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  

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

作　　者：梁小燕[1] 王丕龙[1] 高青[1] 汤丽平[1] 龚能平[1] 陶小红[1] 

机构地区：[1]重庆医科大学附属第一医院消化内科,重庆400016

出　　处：《中国新药与临床杂志》2008年第11期816-819,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：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。AIM To observe the efficacy and safety of csomeprazole 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 for 4 weeks. Symptoms and adverse reaction were recorded by using a scoring system. Gastroscopy was performed at the end of the second week and should repeated by the end of the fourth week if duodenal ulcer was not healed completely. RESULTS Three patients dropped out in the trial. At the end of the second week, ulcer healing rates were 87 % in the trial group and 85 % in the control group （P = 0.841 0） ; but by the end of the fourth week both groups reached 100 % ulcer healing. The relief rates of symptoms were 91% and 87 % respectively in the trial group and control group at the end of the second week （P = 0.540 6） ; and were 95 % and 93 % at the end of the fourth week （P = 0.578 6）. The incidences of adverse reaction （ 17 % vs 15 % ） were comparable in the two groups （P =1.000 0）. CONCLUSION Esomeprazole entericcoated capsules is as effective, safe and well tolerated as esomeprazole magnesium in the treatment of active duodenal ulcer, providing high efficacy of healing and quick relief of symptom.

关 键 词：十二指肠溃疡 治疗结果 随机对照试验 埃索美拉唑 

分 类 号：R975.6[医药卫生—药品]