国产注射用奥美拉唑治疗非食管静脉曲张上消化道出血的疗效与安全性

目的:评价和比较国产与进口注射用奥美拉唑治疗非食管静脉曲张上消化道出血的疗效及安全性.方法:采用多中心随机对照试验,将123例非食管静脉曲张上消化道出血患者随机分为试验组(n=62)及对照组(n=61),试验组给予国产奥美拉唑,对照组给予进口奥美拉唑(商品名洛赛克),两组给药方法相同,均为静脉注射,每次40 mg,qd,疗程3 d.观察两组止血情况和临床疗效以及药物不良反应.结果:试验组和对照组显效率(24h内停止出血)和总有效率(72 h内停止出血)分别为64.5%(40/62),98.4%(61/62)和62.3%(38/61),98.4%(60/61)(P＞0.05),两组患者均未发生与药物相关的不良反应.结论:国产奥美拉唑治疗非食管静脉曲张的上消化道出血安全有效.

Efficacy and safety of omeprazole injection made in China in adults with non-esophagus varicose upper gastrointestinal bleeding.

Objective:To evaluate the efficacy and safety of omeprazole injection made in China in adults with non-esophagus varicose upper gastrointestinal bleeding.Methods:123 patients with non-esophagus varicose upper gastrointestinal bleeding enrolled in a multi-center,randomized and parallel control clinical study were randomly i.v.injected with omeprazole(40 mg,n=62) or Losec(40 mg,n=61) once daily for three days.Results:The hemostasis within 72 hours after the administration of omeprazole and losec was 98.4% versus 98.4%,respectively,and within 24 hours 64.5% versus 62.3%,respectively(P>0.05).No severe adverse events were reported.Conclusion:Omeprazole made in China provides an alternative in the treatment of non-esophagus varicose upper gastrointestinal bleeding.