比阿培南治疗呼吸和泌尿系统细菌性感染的临床试验

Clinical trial of biapenem in treatment of respiratory and urinary tract bacterial infections

目的评价注射用比阿培南治疗呼吸和泌尿系统细菌性感染的有效性和安全性。方法本研究为多中心、随机、单盲、阳性平行对照、非劣效性检验的临床试验,符合入选标准的呼吸和泌尿系统细菌性感染患者分别按中心分层随机分为比阿培南组（静脉滴注,每次0.3 g,每日2次）和美罗培南组（静脉滴注,每次0.5 g,每日3次）。两组疗程7~14 d。观察两组临床疗效、细菌清除率和不良事件。结果本研究全分析集病例285例,其中比阿培南组组143例,美罗培南组142例;安全性数据集288例,两组各144例。比阿培南组和美罗培南组总临床治愈率分别为93.7%（134/143）和92.3%（131/142）,呼吸系统临床治愈率分别为90%（65/72）和94%（66/70）,泌尿系统分别为97%（69/71）和90%（65/72）。两组总细菌清除率分别为88%（66/75）和93%（63/68）,呼吸系统细菌清除率分别为83%（30/36）和91%（29/32）,泌尿系统分别为92%（36/39）和94%（34/36）。两组不良事件发生率分别为3.5%（5/144）和9.0%（13/144）,不良反应发生率分别为4.2%（6/144）和6.9%（10/144）。经统计学分析两组临床治愈率、细菌清除率和不良反应发生率组间比较均无显著差异（P〉0.05）。结论比阿培南治疗呼吸和泌尿系统细菌性感染临床疗效确切,安全性好,其临床和细菌学疗效以及安全性均与美罗培南相当。

AIM To evaluate the efficacy and safety of biapenem for injection in the treatment of respiratory and urinary tract bacterial infections. METHODS In this multicenter, randomized, single-blinded,positive drug parallel-controlled and non-inferior clinical trial, patients with respiratory and urinary tract bacterial infections were randomized into biapenem group and meropenem group, treated with biapenem 0.3 g bid or meropenem 0.5 g tid intravenously for 7-14 days, respectively. The clinical efficacy, bacterialeradication rate, and adverse events were observed for both groups. RESULTS A total of 285 patients（143 in the biapenem group and 142 in the meropenem group） were enrolled in Full Analysis Set and 288 patients（144in each group） were enrolled in Safety Analysis Set. The total clinical cure rates of the biapenem group and the meropenem group were 93.7%（134/143） and 92.3%（131/142） respectively, 90%（65/72） vs. 94%（66/70）in the respiratory bacterial infections and 97%（ 69/71） vs. 90%（ 65/72） in the urinary tract bacterial infections, respectively. The total bacterial eradication rates of the biapenem group and meropenem group were88%（ 66/75） and 93%（ 63/68） respectively, 83%（ 30/36） vs. 91%（ 29/32） in the respiratory bacterial infections and 92%（ 36/39） vs. 94%（ 34/36） in the urinary tract bacterial infections respectively. The incidence of adverse events was 3.5%（ 5/144） in the biapenem group and 9.0%（ 13/144） in the meropenem group. The incidence of adverse reactions was 4.2%（6/144） in the biapenem group and 6.9%（10/144） in the meropenem group. No significant difference was found between the two groups in terms of clinical cure rates,bacterial eradication rates or incidence of adverse reaction（ P 〉 0.05）. CONCLUSION Biapenem is effective and safe in treatment of respiratory and urinary tract bacterial infections, and its clinical and bacteriological efficacy and safety are similar to those of meropenem.