肺泡灌洗液Gene X-pert MTB/RIF在肺结核诊断中的应用价值

余亚丽 李晓波 魏登军

[摘要] 目的 探討支气管肺泡灌洗液Gene X-pert MTB/RIF（简称X-pert）检查对成年人肺结核的诊断价值。 方法 收集2019年10月至2020年7月湖北省十堰市太和医院165例高度疑似肺结核患者的肺泡灌洗液，完善X-pert检查及BALF涂片检测，分别以病原学诊断和临床诊断为诊断金标准，分析X-pert诊断结核的阳性率，评估X-pert对BALF涂片阴性肺结核的诊断价值，并分析X-pert在成人肺结核中的诊断准确性。 结果 最终诊断结核81例，X-pert诊断结核阳性率为39.39%（65/165），BALF涂片的阳性率22.42%（37/165），X-pert诊断结核的阳性率明显高于BALF涂片，差异有统计学意义（P<0.05）;在81例结核病例中，X-pert真阳性率为77.78%（63/81），分别以病原学诊断和临床诊断为诊断金标准，X-pert在病原学诊断结核中阳性率为82.00%（41/50），敏感度为82.00%，特异度为79.13%。在临床诊断结核中阳性率为70.97%（22/31），敏感度为70.97%，特异度为67.91%。在非结核组出现X-pert阳性2例，假阳性率为2.38%（2/84）;以BALF涂片为金标准，在44例BALF涂片阴性的疑似病例中，X-pert检测出结核分枝杆菌阳性27例，检出率为61.36%（27/44）。 结论 支气管肺泡灌洗液Gene X-pert MTB/RIF在结核诊断中敏感性高，且在BALF涂片阴性时可快速检测出结核分枝杆菌，具有较高的临床实用价值。

[关键词] Gene X-pert MTB/RIF;肺泡灌洗液;涂片阴性;肺结核;诊断

[Abstract] Objective To explore the diagnostic value of bronchoalveolar lavage fluid Gene X-pert MTB/RIF（"X-pert"） for adult pulmonary tuberculosis. Methods The alveolar lavage fluid of 165 patients with highly suspected pulmonary tuberculosis from October 2019 to July 2020 in Taihe Hospital of Shiyan City in Hubei Province were collected. The X-pert examination and BALF smear test were done. Using pathogenic diagnosis and clinical diagnosis as the gold standard for diagnosis， the positive rate of X-pert in the diagnosis of tuberculosis was analyzed，  the diagnostic value of X-pert for BALF smear-negative tuberculosis was evaluated， and analyze the diagnostic accuracy of X-pert in adult pulmonary tuberculosis. Results 81 cases of tuberculosis were finally diagnosed. The positive rate of X-pert in the diagnosis of tuberculosis was 39.39%（65/165）， and the positive rate of BALF smear was 22.42%（37/165）. The positive rate of X-pert was significantly higher than that of BALF smear， with a statistical significance（P<0.05）. In 81 cases of tuberculosis， the true positive rate of X-pert was 77.78%（63/81）. Taking pathogenic diagnosis and clinical diagnosis as the gold standards for diagnosis， the positive rate of X-pert was 82.00%（41/50） in the etiological diagnosis of tuberculosis， the sensitivity was 82.00%， and the specificity was 79.13%. In the clinical diagnosis of tuberculosis， the positive rate was 70.97%（22/31）， the sensitivity was 70.97%， and the specificity was 67.91%. In non tuberculosis group， X-pert was positive in 2 cases， and the false positive rate was 2.38%（2/84）. Taking BALF smear as the gold standard， among 44 suspected cases with negative BALF smear， X-pert detected 27 cases of Mycobacterium tuberculosis positive， with a detection rate of 61.36%（27/44）. Conclusion Bronchoalveolar lavage fluid Gene X-pert MTB/RIF has high sensitivity in the diagnosis of tuberculosis， and can quickly detect mycobacterium tuberculosis when the BALF smear is negative， which has high clinical practical value.

[Key words] Gene X-pert MTB/RIF; Alveolar lavage fluid; Smear negative; Tuberculosis; Diagnosis

结核病（Tuberculosis，TB）是由结核分枝杆菌（Mycobacterium tuberculosis，MTB）感染所引起的具有传染性的疾病，主要发生在肺部，是国内外公共卫生面临的巨大挑战[1]。全球MTB感染人数高达960万人，最终因结核死亡的有150万人[2]，我国新发结核病例数居全球第3位，活动性肺结核患病率为459/10万，其中85.62%为涂阴肺结核。相关研究表明，医务人员医源性感染结核病的机率很高[3]，这可能与结核病早期未能得到明确诊断有关。结核病很可能因为诊治不及时而成为危害国民身心健康的“杀手”，早发现、早诊治是有效控制结核病的关键。肺结核确诊主要依赖细菌学及病原学检测结果，但传统方法检出率低、敏感性差，无法满足早期诊断结核的需要，甚至可能漏诊而导致结核的播散。Gene X-pert MTB/RIF是一种新型分子检测方法，它以半巢式实时定量荧光PCR为基础，通过自动提取DNA并扩增rpoB基因中的192 bp片段，进而检测MTB及对利福平是否耐药[4]。……