15) Spinzi GC, et al: Comparison of omeprazole and lansoprazole in short-term triple therapy for Helicobacter pylori infection. Aliment Pharmacol Ther, 12:433-8,1998 (レベル II)
16) Gisbert JP, et al: Systematic review: Rabeprazole-based therapies in Helicobacter pylori eradication. Aliment Pharmacol Ther, 17:751-64,2003 (レベル I)
17) Asaka M, et al: A multicenter, double-blind study on triple therapy with lansoprazole, amoxicillin and clarithromycin for eradication of Helicobacter pylori in Japanese peptic ulcer patients. Helicobacter, 6:254-61,2001 (レベル II)
18) Higuchi K, Maezawa T, Nakagawa K et al: Efficacy and safety of Helicobacter pylori eradication therapy with omeprazole, amoxicillin and high- and low-dose clarithromycin in Japanese patients: a randomised, double-blind, multicentre study. Clin Drug Investig, 26:403-14,2006 (レベル II)
19) Kuwayama H, Asaka M, Sugiyama T, et al: Rabeprazole-based eradication therapy for Helicobacter pylori: a large-scale study in Japan. Aliment Pharmacol Ther, 25:1105-13,2007 (レベル II)
20) Inaba T, Mizuno M, Kawai K et al: Randomized open trial for comparison of proton pump inhibitors in triple therapy for Helicobacter pylori infection in relation to CYP2C19 genotype. J Gastroenterol Hepatol, 17:748-53,2002 (レベル II)
21) Hurenkamp GJ, et al: Equally high efficacy of 4, 7 and 10-day triple therapies to eradicate Helicobacter pylori infection in patients with ulcer disease. Aliment Pharmacol Ther, 14:1065-70,2000 (レベル II)
22) Kung NN, et al: Anti-Helicobacter pylori treatment in bleeding ulcers: randomized controlled trial comparing 2-day versus 7-day bismuth quadruple therapy. Am J Gastroenterol, 92:438-41,1977 (レベル II)
23) Labenz J, et al: Medium- or high-dose omeprazole plus amoxycillin eradicates Helicobacter pylori in gastric ulcer disease. Am J Gastroenterol, 89:726-30,1994 (レベル II)
24) Hokari K, et al: Efficacy of triple therapy with rabeprazole for Helicobacter pylori infection and CYP2C19 genetic polymorphism. Aliment Pharmacol Ther, 15:1479-84,2001 (レベル II)
25) Annibale B, et al: Does pretreatment with omeprazole decrease the chance of eradication of Helicobacter pylori in peptic ulcer patients? Am J Gastroenterol, 92:790-4,1997 (レベル II)
26) Moreno JA, et al: Significant increase in eradication rates of Helicobacter pylori infection with two consecutive dual therapies (omeprazole and amoxycillin or omeprazole and clarithromycin). A randomized study in 450 Spanish patients. J Gastroenterol, 31 Suppl 9:48-52,1996 (レベル II)

・二次除菌
PubMedで280件,医中誌で21件が検索され,英文の16件を採用した。
1) Hojo M, Miwa H, Nagahara A, Sato N: Pooled analysis on the efficacy of the second-line treatment regimens for Helicobacter pylori infection. Scand J Gastroenterol, 36:690-700,2001 (レベル I)
2) Köksal AS, Parlak E, Filik L, Yolcu OF, Odemiş B, Ulker A, Saşmaz N, Ozden A, Sahin B: Ranitidine bismuth citrate-based triple therapies as a second-line therapy for Helicobacter pylori in Turkish patients. J Gastroenterol Hepatol, 20:637-42,2005 (レベル II)
3) Perri F, Festa V, Merla A, Barberani F, Pilotto A, Andriulli A: Randomized study of different 'second-line' therapies for Helicobacter pylori infection after failure of the standard 'Maastricht triple therapy'. Aliment Pharmacol Ther, 18:815-20,2003 (レベル II)
4) Gisbert JP, Gisbert JL, Marcos S, Grávalos RG, Carpio D, Pajares JM: Seven-day 'rescue' therapy after Helicobacter pylori treatment failure: omeprazole, bismuth, tetracycline and metronidazole vs. ranitidine bismuth citrate, tetracycline and metronidazole. Aliment Pharmacol Ther, 13:1311-6,1999 (レベル II)
5) Miwa H, Nagahara A, Kurosawa A, Ohkusa T, Ohkura R, Hojo M, Enomoto N, Sato N: Is antimicrobial susceptibility testing necessary before second-line treatment for Helicobacter pylori infection? Aliment Pharmacol Ther, 17:1545-51,2003 (レベル II)
6) Lamouliatte H, Mégraud F, Delchier JC, Bretagne JF, Courillon-Mallet A, De Korwin JD, Fauchère JL, Labigne A, Fléjou JF, Barthelemy P: Second-line treatment for failure to eradicate Helicobacter pylori: a randomized trial comparing four treatment strategies. Aliment Pharmacol Ther, 18:791-7,2003 (レベル II)
7) Nista EC, Candelli M, Cremonini F, Cazzato IA, Di Caro S, Gabrielli M, Santarelli L, Zocco MA, Ojetti V, Carloni E, Cammarota G, Gasbarrini G, Gasbarrini A: Levofloxacin-based triple therapy vs. quadruple therapy in second-line Helicobacter pylori treatment: a randomized trial. Aliment Pharmacol Ther, 18:627-33,2003 (レベル II)
8) Bilardi C, Dulbecco P, Zentilin P, Reglioni S, Iiritano E, Parodi A, Accornero L, Savarino E, Mansi C, Mamone M, Vigneri S, Savarino V: A 10-day levofloxacin-based therapy in patients with resistant Helicobacter pylori infection: a controlled trial. Clin Gastroenterol Hepatol, 2:997-1002,2004 (レベル II)
9) Perri F, Festa V, Clemente R, Villani MR, Quitadamo M, Caruso N, Bergoli ML, Andriulli A: Randomized study of two "rescue" therapies for Helicobacter pylori-infected patients after failure of standard triple therapies. Am J Gastroenterol, 96:58-62,2001 (レベル II)
10) Isakov V, Domareva I, Koudryavtseva L, Maev I, Ganskaya Z: Furazolidone-based triple 'rescue therapy' vs. quadruple 'rescue therapy' for the eradication of Helicobacter pylori resistant to metronidazole. Aliment Pharmacol Ther, 16:1277-82,2002 (レベル II)
11) Chi CH, Lin CY, Sheu BS, Yang HB, Huang AH, Wu JJ: Quadruple therapy containing amoxicillin and tetracycline is an effective regimen to rescue failed triple therapy by overcoming the antimicrobial resistance of Helicobacter pylori. Aliment Pharmacol Ther, 18:347-53,2003 (レベル II)
12) Georgopoulos SD, Ladas SD, Karatapanis S, Triantafyllou K, Spiliadi C, Mentis A, Artikis V, Raptis SA: Effectiveness of two quadruple, tetracycline- or clarithromycin-containing, second-line, Helicobacter pylori eradication therapies. Aliment Pharmacol Ther, 16:569-75,2002 (レベル II)
13) Michopoulos S, Tsibouris P, Bouzakis H, Balta A, Vougadiotis J, Broutet N, Kralios N: Randomized study comparing omeprazole with ranitidine as anti-secretory agents combined in quadruple second-line Helicobacter pylori eradication regimens. Aliment Pharmacol Ther, 14:737-44,2000 (レベル II)
14) Tursi A, Brandimarte G, Giorgetti GM, Modeo ME: Effect of Lactobacillus casei supplementation on the effectiveness and tolerability of a new second-line 10-day quadruple therapy after failure of a first attempt to cure Helicobacter pylori infection. Med Sci Monit, 10:CR662-6,2004 (レベル II)
15) Nijevitch AA, Shcherbakov PL, Sataev VU, Khasanov RSh, Al Khashash R, Tuygunov MM: Helicobacter pylori eradication in childhood after failure of initial treatment: advantage of quadruple therapy with nifuratel to furazolidone. Aliment Pharmacol Ther, 22:881-7,2005 (レベル II)
16) Miehlke S, Kirsch C, Schneider-Brachert W, Haferland C, Neumeyer M, Bästlein E, Papke J, Jacobs E, Vieth M, Stolte M, Lehn N, Bayerdörffer E: A prospective, randomized study of quadruple therapy and high-dose dual therapy for treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin. Helicobacter, 8:310-9,2003 (レベル II)

・再発防止,除菌治療と逆流性食道炎,胃食道逆流症(GERD)
再発防止効果:検索式で検索された総文献数は計395編(うち英文304編,和文91編)で,研究班により選択された文献数は計31編(うち英文26編,和文5編)であった。最終的な採用文献数は計13編(うち英文13編,和文0編)であった。
除菌治療と逆流性食道炎:検索式で検索された総文献数は198編(うち英文172編,和文26編)で,研究班により選択された文献数は計33編(うち英文30編,和文3編)であった。最終的な採用文献数は計28編(英文28編,わが国から報告された英文論文4編)となった。
1) NIH Consensus Conference. Helicobacter pylori in peptic ulcer disease. NIH Consensus Development Panel on Helicobacter pylori in Peptic Ulcer Disease. JAMA, 272:65-9,1994 (レベル I)
