法罗培南与头孢呋辛酯治疗细菌感染随机双盲多中心临床试验

A multicenter, randomized and controlled clinical trial on faropenem and cefuroxime axetil in treatment of bacterial infections

目的:评价国产法罗培南治疗细菌感染的疗效和安全性。方法:采用多中心随机双盲对照临床研究。共入选263例患呼吸道和泌尿道感染病人,病人随机分配到试验组(法罗培南131例)或对照组(头孢呋辛酯132例)。给药方案均为每次1片,每日3次,口服,疗程6～14 d。结果:合格病例共260例,试验组129例,对照组131例。试验组和对照组的痊愈率分别为75．2％(97／129)和75．6％(99／131),有效率分别是96．9％(125／129)和98．5％(129／131);2组疗效比较差异无显著意义(P>0．05)。试验组分离出的105株致病菌的清除率是97．1％,对照组分离出的100株致病菌的清除率是99．0％,差异无显著意义(P>0．05)。不良反应发生率分别为4．6％(6／130)和4．5％(6／132),均无显著差异(P> 0．05)。结论:国产法罗培南治疗呼吸道感染和泌尿道感染的疗效和安全性与头孢呋辛酯相仿。

AIM： To evaluate the clinical efficacy and safety of domestic faropenem in the treatment of bacterial infections. METHODS： A total of 263 patients either with respiratory infection or urinary infection were enrolled into this multicenter, double-blinded, randomized controlled clinical study, including 131 patients received domestic faropenem tablets as the trial group and 132 patients received cefuroxime axetil tablets as the control group. Every individual in both groups was given 1 tablet tid, orally for 6 to 14 d. RESULTS： The cure and effective rates were 75.2 % （97/129） and 96.9 % （125/129） in trial group, 75.6 % （99/131） and 98.5 % （129/131） in control group. The bacterial eradication rates were 97.1% vs 99.0 % and the adverse events rates were 4.6 % （6/130） vs 4.5 % （6/132） in the trial and control groups, respectively. There were no significant differences between the two groups （P 〉 0.05）. CONCLUSION ： Domestic faropenem is as effective and well-tolerated as cefuroxime axetil for the treatment of bacterial infections.