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目的:系统评价宁泌泰胶囊治疗复杂性尿路感染(UTI)的临床疗效和安全性。方法:通过计算机检索CNKI、Cochrane Library、维普、万方数据库、Pub Med等5个数据库(建库至2015年9月),纳入宁泌泰胶囊治疗复杂性UTI临床随机对照试验研究文献。文献质量评价采用Cochrane5.1.0手册标准进行评价。数据提取由2名评价员独立完成,不一致时讨论解决。相关数据采用Rev Man5.2软件进行分析。结果:共检索出相关文献321篇,最终纳入2个随机对照临床试验(RCT),共170名患者。结果显示,研究同质性好I2=0%,选择固定效应模型,合并RR及95%CI为:1.25(1.09,1.44)。Meta分析结果提示:宁泌泰治疗复杂性UTI有效率较单用左氧氟沙星胶囊为优。结论:宁泌泰胶囊是临床常用的中成药之一,临床研究较多,但临床疗效尚缺乏科学证据,总体研究缺乏科学的方案设计、评价体系和循证医学证据,希望宁泌泰胶囊今后能多开展多中心、高质量的研究,提高中药产品质量,为中药产业的发展做出更多的贡献。
Objective: To systematically evaluate the clinical efficacy and safety of Ningbitai capsule in the treatment of complicated urinary tract infection (UTI). Methods: Five databases of CNKI, Cochrane Library, VIP, Wanfang Database and Pub Med were searched by computer. The database of Ningbitai capsule was included in the randomized controlled clinical trial of UTI. Literature quality evaluation using Cochrane5.1.0 manual standards for evaluation. Data extraction by two independent evaluators to complete, inconsistent discussion and solution. Relevant data were analyzed using Rev Man5.2 software. RESULTS: A total of 321 articles were retrieved and finally included in two randomized controlled clinical trials (RCTs) for a total of 170 patients. The results showed good homogeneity I2 = 0%. The fixed effects model was selected. The combined RR and 95% CI were 1.25 (1.09, 1.44). Meta analysis showed that: Ning Bi Thai treatment of complex UTI efficiency than single levofloxacin capsules is better. Conclusion: Ningbitai capsule is one of the most commonly used proprietary Chinese medicines in clinic. There are a lot of clinical studies. However, there is a lack of scientific evidence for clinical curative effect. The overall study lacks scientific program design, evaluation system and evidence-based medicine. To carry out multi-center, high-quality research, improve the quality of Chinese medicine products for the development of Chinese medicine industry to make more contributions.