2) Bayerdörffer E, Miehlke S, Lehn N, Mannes GA, Höchter W, Weingart J, Klann H, Sommer A, Heldwein W, Hatz R, Simon T, Bolle KH, Bästlein E, Meining A, Ruckdeschel G, Stolte M: Cure of gastric ulcer disease after cure of Helicobacter pylori infection--German Gastric Ulcer Study. Eur J Gastroenterol Hepatol, 8(4):343-9,1996 (レベル II)
3) Fukuda Y, Yamamoto I, Okui M, Tonokatsu Y, Shimoyama T: Combination therapies with a proton pump inhibitor for Helicobacter pylori-infected gastric ulcer patients. J Clin Gastroenterol, 20 Suppl 2:S132-5,1995 (レベル III)
4) Lazzaroni M, Perego M, Bargiggia S, Maconi G, Fiocca R, Solcia E, Franceschi M, Cesana B, Bianchi Porro G: Helicobacter pylori eradication in the healing and recurrence of benign gastric ulcer: a two-year, double-blind, placebo controlled study. Ital J Gastroenterol Hepatol, 29(3):220-7,1997 (レベル II)
5) Axon AT, O'Moráin CA, Bardhan KD, Crowe JP, Beattie AD, Thompson RP, Smith PM, Hollanders FD, Baron JH, Lynch DA, Dixon MF, Tompkins DS, Birrell H, Gillon KR: Randomised double blind controlled study of recurrence of gastric ulcer after treatment for eradication of Helicobacter pylori infection. BMJ, 314(7080):565-8,1997 (レベル II)
6) Malfertheiner P, Bayerdörffer E, Diete U, Gil J, Lind T, Misiuna P, O'Morain C, Sipponen P, Spiller RC, Stasiewicz J, Treichel H, Ujszászy L, Unge P, Zanten SJ, Zeijlon L: The GU-MACH study: the effect of 1-week omeprazole triple therapy on Helicobacter pylori infection in patients with gastric ulcer. Aliment Pharmacol Ther, 13(6):703-12,1999 (レベル II)
7) Seppälä K, Pikkarainen P, Sipponen P, Kivilaakso E, Gormsen MH: Cure of peptic gastric ulcer associated with eradication of Helicobacter pylori. Finnish Gastric Ulcer Study Group. Gut, 36(6):834-7,1995 (レベル II)
8) Graham DY, Lew GM, Klein PD, Evans DG, Evans DJ Jr, Saeed ZA, Malaty HM: Effect of treatment of Helicobacter pylori infection on the long-term recurrence of gastric or duodenal ulcer. A randomized, controlled study. Ann Intern Med, 116(9):705-8,1992 (レベル II)
9) Kim N, Oh JH, Lee CG, Lim C, Won KH, Choi WR, Lee SH, Lim SH, Lee KH: Effect of eradication of Helicobacter pylori on the benign gastric ulcer recurrence --a 24 month follow-up study. Korean JIntern Med, 14(2):9-14,1999 (レベル II)
10) Van der Hulst RW, Rauws EA, Köycü B, Keller JJ, Bruno MJ, Tijssen JG, Tytgat GN: Prevention of ulcer recurrence after eradication of Helicobacter pylori: a prospective long-term follow-up study. Gastroenterology, 113(4):1082-6,1997 (レベル III)
11) Ford AC, Delaney BC, Forman D, Moayyedi P: Eradication therapy in Helicobacter pylori positive peptic ulcer disease: systematic review and economic analysis. Am J Gastroenterol, 99(9):1833-55,2004 (レベル I)
12) Asaka M, Kato M, Sugiyama T, et al: Follow-up survey of a large-scale Multicenter, double -blind study of triple therapy with lansoprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in Japanese peptic ulcer patients. J Gastroenterol, 38(4):339-47,2003 (レベル II)
13) Miwa H, Sakaki N, Sugano K, Sekine H, Higuchi K, Uemura N, Kato M, Murakami K, Kato C, Shiotani A, Ohkusa T, Takagi A, Aoyama N, Haruma K, Okazaki K, Kusugami K, Suzuki M, Joh T, Azuma T, Yanaka A, Suzuki H, Hashimoto H, Kawai T, Sugiyama T: Recurrent peptic ulcers in patients following successful Helicobacter pylori eradication: a multicenter study of 4940 patients. Helicobacter, 9(1):9-16,2004 (レベル III)
14) Labenz J, Blum AL, Bayerdörffer E, Meining A, Stolte M, Börsch G: Curing Helicobacter pylori infection in patients with duodenal ulcer may provoke reflux esophagitis. Gastroenterology, 112(5):1442-7,1997 (レベル IV)
15) Hamada H, Haruma K, Mihara M, Kamada T, Yoshihara M, Sumii K, Kajiyama G, Kawanishi M: High incidence of reflux oesophagitis after eradication therapy for Helicobacter pylori; impacts of hiatal hernia and corpus gastritis. Aliment Pharmacol Ther, 14(6):729-35,2000 (レベル IV)
16) Fallone CA, Barkun AN, Friedman G, Mayrand S, Loo V, Beech R, Best L, Joseph L: Is Helicobacter pylori eradication associated with gastroesophageal reflux disease? Am J Gastroenterol, 95(4):914-20,2000 (レベル IV)
17) Moayyedi P, Bardhan C, Young L, Dixon MF, Brown L, Axon AT: Helicobacter pylori eradication does not exacerbate reflux symptoms in gastroesophageal reflux disease. Gastroenterology, 121(5):1120-6,2001 (レベル II)
18) Schwizer W, Thumshirn M, Dent J, Guldenschuh I, Menne D, Cathomas G, Fried M: Helicobacter pylori and symptomatic relapse of gastro-oesophageal reflux disease; a randomised controlled trial. Lancet, 357(9270):1738-42,2001 (レベル II)
19) Ott EA, Mazzoleni LE, Edelweiss MI, Sander GB, Wortmann AC, Theil AL, Somm G, Cartell A, Rivero LF, Uchôa DM, Francesconi CF, Prolla JC: Helicobacter pylori eradication does not cause reflux oesophagitis in functional dyspeptic patients: a randomized, investigator-blinded, placebo-controlled trial. Aliment Pharmacol Ther, 21:1231-9,2005 (レベル II)
20) Levine A, Milo T, Broide E, Wine E, Dalal I, Boaz M, Avni Y, Shirin H: Influence of Helicobacter pylori eradication on gastroesophageal reflux symptoms and epigastric pain in children and adolescents. Pediatrics, 113:54-8,2004 (レベル IVa)
21) Kuipers EJ, Nelis GF, Klinkenberg-Knol EC, Snel P, Goldfain D, Kolkman JJ, Festen HP, Dent J, Zeitoun P, Havu N, Lamm M, Walan A: Cure of Helicobacter pylori infection in patients with reflux oesophagitis treated with long term omeprazole reverses gastritis without exacerbation of reflux disease: results of a randomised controlled trial. Gut, 53:12-20,2004 (レベル II)
22) Vaira D, Vakil N, Rugge M, Gatta L, Ricci C, Menegatti M, Leandro G, Holton J, Russo VM, Miglioli M: Effect of Helicobacter pylori eradication on development of dyspeptic and reflux disease in healthy asymptomatic subjects. Gut, 52:1543-7,2003 (レベル IVb)
23) Mantzaris GJ, Petraki K, Archavlis E, Amberiadis P, Christoforidis P, Kourtessas D, Chiotakakou E, Triantafyllou G: Omeprazole triple therapy versus omeprazole quadruple therapy for healing duodenal ulcer and eradication of Helicobacter pylori infection: a 24-month follow-up study. Eur J Gastroenterol Hepatol, 14:1237-43,2002 (レベル II)
24) Vakil N, Hahn B, McSorley D: Recurrent symptoms and gastro-oesophageal reflux disease in patients with duodenal ulcer treated for Helicobacter pylori infection. Aliment Pharmacol Ther, 14(1):45-51,2000 (レベル II)
25) McColl KE, Dickson A, El-Nujumi A, El-Omar E, Kelman A: Symptomatic benefit 1-3 years after H. pylori eradication in ulcer patients: impact of gastroesophageal reflux disease. Am J Gastroenterol, 95(1):101-5,2000 (レベル II)
26) Tefera S, Hatlebakk JG, Berstad A: The effect of Helicobacter pylori eradication on gastro-oesophageal reflux. Aliment Pharmacol Ther, 13(7):915-20,1999 (レベル IV)
27) Ishiki K, Mizuno M, Take S, Nagahara Y, Yoshida T, Yamamoto K, Okada H, Yokota K, Oguma K, Shiratori Y: Helicobacter pylori eradication improves pre-existing reflux esophagitis in patients with duodenal ulcer disease. Clin Gastroenterol Hepatol, 2:474-9,2004 (レベル IVa)
28) Kupcinskas L, Jonaitis L, Kiudelis G: A 1 year follow-up study of the consequences of Helicobacter pylori eradication in duodenal ulcer patients: unchanged frequency of erosive oesophagitis and decreased prevalence of non-erosive gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol, 16:369-74,2004 (レベル IVa)
29) Sasaki A, Haruma K, Manabe N, Tanaka S, Yoshihara M, Chayama K: Long-term observation of reflux oesophagitis developing after Helicobacter pylori eradication therapy. Aliment Pharmacol Ther, 17:1529-34,2003 (レベル IVa)
30) Malfertheiner P, Dent J, Zeijlon L, Sipponen P, Veldhuyzen Van Zanten SJ, Burman CF, Lind T, Wrangstadh M, BayerdOrffer E, Lonovics J: Impact of Helicobacter pylori eradication on heartburn in patients with gastric or duodenal ulcer disease -- results from a randomized trial programme. Aliment Pharmacol Ther, 16:1431-42,2002 (レベル II)
