CT引导下肺穿刺活检标本行PCR检测诊断肺结核的临床价值

Clinical value of PCR test in diagnosis of pulmonary tuberculosis by using CT-guided lung biopsy specimens

目的 探讨CT引导下肺穿刺活检标本行PCR检测在肺结核诊断中的价值。方法 回顾性选取2017年1月至2018年3月同济大学附属上海市肺科医院曾疑诊为肺结核、后经病理证实或试验性抗结核治疗确诊的全部111例患者,其中肺结核患者73例（65.8%）,非肺结核患者38例（34.2%;包括结节病3例、肺癌17例、隐球菌感染3例、曲菌感染4例、肺脓肿3例、异物肉芽肿2例,支气管扩张症6例）。111例患者均在CT引导下获取肺穿刺活检标本行涂片细胞病理学检查（简称“细胞病理学检查”）,其中13例因两次细胞病理学检查不能确诊而行CT引导下粗针肺穿刺活检标本组织病理学检查（简称“组织病理学检查”）;上述标本同时采用PCR检测结核分枝杆菌DNA（分别简称为“细胞病理学标本TB-PCR检测”与“组织病理学标本TB-PCR检测”）。以临床最终诊断为标准,探究细胞病理学标本TB-PCR检测诊断肺结核的敏感度、特异度、阳性预测值、阴性预测值、正确指数（一致性）,以及组织病理学标本TB-PCR检测的检出效用。采用SPSS 21.0软件对数据进行统计学处理,计数资料采用χ2检验,以P〈0.05为差异有统计学意义。 结果 以临床最终诊断为标准,细胞病理学标本TB-PCR检测的敏感度、特异度、阳性预测值、阴性预测值、正确指数分别为83.6%（61/73）、89.5%（34/38）、93.8%（61/65）、73.9%（34/46）、0.73;对肺结核的检测阳性率[83.6%（61/73）]明显高于单一细胞病理学检查[39.7%（29/73）]（χ2=29.663,P=0.000）。73例肺结核患者中,13例经组织病理学标本TB-PCR检测阳性者8例,而经细胞病理学标本TB-PCR检测阳性者为12例。另外,肺结核患者中9例（12.3%,9/73）经细胞病理学、组织病理学检查及传统检测方法（痰涂片抗酸染色及痰培养）均未能诊断结核病,经细胞病理学标本TB-PCR检测后有4例阳性。 结论 CT引导下肺穿刺活检标本行TB-PCR检测可提高肺结核诊断的阳性率,具有良好的临床应用价值。

Objective To explore the clinical value of polymerase chain reaction （PCR） test in diagnosis of pulmonary tuberculosis （PTB） by using CT-guided lung biopsy specimens.Methods A retrospective study was conducted by collecting information and data from a total of 111 patients, who visited Shanghai Pulmonary Hospital from January 2017 to March 2018 and were suspected to have PTB at beginning, finally, by pathological test or experimental therapy with anti-TB drugs, 73 （65.8%） cases were confirmed to be PTB patients and 38 （34.2%） cases were non-TB patients （3 patients had sarcoidosis, 17 patients had lung cancer, 3 patients were infected by cryptococcus, 4 patients were infected by aspergillus, 3 patients had lung abscess, 2 patients had foreign body granuloma and 6 patients had bronchiectasis）. The biopsy specimens were obtained from all enrolled 111 patients by using CT-guided lung puncture and smear cytopathology examination was performed; among them, the biopsy specimens were obtained from 13 cases by using CT-guided coarse needle lung puncture and histopathological examination was performed because the diagnosis of those patients couldn’t be confirmed after cytopathology examination had been conducted for 2 times. At the same time, PCR test was also performed to those biopsy specimens to detect Mycobacterium tuberculosis （MTB） DNA. The final clinical diagnosis was regarded as a standard. Based on the clinical diagnosis results, the sensitivity, specificity, positive and negative predictive values, correct indices （consistency） of TB-PCR test in diagnosis of PTB by using cytopathological specimens, as well as the effects of TB-PCR test by using histopathological specimens were explored. SPSS 21.0 software was used for statistical analysis of the data. Count variables were analyzed by χ2 test and P〈0.05 was regarded as statistically significant difference. Results Regarding the final clinical diagnosis as a standard, the sensitivity, specificity, positive predictive value, negative predictive value and correct indices of TB-PCR test in PTB diagnosis by using cytopathological specimens were 83.6% （61/73）, 89.5% （34/38）, 93.8% （61/65）, 73.9% （34/46） and 0.73 respectively. The positive rate of TB-PCR for PTB was 83.6% （61/73）, which was significantly higher than that of single cytopathological examination （39.7% （29/73） （χ2=29.663, P=0.000）. Among 73 cases with PTB, TB-PCR test by using histopathological specimens were performed in 13 cases and the results were positive in 8 cases; the results of TB-PCR test by using cytopathological specimens were positive in 12 cases. Among the PTB patients, 9 patients （12.3%, 9/73） were not diagnosed as TB by cytopathological and histopathological examinations, as well as the traditional tests （such as sputum smear microscopy and sputum culture）; however, 4 patients were positive through TB-PCR test by using cytopathological specimens. Conclusion The diagnosis rate of PTB can be improved by using TB-PCR test with CT-guided lung biopsy specimens and this method has valuable of clinical application. Key words： Tuberculosis, pulmonary, Biopsy, fine-needle, Polymerase chain reaction, Sensitivity and specificity, Evaluation study