国产与进口头孢吡肟治疗泌尿系感染随机单盲对照临床研究  

Randomized controlled multicentric clinical trial of domestic and imported cefepime in the treatment of acute urinary infections

作　　者：高磊[1] 张薇[1] 薛峰[1] 肖永红[1] 张欣洲 李涌泉 李德天[3] 苏雪松[3] 边晓慧[3] 杨旭[3] 王磊 高轶喆 

机构地区：[1]北京大学第一医院临床药理研究所抗感染科,北京100083 [2]深圳市人民医院,广东深圳518020 [3]中国医科大学附属第二医院,辽宁沈阳110015 [4]深圳市制药厂,广东深圳518020

出　　处：《中国临床药理学杂志》2005年第2期83-86,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价国产与进口头孢吡肟治疗急性中重度泌尿系统感染的有效性和安全性.方法用区组随机平行对照、多中心单盲试验设计,用进口头孢吡肟作对照药.共入组127例病例,剔除5例,进入疗效分析病例数为122例,其中试验组61例,对照组61例.国产和进口头孢吡肟均为每次给药2 g,30～60min内静脉点滴,bid,疗程7～14天.结果治疗结束后,临床有效率分别为试验组98.36%,对照组96.72%;试验组与对照组致病菌清除率均为100%.2组药物不良反应发生率分别为6.45%和10.77%.2组对比差异均无统计学意义(P＞0.05).结论国产与进口头孢吡肟对急性泌尿系统感染均安全、有效.Objective To compare the clinical and bacterial efficacy and safety of domestic and imported cefepime in the treatment of moderate to severe urinary tract infection. Methods A randomized controlled clinical trial was conducted in the treatment of patients with urinary tract infection. One hundred and twenty seven patients were enrolled in the trial, 5 patients were withdrawn. There were 61 cases in domestic group and 61 cases in imported group assessable respectively. Both drugs were given intravenously 2 g for urinary tract infection respectively within 30 to 60 minutes by infusion,twice daily. The duration of treatment was 7 to14 days in both groups. Results The overall clinical efficacy rate of domestic and imported group was 98.36% and 96.72%, the bacterial eradication rate both was 100%, and the incidence of adverse reaction was 6.45% and 10.77% respectively. The difference was no significant between two groups. Conclusion Domestic cefepime is as effective and safe as imported one in the treatment of moderate and severe urinary tract infection.

关 键 词：头孢吡肟 急性泌尿系统感染 抗感染 

分 类 号：R978.11[医药卫生—药品] R515[医药卫生—药学]