国产与进口埃索美拉唑治疗十二指肠溃疡的随机对照研究

目的通过与进口埃索美拉唑镁肠溶片比较,观察国产埃索美拉唑肠溶胶囊治疗十二指肠溃疡(DU)的疗效和安全性。方法随机、双盲双模拟、阳性药物对照研究。60例经胃镜确诊的DU活动期病人随机分为试验组和对照组,分别服用国产埃索美拉唑肠溶胶囊40mg及进口埃索美拉唑镁肠溶片空白模拟片1片和进口埃索美拉唑镁肠溶片40mg及国产埃索美拉唑肠溶胶囊的空白模拟胶囊1粒,均qd,连续4wk。记录治疗前后病人的症状,治疗期间出现的不良反应。治疗前及治疗后2wk进行胃镜检查,若2wk时溃疡未愈合,wk4再复查胃镜。结果(1)治疗2wk后,试验组溃疡愈合率为87%,对照组为85%(P=0.841 0);治疗4wk后2组溃疡愈合率均达100%。(2)2组用药后症状均明显改善,治疗2wk和4wk后2组间症状的改善程度均无显著差异(P=0.5406,P=0.5786)。(3)2组不良反应发生率相似,试验组为17%,对照组为15%(P=1.0000)。结论2种埃索美拉唑制剂均能有效地促进溃疡愈合,快速缓解病人的症状,疗效相当,安全性好。

Randomized controlled trial of esomeprazole enteric-coated capsules versus esomeprazole magnesium imported for treatment of duodenal ulcer

AIM To observe the efficacy and safety of esomeprazole enteric-coated capsules on endoscopic monitored healing and symptom relief in duodenal ulcer patients.METHODS A randomized, double-blind,double-dummy,parallel-controlled study was conducted in 60 patients with active duodenal ulcer confirmed gastroscopy and in turn all 60 patients were randomly divided into esomeprazole enteric-coated capsules group(trial group)and someprazole magnesium group(control group)40 mg of each drug was administered once daily ...