注射用头孢唑肟钠治疗细菌性感染的多中心随机对照临床研究

A multicenter randomized controlled clinical trial of injectable ceftizoxime in the treatment of bacterial infections

目的评价国产注射用头孢唑肟钠治疗呼吸系统及泌尿系统细菌性感染的临床疗效和安全性.方法采用多中心、随机、盲法、平行对照试验设计,选择呼吸系统和泌尿系统细菌性感染患者,试验组(A组)应用国产注射用头孢唑肟钠,对照组(B组)应用进口注射用头孢唑肟钠(商品名益保世灵),用法均为2.0 g,静脉滴注,每12小时1次;下呼吸道感染疗程为7～14 d,泌尿系统感染为5～14 d.结果本研究共入选病例144例,其中下呼吸道感染和泌尿系统感染各72例.A、B两组基本临床特征差异无统计学意义,资料具有可比性.疗效分析显示,A组与B组的痊愈率分别为81.9%和63.9%,总有效率分别为98.6%和98.6%,两组差异无统计学意义(P＞0.05).A、B两组细菌清除率分别为100%和98.4%(P＞0.05).本研究两组不良反应发生率均较低(2.8%与2.8%,P＞0.05),未见严重不良反应.结论国产注射用头孢唑肟钠对临床常见致病菌引起的下呼吸道、泌尿系统感染,临床疗效较好而不良反应发生率低,有较高的临床应用价值.

Objective To evaluate the efficacy and safety of domestic injectable ceftizoxime in the treatment of bacterial infections. Methods The trial was designed as a randomized, double blind and multiple center study. Patients with respiratory or uri nary tract bacterial infections were randomized into treatment group（A） or control group（B）. Patients in the treatment group were treated with domestic injectable ceftizoxime 2.0 g, iv, ql2 h, and patients in control group were treated with injectable ceftizoxime （Epocelin） 2.0 g, iv, q12 h, for 7-10 d （lower respiratory tract infections） or 5-14 d （urinary tract infections）. Resuits A total of 144 patients （72 with respiratory tract infections, 72 with urinary tract infections） were enrolled and completed the trial. There was no significant difference between the two groups in terms of basic clinical characteristics. The total clinical cure rate were 81.9% and 63. 9% in A and B group respectively. The total clinical effective rate were both 98. 6% in two groups. There was no significant difference （P〉0.05） between the two groups in terms of clinical efficacy. There was also no significant difference （100.0% vs 98.4% ） between two groups with regard to bacterial eradication rate. The incidence of adverse reaction was 2.8% in the treatment group and 2.8% in control group （P〉0.05）. No severe adverse reaction was found. Conclusions Domestic injectable ceftizoxime is an effective and safe antibiotic for the treatment of lower respiratory tract and urinary tract bacterial infections.