法罗培南钠片治疗细菌性感染的随机双盲对照临床研究

目的评价国产法罗培南钠片治疗细菌性感染的临床疗效与安全性。方法采用多中心、双盲、随机对照试验设计，以头孢克洛为对照药，两组均口服，每次2片，tid，疗程5～10d。结果本研究共纳入60例，法罗培南组和头孢克洛组各30例，其中法罗培南组及头孢克洛组纳入ITT分析均为30例，PP分析分别为28和30例。疗程结束时，呼吸系统PP人群中，法罗培南组与头孢克洛组治疗后总痊愈率和有效率分别为71．43％与47．67％和92．86％与93．33％，泌尿道PP人群中，法罗培南组与头孢克洛组总痊愈率和有效率分别为85．71％与73．33％和100％与93．33％。疗程结束时两组细菌清除率均分别为83．33％和79．17％，法罗培南组和头孢克洛组的不良反应发生率分别为10．71％和20％，主要表现为恶心、呕吐、头晕、皮疹、腹泻等。以上结果两组比较无统计学差异（P〉0．05）。结论国产法罗培南钠片治疗呼吸道感染和泌尿道感染疗效确切，安全性较好。

A multicenter, randomized controlled clinical study on faropenem sodium tablets in the treatment of bacterial infections

Objective To evaluate the clinical efficacy and safety of domestic faropenem in the treatment of bacterial infections.Methods We designed a multicenter,double-blind,randomized controlled clinical trial and used cefaclor as control.Both groups were given 2 tablets three times daily,orally for 5 to 10 days.Results A total of 60 patients were enrolled in the study.Two groups were both distributed 30 patients.There was 30 patients who enrolled in ITT(intention to treat analysis) and the group of faropenem was 28 and the group of cefaclor was 30 in PP(per protocol).The cure and effective rates were 71.43% vs 47.67% and 92.86% vs 93.33% in the per-protocol patients with respiratory infections,the cure and effective rates were 85.71% vs 73.33% and 100% vs 93.33% in the per-protocol patients with urinary infections;the bacterial eradication rate were 83.33% vs 79.17%;the adverse events rate were 10.71% vs 20%,the adverse events were nausea,vomit, dizziness,rash,diarrhea and so on.There were no significant differences between the two groups(P>0.05).Conclusions Domestic faropenem is effective and safe for the treatment of bacterial infections.