国产洛美沙星治疗急性细菌性感染的随机对照临床研究  

A Randomized Controlled Clinical Study of Domestic Lomefloxacin in the Treatment of Acute Bacterial Infections

作　　者：梁德荣[1] 徐楠[1] 苗佳[1] 张辉明[1] 郑经川[2] 干梦九[2] 李佩璋[3] 张楚[3] 

机构地区：[1]华西医科大学附属第一医院国家药品临床研究基地,成都610041 [2]浙江医科大学附一院,杭州310003 [3]浙江省杭州市第一人民医院,杭州310006

出　　处：《华西医学》2000年第4期423-426,共4页West China Medical Journal

摘　　要：应用两种国产洛美沙星胶囊治疗急性细菌性感染 40 5例 ,其中随机对照组 10 3对、开放试验组 199例。两药均为 2 0 0mg每日两次口服 ,疗程 7～ 14日。结果表明 ,试验组与对照组的痊愈率和有效率分别为 76 70 %与80 5 8%和 95 15 %与 92 2 3%。细菌清除率分别为 90 2 0 %与 90 91%。以上结果组间比较均无统计学差异 (P >0 0 5 )。开放组痊愈率和有效率分别为 79 40 %与 93 47% ,细菌清除率为 96 15 %。试验组与对照组的不良反应发生率分别为 6 80 %与 5 83% (P >0 0 5 ) ,开放组为 5 0 3%。不良反应多呈轻度 ,勿需处理可自行缓解。以上结果提示 ,两种国产洛美沙星胶囊同样安全、有效。The efficacy and safety of domestic lomefloxacin were evaluated and 405 patients were enrolled in the randomized controlled study.Another domestic lomefloxacin was chosen as a control drug.Both drugs were administered 200mg,twice a day for 7～14 days.In the controlled trial,206 cases were randomized to receive one of the two kinds of lomefloxcin (103 cases in each group).The cure rates and the efficacy rates were 76 70%,80 58% and 95 15%,92 23% respectively.The bacterial clearance rates were 90 20% and 90 91%.There were no significant differences of the above results between the two groups ( P >0 05)。199 patients entered the open trial.Its cure rate,efficacy rate and bacterial clearance rate were 79 40%,93 47% and 96 15% respectively.The side-effect rates of the three groups were 6 80%,5 83% and 5 03%.There was no statistical difference between the controlled groups ( P >0 05)。Most of the adverse drug reactions were mild.This study suggests that both of the domestic lomefloxacin are effective and well tolerated.

关 键 词：洛美沙星 急性细菌感染 随机对照临床研究 

分 类 号：R969[医药卫生—药理学]