加替沙星治疗难治、耐多药肺结核有效性和安全性的系统评价-余文韬.doc

加替沙星治疗难治、耐多药肺结核 有效性和安全性的系统评价 余文韬*，尹茜，吴斌，唐尧# （四川大学华西医院药剂科，成都市） 摘要 目的:系统评价加替沙星治疗难治、耐多药肺结核的疗效和安全性。方法：计算机检索Cochrane图书馆和PubMed、EMASE、CBM、VIP、CNKI数据库，按纳入排除标准选择试验，并对其进行质量评价。用RevMan5.0软件对数据进行Meta分析。结果：共纳入12篇研究， Meta分析结果显示加替沙星治疗组与对照组相比，痰菌转阴率、病灶吸收情况、空洞改变的情况均优于对照组，差异具有统计学意义（P0.05）。结论：目前现有的证据表明，加替沙星与一线抗结核药物联用治疗难治、耐多药肺结核的疗效优于一线抗结核药物的方案，且加替沙星可能是优于左氧氟沙星的氟喹诺酮类二线抗结核药物，但由于纳入的文献数量有限，质量普遍不高，存在潜在的发表偏倚上述结果有待高质量，大样本的随机双盲对照试验加以验证。 关键词 加替沙星；抗结核药物；肺结核；系统评价 Systematic review of combination regimens with gatifloxacin in treatment of MDR-TB ABSTRACT: OBJECTIVE: to assess the clinical efficacy of combination regimens with gatifloxacin in treatment of MDR-TB. METHOD: literatures were retrieved from PuMed, EMBASE, Cochrane, SCI, CBM, VIP, CNKI, WangFang databases by computer. Literatures were enrolled according to including criteria and excluding criteria, the quality were evaluated and meta-analysis was conducted by RevMan 5.0 software. RESULT: the meta-analysis of 12 included RCTs showed that sputum culture conversion rate, focus absoption rate, cavity change rate in trial group were significantly differenet from control group(P＜0.5).CONCLUSION:The analysis indicates gatifloxacin with first-line antituberculosis drugs has a better effect in treatment of MDR-TB than first-line antituberculosis drugs alone.fluoroquinolones, maybe a better choice than levofloxacin. However, the reliability of this review is affected by poor quality of included studys, large-scale randomized controlled trials of high quality are needed to confirm the above conclusions. KEY WORDS Gatifloxacin; Antituberculosis drug; Pulmonary tuberculosis; Systematic review 难治性、耐多药肺结核（MDR-TB）））））”、“Tequin”、“tuberculosis”。 1.3数据提取与质量评价 由两名评价员独立纳入试验、评价质量，按设计好的信息提取表提取信息。两研究员对质量评价和信息提取表进行交叉核对，如意见不一致时通过讨论或征求第三方研究者的意见解决。如果信息缺失应尽量与作者缺的联系，获取补齐。纳入试验的方法学质量评价参考Cochrane系统评价手册5.0版评价RCT质量的简单评估法进行。 1.4统计学方法 采用Cochrane协作网提供的RevMan5.0进行Meta分析。采用χ2检验判断各纳入研究结果间的异质性，如各研究无统计学异质性（P≥0.1）采用固定效应模型，存在异质性（P0.1）采用随机效应模型进行合并分析。分类变量采用相对危险度（RR）并用95%CI表示效应量。 2 结果