浙江省推广基于GeneXpert MTB/RIF检测的结核病诊断流程的效果分析  

Analysis of the efficiency of tuberculosis diagnosis progress based on GeneXpert MTB/RIF application in Zhejiang Province

作　　者：柳正卫[1] 彭颖[1] 张明五[1] 张钰[1] 陈松华[1] 陈彬[1] 王晓萌[1] LIU Zheng-wei;PENG Ying;ZHANG Ming-wu;ZHANG Yu;CHEN Song-hua;CHEN Bin;WANG Xiao-meng(Department of TB Control and Prevention,Zhejiang Provincial Center for Disease Control and Prevention,Hangzhou 310051,China)

机构地区：[1]浙江省疾病预防控制中心结核病预防控制所,杭州310051

出　　处：《中国防痨杂志》2021年第8期790-795,共6页Chinese Journal of Antituberculosis

基　　金：浙江省医药卫生科技计划项目(2019RC135);浙江省医药卫生科技计划项目(2020KY512);国家卫生健康委员会卫生技术评估重点实验室(复旦大学)(FHTA2019-05)。

摘　　要：目的评价以GeneXpert MTB/RIF(简称“Xpert”)检测技术为基础的结核病诊断流程对提高结核病病原学阳性比例及缩短耐药筛查时间的效果。方法从《中国疾病预防控制信息系统》子系统《结核病信息管理系统》中,收集2015—2020年浙江省90家结核病定点医疗机构登记的151526例活动性肺结核患者的登记治疗情况、实验室检查结果情况、耐药筛查情况等信息。分析浙江省不同时间的肺结核病原学阳性检测结果,评价耐药结核病的诊断时效。结果2015—2017年,浙江省活动性肺结核病原学阳性率分别为39.05%(10695/27385)、37.75%(9877/26166)和40.68%(10580/26009),差异有统计学意义(χ^(2)=47.206,P<0.01);2018—2020年浙江省活动性肺结核病原学阳性率分别为56.11%(14197/25302)、62.27%(15161/24348)和64.39%(14369/22316),呈逐年递增趋势,差异有统计学意义(χ^(2)趋势=374.701,P<0.01)。2017—2020年,Xpert在病原学阳性患者检出中的贡献率从0.63%(67/10580)提高至24.02%(3452/14369);在涂阴肺结核患者中检测率及阳性检出率从2.00%(321/16048)和40.81%(131/321)分别提升至54.62%(7338/13434)和60.63%(4449/7338)。2020年涂片、培养和Xpert联合用于病原学检测的检测率达到99.62%(22178/22262),阳性检出率达到64.37%(14275/22178),明显高于单独进行涂片和培养检测的阳性率[分别为39.30%(8697/22131)和50.66%(7629/15059)],差异均有统计学意义(χ^(2)值分别为2788.140和695.491,P值均<0.01)。与传统比例法药物敏感性试验相比,采用以Xpert检测为主的分子药物敏感性试验进行耐药结核病筛查,可将耐药患者诊断时间[中位数(四分位数)]从2015年的62.5(34.0,94.3)d缩减至2020年的1.0(0.0,7.0)d。结论基于Xpert检测技术的结核病诊断流程,能够明显提升基层结核病病原学检测阳性率,且可明显缩短耐药结核病患者的诊断时间。Objective To evaluate the effectiveness of the diagnostic process of tuberculosis based on the GeneXpert MTB/RIF(Xpert)in increasing the proportion of positive etiology and shorten the time of drug-resistant screening.Methods From the Tuberculosis Information Management System,the subsystem of China Disease Prevention and Control Information System,the registered treatment,laboratory results and drug-resistant screening,etc.of 151526 active pulmonary tuberculosis patients registered from 90 designated tuberculosis medical institutions in Zhejiang Province between 2015 and 2020.The positive etiology results of pulmonary tuberculosis at different times in Zhejiang Province were analyzed to evaluate the effectiveness of drug-resistant tuberculosis.Results From 2015 to 2017,the positive etiology rates of active pulmonary tuberculosis in Zhejiang were 39.05%(10695/27385),37.75%(9877/26166)and 40.68%(10580/26009),respectively,the differences were statistically significant(χ^(2)=47.206,P<0.01).From 2018 to 2020,the pathogenic positive rate of active tuberculosis in Zhejiang Province was 56.11%(14197/25302),62.27%(15161/24348)and 64.39%(14369/22316),showing an increasing trend year by year.The differences were statistically significant(χ^(2)trend=374.701,P<0.01).From 2017 to 2020,the contribution rate of Xpert in etiology-positive cases increased from 0.63%(67/10580)to 24.02%(3452/14369),and the detection rate and positive contribution rate in smear-negative pulmonary tuberculosis increased from 2.00%(321/16048)and 40.81%(131/321)to 54.62%(7338/13434)and 60.63%(4449/7338),respectively.When smear,culture and Xpert were combined used to detect tuberculosis,the etiological detection rate in 2020 reached 99.62%(22178/22262);and the positive rate of detection was 64.37%(14275/22178),significantly higher than those of smear(39.30%,8697/22131)and culture only(50.66%,7629/15059)(χ^(2)=2788.140,695.491,both P<0.01).Compared with the traditional proportional method of phenotypic susceptibility test,the drug-resistant tuberculos

关 键 词：结核 诊断 核酸扩增技术 方案评价 

分 类 号：R52[医药卫生—内科学]