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

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 One hundred and twenty seven patients were enrolled in the trial, 5 patients were withdrawn.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.