普卢利沙星治疗急性尿路感染的随机双盲对照试验  

Prulifloxacin in the Treatment of Urinary Tract Infection:A Double-Blind,Randomized Controlled Trial

作　　者：邱红渝[1] 蔡永宁[2] 付平[1] 郑莉[2] 吴小候[3] 冷静[4] 张桂发[5] 钟慧[1] 沙朝晖[1] 李孜[1] 米绪华[1] 戴强 陆丁 

机构地区：[1]四川大学华西医院肾脏内科,成都610041 [2]四川大学华西医院国家药品临床研究基地 [3]重庆医科大学附一院泌尿外科,重庆400016 [4]上海第二医科大学附属仁济医院,上海200001 [5]皖南医学院弋矶山医院,广州241001 [6]江苏亚邦爱普森药业有限公司,南京224600

出　　处：《中国循证医学杂志》2006年第6期399-403,共5页Chinese Journal of Evidence-based Medicine

摘　　要：目的评价普卢利沙星治疗急性尿路感染的有效性和安全性。方法根据本研究的纳入和排除标准,选取急性尿路感染患者144例,按计算机随机表产生的随机号将患者分为两组,进行随机双盲、双模拟对照试验。试验组服用普卢利沙星200mgbid;对照组服用左氧氟沙星200mgbid。疗程均为5～10天。结果两组各有67和61例可进入全分析集(FAS),各有63和59例可进行符合方案集(PP)分析。FAS分析结果显示,试验组和对照组的临床有效率分别为85.07%和88.52%;细菌阴转率试验组为93.75%,对照组为93.88%。PP分析结果显示,试验组和对照组的有效率分别为90.48%和91.53%;细菌阴转率分别为97.83%和97.87%。两组临床疗效和细菌学疗效阴转率差异均无统计学意义(P>0.05)。普卢利沙星和左氧氟沙星的不良反应发生率分别为2.8%和5.6%。结论普卢利沙星对敏感菌引起的尿路感染疗效确切,安全性好。Objective To assess the effectiveness and safety ofprulifloxacin in the treatment of urinary tract infection. Methods The double-blind, double dummy and randomized controlled method was adopted. One hundred and forty-four patients were randomized to the treatment group （prulifloxacin, 4 tablets, bid） and the control group （levofloxacin, 4 tablets, bid）. The randomization code was produced by computer. The treatment duration for both groups was from 7 to l0 days. Results Data were analyzed on the basis of full analysis sets （FAS） and per-protocol （PP） analysis. The total improvement rates of the trial and control groups were 85.07% and 88.52% respectively by FAS analysis, and 90.48% and 91.53% respectively by PP analysis. There was no significant difference between the two groups in improvement rates （P〉0.05）. Bacterial negative rates in the trial and control groups were 93.75% and 93.88% respectively by FAS analysis and 97.83% and 97.87% respectively by PP analysis. The results showed no statistical significance difference between the two groups in bacterial negative rates （P〉0.05）. The adverse events in the prulifloxacin and levofloxacin groups were 2.80% and 5.60% respectively. Conclusion Prulifloxacin has the same clinical effectiveness as levofloxacin with a few toxic adverse effects in the treatment of urinary tract infection.

关 键 词：尿路感染 普卢利沙星 左氧氟沙星 随机双盲对照试验 

分 类 号：R691.3[医药卫生—泌尿科学]