比阿培南治疗细菌性肺炎和尿路感染的多中心随机对照临床试验

A multicenter, open-label, randomized controlled clinical trial to compare biapenem with meropenem in the treatment of bacterial pneumonia and urinary tract infections

目的评价比阿培南治疗细菌性肺炎和尿路感染的疗效和安全性。方法本研究为多中心、开放、随机对照试验,细菌性肺炎和尿路感染患者分别按中心分层随机接受比阿培南或美罗培南治疗。结果①比阿培南组和美罗培南组有效率分别为87.0%(107/123)和90.1%(109/121),其中两组细菌性肺炎有效率分别为90.0%(63/70)和91.9%(57/62),尿路感染有效率分别为83.0%(44/53)和88.1%(52/59);②两组细菌清除率分别为96.3%(77/80)和98.8%(79/80),其中肺炎细菌清除率分别为100%(42/42)和100%(39/39),尿路感染细菌清除率分别为92.1%(35/38)和97.6%(40/41);③两组不良反应发生率分别为4.7%(6/129)和3.1%(4/128),药物相关实验室异常发生率分别为17.1%(22/129)和19.5%(25/128),分别有2例(1.6%)和4例(3.1%)因不良反应终止治疗。经统计学分析两组的有效率、细菌清除率和不良反应发生率差异均无统计学意义。结论比阿培南治疗细菌性肺炎和尿路感染疗效确切,患者耐受性良好,其临床和细菌学疗效以及不良反应发生率均与对照药美罗培南相仿。

Objective To evaluate the efficacy and safety of biapenem versus meropenem in the treatment of bacterial pneumonia and urinary tract infections. Methods In this multicenter, open-label, randomized controlled clinical trial, patients with bacterial pneumonia or urinary tract infections were assigned randomly to receive biapenem or meropenem. Results The overall clinical efficacy rates of biapenem and meropenem were 87.0% （107/123） and 90. 1% （109/121） respectively. Specifically, the efficacy rates were 90.0% （63/70） vs. 91.9% （57/62） for bacterial pneumoni- a, and 83.0% （44/53） vs. 88. 1% （52/59） for urinary tract infections, respectively. The overall bacterial eradication rates of biapenem and meropenem were 96.3% （77/80） and 98.8% （79/80） respectively, specifically 100% （42/42） vs. 100% （39/39） for bacterial pneumonia, and 92.1% （35/38） vs. 97.6% （40/41） for urinary tract infections. The incidence of adverse reaction was 4. 7% （6/129） in biapenem group and and 3.1% （4/128） in meropenem group. The incidence of drug-related laboratory abnormality was 17. 1% （22/129） in biapenem group and 19.5% （25/128） in meropenem group. Discontinuation due to adverse reaction was reported in 2 （1.6%） patients of biapenem group and 4 （3.1%） patients of meropenem group. No statistically significant difference was found between the two groups in terms of efficacy rate, bacterial eradication rate or incidence of adverse reaction. Conclusions Biapenem is effective and well-tolerated in treating bacterial pneumonia and urinary tract infection, which is comparable to meropenem in terms of efficacy and safety.