31) Fukuchi T, Ashida K, Yamashita H, Kiyota N, Tsukamoto R, Takahashi H, Ito D, Nagamatsu R: Influence of cure of Helicobacter pylori infection on gastric acidity and gastroesophageal reflux: study by 24-h pH monitoring in patients with gastric or duodenal ulcer. J Gastroenterol, 40:350-60,2005 (レベル IVa)

5.非除菌治療
検索式で検索された総文献数は計2,558編(うち英文1,810編,和文748編)で,研究班により選択された文献数は計366編(うち英文295編,和文71編)であった。最終的な採用文献数は計96編(英文66編,和文30編)となった。
1) Avner DL, Movva R, Nelson KJ, McFarland M, Berry W, Erfling W: Comparison of once daily doses of lansoprazole (15, 30, and 60 mg) and placebo in patients with gastric ulcer. Am J Gastroenterol, 90:1289-94,1995 (レベル II)
2) Valenzuela JE, Kogut DG, McCullough AJ, et al: Comparison of once-daily doses of omeprazole (40 and 20 mg) and placebo in the treatment of benign gastric ulcer: a multicenter, randomized, double-blind study. Am J Gastroenterol, 91:2516-22,1996 (レベル II)
3) Cloud ML, Enas N, Humphries TJ, Bassion S: Rabeprazole in treatment of acid peptic diseases: results of three placebo-controlled dose-response clinical trials in duodenal ulcer, gastric ulcer, and gastroesophageal reflux disease (GERD). The Rabeprazole Study Group. Dig Dis Sci, 43:993-1000,1998 (レベル II)
4) Dekkers CP, Beker JA, Thjodleifsson B, Gabryelewicz A, Bell NE, Humphries TJ: Comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of active gastric ulcer-a European multicentrestudy. The European Rabeprazole Study Group. Aliment Pharmacol Ther, 12:789-95,1998 (レベル II)
5) Choi KW, Sun HS, Yoon CM, et al: A double-blind, randomized, parallel group study of omeprazole and ranitidine in Korean patients with gastric ulcer. J Gastroenterol Hepatol, 9:118-23,1994 (レベル II)
6) E3810研究会:胃潰瘍に対するE3810の臨床的有用性の検討多施設二重盲検によるFamotidineとの比較.臨床評価,21:337-59,1993 (レベル II)
7) 竹本忠良,並木正義,後藤由夫:胃潰瘍に対するLansoprazole(AG-1749)の臨床的有用性の検討 多施設二重盲検法によるFamotidineとの比較.臨床成人病,21:327-45,1991 (レベル II)
8) Omeprazole 20 mg uid and ranitidine 150 mg bid in the treatment of benign gastric ulcer. Italian Cooperative Group on Omeprazole. Hepatogastroenterology, 38:400-3,1991 (レベル II)
9) Walan A, Bader JP, Classen M, et al: Effect of omeprazole and ranitidine on ulcer healing and relapse rates in patients with benign gastric ulcer. N Engl J Med, 320:69-75,1989 (レベル II)
10) Omeprazole研究会:Omeprazole(OPZ)の胃潰瘍に対する臨床的有用性の検討 多施設二重盲検法によるFamotidine(FAM)との比較.薬理と治療,16:543-61,1988 (レベル II)
11) 西元寺克禮,横田欽一,呉禎吉,紺野潤,望月福治,三田地泰司,他:胃潰瘍に対するパリエット錠10mgの臨床評価.薬理と治療,30:675-93,2002 (レベル II)
12) 福地創太郎,常岡健二,平塚秀雄,他:シメチジンとオメプラゾールの高位胃潰瘍に対する治療効果の検討.新薬と臨床,47:1544-54,1998 (レベル III)
13) Michel P, Lemaire M, Colin R, et al: Short report: treatment of gastric ulcer with lansoprazole or ranitidine: a multicentre clinical trial. Aliment Pharmacol Ther, 8:119-22,1994 [Erratum in: Aliment Pharmacol Ther 1994 Jun;8(3):357] (レベル II)
14) Bardhan KD, Ahlberg J, Hislop WS, et al: Rapid healing of gastric ulcers with lansoprazole. AlimentPharmacol Ther, 8:215-20,1994 (レベル II)
15) Double blind comparative study of omeprazole and ranitidine in patients with duodenal or gastric ulcer: a multicentre trial. Cooperative study group. Gut, 31:653-6,1990 (レベル II)
16) Classen M, Dammann HG, Domschke W, et al: Omeprazole heals duodenal, but not gastric ulcers more rapidly than ranitidine. Results of two German multicentre trials. Hepatogastroenterology, 32:243-5,1985 (レベル II)
17) Salas M, Ward A, Caro J: Are proton pump inhibitors the first choice for acute treatment of gastric ulcers? A meta analysis of randomized clinical trials. BMC Gastroenterol, 2:17,2002 (レベル I)
18) Tunis SR, Sheinhait IA, Schmid CH, Bishop DA, Ross SD: Lansoprazole compared with histamine2-receptor antagonists in healing gastric ulcers: a meta-analysis. Clin Ther, 19:743-57,1997 (レベル I)
19) Di Mario F, Battaglia G, Leandro G, Grasso G, Vianello F, Vigneri S: Short-term treatment of gastric ulcer: A meta-analytical evaluation of blind trials. Dig Dis Sci, 41:1108-31,1996 (レベル I)
20) Eriksson S, Långström G, Rikner L, Carlsson R, Naesdal J: Omeprazole and H2-receptor antagonists in the acute treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis: a meta-analysis. Eur J Gastroenterol Hepatol, 7:467-75,1995 (レベル I)
21) Lauritsen K: Omeprazole in the treatment of prepyloric ulcer: review of the results of the Danish Omeprazole Study Group. Scand J Gastroenterol Suppl, 166:54-7;discussion 74-5,1989 (レベル II)
22) Omeprazole and cimetidine in the treatment of ulcers of the body of the stomach: a double blind comparative trial. Danish Omeprazole Study Group. BMJ, 298:645-7,1989 (レベル II)
23) Bate CM, Wilkinson SP, Bradby GV, et al: Randomised, double blind comparison of omeprazole and cimetidine in the treatment of symptomatic gastric ulcer. Gut, 30:1323-8,1989 (レベル II)
24) Lauritsen K, Rune SJ, Wulff HR, et al: Effect of omeprazole and cimetidine on prepyloric gastric ulcer: double blind comparative trial. Gut, 29:249-53,1988 (レベル II)
25) Isenberg JI, Peterson WL, Elashoff JD, et al: Healing of benign gastric ulcer with low-dose antacid or cimetidine. A double-blind, randomized, placebo-controlled trial. N Engl J Med, 308:1319-24,1983 (レベル II)
26) Leroux P, Farley A, Archambault A, et al: Effect of ranitidine on healing of peptic ulcer: a 2-month study. Am J Gastroenterol, 78:227-30,1983 (レベル II)
27) Schulz TB, Berstad A, Rydning A, Frislid K. Treatment of gastric ulcer with ranitidine. Scand J Gastroenterol, 19:119-21,1984 (レベル II)
28) Graham DY, Akdamar K, Dyck WP, et al: Healing of benign gastric ulcer: comparison of cimetidine and placebo in the United States. Ann Intern Med, 102:573-6,1985 (レベル II)
29) Cloud ML, Enas N, Offen WW. Nizatidine versus placebo in active benign gastric ulcer disease: an eight-week, multicenter, randomized, double-blind comparison. The Nizatidine Benign Gastric Ulcer Disease Study Group. Clin Pharmacol Ther, 52:307-13,1992 (レベル II)
30) Barbara L, Corinaldesi R, Dobrilla G, et al: Ranitidine vs cimetidine: short-term treatment of gastric ulcer. Hepatogastroenterology, 30:151-3,1983 (レベル II)
31) 三好秋馬,谷内昭,佐藤勝巳,他:胃潰瘍を対象としたFamotidineの臨床評価 二重盲検法によるcimetidineとの比較.内科宝函,31:109-27,1984 (レベル II)
32) 三好秋馬,谷内昭,吉田豊:TZU-0460の胃潰瘍に対する有用性の検討 cimetidineを対照薬とした多施設二重盲検試験.診療と新薬,22:2897-918,1985 (レベル II)
33) Naccaratto R, Cremer M, Dammann HG, et al: Nizatidine versus ranitidine in gastric ulcer disease. A European multicentre trial. Scand J Gastroenterol Suppl, 136:71-8,1987 (レベル II)
34) Inoue M: Clinical studies on the use of roxatidine acetate for the treatment of peptic ulcer in Japan. Drugs, 35 Suppl 3:114-9,1988 (レベル II)
35) Judmaier G: A comparison of roxatidine acetate and ranitidine in gastric ulcer healing. Drugs, 35 Suppl 3:120-6,1988 (レベル II)
36) 三好秋馬,松尾裕,岩崎有良:胃潰瘍に対するZL-101(Nizatidine)の臨床的有用性の検討 シメチジンを対照薬とした多施設二重盲検試験.薬理と治療,17:369-92,1989 (レベル II)
37) 松尾裕,三好秋馬,三輪剛,他:胃潰瘍に対するFRG-8813(Lafutidine)の臨床的有用性の検討 ファモチジンを対照薬とした多施設二重盲検比較試験.臨床医薬,14:2085-102,1998 (レベル II)
38) 三好秋馬,三輪剛,中澤三郎:胃潰瘍に対するエグアレンナトリウムとシメチジンとの併用試験 (第一報)初期治療効果の検討 シメチジン単独療法との比較試験.内科宝函,42:101-16,1995 (レベル II)
39) Murata H, Kawano S, Tsuji S, Kamada T, Matsuzawa Y, Katsu K, et al: Combination therapy of ecabet sodium and cimetidine compared with cimetidine alone for gastric ulcer: prospective randomized multicenter study. J Gastroenterol Hepatol, 18:1029-33,2003 (レベル III)
40) 三輪剛,椎名泰文,柴田晴道:ソロン(SU-88)とタガメットとの併用による胃潰瘍の治療および再発に対する臨床評価 タガメット単独療法との比較試験.診療と新薬,23:310-28,1996 (レベル III)
41) Houston LJ, Mills JG, Wood JR: Does co-prescription of sucralfate with ranitidine therapy enhance the healing of gastric ulcers? Am J Gastroenterol, 88:675-9,1993 (レベル II)
