利福喷丁与利福平治疗肺结核的疗效和安全性的Meta分析

Meta-analysis on efficacy and safety of rifapentine and rifampicin in treatment of pulmonary tuberculosis

目的通过Meta分析的方法评价利福喷丁与利福平治疗肺结核的疗效与安全性，为利福喷丁在临床上治疗肺结核提供更为可靠、科学的依据。方法计算机检索万方数据库、维普数据库、超星数据库、CNKI数据库、PubMed、中国医院数字图书馆、SionMed、TheCochraneLibrary数据库，检索年限为2000年9月至2014年9月，以利福喷丁、利福平、肺结核、rifampicin、rifapentine、pulmonarytuberculosis为检索词，检索公开发表的关于利福喷丁与利福平治疗肺结核的临床随机对照试验。共检索到65篇随机对照实验研究（randomizedcontrolledtrial，RCT）文献，根据纳入标准与排除标准，共纳入17个研究，通过Meta分析方法，运用RevMan5．3软件对纳入的文献进行分析。结果共纳入RCT文献17篇，总样本量为2704例。其中利福喷丁治疗组为1377例，利福平治疗组为1327例，以空洞闭合率、病灶吸收率、痰菌转阴率作为疗效指标，其合并OR值分别是1．57（95％CI：1．23～2．00）、1．91（95％CI：1．1543．16）、2．24（95％CI：1．42～3．53），其差异均有统计学意义（P值均〈0．05）。不良反应方面，利福喷丁组与利福平组仅关节痛的发生率[（利福喷丁组：1．0％（14／1377），利福平组1．1％（15／1327）]差异无统计学意义（x^2=0．08，P〉O．05），而肝功能异常、皮疹、胆红素异常、白细胞降低、发热、蛋白尿、胃肠道不良反应发生率EN福喷丁组：7．8％（108／1877）、0．1％（1／1377）、0．0％、0．9％（12／1377）、0．0％、0．O％、8．7％（120／1377）；利福平组：21．2％（281／1327）、2．5％（33／1327）、3．5％（46／1327）、2．7％（36／1327）、0．4％（5／1327）、0．4%（5／1327）、20．0％（265／1327）]差异有统计学意义（x^2值分别为96．84、31．68、48．48、13．11、5．19、5．19、69．59，P值均〈O．05）。结论与利福平相比，在治疗肺结核方面，利福喷丁在促进空洞闭合、病灶吸收、痰菌转阴方面疗效更显著，且差异具有统计学意义；同时，利福喷丁的安全性优于利福平。

Objective To evaluate the effectiveness and safety of rifampicin and rifapentine on treating pul- monary tuberculosis through meta-analysis and to provide a more reliable and scientific evidence for rifapentine on the clinical treatment of pulmonary tuberculosis. Methods We electrically searched Wan Fang Data,Wei Pu Data, Chao Xing Data, CNKI, PubMed, CHKD, SionMed and The Cochrane Library, The retrieval time was between Sep- tember 2000 and September 2014, the searching key terms were： rifapentine, rifampicin, pulmonary tuberculosis, search the public published clinical randomized controlled trials on the treatment of pulmonary tuberculosis with rifampicin and rifapentine. Totally 65 papers were retrieved, according to the inclusion criteria and exclusion criteria, 17 RCTS were included in the analysis. All the collected studies were analyzed with meta-analysis method by RevMan 5.3 software. Results Seventeen RCTs were involved with the total 2704 sample cases, among which 1377 cases in the rifapentine treatment group, 1327 cases in the rifampicin treatment group. The OR values for cavity- closure rate, nidus-absorption rate, bacterium-sputum negative conversion rate were respectively 1.57 （95% CI： 1.23--2.00）, 1.91 （95%CI： 1.15-- 3.16）, 2.24 （95%CI： 1.42-- 3.53）, the difference had a statistically signifi- cance （P〈0. 05）. In terms of drug safety, the rifampicin group （15/1327） and rifapentine group （14/1377） had no significant difference in joint-pain incidence （x^2 =0. 08, P〈0.05）, while there had statistically significant differencein the incidence of abnormal liver function, skin rashes, abnormal bilirubin, decreased white blood cells, fever, albuminuria, gastrointestinal adverse reactions, （rifapentine group.. 108/1377, 1/1377, 0/1377, 12/1377, 0/1377, 0/1377,12/1377,rifampiein group：281/1327,33/1327,46/1327,36/1327,5/1327,5/1327,265/1327, Xe 96.84, 31.68,48.48,13.11,5.19,5.19,69.59, P〈0. 05）. Conclusion Based on the results, we concluded that in com- pared with rifampicin, rifapentine has advantages in treating pulmonary tuberculosis on cavity closure, nidus absorp- tion, bacterium sputum negative conversion and has less adverse reaction and better tolerance. Meanwhile, rifapen- tine is safer than rifarnpicin.