Kipiani Maia, Graciaa Daniel S, Buziashvili Mariana, Darchia Lasha, Avaliani Zaza, Tabagari Nino, Mirtskhulava Veriko, Kempker Russell R
National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.
The University of Georgia, Tbilisi, Georgia.
Open Forum Infect Dis. 2021 Nov 6;8(12):ofab551. doi: 10.1093/ofid/ofab551. eCollection 2021 Dec.
Although rapid molecular diagnostic tests for tuberculosis (TB) have decreased detection time of and drug resistance, whether their use improves clinical care and outcomes is uncertain. To address these knowledge gaps, we evaluated whether use of the Xpert MTB/RIF assay impacts treatment and clinical outcome metrics among patients treated for sputum smear-negative multidrug-resistant (MDR)-TB.
We conducted a retrospective cohort study of adult patients initiating treatment for sputum smear-negative MDR-TB at the National Center for Tuberculosis and Lung Diseases in Tbilisi, Georgia from 2011 to 2016. The Xpert MTB/RIF was introduced in Georgia in 2010 and implemented into programmatic use in 2014. Exposure was availability of an Xpert result at time of diagnosis. Time to second-line treatment initiation, sputum culture conversion, and end-of-treatment outcomes were determined. Time to event was compared using a Cox proportional hazards model.
Among 151 patients treated for sputum smear-negative MDR-TB (96% culture positive), the Xpert was utilized in the clinical management of 78 (52%) patients and not used in 73 (48%). An adjusted analysis controlling for potential confounders found that patients in the Xpert group had shorter median time to second-line treatment (13 vs 56 days; adjusted hazard ratio [aHR], 10.21; < .0001) and culture conversion (61 vs 93 days; aHR, 1.93; < .001). There was no difference in treatment outcomes.
Use of the Xpert in the management of sputum smear-negative MDR-TB decreases time to second-line therapy and sputum culture conversion, providing evidence of its clinical impact and supporting its programmatic utility.
尽管结核病（TB）的快速分子诊断检测缩短了检测时间并能检测耐药性，但这些检测的使用是否能改善临床护理和治疗结果尚不确定。为填补这些知识空白，我们评估了使用Xpert MTB/RIF检测对痰涂片阴性耐多药（MDR）结核病患者的治疗及临床结局指标的影响。
我们对2011年至2016年在格鲁吉亚第比利斯国家结核病和肺部疾病中心开始治疗痰涂片阴性MDR-TB的成年患者进行了一项回顾性队列研究。Xpert MTB/RIF检测于2010年引入格鲁吉亚，并于2014年纳入项目使用。暴露因素为诊断时是否有Xpert检测结果。确定二线治疗开始时间、痰培养转阴时间和治疗结束时的结局。使用Cox比例风险模型比较事件发生时间。
在151例接受痰涂片阴性MDR-TB治疗的患者中（96%培养阳性），78例（52%）患者的临床管理中使用了Xpert检测，73例（48%）未使用。对潜在混杂因素进行校正分析发现，Xpert检测组患者二线治疗的中位时间较短（13天对56天；校正风险比[aHR]，10.21；P<0.0001），痰培养转阴时间也较短（61天对93天；aHR，1.93；P<0.001）。治疗结局无差异。
在痰涂片阴性MDR-TB的管理中使用Xpert检测可缩短二线治疗时间和痰培养转阴时间，证明了其临床影响并支持其在项目中的应用价值。
