XpertMTB／RIF对结核性脑膜炎诊断的临床评价  

The evaluation of Xpert MTB/RIF for the diagnosis of tuberculous meningitis

作　　者：张瑞雪[1] 龙铟[2] 冯国栋[3] 刘昊[1] 白广红 徐修礼[1] 程晓东[1] 郝晓柯[1] 刘家云[1] 

机构地区：[1]第四军医大学西京医院检验医学研究所,西安710032 [2]第四军医大学西京医院中医科,西安710032 [3]第四军医大学西京医院神经内科,西安710032 [4]陕西省结核病防治院检验科

出　　处：《中华检验医学杂志》2016年第6期442-447,共6页Chinese Journal of Laboratory Medicine

基　　金：第四军医大学西京医院学科助推计划重大临床技术项目（XJZT10203）

摘　　要：目的旨在评价XpertMTB／RIF对结核性脑膜炎（TBM）的诊断价值。方法选取2013年10月至2015年6月在西京医院就诊的疑似脑膜炎的连续病例116例（男性79例，女性37例），取1ml脑脊液标本进行XpertMTB／RIF检测，同时完成脑脊液抗酸染色和MGIT960液体培养等相关检测，并按照最新的结核性脑膜炎诊断标准对入组患者进行分组。分别以临床评分〉5分和MGIT960液体培养作为参考标准来评价XpertMTB／RIF的诊断性能。采用χ2检验和Fisher确切概率法进行计数资料的比较，采用非参数的秩和检验进行计量资料的比较，P〈0．05认为差异有统计学意义。结果116例纳入研究对象中经培养确诊的TBM患者有23例，很可能的TBM患者有16例，可能的TBM患者有27例，非结核性脑膜炎患者50例。以临床评分〉5分为参考标准，XpertMTB／RIF的灵敏度（39．4％）与MGIT960液体培养（34．8％）相当（x2=0．292，P=0．589），明显优于抗酸染色法（9．9％）（χ2=16．500，12．771，P〈0．001）。而XpertMTB／RIF、MGIT960培养和抗酸染色的特异性分别为98．0％、100．0％及98．0％，差异无统计学意义（χ2=1．014，P=0．602）；若以MGIT960液体培养为参考标准，XpertMTB／RIF诊断TBM的灵敏度为91．3％。结论XpertMTB／RIF能够快速特异地检测脑脊液中结核分枝杆菌及其利福平耐药，此法具有较好的确诊结核性脑膜炎的价值，且灵敏度与MGIT960液体培养法相当，可作为首选方法用于结核性脑膜炎的早期诊断。Objective To evaluate the diagnostic performance of Xpert MTB/RIF for the diagnosis of tuberculous meningitis （TBM）. Methods This was a prospective, single center clinical trial. A total of 116 consecutive patients with suspected meningitis who were admitted to Xijing Hospital from October 2013 to June 2015 were recruited. Myeobacterium tuberculosis （MTB） and rifampicin （RIF） resistance mutations in 1 ml eerebrospinal fluid （CSF） were detected with Xpert MTB/RIF and the remaining sample was tested by Ziehl-Neelsen staining, MGIT960 liquid culture and other laboratory tests. And the enrolled patients were grouped according to the 2010 South African expert consensus. The diagnostic performance of Xpert MTB/ RIF was evaluated by comparing against clinical score 〉 5 points and MGIT960 liquid culture as reference standards respectively. The comparison was performed using a χ2 test or Fisher＇s exact test for categorical variables and a nonparametrie rank sum test for continuous variables. Results Among the enrolled 116 subjects, 23 subjects were diagnosed as definite-TBM by MGIT960 liquid culture, 16 subjects were classified as probable TBM, 27 subjects were classified as possible TBM, and 50 subjects were classified as non-TBM. When clinical score 〉 5 points was used as a reference standard, the sensitivity of Xpert MTB/RIF （39. 4% ） was comparable with that of MGIT960 liquid culture （ 34. 8% ） （ χ2 = 0. 292, P = 0. 589）, and significantly better than that of Ziehl-Neelsen staining （9. 9% ） （χ2 = 16. 500, 12. 771, P 〈 0. 001 ）. No significant differences were found among the specificities of Xpert MTB/RIF, MGIT960 liquid culture and Ziehl-Neelsen staining （ 98.0%, 100. 0% vs 98.0% ,χ2 = 1. 014, P = 0. 602 ）. When tested against MGIT960 liquid culture as a reference standard, the sensitivity of Xpert MTB/RIF was 91.3% . Conclusions Xpert MTB/RIF is a rapid and specific method to detect MTB and RIF resistance in CSF. It exhibits a good rule in value for the diagnosis o

关 键 词：结核  脑膜 结核分枝杆菌 利福平 抗药性 细菌 聚合酶链反应 敏感 性与特异性 

分 类 号：R529.3[医药卫生—内科学]