注射用头孢噻利治疗急性细菌感染的多中心双盲随机对照临床研究

A multicenter,double-blind,randomized controlled clinical trial of injectable cefoselis in the treatment of acute bacterial infections

目的评价国产注射用头孢噻利治疗急性细菌感染的临床疗效和安全性。方法采用多中心、双盲、随机、平行对照临床研究方法 ,选择急性呼吸系统和泌尿系统细菌感染患者。试验组应用注射用头孢噻利1～2g静脉滴注,每日2次;对照组应用注射用头孢吡肟1～2g静脉滴注,每日2次。疗程7～14d。结果本研究共完成病例241例,其中呼吸系统感染121例,泌尿系统感染120例。试验组痊愈率和有效率分别为60.2%和96.7%,对照组痊愈率和有效率分别为54.2%和94.9%,两组比较差异均无统计学意义(P>0.05)。试验组细菌清除率为94.4%,对照组细菌清除率为100%,清除率的组间差别无统计学意义(P>0.05)。试验组不良反应发生率为3.3%,对照组为5.1%,两组比较差异无统计学意义(P>0.05),未见严重不良反应。结论国产注射用头孢噻利治疗急性呼吸系统和泌尿系统细菌感染,临床疗效确切,安全性较好。

Objective To evaluate the efficacy and safety of domestic injectable cefoselis in the treatment of acute bacterial infections.Methods A multicenter double-blind randomized controlled clinical trial was conducted. Patients with acute respiratory or urinary tract bacterial infection were randomized into treatment group or control group. Patients in treatment group were treated with injectable cefoselis. The patients in control group were treated with injectable cefepime. Both drugs were administered intravenously at a dose of 1-2 g twice daily for 7-14 days. Results A total of 241 patients （121 with respiratory tract infections,120 with urinary tract infections） were enrolled and completed the trial.The cure rate and efficacy rate were 60.2% and 96.7% in treatment group,and 54.2% and 94.9% in control group,respectively. The bacterial eradication rates in treatment and control groups were 94.4% and 100% respectively. There was no significant difference between the two groups （P0.05）. The incidence of adverse reaction was 3.3% in treatment group,and 5.1% in control group. There was also no significant difference between the two groups （P0.05）. No serious adverse reaction was reported. Conclusions Injectable cefoselis is effective and safe for the treatment of acute respiratory or urinary tract bacterial infections.