42) 越智浩二,原田英雄,水島孝明:レバミピド(ムコスタ錠)とH2受容体拮抗薬併用による胃潰瘍初期治療の有用性の検討.新薬と臨床,44:829-40,1995 (レベル II)
43) 木村健,吉田行雄,市田文弘:胃潰瘍に対するTeprenoneの治療効果 多施設共同臨床研究.診断と治療,76:3015-28,1988 (レベル III)
44) Shirakabe H, Takemoto T, Kobayashi K, et al: Clinical evaluation of teprenone, a mucosal protective agent, in the treatment of patients with gastric ulcers: a nationwide, multicenter clinical study. Clin Ther, 17:924-35,1995 (レベル III)
45) 西元寺克礼,岡部治弥,野村喜重郎:胃潰瘍の治癒,再発に対するセルベックス併用療法の有用性 シメチジン単独療法とセルベックス併用療法の比較検討.臨牀と研究,65:1687-92,1988 (レベル III)
46) Dammann HG, Walter TA, Hentschel E, Müller P, Simon B: Famotidine: nocturnal administration for gastric ulcer healing. Results of multicenter trials in Austria and Germany. Digestion, 32 Suppl 1:45-50,1985 (レベル II)
47) Paoluzi P, Torsoli A, Bianchi PG, et al: Famotidine (MK-208) in the treatment of gastric ulcer. Results of a multicenter double-blind controlled study. Digestion, 32 Suppl 1:38-44,1985 (レベル II)
48) Lyon DT: Efficacy and safety of famotidine in the management of benign gastric ulcers. Am J Med, 81:33-41,1986 (レベル II)
49) Dammann HG, Walter TA, Hentschel E, Muller P, Simon B: Famotidine: proven once-a-day treatment for gastric ulcer. Scand J Gastroenterol Suppl, 134:29-33,1987 (レベル II)
50) Simon B, Müller P, Dammann HG: Famotidine once-a-day in the therapy of acute, benign gastric ulcer: a worldwide experience. J Clin Gastroenterol, 9 Suppl 2:19-22,1987 (レベル II)
51) Frank WO, Young M, Palmer RH, Karlstadt R, Rockhold F, Mounce W: Once-daily bedtime dosing regimen of cimetidine in the treatment of gastric ulcer. Clin Ther, 11:595-603,1989 (レベル II)
52) Frank WO, Young MD, Palmer R, et al: Acute treatment of benign gastric ulcer with once-daily bedtime dosing of cimetidine compared with placebo. Aliment Pharmacol Ther, 3:573-84,1989 (レベル II)
53) McCullough AJ, Graham DY, Knuff TE, et al: Suppression of nocturnal acid secretion with famotidine accelerates gastric ulcer healing. Gastroenterology, 97:860-6,1989 (レベル II)
54) Johnson JA, Euler AR, Northcutt AR, McSorley DJ: Ranitidine 300 mg at bedtime is effective for gastric ulcers: a 12-wk, multicenter, randomized, double-blind, placebo-controlled comparison. The Ranitidine 300 mg HS Gastric Ulcer Study Group. Am J Gastroenterol, 88:1071-5,1993 (レベル II)
55) Brazer SR, Tyor MP, Pancotto FS, et al: Randomized, double-blind comparison of famotidine with ranitidine in treatment of acute, benign gastric ulcer disease. Community-based study coupled with a patient registry. Dig Dis Sci, 34:1047-52,1989. (レベル II)
56) Cochran KM, Cockel R, Crowe J, et al: Comparison of 40 mg famotidine nightly and 150 mg ranitidine b.d.: ulcer healing and symptom relief in benign gastric ulcer. Aliment Pharmacol Ther, 3:461-70,1989 (レベル II)
57) Di Mario F, Battaglia G, Naccarato R, et al: Comparison of 150 mg nizatidine BID or 300 mg at bedtime, and 150 mg ranitidine BID in the treatment of gastric ulcer--an 8-week randomized, double-blind multicentre study. Hepatogastroenterology, 37 Suppl 2:62-5,1990 (レベル II)
58) Brandstätter G, Marks IN, Lanza F, et al: A multicenter, randomized, double-blind comparison of roxatidine with ranitidine in the treatment of patients with uncomplicated benign gastric ulcer disease. The Multicenter Roxatidine Cooperative Study Group. Clin Ther, 17:467-78,1995 (レベル II)
59) Cerlek S, Papa B, Katicić M, Colić-Cvrlje V, Mielenz H: Pirenzepin in gastric and duodenal ulcer: a double-blind trial. J Int Med Res, 9:148-51,1981 (レベル II)
60) Gonvers JJ, Realini S, Bretholz A, et al: Gastric ulcer: a double-blind comparison of 100 mg pirenzepine plus antacid versus 800 mg cimetidine plus antacid. Scand J Gastroenterol, 21:806-8,1986 (レベル II)
61) Reed PI, Jazrawi RP, Northfield TC, et al: Enprostil, a prostaglandin E2 analogue, in the treatment of gastric ulcer--a multicentre comparison with pirenzepine. Br J Clin Pract, 44:48-51,1990 (レベル II)
62) Lam SK, Lau WY, Lai CL, et al: Efficacy of sucralfate in corpus, prepyloric, and duodenal ulcer-associated gastric ulcers. A double-blind, placebo controlled study. Am J Med, 79:24-31,1985 (レベル II)
63) Lahtinen J, Aukee S, Miettinen P, Poikolainen E, Pääkkönen M, Sandström R: Sucralfate, and cimetidine for gastric ulcer. Scand J Gastroenterol Suppl, 83:49-51,1983 (レベル II)
64) Hallerbäck B, Anker-Hansen O, Carling L, et al: Short term treatment of gastric ulcer: a comparison of sucralfate and cimetidine. Gut, 27:778-83,1986 (レベル II)
65) Svedberg LE, Carling L, Glise H, et al: Short-term treatment of prepyloric ulcer. Comparison of sucralfate and cimetidine. Dig Dis Sci, 32:225-31,1987 (レベル II)
66) Herrerias-Gutierrez JM, Pardo L, Segu JL: Sucralfate versus ranitidine in the treatment of gastric ulcer. Randomized clinical results in short-term and maintenance therapy. Am J Med, 86:94-7,1989 (レベル II)
67) Hjortrup A, Svendsen LB, Beck H, Hoffmann J, Schroeder M: Two daily doses of sucralfate or cimetidine in the healing of gastric ulcer. A comparative randomized study. Am J Med, 86:113-5,1989 (レベル II)
68) Rey JF, Legras B, Verdier A, Vicari F, Gorget C: Comparative study of sucralfate versus cimetidine in the treatment of acute gastroduodenal ulcer. Randomized trial with 667 patients. Am J Med, 86:116-21,1989 (レベル II)
69) Glise H, Carling L, Hallerbäck B, Kagevi I, Solhaug JH, Svedberg LE, et al: Treatment of peptic ulcers--acid reduction or cytoprotection? Scand J Gastroenterol Suppl, 140:39-47,1987 (レベル II)
70) Blum AL, Bethge H, Bode JC, Domschke W, Feurle G, Hackenberg K, et al: Sucralfate in the treatment and prevention of gastric ulcer: multicentre double blind placebo controlled study. Gut, 31:825-30,1990 (レベル II)
71) Agrawal NM, Saffouri B, Kruss DM, Callison DA, Dajani EZ: Healing of benign gastric ulcer. A placebo-controlled comparison of two dosage regimens of misoprostol, a synthetic analog of prostaglandin E1. Dig Dis Sci, 30:164S-170S,1985 (レベル II)
72) Rachmilewitz D, Chapman JW, Nicholson PA: A multicenter international controlled comparison of two dosage regimens of misoprostol with cimetidine in treatment of gastric ulcer in outpatients. Dig Dis Sci, 31:75S-80S,1986 (レベル II)
73) Shield MJ: Interim results of a multicenter international comparison of misoprostol and cimetidine in the treatment of out-patients with benign gastric ulcers. Dig Dis Sci, 30:178S-184S,1985 (レベル II)
74) Gonvers JJ, Aenishänslin W, Backwinkel K, et al: Gastric ulcer: a double blind comparison of 800 mcg misoprostol versus 300 mg ranitidine. Hepatogastroenterology, 34:233-5,1987 (レベル II)
75) Navert H: Treatment of gastric ulcer with enprostil. Am J Med, 81:75-9,1986 (レベル II)
76) Rachmilewitz D: Efficacy of prostanoids in the treatment of gastric ulcer. Clin Invest Med, 10:238-42,1987 (レベル II)
77) Dammann HG, Hüttemann W, Kalek HD, Rohner HG, Simon B: Comparative clinical trial of enprostil and ranitidine in the treatment of gastric ulcer. Am J Med, 81:80-4,1986 (レベル II)
78) Morgan AG, Pacsoo C, Taylor P, McAdam WA: A comparison between enprostil and ranitidine in the management of gastric ulceration. Aliment Pharmacol Ther, 4:635-41,1990 (レベル II)
79) Bardhan KD, Walker R, Hinchliffe RF, et al: Gastric ulcer healing: a comparison of enprostil versus ranitidine. J Clin Gastroenterol, 13:157-62,1991 (レベル II)
80) 三浦邦彦,国崎忠彦,八尾恒良:胃潰瘍に対するFPF1002(シメチジン)の臨床効果 多施設二重盲検試験.臨牀と研究,60:1652-66,1983 (レベル II)
81) 三好秋馬,三輪剛,武藤弘:胃潰瘍に対するFamotidineの臨床評価(ゲファルナートを対照とした二重盲検法による検討).診療と新薬,20:2069-88,1983 (レベル II)
82) 竹本忠良,岡崎幸紀,並木正義:二重盲検法によるRanitidineの臨床的有用性の検討 (第一報)胃潰瘍を対象として.臨床成人病,13:123-42,1983 (レベル II)
