拉呋替丁片治疗十二指肠溃疡的多中心、随机、双盲、双模拟对照研究

目的观察拉呋替丁片治疗十二指肠溃疡的安全性和有效性。方法采用多中心、随机、双盲、双模拟对照设计。按入选标准将入选患者随机分为拉呋替丁组（111例）和法莫替丁组（109例）两组。拉呋替丁组给予拉呋替丁片10 mg,每天2次;法莫替丁组给予法莫替丁片20 mg每天2次。连续服用4周。观察治疗后溃疡愈合及临床症状的缓解情况。结果法莫替丁组痊愈率为35.78%,拉呋替丁组为51.35%。法莫替丁组愈合率为77.98%,拉呋替丁组为79.28%。法莫替丁组临床有效率为94.50%,拉呋替丁组为91.89%。两组患者总体疗效、愈合率及临床有效率比较均无显著性差异（P〉0.05）,但拉呋替丁组痊愈率明显高于法莫替丁组（P〈0.05）。两组均未发生严重不良反应。结论拉呋替丁用于治疗十二指肠溃疡可有效促进溃疡愈合,改善患者临床症状,效果与法莫替丁相近。

Efficacy of Lafutidine in the Treatment of Duodenal Ulcer - a Multi-center, Randomized, Double-blinded, Double-dummy, Controlled Study

Objective To assess the efficacy and safety of lafutidine for the treatment of duodenal ulcer.Methods Duodenal ulcer patients selected from multiple centers were randomized into two groups:group A(n=111) received Lafutidine 10mg bid and group B(n=109) received Famotidine 20mg bid for 4 weeks.Results 51.35% ulcers reached S2 stage in group A versus 35.78% in group B(P<0.05).There was no significant difference of the healing rate(79.28% vs 77.98%,P>0.05) and the positive efficacy(91.89% vs 94.50%,P>0.05).No serious side effects were found.Conclusion Lafutidine can improve the symptoms and ulcer healing in patients with duodenal ulcer as Famotidine does.Lafutidine is an efficient and safe acid inhibitor.