国产与进口注射用头孢吡肟随机单盲对照治疗呼吸道感染临床研究

目的评价国产与进口注射用头孢吡肟（第4代头孢类抗生素）治疗急性呼吸道感染的安全性和有效性。方法用随机平行对照多中心单盲设计，试验组为国产头孢吡肟，对照组为进口头孢吡肟，用法均为每次2g，每日2次，静脉点滴，疗程7～14天。结果本试验进入FAS人群154例，试验组77例，对照组77例；129例进入PP人群，试验组63例，对照组66例。治疗结束后，FAS人群：试验组与对照组总痊愈率分别为53．25％和55．84％。有效率分别为79．22％和76．62％。PP人群：试验组与对照组的总痊愈率分别为65．08％和65．15％，有效率分别为96．83％和89．39％；细菌清除率分别为92．16％与93．22％。154例进入安全性分析，2组药物不良反应发生率分别为10．39％和7．79％，上述结果差异均无显著性。结论国产与进口注射用头孢吡肟治疗细菌性呼吸道感染均有效、安全。

Randomized controlled clinical trial of domestic cefepime versus imported cefepime in the treatment of respiratory tract infections

Objective To evaluate the efficacy and safety of domestic cefepime in the treatment of the patients with respiratory tract infections. MethodsA randomized controlled, parallel, multicenter, single blind clinical trial was conducted. Patients were randomized into each group in the study. Trial group patients received domestic cefepime 2 g every 12 hours, and controlled group patients received imported cefepime 2 g every 12 hours by intravenous infusion. The duration was 7~14 days in both groups.ResultsOne hundred fifty-four cases in the FAS,77 patients in trial group received domestic cefepime,and 77 patients in control group received imported cefepime.One hundred twenty-nine cases in the PP, 63 patients in domestic cefepime group, and 66 patients in imported cefepime group. The overall cure rates of each group in FAS analysis were 53.25% and 55.84%, the overall efficacy rates were 79.22% and 76.62%. In PP analysis, the overall cure rates for the domestic cefepime were 65.08% and 65.15%, the overall efficacy rates for the imported cefepime were 96.83% and 89.39%, respectively. The bacterial eradication rates of each group in PP analysis were 92.16% and 93.22%, respectively. The adverse drug reaction was evaluated in 154 cases. The adverse drug reaction rates of trial and control groups were 10.39% and 7.79%, respectively. The results showed that there were no statistical differences between these two groups (P>0.05).Conclusion Domestic cefepime was effective and safe as imported cefepime for the treatment of respiratory tract bacterial infections.