曲昔派特治疗胃溃疡的多中心随机双盲对照研究

目的]观察曲昔派特治疗胃溃疡的疗效。方法]将胃溃疡患者随机分为试验组和对照组。试验组,61例,治疗用曲昔派特(100mg/次,tid,餐后服用)加模拟雷尼替丁安慰剂(1粒/次,bid,早餐前及睡前服用);对照组,60例,治疗用雷尼替丁(150mg/次,bid,早餐前及睡前服用)加模拟曲昔派特安慰剂(1片/次,tid,餐后服用)。治疗8周后评估2组主要临床症状、内镜下溃疡愈合率、胃液分析及血清胃泌素结果。结果]试验组、对照组主要临床症状缓解率分别为88.5%、93.3%,内镜下溃疡愈合率分别为86.9%、95%;2组比较差异均无统计学意义(P0.05)。对照组治疗后胃酸分泌值、血清胃泌素均较治疗前有所降低(P0.05、P0.01),而试验组治疗前、后比较差异无统计学意义(P0.05)。结论]曲昔派特在不影响胃酸分泌的情况下对胃溃疡的疗效可达到与雷尼替丁相当程度。

A multicenter,randomized, double-blind controlled study to evaluate the clinical efficacy of troxipide on gastric ulcer

Objective]To explore the curative effect of troxipide in treatment of gastric ulcer. Methods] The total of 121 patients were randomly divided into troxipide group（troxipide 100 mg rid,after meals plus a simulation of ranitidine placebo one tablet bid）and ranitidine group（ranitidine 150 mg bid,before break- fast and bedtime plus a simulation of a troxipide placebo one tablet tid）. Patients were assessed by chief clinical symptoms and endoscopic healing rate of ulcer after 8 weeks of treatment. Results]The clinical re- mission rate were 88.5 % （troxipide group）vs. 93.3% （ranitidine group）, P=0. 358 ;endoscopic healing rate of ulcer were 86.9%（troxipide group）vs. 95%（ranitidine group）,P=0. 121 ;and the gastric juice or the se- rum gastrin analysis suggest that troxipide did not affect the secretion of gastric acid, while ranitidine showed acid suppression effect. Conclusion]The curative effects of troxipide on gastric ulcer approximately equal to ranitidine without affect the secretion of gastric acid.