83) Ishimori A, Yamagata S: Therapeutic effect of pirenzepine dihydrochloride on gastric ulcer evaluated by a double-blind controlled clinical study. Phase III study. Arzneimittelforschung, 32(5):556-65,1982 (レベル II)
84) 名尾良憲,平沢尭,本田利男:消化性潰瘍治療剤SU-88の胃潰瘍に対する二重盲検法による臨床的評価.臨床成人病,12:1893-903,1982 (レベル II)
85) 滝野辰郎,児玉正,岡野均:胃潰瘍に対するMN-1695〔2,4-diamino-6- (2,5-dichlorophenyl) -s-triazine maleate〕の臨床評価 ゲファルナートを対照薬とした多施設二重盲検群間比較試験.臨床医薬,3:199-228,1987 (レベル II)
86) 崎田隆夫,中村孝司,石川誠:胃潰瘍に対するミソプロストール(SC-29333)の臨床評価 塩酸セトラキサートを対照薬とした多施設二重盲検比較試験.臨床評価,14:757-91,1986 (レベル II)
87) OPC-12759研究会:胃潰瘍に対する Proamipide(OPC-12759)の薬効評価 多施設二重盲検比較試験による塩酸セトラキサートとの比較.臨床成人病,19:1265-91,1989 (レベル II)
88) RS-84135研究班:胃潰瘍に対するエンプロスチル(TA/RS-84135)の臨床評価 塩酸セトラキサートを対照薬とした多施設二重盲検試験による検討.Progress in Medicine, 9:187-211,1989 (レベル II)
89) 三好秋馬,松尾裕,三輪剛:胃潰瘍に対するZ-103の臨床的有用性の検討 塩酸セトラキサートを対照薬とした多施設二重盲検試験.薬理と治療,20:199-223,1992 (レベル II)
90) KU-54研究会:胃潰瘍に対するKU-54とCetraxateとの二重盲検比較試験 多施設における検討.医学と薬学,12:487-539,1984 (レベル II)
91) 三好秋馬,谷内昭,吉田豊:胃潰瘍に対するCS-684の臨床評価 塩酸サトラキサートを対照薬とした多施設二重盲検群間比較試験.Progress in Medicine, 5:981-1002,1985(レベル II)
92) 三好秋馬,常岡健二,竹内正:胃潰瘍に対するOU-1308の臨床評価 塩酸セトラキサートを対照薬とした多施設二重盲検比較試験.臨床医薬,2:185-209,1986 (レベル II)
93) 三好秋馬,谷内昭,佐藤勝巳:胃潰瘍に対するTA903の薬効評価 多施設二重盲検試験による塩酸セトラキサートとの比較.Progress in Medicine, 6:2273-95,1986 (レベル II)
94) 三好秋馬,谷内昭,松尾裕:胃潰瘍に対するTA-2711の臨床評価 塩酸セトラキサートを対照薬とした多施設二重盲検試験による検討.Progress in Medicine, 11:1326-46,1991 (レベル II)
95) 三好秋馬,岡部治弥,三輪剛,他:胃潰瘍に対するエグアレンナトリウムの臨床評価(改訂版) 塩酸セトラキサートを対照薬とした多施設二重盲検群間比較試験.薬理と治療,27:837-52,1999 (レベル II)
96) 芦沢真六,白川和夫,崎田隆夫:セルベックス-カプセル(E-0671)の胃潰瘍に対する治療効果 プログルミドとの多施設二重盲検比較試験.Progress in Medicine, 3:1169-91,1983 (レベル II)

6.維持療法
1980年〜2001年までの文献検索式で検索された総文献数は計77編(うち英文40編,和文37編)で,研究班により選択された文献数は計63編(うち英文31編,和文32編)であった。最終的な採用文献数は計17編(英文16編,和文1編)となった。他に文中に,不採用文献4編を引用した。また,2002年〜2005年の新しい検索式で検索された文献数は5編(英文2編,和文3編)であるが,採用文献はなく,このうち1編を文中に引用した(不採用文献)。これら22文献(採用17,不採用5)を以下に示す。
1) Hentschel E, Schütze K, Weiss W, Rüdiger E, Judmair G, Reichel W, Kerstan E, Horton J: Effect of cimetidine treatment in the prevention of gastric ulcer relapse: a one year double blind multicentre study. Gut, 24:853-6,1983 (レベル II)
2) Barr GD, Kang JY, Canalese J, Piper DW: A two-year prospective controlled study of maintenance cimetidine and gastric ulcer. Gastroenterology, 85:100-4,1983 (レベル II)
3) Alstead EM, Ryan FP, Holdsworth CD, Ashton MG, Moore M: Ranitidine in the prevention of gastric and duodenal ulcer relapse. Gut, 24:418-20,1983 (レベル II)
4) Classen M, Bethge H, Brunner G, Dirr B, Frotz H, Gabor M, Gail H, Grabner R, Hagenmüller F, Heinkel K, Kaess H, Kerstan E, Kuntzen O, Maier K, Meiderer S, Reichel W, Reissigl H, Schwanberger K, Seifert E, Thaler H, Weiss W, Wördehoff D, Wotzka R: Effect of sucralfate on peptic ulcer recurrence: a controlled double-blind multicenter study. Scand J Gastroenterol Suppl, 83:61-8,1983 (レベル II)
5) 増田久之,佐藤誠,井上修一,荒川弘道,林茂樹,大久保俊治,浜島昭雄,海野勝男:胃潰瘍の再発防止に対する二重盲検比較試験による臨床的薬効評価─胃潰瘍再発に対するスクラルフェートの作用.臨牀と研究,60:2265-72,1983 (レベル II)
6) Kinloch JD, Pearson AJ, Woolf IL, Young PH: The effect of cimetidine on the maintenance of healing of gastric ulceration. Postgrad Med J, 60:665-7,1984 (レベル II)
7) Dawson J, Jain S, Cockel R: Effect of ranitidine and cimetidine on gastric ulcer healing and recurrence. Scand J Gastroenterol, 19:665-8,1984 (レベル II)
8) Marks IN, Wright JP, Girdwood AH, Gilinsky NH, Lucke W: Maintenance therapy with sucralfate reduces rate of gastric ulcer recurrence. Am J Med, 79(2C):32-5,1985 (レベル II)
9) Piper DW, Pym BM, Toy S, Gellatly R, Byth K, Seville P: The effect of maintenance cimetidine therapy on the medical, social and economic aspects of patients with chronic gastric ulcers. A placebo-controlled prospective study. Med J Aust, 145:400-3,1986 (レベル II)
10) Jorde R, Burhol PG, Hansen T: Ranitidine 150 mg at night in the prevention of gastric ulcer relapse. Gut, 28:460-3,1987 (レベル II)
11) Marks IN, Girdwood AH, Wright JP, Newton KA, Gilinsky NH, Kalvaria I, Burns DG, O'Keefe SJ, Tobias R, Lucke W: Nocturnal dosage regimen of sucralfate in maintenance treatment of gastric ulcer. Am J Med, 83(3B):95-8,1987 (レベル II)
12) Blum AL, Bethge H, Bode JC, Domschke W, Feurle G, Hackenberg K, Hammer B, Hüttemann W, Jung M, Kachel G, Kaess H, Manegold BC, Peter P, Pfleiderer T, Rohner HG, Rasenack U, Sanwald R, Stalder GA, Vollotton J-J: Sucralfate in the treatment and prevention of gastric ulcer: multicentre double blind placebo controlled study. Gut, 31:825-30,1990 (レベル II)
13) Roxatidine acetate as maintenance treatment for patients with peptic ulcer disease. The European Cooperative Roxatidine Study Group. Clin Ther, 13:47-57,1991 (レベル II)
14) Berlin RG, Root JK, Cook TJ: Nocturnal therapy with famotidine for 1 year is effective in preventing relapse of gastric ulcer. Aliment Pharmacol Ther, 5:161-71,1991 (レベル II)
15) Battaglia G: Risk factors of relapse in gastric ulcer: a one-year, double-blind, comparative study of nizatidine versus placebo. Ital J Gastroenterol, 26(1 Suppl 1):19-22,1994 (レベル II)
16) Sue SO, Dawson DM, Brown JA, Wood DR, Kleoudis CS: Effectiveness of ranitidine 150 mg at bedtime as maintenance therapy for healed gastric ulcers. Clin Ther, 18:1175-83,1996 (レベル II)
17) Kovacs TO, Campbell D, Haber M, Rose P, Jennings DE, Richter J: Double-blind comparison of lansoprazole 15 mg, lansoprazole 30 mg, and placebo in the maintenance of healed gastric ulcer. Dig Dis Sci, 43:779-85,1998 (レベル II)
18) Takemoto T, Kimura K, Okita K, Tsuneoka K, Ohshiba S, Namiki M, Fukuchi S, Miyake T, Fukutomi H, Okazaki Y, Tanaka T: Efficacy of sucralfate in the prevention of recurrence of peptic ulcer--double blind multicenter study with cimetidine. Scand J Gastroenterol Suppl, 140:49-60,1987 (レベル III)
19) Takemoto T, Namiki M, Ishikawa M, Tsuneoka K, Oshiba S, Kawai K, Ogawa N: Ranitidine and sucralfate as maintenance therapy for gastric ulcer disease: endoscopic control and assessment of scarring. Gut, 30:1692-7,1989 (レベル III)
20) Herrerias-Gutierrez JM, Pardo L, Segu JL: Sucralfate versus ranitidine in the treatment of gastric ulcer. Randomized clinical results in short-term and maintenance therapy. Am J Med, 86(6A):94-7,1989 (レベル III)
21) 三好秋馬,三輪剛,小川暢也:胃潰瘍に対するエグアレンナトリウムとシメチジンとの併用試験.第2報:再発予防効果の検討─シメチジン単独維持療法との比較試験─.内科宝函,42:125-34,1995 (レベル III)
22) Koizumi W, Tanabe S, Imaizumi H, Kida M, Ohida M, Koshida Y, Mitomi H, Hosaka Y, Nagaba S, Sasaki T, Higuchi K, Saigenji K: Inhibition of peptic ulcer relapse by ranitidine and ecabet independently of eradication of Helicobacter pylori: a prospective, controlled study versus ranitidine. Hepatogastroenterology, 50:577-81,2003 (レベル III)

7.NSAID潰瘍
・治療

検索式で検索された文献のうち,研究班により選択された文献数は計43編(うち英文43編,和文0編)であった。最終的な採用文献数は計24編(英文24編,和文0編)となった。
1) Tildesley G, Ehsanullah RS, Wood JR: Ranitidine in the treatment of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drugs. Br J Rheumatol, 32:474-8,1993 (レベル II)
2) Jaszewski R, Graham DY, Stromatt SC: Treatment of nonsteroidal antiinflammatory drug-induced gastric ulcers with misoprostol. A double-blind multicenter study. Dig Dis Sci, 37:1820-4,1992 (レベル II)
3) Lancaster-Smith MJ, Jaderberg ME, Jackson DA: Ranitidine in the treatment of non-steroidal anti-inflammatory drug associated gastric and duodenal ulcers. Gut, 32:252-5,1991 (レベル II)
4) Malchow-Møller A. Treatment of peptic ulcer induced by non-steroidal anti-inflammatory drugs. Scand J Gastroenterol Suppl, 127:87-91,1987 (レベル II)
5) Sontag SJ, Schnell TG, Budiman-Mak E, et al: Healing of NSAID-induced gastric ulcers with a synthetic prostaglandin analog (enprostil). Am J Gastroenterol, 89:1014-20,1994 (レベル II)
6) Roth S, Agrawal N, Mahowald M, et al: Misoprostol heals gastroduodenal injury in patients with rheumatoid arthritis receiving aspirin. Arch Intern Med, 149:775-9,1989 (レベル II)
