比阿培南治疗急性细菌性感染多中心随机对照临床研究

Multi-center randomized control clinical study of biapenem on acute bacterial infection

目的以美罗培南为对照,评价比阿培南治疗呼吸系统和泌尿系统急性细菌性感染的安全性和有效性。方法采用多中心、双盲、随机、阳性药平行对照研究方法,将288例病例随机分为治疗组和对照组,各144例。对照组用美罗培南治疗,治疗组用比阿培南治疗,两组疗程7-14 d,视病情和病种而异,比较两组疗效。结果治疗组和对照组的临床总痊愈率分别为68.31%和72.92%,总有效率分别为95.77%和92.36%,总细菌清除率分别为89.71%和87.95%。PPS分析和FAS分析一致。总不良反应发生率分别为7.04%和5.56%。以上结果组间比较差异均无统计学意义。结论比阿培南治疗呼吸系统和泌尿系统急性细菌性感染,不良反应少,安全性好。

Objective To observe the safety and efficacy of biapenem on acute bacterial infection in respiratory and urinary system. Methods A double blind, multi-center, randomized clinical study with active control was performed. Total 288 patients were divided into treatment group （144 patients treated with biapenem） and control group （144 patients treated with meropenem）. Treatment duration was 7-14 days based on disease type and status. The efficacy were compared. Results The recovery rate of treatment group and control group were 68.31% and 72.92% respectively. The efficacy rates were 95.77% and 92.36%, and the bacterial clearance rates were 89.7 % and 87.95%. Through PPS and FAS analysis of above results, there was no statistical difference between treatment group and control group. Conclusion Biapenem has good safety and efficacy on acute bacterial infection in respiratory and urinary system.