法罗培南钠片治疗急性细菌性感染随机双盲对照临床研究

Double-blind randomized controlled multicenter clinical trial of faropenem sodium tablets in the treatment of acute bacterial infections

目的评价法罗培南钠片(青霉烯类抗生素)治疗临床常见致病菌引起的呼吸、泌尿系统细菌感染性疾病的疗效和安全性。方法用多中心随机双盲单模拟阳性药平行对照试验方法,共入选有效病例226例,试验组(法罗培南钠)入选114例,对照组(头孢泊肟酯)入选112例,法罗培南钠片每日600mg,头孢泊肟酯片每日200mg,疗程均为7～14天。结果试验组与对照组临床痊愈率分别为83.33%和80.36%,总有效率分别为95.61%和95.54%;细菌清除率均为98.94%。药物不良反应发生率分别为6.84%和6.14%。结论法罗培南钠片治疗临床常见急性细菌性感染安全、有效。

Objective To evaluate the efficacy and safety of faropenem sodium tablets in the treatment of respiratory and urinary bacteria infections. Methods A double - blind randomized , single simulation, parallele controlled, muhicenter clinical trial was carried out. In the study , 114 proper patients were enrolled in faropenem sodium （trial group）, while 112 proper patients were enrolled in cefpodoxime axetil （control group）. Cefpodoxime axetil was as the controlled drug. The daily dose of faropenem sodium and cefpodoxime axetil are 600 mg and 200mg respectively. The treatment duration for both groups was from 7 to 14 days. Resuits The cure rate for trial and control was 83.33% and 80.36%. The effective rate for trial and control was separately 95.61% and 95.54%. The bacterial eradication rate for trial and control was both 98.94%. The incidence of drug adverse reaction was 6.84% and 6.14% , respectively. Conclusion Faropenem sodium tablets is both effective and safe drug for acute bacterial infection.