【摘要】 目的 评价注射用国产头孢替安治疗细菌性感染的疗效与安全性。方法 采用随机平行对照试验设计，以头孢替安国产品为试验药,西力欣为对照药治疗呼吸道、尿道和腹腔感染，观察其疗效和安全性。结果 两组共入选107例，国产头孢替安组53例，西力欣组54例，治疗结果两组的总有效率分别为98.1%(52/53)和96.3%(52/54)，治愈率为69.8%(37/53)和65.0%(35/54)，细菌清除率分别为97.8%(45/46)和95.4%(42/44)；不良反应发生率分别为1.4%(1/70)和2.7%(2/73)，实验室检查异常者分别为4.3%(3/70)和5.5%(4/73)。上述结果经统计学处理，差异均无显著性。结论 国产头孢替安治疗呼吸道、尿路感染和腹腔感染的疗效和安全性与西力欣相仿。

     【关键词】 头孢替安； 细菌性感染； 随机对照临床试验

    A randomized controlled study of domestic and imported cefuroxime in the treatment of bacterial infections

    GU Jian-hua,HAO Ming-li.Surgery Department of the First Central Hospital of Tianjin,Tianjin 300192,China

    【Abstract】 Objective To evaluate the clinical efficiency and safety of domestic and imported cefotiam in the treatment of bacterial infections.Methods Patients with respiratory tract infections,urinary tract infections,intraabdominal infections were treated with domestic or cefuroxime in a randomized controlled study.Results A total of 107 patients were enrolled in this study,53 cases were in domestic group,54 cases in cefuroxime group.The cure rates and the effective rates of domestic and cefuroxime groups were 69.8%,65.0% (P>0.05) and 98.1%,96.3% (P>0.05),respectively.The bacterial eradication rates of the two groups were 97.8%,95.4%,respectively. The rates of adverse reaction and abnormal laboratory findings in the two groups were 1.4%,2.7% and 4.3%,5.5%,respectively.There was no statistical significance between the two groups.Conclusion Domestic made cefotiam is as effective and well-tolerated as cefuroxime for the treatment of bacterial infections. ......