国产巴洛沙星随机对照治疗泌尿系统细菌感染的研究

Study of Randomized Control Trials of Domestic Balofloxacin for Treatment of Bacterial Infections in Urinary System

目的:评价国产巴洛沙星口服治疗泌尿系统细菌感染的临床疗效和安全性。方法:按照系统评价的要求全面检索中国知网中文期刊全文数据库、万方数据医药期刊数据库、维普中文期刊全文数据库内有关国产巴洛沙星治疗泌尿系统细菌感染的文献,并逐个进行质量评价和资料提取,用RevMan 4.2.10软件进行Meta分析。结果:共纳入3项研究,626例患者。试验组(巴洛沙星)和对照组(左氧氟沙星)治疗泌尿系统细菌感染的痊愈率比较,合并比值比(OR)为0.94,经Z检验,P=0.74,2组无显著性差异。试验组和对照组治疗泌尿系统细菌感染的有效率比较,OR为0.65,经Z检验,P=0.41,2组无显著性差异。试验组和对照组治疗泌尿系统细菌感染的细菌清除率比较,OR为1.20,经Z检验,P=0.63,2组无显著性差异。试验组和对照组治疗泌尿系统细菌感染的不良反应率比较,OR为0.90,经Z检验,P=0.77,2组无显著性差异。结论:现有的临床研究证据表明,国产巴洛沙星治疗泌尿系统细菌感染疗效确切,安全性较好,临床应用价值较高。

OBJECTIVE： To evaluate the clinical efficacy and safety of domestic balofloxacin administered orally for bacterial infections in urinary system.METHODS： In answer to the requirement of systemic evaluation,the pertinent literature about domestic balofloxacin treating bacterial infections in urinary system was retrieved from CNKI,Wanfang data（medical journal database） and VIP databases by computer.The included studies were given quality evaluation and the collected data were given meta-analysis by using RevMan 4.2.2 software.RESULTS： A total of 3 studies involving 626 patients were enrolled.There were no significant differences between the trial group（balofloxacin-treated group） and the control group（Levofloxacin-treated group） in terms of the clinical cure rate [OR=0.94,P=0.74（via Z test）],clinical response rate [OR=0.65,P=0.41（via Z test）],bacterial clearance rate [OR=1.20,P=0.63（via Z test）] and rate of patients with adverse drug reactions [OR=0.90,P=0.77（via Z test）].CONCLUSION： The available clinical evidences indicate that domestic balofloxacin is safe and effective with high clinical value in the treatment of bacterial infections in urinary system.