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目的:评价国产帕珠沙星与左氧氟沙星治疗呼吸、泌尿系统细菌感染的疗效及不良反应发生情况。方法:通过检索CNKI数据库,收集1993年至2008年国内公开发表的帕珠沙星和左氧氟沙星治疗呼吸、泌尿系统细菌感染相关的随机对照研究文献(RCT)。根据入选标准严格筛选文献并按meta分析要求对入选文献进行质量评估,应用Revman5.0和Stata10.0软件进行分析,计算国产帕珠沙星与左氧氟沙星治疗呼吸、泌尿系统感染的治愈率、有效率、细菌清除率及不良反应发生率的优势比(OR)、95%可信区间(CI)及P值。结果:本研究共入选2005年至2008年进行的10项RCT研究,纳入1974例患者,其中帕珠沙星组982例,左氧氟沙星组992例。meta分析结果显示,国产帕珠沙星组与左氧氟沙星组治疗急性细菌性感染临床痊愈率分别为66.6%和65.7%;有效率分别为92.3%和91.5%;细菌清除率分别为95.1%和93.3%;不良反应发生率分别为12.5%和12.9%;其各自的综合OR值分别为1.05(95%CI为0.86～1.27,P=0.650)、1.10(95%CI为0.79～1.53,P=0.560)、1.45(95%CI为0.93～2.27,P=0.100)、0.97(95%CI为0.74～1.26,P=0.810),差异均无统计学意义。结论:国产帕珠沙星与左氧氟沙星治疗呼吸、泌尿系统感染的疗效与不良反应发生情况相似。
Objective: To evaluate the curative effect and adverse reactions of domestic pazufloxacin and levofloxacin in the treatment of respiratory and urinary bacterial infections. Methods: A randomized controlled study (RCT) of Pazufloxacin and levofloxacin published in China from 1993 to 2008 on the bacterial infections of respiratory and urinary system was collected by searching CNKI database. According to the selected criteria strict screening of the literature and according to meta-analysis of the quality of selected documents, the application of Revman5.0 and Stata10.0 software analysis, domestic pazufloxacin and levofloxacin treatment of respiratory and urinary tract infections cure rate, effective , Odds ratio (OR), 95% confidence interval (CI) and P value of bacterial clearance rate and adverse reaction rate. RESULTS: Ten RCTs were enrolled in this study from 2005 to 2008, and included 1974 patients, of whom 982 were pazufloxacin and 992 were levofloxacin. Meta analysis showed that the clinical cure rates of domestic pazufloxacin group and levofloxacin group were 66.6% and 65.7% respectively, the effective rates were 92.3% and 91.5% respectively, and the bacterial clearance rates were 95.1% and 93.3% respectively ; The incidences of adverse reactions were 12.5% and 12.9%, respectively; the respective comprehensive ORs were 1.05 (95% CI 0.86-1.27, P 0.650), 1.10 (95% CI 0.79-1.53, P 0.560) , 1.45 (95% CI 0.93-2.27, P = 0.100), 0.97 (95% CI 0.74-1.26, P = 0.810), the difference was not statistically significant. Conclusion: The efficacy of domestic pazufloxacin and levofloxacin in treating respiratory and urinary tract infections is similar to that of adverse reactions.