传统组织病理学检查与Xpert MTB/RIF检测在脊柱结核诊断中的作用（临床论著）

来源：中国脊柱脊髓杂志

董伟杰，秦世炳，兰汀隆，范  俊，唐 恺，李  元，严广璇，王 恒

（首都医科大学附属北京胸科医院骨科 101149 北京市）

基金项目：北京市科技计划课题（编号：D141107005214002）

第一作者简介：男（1979-），副主任医师，医学硕士，研究方向：骨关节结核基础与临床研究

电话：（010）89509328  E-mail：weijied@sina.com

通讯作者：秦世炳  E-mail：qinsb@sina.com

【摘要】 目的：评价传统组织病理学（简称“病理”）检查与Xpert MTB/RIF（简称“Xpert”）检测在脊柱结核诊断中的作用。方法：回顾性分析2015年1月~2018年4月在我院诊断为脊柱结核的442例患者的资料，男227例（51.4%），女215例（48.6%）；年龄18~86岁（46.3±18.0岁）；胸椎结核165例，腰椎结核162例，腰骶椎结核53例，胸腰段结核46例，颈椎结核11例，颈胸段结核5例。所有患者通过穿刺或手术获得病灶中的脓液、死骨、肉芽组织及干酪样坏死组织，同时进行传统组织病理学检查与Xpert检测，计算两者的阳性率与阴性率。病理诊断分四类，一类、二类为确诊结核，三类、四类为未诊断结核。以病理诊断为标准，获得Xpert检测的敏感度、特异度，计算kappa值评估两者的一致性。以病理诊断为金标准，绘制Xpert检测的受试者工作特征（reciever operating characteristic，ROC）曲线并计算曲线下面积（area under curve，AUC），评估Xpert检测的价值。结果：442例患者中，病理确诊为结核292例（66.1%，95%CI为61.4%~70.5%），病理未诊断结核150例（33.9%，95%CI为29.5%~38.6%）；Xpert检测阳性363例（82.1%，95%CI为78.2%~85.6%），阴性79例（17.9%，95%CI为14.4%~21.8%），发现rpoB突变43例（9.7%）。Xpert检测阳性率高于病理检查（χ2=46.2477，P<0.001）。以病理诊断为金标准，病理确诊为结核的292例中，Xpert阳性273例，阴性19例；病理为三、四类诊断未确诊结核的150例中，Xpert阳性90例，阴性60例；Xpert的敏感度为93.5%（273/292），特异度为40%（60/150）。病理与Xpert两种检测确诊脊柱结核的kappa值=0.378（95%CI为0.290~0.466），一致性欠佳。Xpert检测诊断脊柱结核的AUC为0.667。病理检查与Xpert检测联合诊断脊柱结核的阳性率为86.4%（382/442）。结论：Xpert检测可以提高脊柱结核的确诊率并发现利福平耐药突变，标本量足够的前提下推荐同时行病理检查和Xpert检测。

【关键词】 脊柱结核；诊断；病理检查；Xpert MTB/RIF检测

doi：10.3969/j.issn.1004-406X.2019.08.03

中图分类号：R529.2，R446.8，R446.5    文献标识码：A   文章编号：1004-406X（2019）-08-0692-06

Evaluation of the role of traditionalhistopathology and Xpert MTB/RIF assay in the diagnosis of spinal tuberculosis/DONGWeijie, QIN Shibing, LAN Tinglong, et al//Chinese Journal of Spine and SpinalCord, 2019, 29(8): 692-697

【Abstract】 Objectives: To evaluate the role of traditionalhistopathology(pathology) and Xpert MTB/RIF (Xpert) in the diagnosis of spinaltuberculosis(TB).  Methods: Weretrospectively analyzed the data of 442 patients clinically diagnosed withspinal TB in Beijing Chest Hospital affiliated to Capital Medical Universityfrom January 2015 to April 2018. Among the 442 patients, 227(51.4%) were maleand 215(48.6%) were female; aged 18-86 years(46.3±18.0 years old). There were 165 cases of thoracic TB, 162 cases oflumbar TB, 53 cases of lumbosacral TB, 46 cases of thoracolumbar TB, 11 casesof cervical TB, and 5 cases of cervical-thoracic TB. For all patients, pus,sequestrum, granulation tissue and caseous necrotic tissue in the focus wereobtained through puncture or surgery, and traditional histopathologicalexamination and Xpert examination were performed to calculate the positive andnegative rates of both methods. Histopathological diagnosis was classified intofour categories, the first and second categories were confirmed TB, and thethird and fourth categories were undiagnosed TB. With histopathologicaldiagnosis as the gold standard, the sensitivity and specificity of Xpert wereobtained, and the kappa value was calculated to evaluate the consistency rateof the two methods. Taking histopathological diagnosis as the gold standard,the receiver operating characteristic (ROC) curve of Xpert was drawn and thearea under curve(AUC) was calculated to assess the value of Xpert assay.Results: Out of the 442 patients, 292 were diagnosed with confirmed TB byhistopathology (66.1%, 95%CI: 61.4%-70.5%), and 150 were undiagnosed TB byhistopathology(33.9%, 95%CI: 29.5%-38.6%). The Xpert was positive in 363cases(82.1%, 95%CI: 78.2%-85.6%), and negative in 79 cases(17.9%, 95%CI:14.4%-21.8%), and rpoB mutations were found in 43 cases(9.7%). The positiverate of Xpert was higher than that of histopathology(χ2=46.2477, P<0.001).Keeping histopathological diagnosis as the gold standard, of the 292 casesdiagnosed to be confirmed TB by histopathology, Xpert was positive in 273 casesand negative in 19 cases; while among the 150 cases of undiagnosed TB bypathology, Xpert was positive in 90 cases and negative in 60 cases. Thesensitivity and specificity of Xpert were 93.5%(273/292) and 40%(60/150)respectively. The Kappa value of spinal TB diagnosed by histopathology andXpert was 0.378(95%CI: 0.290-0.466), indicating poor consistency. The AUC ofXpert was 0.667. The positive rate of joint diagnosis of spinal tuberculosis byhistopathological examination and Xpert assay was 86.4%(382/442). Conclusions:Xpert can improve the diagnosis rate of spinal tuberculosis and detectrifampicin-resistant mutations. It is recommended to perform bothhistopathology examination and Xpert assay when the amount of sample issufficient.

【Key words】 Spinal tuberculosis; Diagnosis; Histopathology; Xpert MTB/RIF

【Author′s address】 Department of Orthopaedics, Beijing Chest Hospital, Capital MedicalUniversity, Beijing,101149, China

图1  以病理为金标准时Xpert诊断脊柱结核的ROC曲线

Figure1ROC curve of Xpert in the diagnosis of spinaltuberculosis with histopathology as the gold standard

本文为删节版，原文见《中国脊柱脊髓杂志》2019年8月刊