中国开展Genotype MTBDR plus检测结核分枝杆菌对异烟肼和利福平耐药性的Meta分析

Evaluation of Genotype MTBDR plus in diagnosing isoniazid and rifampicin resistance of Mycobacteriumtuberculosis in China： a meta-analysis

目的评价中国开展Genotype○R MTBDR plus检测结核分枝杆菌（MTB）对异烟肼和利福平耐药性的诊断效果。方法通过检索PubMed数据库、Science Direct数据库、中国生物医学文献光盘数据库、中国期刊全文数据库和万方数据库，收集2007年1月至2015年11月发表的在中国开展Genotype○R MTBDR plus检测MTB对异烟肼和利福平耐药性的相关文献，进行Meta分析。结果共检索到中、英文文献227篇，本研究纳入16篇，发表时间为2009年至2015年。Genotype○R MTBDR plus检测MTB对异烟肼耐药性的总灵敏度为0.83（95%CI为0.81～0.85），特异度为0.97（95%CI为0.97～0.98），受试者工作特征曲线下面积（AUC）为0.91；检测利福平的总灵敏度为0.94（95%CI为0.93～0.96），特异度为0.98（95%CI为0.97～0.98），AUC为0.99；检测耐多药的总灵敏度为0.82（95%CI为0.79～0.84），特异度为0.99（95%CI为0.98～0.99），AUC为0.99。结论中国开展Genotype○R MTBDR plus检测MTB对异烟肼耐药性的检测效能中等，对利福平耐药性及耐多药的检测效果较好。与国外相比，国内Genotype○R MTBDR plus检测的准确性尚有提高的空间。

Objective To evaluate the value of Genotype MTBDR plus in diagnosing isoniazid and rifampicin resistant Mycobacterium tuberculosis （MTB） in China. Methods By searching PubMed, Science Direct, CBMDISC, CNKI, and Wanfang database, the studies published from January 2007 to November 2015, using Genotype MTBDR plus to diagnose isoniazid and rifampicin resistant MTB in China were collected. The recta-analysis was performed by using Meta-Discl. 4 software. Results Totally 227 articles were found, and 16 articles published from 2009 to 2015 were finally included in this study. The results of meta-analysis showed that the pooled sensitivity and specificity of Genotype MTBDR plus in diagnosing isoniazid resistance were 0.83 （95%CI..0. 81--0. 85） and 0. 97 （95%CI： 0. 97--0. 98） respectively, and the area under the curve （AUC） was 0. 91. The pooled sensitivity and specificity in diagnosing rifampicin resistance were 0. 94 （95% CI： O. 93- 0. 96） and 0. 98 （95% C1： 0.97--0.98）, respectively, and the AUC was 0.99. The pooled sensitivity and specificity in diagnosing multi-drug resistance （MDR） were 0.82 （95%CI： 0.79--0.84） and 0.99 （95%CI： 0.98--0. 99）, respectively, and the AUC was 0.99. Conclusions In China, the diagnostic value of Genotype MTBDR plus is moderate in detecting isoniazid-resistance MTB, and is better in detecting rifampicin-resistant and MDR MTB. The performance of Genotype MTBDR plus in China needs further improvement incomparison with that from foreign countries.