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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 evaluate the efficacy and safety of prulifloxacin in the treatment of acute urinary tract infection. Methods According to the criteria of inclusion and exclusion in this study, 144 patients with acute urinary tract infection were selected and divided into two groups according to the random numbers generated by the randomized computer table. Randomized double-blind and double-dummy controlled trials were conducted. The test group took prulifloxacin 200mgbid; the control group took levofloxacin 200mgbid. Treatment are 5 to 10 days. RESULTS: Sixty-seven and sixty-one patients entered the full analysis set (FAS) in each of the two groups, with 63 and 59 eligible for protocol set (PP) analysis. FAS analysis showed that the clinical effective rates of the experimental group and the control group were 85.07% and 88.52% respectively; the bacterial negative conversion rate was 93.75% in the test group and 93.88% in the control group. The results of PP analysis showed that the effective rates of the test group and the control group were 90.48% and 91.53% respectively; the negative rate of bacteria was 97.83% and 97.87% respectively. There was no significant difference between the two groups in clinical curative effect and bacteriological efficacy negative conversion rate (P> 0.05). The adverse reactions of prulifloxacin and levofloxacin were 2.8% and 5.6% respectively. Conclusion Prulifloxacin is effective and safe to urinary tract infections caused by sensitive bacteria.