利奈唑胺治疗耐多药和广泛耐药肺结核的疗效和安全性的Meta分析

Efficacy and safety of linezolid for multidrug-resistant and extensively drug-resistant pulmonary tuberculosis:a Meta-analysis

目的:系统评价利奈唑胺治疗耐多药和广泛耐药肺结核的疗效和安全性。方法:计算机检索Web of Science、Cochrance Library、Pubmed、Embase、维普(VIP)、中国知网(CNKI)和万方(Wan Fang DATA)数据库,收集利奈唑胺治疗耐多药和广泛耐药肺结核的随机对照试验(randomized controlled trial,RCT),检索时限均为从建库至2016年9月30日,同时手工检索纳入文献的参考文献。由两名研究者独立筛选文献、提取资料,并评价文献质量,采用Rev Man 5.3软件进行Meta分析。结果:共纳入8个RCT,417例患者。Meta分析结果显示:利奈唑胺组的痰菌阴转率(RR=1.62,95%CI:1.43~1.84,P<0.00001)、病灶吸收率(RR=1.92,95%CI:1.59~2.32,P<0.00001)、空洞闭合率(RR=2.09,95%CI:1.66~2.63,P<0.00001)和症状改善率(RR=1.45,95%CI:1.26~1.67),P<0.0001)均高于对照组,差异有统计学意义;利奈唑胺组的总体不良反应发生率(RR=1.39,95%CI:0.86~2.25,P=0.18)、贫血或白细胞减少发生率(RR=1.08,95%CI:0.66~1.76,P=0.77)、末梢神经炎发生率(RR=1.68,95%CI:0.87~3.22,P=0.12)、胃肠道症状发生率(RR=1.53,95%CI:1.00~2.33,P=0.05)、尿蛋白强阳性发生率(RR=0.95,95%CI:0.50~1.82,P=0.89)和凝血指标异常发生率(RR=0.84,95%CI:0.42~1.68,P=0.62)与对照组相比均无统计学差异(P均>0.05)。结论:当前证据表明,利奈唑胺联合常规抗结核治疗方案治疗耐多药和广泛耐药肺结核的疗效优于常规抗结核治疗方案,且安全性与常规抗结核治疗方案相当。

Objective： To systematically review the efficacy and safety of linezolid for multidrug-resistant and extensively drug- resistant pulmonary tuberculosis. Methods： We searched databases including Web of Science, Cochrance Library, Pubmed, Embase, VIP, CNKI, and WanFang DATA to collect randomized controlled trials （RCTs） about linezolid for multidrug-resistant and extensively drug- resistant pulmonary tuberculosis from inception to September 2016. The references of these RCTs were also searched. Two reviewers independently screened literatures, extracted data and assessed quality of included studies. Then, Meta-analysis was performed using RevMan 5.3 software. Results： A total of 8 RCTs involving 417 patients were included. The results of Meta-analysis indicated that： The sputum negative conversion rate （RR=1.62, 95%CI 1.43 to 1.84, P〈0.00001）, focal absorption rate （RR=1.92, 95%CI 1.59 to 2.32, P〈0.00001）, cavity closure rate （RR=2.09, 95%CI 1.66 to 2.63, P〈0.00001） and symptoms improvement rate （RR=1.45, 95%CI 1.26 to 1.67, P〈0.0001） in the linezolid group were higher than those in the control group. However, there were no significant differences in the incidence of total adverse drug reactions （RR=1.39, 95%CI 0.86 to 2.25, P=0.18）, anemia or leukopenia （RR=1.08, 95%CI 0.66 to 1.76, P=0.77）, peripheral neuritis （RR=1.68, 95%CI 0.87 to 3.22, P=0.12）, gastrointestinal symptoms （RR=1.53, 95%CI 1.00 to 2.33, P=0.05）, strong positive urinary protein （RR=0.95, 95%CI 0.50 to 1.82, P=0.89） and abnormal coagulation indexes （RR=0.84, 95%CI 0.42 to 1.68, P=0.62） between the two groups. Conclusion： Current evidence shows that, compared with conventional antituberculosis regimen, linezolidcombined with conventional antituberculosis regimen has better efficacy and similar safety for multidrug-resistant and extensively drug- resistant pulmonary tuberculosis. Due to the limited quality and quantity of included studies, RCTs with higher quality and larger samples are needed to verify the above conclusion.