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  

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

作　　者：赵彩芸[1] 肖永红[1] 薛峰[1] 张薇[1] 葛庚芝[2] 张菊英[2] 杨静[2] 林宇辉[3] 杨亦斌[3] 吴开松[3] 邹世清[3] 陈真顺[3] 杜春仙[3] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034 [2]天津医科大学第二医院,天津300211 [3]武汉大学中南医院,武汉430071

出　　处：《中国临床药理学杂志》2007年第3期163-167,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：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。Objective To evaluate the efficacy and safety of domestic cefepime in the treatment of the patients with respiratory tract infections. Methods A randomized controlled, parallel, muhicenter, 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. Results One 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.

关 键 词：国产与进口头孢吡肟 呼吸道感染 

分 类 号：R515[医药卫生—内科学] R978.11[医药卫生—临床医学]