7) O'Laughlin C, Silvoso GK, Ivey KJ: Resistance to medical therapy of gastric ulcers in rheumatic disease patients taking aspirin. A double-blind study with cimetidine and follow-up. Dig Dis Sci, 27:976-80,1982 (レベル II)
8) Hudson N, Taha AS, Russell RI, et al: Famotidine for healing and maintenance in nonsteroidal anti-inflammatory drug-associated gastroduodenal ulceration. Gastroenterology, 112:1817-22,1997 (レベル II)
9) Simon B, Müller P: Nizatidine in therapy and prevention of non-steroidal anti-inflammatory drug-induced gastroduodenal ulcer in rheumatic patients. Scand J Gastroenterol Suppl, 206:25-8,1994 (レベル III)
10) Wu CS, Wang SH, Chen PC, et al: Does famotidine have similar efficacy to misoprostol in the treatment of non-steroidal anti-inflammatory drug-induced gastropathy? Int J Clin Pract, 52:472-4,1998 (レベル II)
11) Hawkey CJ, Karrasch JA, Szczepañski L, et al: Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group. N Engl J Med, 338:727-34,1998 (レベル II)
12) Yeomans ND, Tulassay Z, Juhász L, et al: A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group. N Engl J Med, 338:719-26,1998 (レベル II)
13) Agrawal NM, Campbell DR, Safdi MA, et al: Superiority of lansoprazole vs ranitidine in healing nonsteroidal anti-inflammatory drug-associated gastric ulcers: results of a double-blind, randomized, multicenter study. NSAID-Associated Gastric Ulcer Study Group. Arch Intern Med, 160:1455-61,2000 (レベル II)
14) Campbell DR, Haber MM, Sheldon E, et al: Effect of H. pylori status on gastric ulcer healing in patients continuing nonsteroidal anti-inflammatory therapy and receiving treatment with lansoprazole orranitidine. Am J Gastroenterol, 97:2208-14,2002 (レベル II)
15) Massimo Claar G, Monaco S, Del Veccho Blanco C, et al: Omeprazole 20 or 40 mg daily for healing gastroduodenal ulcers in patients receiving non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther, 12:463-8,1998 (レベル II)
16) Bianchi Porro G, Lazzaroni M, Manzionna G, et al: Omeprazole and sucralfate in the treatment of NSAID-induced gastric and duodenal ulcer. Aliment Pharmacol Ther, 12:355-60,1998 (レベル II)
17) Bianchi Porro G, Parente F, Imbesi V, et al: Role of Helicobacter pylori in ulcer healing and recurrence of gastric and duodenal ulcers in longterm NSAID users. Response to omeprazole dual therapy. Gut, 39:22-6,1996 (レベル II)
18) Chan FK, Sung JJ, Suen R, et al: Does eradication of Helicobacter pylori impair healing of nonsteroidal anti-inflammatory drug associated bleeding peptic ulcers? A prospective randomized study. Aliment Pharmacol Ther, 12:1201-5,1998 (レベル II)
19) Hawkey CJ, Tulassay Z, Szczepanski L, et al: Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Helicobacter Eradication for Lesion Prevention. Lancet, 352:1016-21,1998 (レベル II)
20) Hawkey CJ, Naesdal J, Wilson I, et al: Relative contribution of mucosal injury and Helicobacter pylori in the development of gastroduodenal lesions in patients taking non-steroidal anti-inflammatory drugs. Gut, 51:336-43,2002 (レベル II)
21) Lai KC, Lam SK, Chu KM, et al: Lansoprazole reduces ulcer relapse after eradication of Helicobacter pylori in nonsteroidal anti-inflammatory drug users--a randomized trial. Aliment Pharmacol Ther, 18:829-36,2003 (レベル II)
22) Chan FK, Hung LC, Suen BY, et al: Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med, 347:2104-10,2002 (レベル II)
23) Chan FK, Chung SC, Suen BY, et al: Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen. N Engl J Med, 344:967-73,2001 (レベル II)
24) Lai KC, Lam SK, Chu KM, et al: Lansoprazole for the prevention of recurrences of ulcer complications from long-term low-dose aspirin use. N Engl J Med, 346:2033-8,2002 (レベル II)
25) Huang JQ, Sridhar S, Hunt RH: Role of Helicobacter pylori infection and non-steroidal anti-inflammatory drugs in peptic-ulcer disease: a meta-analysis. Lancet, 359:14-22,2002 (レベル I)

・予防
検索式で検索された文献のうち,研究班により選択された文献数は計62編(うち英文60編,和文2編)であった。最終的な採用文献数は計54編(英文54編,和文0編)となった。
1) Graham DY, Agrawal NM, Roth SH: Prevention of NSAID-induced gastric ulcer with misoprostol: multicentre, double-blind, placebo-controlled trial. Lancet, 2(8623):1277-80,1988 (レベル II)
2) Jiranek GC, Kimmey MB, Saunders DR, Willson RA, Shanahan W, Silverstein FE: Misoprostol reduces gastroduodenal injury from one week of aspirin: an endoscopic study. Gastroenterology, 96(2 Pt 2 Suppl):656-61,1989 (レベル II)
3) Saggioro A, Alvisi V, Blasi A, Dobrilla G, Fioravanti A, Marcolongo R, Marcolengo R: Misoprostol prevents NSAID-induced gastroduodenal lesions in patients with osteoarthritis and rheumatoid arthritis. Ital J Gastroenterol, 23(3):119-23,1991 (レベル II)
4) Bolten W, Gomes JA, Stead H, Geis GS: The gastroduodenal safety and efficacy of the fixed combination of diclofenac and misoprostol in the treatment of osteoarthritis. Br J Rheumatol, 31(11):753-8;1992 (レベル II)
5) Verdickt W, Moran C, Hantzschel H, Fraga AM, Stead H, Geis GS: A double-blind comparison of the gastroduodenal safety and efficacy of diclofenac and a fixed dose combination of diclofenac and misoprostol in the treatment of rheumatoid arthritis. Scand J Rheumatol, 21(2):85-91,1992 (レベル II)
6) Roth SH, Tindall EA, Jain AK, McMahon FG, April PA, Bockow BI, Cohen SB, Fleischmann RM: A controlled study comparing the effects of nabumetone, ibuprofen, and ibuprofen plus misoprostol on the upper gastrointestinal tract mucosa. Arch Intern Med, 153(22):2565-71,1993 (レベル II)
7) Melo Gomes JA, Roth SH, Zeeh J, Bruyn GA, Woods EM, Geis GS: Double-blind comparison of efficacy and gastroduodenal safety of diclofenac/misoprostol, piroxicam, and naproxen in the treatment of osteoarthritis. Ann Rheum Dis, 52(12):881-5,1993 (レベル II)
8) Graham DY, White RH, Moreland LW, Schubert TT, Katz R, Jaszewski R, Tindall E, Triadafilopoulos G, Stromatt SC, Teoh LS: Duodenal and gastric ulcer prevention with misoprostol in arthritis patients taking NSAIDs. Misoprostol Study Group. Ann Intern Med. 119(4):257-62,1993 (レベル II)
9) Elliott SL, Yeomans ND, Buchanan RR, Smallwood RA: Efficacy of 12 months' misoprostol as prophylaxis against NSAID-induced gastric ulcers. A placebo-controlled trial. Scand J Rheumatol, 23(4):171-6,1994 (レベル II)
10) Raskin JB, White RH, Jackson JE, Weaver AL, Tindall EA, Lies RB, Stanton DS: Misoprostol dosage in the prevention of nonsteroidal anti-inflammatory drug-induced gastric and duodenal ulcers: a comparison of three regimens. Ann Intern Med, 123(5):344-50,1995 (レベル II)
11) Agrawal NM, Van Kerckhove HE, Erhardt LJ, Geis GS: Misoprostol coadministered with diclofenac for prevention of gastroduodenal ulcers. A one-year study. Dig Dis Sci, 40(5):1125-31,1995 (レベル II)
12) Bocanegra TS, Weaver AL, Tindall EA, Sikes DH, Ball JA, Wallemark CB, Geis GS, Fort JG: Diclofenac/misoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip: a randomized, placebo controlled trial. Arthrotec Osteoarthritis Study Group. J Rheumatol, 25(8):1602-11,1998 (レベル II)
13) Rostom A, Dube C, Wells G, Tugwell P, Welch V, Jolicoeur E, McGowan J: Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev, (4):CD002296,2002 (レベル I)
14) Goldstein JL, Huang B, Amer F, Christopoulos NG: Ulcer recurrence in high-risk patients receiving nonsteroidalanti-inflammatory drugs plus low-dose aspirin: results of a post HOC subanalysis. Clin Ther, 26:1637-43,2004 (レベル II)
15) Ehsanullah RS, Page MC, Tildesley G, Wood JR: Prevention of gastroduodenal damage induced by non-steroidal anti-inflammatory drugs: controlled trial of ranitidine. BMJ, 297(6655):1017-21,1988 (レベル II)
