第二次实时荧光定量核酸扩增检测在结核病诊断中的增值成本效益分析  

Incremental Cost-effectiveness of the Second Xpert MTB/RIF Assay for Detection of Mycobacterium tuberculosis

作　　者：王淑琦 孙晴 姜广路[1] 付育红[1] 尚媛媛[1] 黄海荣[1] 王桂荣[1] Wang Shuqi;Sun Qing;Jiang Guanglu;Fu Yuhong;Shang Yuanyuan;Huang Hairong;Wang Guirong(National Clinical Laboratory on Tuberculosis,Beijing Key Laboratory for Drug Resistant Tuberculosis Research,Beijing Chest Hospital,Capital Medical University,Beijing Tuberculosis and Thoracic Tumor In stto Beijing 101149,China)

机构地区：[1]首都医科大学附属北京胸科医院,北京市结核病胸部肿瘤研究所,国家结核病临床实验室,北京市耐药结核病研究重点实验室,101149

出　　处：《结核病与胸部肿瘤》2019年第3期185-190,共6页Tuberculosis and Thoracic Tumor

基　　金：国家科技重大专项课题(2017ZX09304009-004,2017ZX10302301-003-004);国家自然科学基金(81703632);北京市自然科学基金(7172050);北京市科学技术委员会基金(Z171100001017065);北京市通州区科技计划项目(KJ2019CX006);北京市卫生与健康科技成果和适宜技术推广项目(2018-TG42)。

摘　　要：目的探讨第二次实时荧光定量核酸扩增(Xpert MTB/RIF,Xpert)检测在结核病诊断中的增值成本效益。方法连续纳入2015年3月至2018年3月在1周内连续进行了2次Xpert检测的2896例疑似结核病患者,其中包括2402例疑似肺结核患者(肺结核组),男1523例,女879例,年龄平均46岁。收集患者临床检测标本,其中痰标本2144例,BALF 258例。疑似肺外结核494例(肺外结核组),男318例,女176例,平均年龄42岁,收集胸腔积液标本157例,脑脊液标本106例,尿液标本34例,骨结核脓液标本197例。所有标本进行2次Xpert检测并行涂片镜检、液体快速培养(BACTEC MGIT 960),培养阳性菌进行药敏试验。肺结核组和肺外结核组标本分别根据涂片检査结果,分为肺结核涂阳组、肺结核涂阴组和肺外结核涂阳组、肺外结核涂阴组。使用X2检验比较第1次和第2次Xpert检测的增值成本效益,/检验评估不同群体成本之间差异的显著性。结果28%例疑似结核病患者标本中,2次Xpert检测结果中任一次阳性者1639例(包含2次检测均为阳性者,全文同),第1次Xpert检测阳性1502例(91.6%),第2次检测阳性者增加了137例(8.4%)。第2次X pert检测的增值效能涂阴组(108/727,14.9%)显著高于涂阳组(29/912,3.2%),两组比较差异有统计学意义(χ^2=221.404,P<0.001);肺外结核组(23/206,11.2%)髙于肺结核组(114/433,8.0%),差异有统计学意义(χ^2=2.422,P=0.012)。药敏试验结果显示,2896例标本中371例为利福平耐药,其中91.4%(339/371)由第1次Xpert检出,第2次Xpert检出率增加了8.1%(30/371)。第2次检测的增值成本效益显著:以650元/次测算,肺结核组第1次和第2次检测的平均成本分别为0.12万元和0.22万元(P<0.001),增值成本为1.37万元;肺外结核组第1次和第2次检测的平均成本分别为0.18万元和0.31万元(P<0.001),增值成本为1.40万元(与同肺结核组增值成本比较,P<0.001)。在肺结核和肺外结核患者标本检测中,涂阴患者第2Objective To study the incremental cost-effectiveness of the second Xpert assay in detection of Mycobacterium tuberculosis(Mtb)and rifampicin(RIF)resistance.Methods We continuously collected 2896 specimens from suspected tuberculosis patients who had undergone 2 Xpert tests in a week from March 2015 to March 2018,including 2402 suspected tuberculosis patients with 1523 males and 879 females,with an average age of 50 years.Among them,2144 specimens of sputum and 258 cases of bronchoalveolar lavage fluid were collected.We also enrolled 494 patients with suspected extrapulmonary tuberculosis,318 males and 176 females,with an average age of 42 years.Among them,157 pleural effusion specimens,106 cerebrospinal fluid specimens,34 urine specimens and 197 pus specimens were collected.All specimens were subjected to two Xpert tests,smear microscopy,liquid rapid culture(BACTEC MGIT960),and positively cultured bacteria were tested for drug susceptibility.Results Among the 2896 specimens from suspected tuberculosis patients,either one of the two Xpert test results was positive(including both tests were positive,the same below)in 1639 patients,and 1502(91.6%)were positive in the first Xpert tests.The additional 137(8.4%)test results were positive in the second tests.According to the smear test results,all specimens were divided into the smear negative group and the smear positive group.The second Xpert test was significantly higher than the smear-positive group(14.86%,3.2%,P<0.001),and the extrapulmonary tuberculosis group was higher than the tuberculosis group(11.2%,8.0%,P=0.12).Of the susceptibility test results,a total of 371 were rifampicin-resistant specimens.The first Xpert detected 91.4%(339/371),and the second Xpert detected the additional 8.1%(30/371).The cost increase of the second test was very significant.Tests were calculated at 650 yuan per time,the tuberculosis group was 1184 yuan and 13696 yuan(P<0.001);the extrapulmonary tuberculosis group was 1755 yuan and 13961 yuan(P<O.OO1).In the test of specimens of tuber

关 键 词：结核 诊断 成本及成本分析 

分 类 号：R52[医药卫生—内科学]