国产与进口注射用头孢唑肟注射液治疗细菌性感染性疾病随机双盲多中心随机对照临床研究

目的：评价头孢唑肟国产品治疗细菌性感染的疗效和安全性。方法：采用多中心随机双盲对照临床观察，共160例患呼吸道或泌尿道感染的病人入组，国产品组和进口品组各80例。治疗方法均为头孢唑肟2g，每日二次，疗程7-14天。结果：国产品组和进口品组的痊愈率分别为62．5％（50／80）、56．25％（45／80），有效率均为90％（72／80），细菌清除率分别为87．1％（54／62）和90．3％（56／62），不良反应发生率分别为8．75％（7／80）和7．50％（6／80）。经统计学分析均无显著差异（P〉0．05）。结论：国产注射用头孢唑肟治疗呼吸道感染和泌尿道感染的疗效和安全性与进口头孢唑肟相仿。

A multicenter, randomized controlled clinical study on domestic and imported ceftizoxime injection in the treatment of bacterial infections

Objective: To evaluate the clinical efficacy and safety of domestic ceftizoxime in the treatment of bacterial infections.Methods: A total of 160 patients with respiratory infections or urinary infections were enrolled into this multicenter,double-blinded,randomized controlled clinical study.80 patients received domestic ceftizoxime as trial group and 80 patients received imported ceftizoxime as control group.Both groups were given ceftizoxime 2g twice daily,iv gtt for 7 to 14 days.Results: The cure and effective rates were 62.5% and 90% in domestic group,56.25% and 90% in imported group;the bacterial eradication rate were 87.1% and 90.3%;the adverse events rate were 8.75% and 7.50%,respectively.There were no significant differences between the two groups(P>0.05).Conclusions: Domestic made ceftizoxime is as effective and well-tolerated as imported one for the treatment of bacterial infections.