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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(P<0.01),菌阳肺结核组B抗原的SFCs高于菌阴肺结核组(P<0.05),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。
Objective To investigate the value of T-SPOT.TB in the diagnosis and differential diagnosis of pulmonary tuberculosis. Methods A total of 700 patients with suspected pulmonary tuberculosis in the Chest Hospital of Xinjiang Uygur Autonomous Region from April 2014 to December 2016 were enrolled in this study. Elbow median venous blood was collected for T-SPOT.TB detection on the morning of the next day of hospitalization. CT examination of the thorax was completed. Or by bronchoscopy brush samples after smear acid-fast staining of sputum and lavage fluid Mycobacterium tuberculosis and ordinary bacterial culture; if necessary, take biopsy histopathology and diagnostic anti-TB, anti-infective treatment. T-SPOT.TB detection according to kit instructions operation, blood 5ml isolated mononuclear cells (PBMC), pre-coated anti-human γ-interferon antibody in the hole by 2.5 × 105 PBMCs, respectively, with two kinds of tuberculosis Mycobacterial-specific antigens, ie, early secreted target anti-6 (ESAT-6) and cultured filter protein 10 (CFP-10) were co-incubated and spot- forming cells (SFCs) were counted. The gold standard: (1) Mycobacterium tuberculosis smear or culture positive; (2) clinical diagnosis. Satisfying any one is positive. Observe the diagnostic efficacy of T-SPOT.TB on active pulmonary tuberculosis and determine the best critical value of T-SPOT.TB in diagnosing active tuberculosis. The patients were divided into active tuberculosis group and non-pulmonary tuberculosis group, and then the active tuberculosis patients were divided into the primary treatment of tuberculosis and retreatment tuberculosis subgroups; Mycobacterium tuberculosis smear or culture positive (referred to as bacilli) and tuberculosis branch Bacillus smear or culture negative (referred to as bacteria Yin) subgroup. The differences of SFCs between A and B antigens detected by T-SPOT.TB in each group were compared. Results A total of 624 out of 700 suspected TB cases were diagnosed. Among them, 528 cases (84.6%) were diagnosed as active tuberculosis (TB), and 96 (15.4%) were excluded from tuberculosis. The results of T-SPOT.TB were positive in 414 cases of active tuberculosis group, negative of T-SPOT.TB in 47 cases of non-tuberculosis group, the sensitivity and specificity of T-SPOT.TB were 78.4% and 49.0% respectively, and the positive predictive value 89.4%, negative predictive value 29.2%, positive likelihood ratio 1.537, negative likelihood ratio 0.441. The receiver operating characteristic curve (ROC) was plotted. When the A antigen value was 16.0 SFCs / 2.5 × 105 PBMC and the B antigen value was 7.0 SFCs / 2.5 × 105 PBMC, the specificity of T-SPOT.TB was increased To 62.5% with a sensitivity of 72.7%. The SFCs of A and B antigens in active tuberculosis group were significantly higher than those in non-tuberculosis group (P <0.01), SFCs of B antigen in positive bacilli tuberculosis group were higher than that of negative yin lung tuberculosis group (P <0.05), and the other groups had no significant difference . Conclusion T-SPOT.TB has high sensitivity and low specificity in the diagnosis of active pulmonary tuberculosis in high-prevalence and high-infection areas of tuberculosis. It needs comprehensive judgment in combination with clinical manifestations. High spots to determine the activity of tuberculosis have some implications.