结核分枝杆菌感染T细胞斑点试验在疑诊肺结核患者中的临床应用

发布时间：2019-03-22 18:21

【摘要】：目的探讨结核分枝杆菌感染T细胞斑点试验(T-SPOT.TB)在肺结核诊断和鉴别诊断中的应用价值。方法纳入2014年4月-2016年12月新疆维吾尔自治区胸科医院疑似肺结核患者700例,于入院次日清晨采集肘正中静脉血用于T-SPOT.TB检测;完善胸部CT检查;取痰液或经支气管镜刷检取样后行涂片抗酸染色,对痰液和灌洗液行结核杆菌及普通细菌培养;必要时取活检行组织病理学检查和诊断性抗结核、抗感染治疗。T-SPOT.TB检测按试剂盒说明书操作,取血5ml分离单个核细胞(PBMC),在预包被抗人γ-干扰素抗体的孔中加入2.5×105个PBMCs,分别与两种结核分枝杆菌特异性抗原,即早期分泌靶抗6(ESAT-6)和培养过滤蛋白10(CFP-10)共同孵育,计数斑点形成细胞(SFCs)。本研究金标准:(1)结核分枝杆菌涂片或培养阳性;(2)临床诊断。满足任何一条即为阳性。观察T-SPOT.TB对活动性肺结核的诊断效能,确定T-SPOT.TB诊断活动性肺结核的最佳临界值。将患者分为活动性肺结核组与非肺结核病组,再将活动性肺结核患者分为初治肺结核与复治肺结核亚组;结核分枝杆菌涂片或培养阳性(简称菌阳)与结核分枝杆菌涂片或培养阴性(简称菌阴)亚组。比较各组患者T-SPOT.TB检测A、B抗原所得SFCs的差异。结果 700例疑诊肺结核患者中624例获得确诊,其中528例(84.6%)确诊为活动性肺结核纳入活动性肺结核组,96例(15.4%)排除肺结核纳入非肺结核组。活动性肺结核组中414例T-SPOT.TB检测结果为阳性,非肺结核组47例T-SPOT.TB检测结果为阴性,T-SPOT.TB检测灵敏度78.4%,特异度49.0%,阳性预测值89.4%,阴性预测值29.2%,阳性似然比为1.537,阴性似然比为0.441。绘制受试者工作特征曲线(ROC),可见当A抗原取值16.0 SFCs/2.5×105 PBMC、B抗原取值7.0 SFCs/2.5×105 PBMC进行并联检测时,T-SPOT.TB的特异度提高至62.5%,灵敏度为72.7%。活动性肺结核组A、B抗原的SFCs显著高于非肺结核组(P0.01),菌阳肺结核组B抗原的SFCs高于菌阴肺结核组(P0.05),其余各组差异无统计学意义。结论 T-SPOT.TB在结核高流行、高感染地区对活动性肺结核诊断的灵敏度较高、特异度低,需结合临床表现进行综合判定。较高的斑点数对判断活动性肺结核有一定的提示意义。
[Abstract]:Objective to evaluate the diagnostic and differential diagnostic value of Mycobacterium tuberculosis infection T cell dot test (T-SPOT.TB). Methods from April 2014 to December 2016, 700 suspected pulmonary tuberculosis patients in the chest Hospital of Xinjiang Uygur Autonomous region were enrolled in this study. The blood of the median elbow vein was collected in the morning after admission for T-SPOT.TB detection, and the chest CT examination was improved. Sputum was collected or brushed by bronchoscope and then stained with acid-fast smears. The sputum and lavage fluid were cultured for tuberculosis and common bacteria. Histopathological examination and diagnostic anti-tuberculosis therapy were performed when necessary. T-SPOT.TB detection was performed according to the instructions of the kit, and blood 5ml was taken to isolate (PBMC), from mononuclear cells. 2. 5 脳 10 ~ 5 PBMCs, were added to the pre-coated pore of anti-human interferon-纬 antibody and incubated with two Mycobacterium tuberculosis specific antigens, namely, early secretory target anti-6 (ESAT-6) and culture filtration protein 10 (CFP-10), respectively. Counting dot forming cell (SFCs). This fellowship standard: (1) Mycobacterium tuberculosis smear or culture positive; (2) clinical diagnosis. To satisfy any one is positive. To observe the diagnostic efficacy of T-SPOT.TB in the diagnosis of active pulmonary tuberculosis and to determine the optimal critical value of T-SPOT.TB in the diagnosis of active pulmonary tuberculosis. Patients were divided into active pulmonary tuberculosis group and non-pulmonary tuberculosis group, and then active pulmonary tuberculosis patients were divided into primary pulmonary tuberculosis group and re-treatment pulmonary tuberculosis subgroup. Mycobacterium tuberculosis smear or culture positive (abbreviated as positive) and Mycobacterium tuberculosis smear or culture negative (negative) subgroup. The difference of SFCs of A and B antigen detected by T-SPOT.TB in each group was compared. Results of the 700 suspected pulmonary tuberculosis patients, 624 cases were diagnosed, 528 cases (84.6%) were diagnosed as active pulmonary tuberculosis and 96 cases (15.4%) were excluded as non-pulmonary tuberculosis group, and 528 cases (84.6%) were diagnosed as active pulmonary tuberculosis group and 96 cases (15.4%) were excluded from pulmonary tuberculosis group. The results of T-SPOT.TB were positive in the active pulmonary tuberculosis group and negative in 47 cases of the non-pulmonary tuberculosis group. The sensitivity, specificity and positive predictive value of T-SPOT.TB were 78.4%, 49.0% and 89.4%, respectively, and the positive predictive value was 89.4% in the non-pulmonary tuberculosis group. The negative predictive value is 29.2%, the positive likelihood ratio is 1.537, and the negative likelihood ratio is 0.441. When the A antigen value was 16.0 SFCs/2.5 脳 105 PBMC,B antigen value was 7.0 SFCs/2.5 脳 105 PBMC for parallel detection, the specificity of T-SPOT.TB was increased to 62.5% when the receiver operating characteristic curve (ROC),) was drawn. The sensitivity was 72.7%. The SFCs of A and B antigen in active pulmonary tuberculosis group was significantly higher than that in non-pulmonary tuberculosis group (P0.01), and the SFCs of B antigen in bacterial-positive pulmonary tuberculosis group was higher than that in bacteria-negative pulmonary tuberculosis group (P0.05), but there was no significant difference among the other groups. Conclusion T-SPOT.TB has a high sensitivity and low specificity in the diagnosis of active pulmonary tuberculosis in areas with high prevalence of tuberculosis and high infection. Therefore, it is necessary to make a comprehensive evaluation in combination with clinical manifestations. A higher number of spots is of certain significance to the judgement of active pulmonary tuberculosis.
【作者单位】：新疆维吾尔自治区胸科医院综合内科;新疆医科大学第一附属医院老年病科;新疆维吾尔自治区胸科医院重症监护室;
【基金】：新疆维吾尔自治区卫生厅青年科技人才专项科研项目(2014Y25)~~
【分类号】：R521

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