注射用尼扎替丁治疗消化性溃疡出血205例

A multi-center clinical trial to evaluate the efficacy and safety of intravenous nizatidine in the management of peptic ulcer bleeding

目的:研究注射用尼扎替丁治疗消化性溃疡出血的疗效及安全性.方法:采用多中心、随机、双盲、阳性药物平行对照研究.将2008-09/2009-12收集的205例经胃镜证实的消化性溃疡出血患者随机分为两组,试验组102例给予尼扎替丁0.1g,每日3次,对照组103例给予法莫替丁20mg,每日2次,连续5d.结果:共有201例患者可供疗效评价.试验组的临床显效率为85.0%,总有效率为99.0%,对照组的临床显效率为82.2%,总有效率为98.0%,两组间差异无统计学意义(P>0.05).两组不良反应主要为白细胞减少、转氨酶轻度升高和贫血(P>0.05).结论:注射用尼扎替丁是治疗消化性溃疡合并上消化系出血有效且安全的药物.

AIM：To evaluate the safety and safety of intravenous nizatidine in the management of peptic ulcer bleeding.METHODS：A muti-center,randomized,parallel-controlled clinical trial was conducted in 205 patients with endoscopically proved peptic ulcer bleeding.The patients were randomly divided into nizatidine group（n = 102） and control group（n = 103）.Patients in the nizatidine group were intravenously given nizatidine 0.1 g three times daily for 5 days,while those in the control group were intravenously given famotidine 20 mg twice daily for 5 days.RESULTS：There were 201 cases evaluable for efficacy and safety.The effective rate and response rate were comparable between the nizatidine group and the control group（85.0% vs 82.2%;99.0% vs 98.0%;both P 0.05）.Major adverse events include leucopenia,slightly elevated transaminase and anaemia.CONCLUSION：Intravenous nizatidine is a safe and effective drug for treatment of peptic ulcer bleeding.