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目的系统评价国内卷曲霉素联合左氧氟沙星治疗耐多药肺结核的疗效和安全性。方法计算机检索中国生物医学文献数据库(CBM,1978年至2011年10月)、中国期刊全文数据库(CNKI,1994年至2011年10月)、中文科技期刊全文数据库(VIP,1989年至2011年10月)、万方数据库等,并利用Google、Baidu等搜索引擎获取相关临床试验。按照Cochrane系统评价的方法评价纳入研究的质量,并使用Cochrane协作网RevMan4.2.8软件进行统计分析。结果本研究最终纳入6个随机对照试验,总共857例(治疗组441例,对照组416例)。固定效应模型分析结果显示,在痰菌阴转率〔OR合并=4.21,95%CI(3.08,5.75),P<0.05〕,病灶吸收率〔OR合并=1.78,95%CI(1.24,2.54),P<0.05〕,空洞闭合率〔OR合并=2.50,95%CI(1.32,4.71),P<0.01〕方面,卷曲霉素联合左氧氟沙星的治疗组均明显高于对照组。2组不良反应发生率差异无统计学意义〔OR合并=0.82,95%CI为(0.56,1.18),P>0.05〕。结论在疗效方面,卷曲霉素联合左氧氟沙星的治疗组的痰菌阴转率、病灶吸收率、空洞闭合率均高于对照组;但是在安全性方面,2组不良反应发生率相同。由于本系统评价纳入的文献质量较低、数量较少,因此尚需开展更多设计合理、执行严格的多中心大样本的随机对照试验来验证本研究的结论。
Objective To systematically evaluate the efficacy and safety of domestic capreomycin combined with levofloxacin in the treatment of multidrug-resistant pulmonary tuberculosis. Methods The Chinese biomedical literature database (CBM, 1978 to October 2011), Chinese Journal Full-text Database (CNKI, 1994 to October 2011), Chinese Science and Technology Periodical Full-text Database (VIP, 1989 to 2011 10 Month), Wanfang database, etc., and use Google, Baidu and other search engines to obtain relevant clinical trials. The quality of the included studies was assessed according to the Cochrane systematic review and statistical analysis was performed using the Cochrane Collaboration RevMan 4.2.8 software. Results Six RCTs were finally included in this study, for a total of 857 patients (441 in the treatment group and 416 in the control group). Fixed effect model analysis showed that in the sputum negative conversion rate 〔OR = 4.21,95% CI 3.08,5.75, P <0.05〕, the rate of lesion absorption [OR combined = 1.78,95% CI (1.24,2.54) , P <0.05], and the rate of void closure [OR = 2.50,95% CI (1.32, 4.71), P <0.01] was significantly higher in the treatment group with capreomycin plus levofloxacin. There was no significant difference in incidence of adverse reactions between the two groups (OR = 0.82, 95% CI: (0.56, 1.18), P> 0.05). Conclusions In terms of curative effect, the negative conversion rate of sputum, absorption rate of lesions and void closure rate of the treatment group with capsaicin and levofloxacin are higher than those of the control group. However, the safety incidence of adverse reactions in the two groups is the same. Due to the low quality and small number of articles included in this systematic review, more randomized controlled trials with more well-designed, well-executed, multicenter large samples are needed to validate the findings of this study.