16) Robinson MG, Griffin JW Jr, Bowers J, Kogan FJ, Kogut DG, Lanza FL, Warner CW: Effect of ranitidine on gastroduodenal mucosal damage induced by nonsteroidal antiinflammatory drugs. Dig Dis Sci, 34(3):424-8,1989 (レベル II)
17) Robinson M, Mills RJ, Euler AR: Ranitidine prevents duodenal ulcers associated with non-steroidal anti-inflammatory drug therapy. Aliment Pharmacol Ther, 5(2):143-50,1991 (レベル II)
18) Levine LR, Cloud ML, Enas NH: Nizatidine prevents peptic ulceration in high-risk patients taking nonsteroidal anti-inflammatory drugs. Arch Intern Med, 153(21):2449-54,1993 (レベル II)
19) ten Wolde S, Dijkmans BA, Janssen M, Hermans J, Lamers CB: High-dose ranitidine for the prevention of recurrent peptic ulcer disease in rheumatoid arthritis patients taking NSAIDs. Aliment Pharmacol Ther, 10(3):347-51,1996 (レベル II)
20) Raskin JB, White RH, Jaszewski R, Korsten MA, Schubert TT, Fort JG: Misoprostol and ranitidine in the prevention of NSAID-induced ulcers: a prospective, double-blind, multicenter study. Am J Gastroenterol, 91(2):223-7,1996 (レベル II)
21) Bianchi Porro G, Lazzaroni M, Petrillo M: Double-blind, double-dummy endoscopic comparison of the mucosal protective effects of misoprostol versus ranitidine on naproxen-induced mucosal injury to the stomach and duodenum in rheumatic patients. Am J Gastroenterol, 92:663-7,1997 (レベル II)
22) Taha AS, Hudson N, Hawkey CJ, Swannell AJ, Trye PN, Cottrell J, Mann SG, Simon TJ, Sturrock RD, Russell RI: Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. N Engl J Med, 334(22):1435-9,1996 (レベル II)
23) Yeomans ND, Tulassay Z, Juhász L, Rácz I, Howard JM, van Rensburg CJ, Swannell AJ, Hawkey CJ: A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group. N Engl J Med, 338:719-26,1998 (レベル II)
24) Hawkey CJ, Karrasch JA, Szczepañski L, Walker DG, Barkun A, Swannell AJ, Yeomans ND: Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group. N Engl J Med, 338:727-34,1998 (レベル II)
25) Bianchi Porro G, Lazzaroni M, Petrillo M, Manzionna G, Montrone F, Caruso I: Prevention of gastroduodenal damage with omeprazole in patients receiving continuous NSAIDs treatment. A double blind placebo controlled study. Ital J Gastroenterol Hepatol. 30(1):43-7,1998 (レベル II)
26) Stupnicki T, Dietrich K, González-Carro P, Straszak A, Terjung A, Thomas KB, Lühmann R, Fischer R: Efficacy and tolerability of pantoprazole compared with misoprostol for the prevention of NSAID-related gastrointestinal lesions and symptoms in rheumatic patients. Digestion. 68:198-208,2003 (レベル II)
27) Labenz J, Blum AL, Bolten WW, Dragosics B, Rösch W, Stolte M, Koelz HR: Primary prevention of diclofenac associated ulcers and dyspepsia by omeprazole or triple therapy in Helicobacter pylori positive patients: a randomised, double blind, placebo controlled, clinical trial. Gut, 51:329-35,2002 (レベル II)
28) Graham DY, Agrawal NM, Campbell DR, Haber MM, Collis C, Lukasik NL, Huang B; NSAID-Associated Gastric Ulcer Prevention Study Group: Ulcer prevention in long-term users of nonsteroidal anti-inflammatory drugs: results of a double-blind, randomized, multicenter, active- and placebo-controlled study of misoprostol vs lansoprazole. Arch Intern Med, 162:169-75,2002 (レベル II)
29) Miglioli M, Bianchi Porro G, Vaira D, Menegatti M, Brunetti G, Petrillo M, Ardizzone S, Frizziero L, Montrone F, Grandinetti G: Prevention with sucralfate gel of NSAID-induced gastroduodenal damage in arthritic patients. Am J Gastroenterol, 91(11):2367-71,1996 (レベル II)
30) Agrawal NM, Roth S, Graham DY, White RH, Germain B, Brown JA, Stromatt SC: Misoprostol compared with sucralfate in the prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcer. A randomized, controlled trial. Ann Intern Med, 115(3):195-200,1991 (レベル II)
31) Chan FK, Sung JJ, Chung SC, To KF, Yung MY, Leung VK, Lee YT, Chan CS, Li EK, Woo J: Randomised trial of eradication of Helicobacter pylori before non-steroidal anti-inflammatory drug therapy to prevent peptic ulcers. Lancet, 350(9083):975-9;1997 (レベル II)
32) Chan FK, To KF, Wu JC, Yung MY, Leung WK, Kwok T, Hui Y, Chan HL, Chan CS, Hui E, Woo J, Sung JJ: Eradication of Helicobacter pylori and risk of peptic ulcers in patients starting long-term treatment with non-steroidal anti-inflammatory drugs: a randomised trial. Lancet, 359:9-13,2002 (レベル II)
33) Hawkey CJ, Tulassay Z, Szczepanski L, van Rensburg CJ, Filipowicz-Sosnowska A, Lanas A, Wason CM, Peacock RA, Gillon KR: Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Helicobacter Eradication for Lesion Prevention. Lancet, 352(9133):1016-21,1998 (レベル II)
34) Lai KC, Lau CS, Ip WY, Wong BC, Hui WM, Hu WH, Wong RW, Lam SK. Effect of treatment of Helicobacter pylori on the prevention of gastroduodenal ulcers in patients receiving long-term NSAIDs: a double-blind, placebo-controlled trial. Aliment Pharmacol Ther, 17:799-805,2003 (レベル II)
35) Chan FK, Chung SC, Suen BY, Lee YT, Leung WK, Leung VK, Wu JC, Lau JY, Hui Y, Lai MS, Chan HL, Sung JJ: Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen. N Engl J Med, 344:967-73,2001 (レベル II)
36) Vergara M, Catalán M, Gisbert JP, Calvet X: Meta-analysis: role of Helicobacter pylori eradication in the prevention of peptic ulcer in NSAID users. Aliment Pharmacol Ther, 21:1411-8,2005 (レベル I)
37) Lai KC, Lam SK, Chu KM, Wong BC, Hui WM, Hu WH, Lau GK, Wong WM, Yuen MF, Chan AO, Lai CL, Wong J: Lansoprazole for the prevention of recurrences of ulcer complications from long-term low-dose aspirin use. N Engl J Med, 346:2033-8,2002 (レベル II)
38) Laine L, Harper S, Simon T, Bath R, Johanson J, Schwartz H, Stern S, Quan H, Bolognese J: A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis.Rofecoxib Osteoarthritis Endoscopy Study Group. Gastroenterology, 117(4):776-83,1999 (レベル II)
39) Emery P, Zeidler H, Kvien TK, Guslandi M, Naudin R, Stead H, Verburg KM, Isakson PC, Hubbard RC, Geis GS: Celecoxib versus diclofenac in long-term management of rheumatoid arthritis: randomised double-blind comparison. Lancet, 354(9196):2106-11,1999 (レベル II)
40) Goldstein JL, Correa P, Zhao WW, Burr AM, Hubbard RC, Verburg KM, Geis GS: Reduced incidence of gastroduodenal ulcers with celecoxib, a novel cyclooxygenase-2 inhibitor, compared to naproxen in patients with arthritis. Am J Gastroenterol, 96:1019-27,2001 (レベル II)
41) Hawkey CJ, Laine L, Simon T, Quan H, Shingo S, Evans J; Rofecoxib Rheumatoid Arthritis Endoscopy Study Group: Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study. Gut, 52:820-6,2003 (レベル II)
42) Watson DJ, Bolognese JA, Yu C, Krupa D, Curtis S: Use of gastroprotective agents and discontinuations due to dyspepsia with the selective cyclooxygenase-2 inhibitor etoricoxib compared with non-selective NSAIDs. Curr Med Res Opin, 20:1899-908,2004 (レベル II)
43) Pavelka K, Recker DP, Verburg KM: Valdecoxib is as effective as diclofenac in the management of rheumatoid arthritis with a lower incidence of gastroduodenal ulcers: results of a 26-week trial. Rheumatology (Oxford), 42:1207-15,2003 (レベル II)
44) Goldstein JL, Eisen GM, Agrawal N, Stenson WF, Kent JD, Verburg KM: Reduced incidence of upper gastrointestinal ulcer complications with the COX-2 selective inhibitor, valdecoxib. Aliment Pharmacol Ther, 20:527-38,2004 (レベル II)
45) Hawkey CC, Svoboda P, Fiedorowicz-Fabrycy IF, Nasonov EL, Pikhlak EG, Cousin M, Gitton X, Hoexter G: Gastroduodenal safety and tolerability of lumiracoxib compared with Ibuprofen and celecoxib in patients with osteoarthritis. J Rheumatol, 31:1804-10,2004 (レベル II)
46) Farkouh ME, Kirshner H, Harrington RA, Ruland S, Verheugt FW, Schnitzer TJ, Burmester GR, Mysler E, Hochberg MC, Doherty M, Ehrsam E, Gitton X, Krammer G, Mellein B, Gimona A, Matchaba P, Hawkey CJ, Chesebro JH; TARGET Study Group: Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. Lancet, 364(9435):675-84,2004 (レベル II)
