Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.
Department of Infectious Diseases, Zhuji People's Hospital, Zhejiang, China.
Int J Tuberc Lung Dis. 2015 Mar;19(3):319-25, i-ii. doi: 10.5588/ijtld.14.0406.
Although MTBDRplus is validated for the detection of multidrug-resistant tuberculosis (MDR-TB), its role in the assessment of treatment outcome is less clear. We evaluated the association of MTBDRplus results with treatment outcome in new and previously treated patients in an endemic setting in China and determined factors associated with poor treatment outcomes.
We prospectively enrolled 298 smear-positive pulmonary TB patients who received the World Health Organization recommended initial treatment regimen or retreatment regimen. MTBDRplus was compared with conventional drug susceptibility testing and DNA sequencing for the detection of MDR-TB. Treatment responses were monitored using sputum smear, culture and chest radiography.
MTBDRplus successfully identified all MDR-TB and had good concordance with sequencing. MDR-TB rates were low among new patients (4/187, 2.1%), but high in previously treated patients (12/28, 42.9%); 65.2% (15/23) of previously treated cases and 17.1% (27/158) of new cases were unsuccessfully treated (P < 0.001). Seven of eight (87.5%) previously treated MDR-TB patients failed the retreatment regimen. In addition to drug resistance, sputum smear positivity at week 8 and cavitation are associated with treatment failure.
Not only did MTBDRplus correctly identify all MDR-TB cases, MTBDRplus results are also associated with treatment outcomes in previously treated patients. The retreatment regimen should no longer be used; treatment should be guided by molecular testing.
虽然 MTBDRplus 已被验证可用于检测耐多药结核病（MDR-TB），但其在评估治疗结果方面的作用尚不清楚。我们在中国流行地区的新发病例和复治病例中评估了 MTBDRplus 结果与治疗结果的相关性，并确定了与不良治疗结局相关的因素。
我们前瞻性地纳入了 298 例痰涂片阳性的肺结核患者，他们接受了世界卫生组织推荐的初始治疗方案或复治方案。MTBDRplus 与传统的药敏试验和 DNA 测序用于检测 MDR-TB。使用痰涂片、培养和胸部 X 线检查监测治疗反应。
MTBDRplus 成功地识别了所有的 MDR-TB，并且与测序具有良好的一致性。新发病例的 MDR-TB 率较低（4/187，2.1%），但在复治病例中较高（12/28，42.9%）；23 例复治病例中有 65.2%（15/23）和 158 例新发病例中有 17.1%（27/158）治疗失败（P<0.001）。8 例复治 MDR-TB 患者中有 7 例（87.5%）对复治方案失败。除了耐药性外，第 8 周的痰涂片阳性和空洞也是治疗失败的相关因素。
MTBDRplus 不仅正确地识别了所有的 MDR-TB 病例，而且与复治患者的治疗结果相关。不应再使用复治方案；治疗应根据分子检测进行指导。