47) Hunt RH, Harper S, Watson DJ, Yu C, Quan H, Lee M, Evans JK, Oxenius B: The gastrointestinal safety of the COX-2 selective inhibitor etoricoxib assessed by both endoscopy and analysis of upper gastrointestinal events. Am J Gastroenterol, 98:1725-33,2003 (レベル II)
48) Lai KC, Chu KM, Hui WM, Wong BC, Hu WH, Wong WM, Chan AO, Wong J, Lam SK: Celecoxib compared with lansoprazole and naproxen to prevent gastrointestinal ulcer complications. Am J Med, 118(11):1271-8,2005 (レベル II)
49) Chan FK, Hung LC, Suen BY, Wu JC, Lee KC, Leung VK, Hui AJ, To KF, Leung WK, Wong VW, Chung SC, Sung JJ: Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med, 347:2104-10,2002 (レベル II)
50) Pavelka K, Recker DP, Verburg KM: Valdecoxib is as effective as diclofenac in the management of rheumatoid arthritis with a lower incidence of gastroduodenal ulcers: results of a 26-week trial. Rheumatology (Oxford), 42:1207-15,2003 (レベル II)
51) Laine L, Maller ES, Yu C, Quan H, Simon T: Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: a double-blind trial. Gastroenterology, 127:395-402,2004 (レベル II)
52) Mukherjee D, Nissen SE, Topol EJ: Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA, 286:954-9,2001 (レベル II)
53) Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL, Boyce SW, Verburg KM: Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med, 352:1081-91,2005 (レベル II)
54) Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P, Anderson WF, Zauber A, Hawk E, Bertagnolli M; Adenoma Prevention with Celecoxib (APC) Study Investigators: Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med, 352:1071-80,2005 (レベル II)

8.生活指導
1) Piper DW, Hunt J, Heap TR: The healing rate of chronic gastric ulcer in patients admitted to hospital. Scand J Gastroenterol, 15:113-7,1980 (レベル II)
2) Rydning A, Weberg R, Lange O, Berstad A: Healing of benign gastric ulcer with low-dose antacids and fiber diet. Gastroenterology, 91:56-61,1986 (レベル II)
3) Lööf L, Adami HO, Bates S, et al: Psychological group counseling for the prevention of ulcer relapses. A controlled randomized trial in duodenal and prepyloric ulcer disease. J Clin Gastroenterol, 9:400-7,1987 (レベル II)

9.メタアナリシス
検索式で検索された総文献数は計86編(うち英文70編,和文16編)で,研究班により選択された文献数は計22編(うち英文22編,和文0編)であった。最終的な採用文献数は計21編(英文21編,和文0編)となった。
1) Huang JQ, Sridhar S, Hunt RH: Role of Helicobacter pylori infection and non-steroidal anti-inflammatory drugs in peptic-ulcer disease: a meta-analysis. Lancet, 359:14-22,2002 (レベル I)
2) Vergara M, Calvet X, Roqué M: Helicobacter pylori is a risk factor for peptic ulcer disease in cirrhotic patients. A meta-analysis. Eur J Gastroenterol Hepatol, 14:717-22,2002 (レベル I)
3) Meyer JM, Silliman NP, Wang W, Siepman NY, Sugg JE, Morris D, Zhang J, Bhattacharyya H, King EC, Hopkins RJ: Risk factors for Helicobacter pylori resistance in the United States: the surveillance of H. pylori antimicrobial resistance partnership (SHARP) study, 1993-1999. Ann Intern Med, 136:13-24,2002 (レベル I)
4) Leodolter A, Kulig M, Brasch H, Meyer-Sabellek W, Willich SN, Malfertheiner P: A meta-analysis comparing eradication, healing and relapse rates in patients with Helicobacter pylori-associated gastric or duodenal ulcer. Aliment Pharmacol Ther, 15:1949-58,2001 (レベル I)
5) Treiber G, Lambert JR: The impact of Helicobacter pylori eradication on peptic ulcer healing. Am J Gastroenterol, 93:1080-4,1998 (レベル I)
6) Hopkins RJ, Girardi LS, Turney EA: Relationship between Helicobacter pylori eradication and reduced duodenal and gastric ulcer recurrence: a review. Gastroenterology, 110:1244-52,1996 (レベル I)
7) Ford A, Delaney B, Forman D, Moayyedi P: Eradication therapy for peptic ulcer disease in Helicobacter pylori positive patients. Cochrane Database Syst Rev, (4):CD003840,2004 (レベル I)
8) Gisbert JP, Pajares JM: Systematic review and meta-analysis: is 1-week proton pump inhibitor-based triple therapy sufficient to heal peptic ulcer? Aliment Pharmacol Ther, 21:795-804,2005 (レベル I)
9) Di Mario F, Battaglia G, Leandro G, Grasso G, Vianello F, Vigneri S: Short-term treatment of gastric ulcer. A meta-analytical evaluation of blind trials. Dig Dis Sci, 41:1108-31,1996 (レベル I)
10) Eriksson S, Långström G, Rikner L, Carlsson R, Naesdal J: Omeprazole and H2-receptor antagonists in the acute treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis: a meta-analysis. Eur J Gastroenterol Hepatol, 7:467-75,1995 (レベル I)
11) Tunis SR, Sheinhait IA, Schmid CH, Bishop DJ, Ross SD: Lansoprazole compared with histamine2-receptor antagonists in healing gastric ulcers: a meta-analysis. Clin Ther, 19:743-57,1997 (レベル I)
12) Salas M, Ward A, Caro J: Are proton pump inhibitors the first choice for acute treatment of gastric ulcers? A meta analysis of randomized clinical trials. BMC Gastroenterol, 2:17,2002 (レベル I)
13) Sacks HS, Chalmers TC, Blum AL, Berrier J, Pagano D: Endoscopic hemostasis. An effective therapy for bleeding peptic ulcers. JAMA, 264:494-9,1990 (レベル I)
14) Rollhauser C, Fleischer DE: Current status of endoscopic therapy for ulcer bleeding. Baillieres Best Pract Res Clin Gastroenterol, 14:391-410,2000 (レベル I)
15) Gisbert JP, Khorrami S, Carballo F, Calvet X, Gené E, Dominguez-Muñoz JE: H. pylori eradication therapy vs. antisecretory non-eradication therapy (with or without long-term maintenance antisecretory therapy) for the prevention of recurrent bleeding from peptic ulcer. Cochrane Database Syst Rev, (2):CD004062,2004 (レベル I)
16) Levine JE, Leontiadis GI, Sharma VK, Howden CW: Meta-analysis: the efficacy of intravenous H2-receptor antagonists in bleeding peptic ulcer. Aliment Pharmacol Ther, 16:1137-42,2002 (レベル I)
17) Gisbert JP, González L, Calvet X, Roqué M, Gabriel R, Pajares JM: Proton pump inhibitors versus H2-antagonists: a meta-analysis of their efficacy in treating bleeding peptic ulcer. Aliment Pharmacol Ther, 15:917-26,2001 (レベル I)
18) Koch M: Non-steroidal anti-inflammatory drug gastropathy: clinical results with misoprostol. Ital J Gastroenterol Hepatol, 31 Suppl 1:S54-62,1999 (レベル I)
19) Rostom A, Wells G, Tugwell P, Welch V, Dubé C, McGowan J: Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev, (4):CD002296,2000 (レベル I)
20) Rostom A, Dube C, Wells G, Tugwell P, Welch V, Jolicoeur E, McGowan J: Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev, (4):CD002296,2002 (レベル I)
21) Vergara M, Catalán M, Gisbert JP, Calvet X: Meta-analysis: role of Helicobacter pylori eradication in the prevention of peptic ulcer in NSAID users. Aliment Pharmacol Ther, 21:1411-8,2005 (レベル I)
22) Lau H: Laparoscopic repair of perforated peptic ulcer: a meta-analysis. Surg Endosc, 18:1013-21,2004 (レベル I)
23) Sanabria AE, Morales CH, Villegas MI: Laparoscopic repair for perforated peptic ulcer disease. Cochrane Database Syst Rev, (4):CD004778,2005 (レベル I)
24) Messori A, Trippoli S, Vaiani M, Gorini M, Corrado A: Bleeding and pneumonia in intensive care patients given ranitidine and sucralfate for prevention of stress ulcer: meta-analysis of randomised controlled trials. BMJ, 321:1103-6,2000 (レベル I)
25) Moher D, Cook DJ, Eastwood S, et al: Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet, 354:1896-900,1999
26) Stangl DK, Berry DA eds.: Meta-analysis in medicine and health policy. Marcel Dekker Inc, NY, USA, 2000
27) 森實敏夫:臨床医のためのEBMアップグレード メタアナリシス.医学書院,141-63,2002

10.医療経済的評価
検索式より英文59編,和文43編が検索され,研究内容と直接関係のないもの,エビデンスレベルが低いものを除外し,英文21編,和文7編が検討の対象として採用された。
1) 羽生泰樹,清田啓介,井口秀人,菅野康,高貴範,脇信也:消化性潰瘍治療におけるnewtriple therapyとdual therapy―除菌率と費用効果の観点から―.日本臨床,57:135-9,1999 (レベル I)
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