Epicentre, Paris, France.
National Tuberculosis Control Office, Yerevan, Armenia.
Int J Tuberc Lung Dis. 2019 Oct 1;23(10):1060-1067. doi: 10.5588/ijtld.18.0649.
Identification of good prognostic marker for tuberculosis (TB) treatment response is a necessary step on the path towards a surrogate marker to reduce TB trial duration. We performed a retrospective analysis on routinely collected data in 6 drug-resistant TB (DRTB) programs. Culture conversion, defined as two consecutive negative cultures, was assessed, and performance of culture conversion at Month 2 and Month 6 to predict treatment success were explored. To explore factors associated with positive predicted value (PPV) and the specificity of culture conversion, a multinomial logistic regression was fitted. This study included 634 patients: 68.5% were males; the median age was 35 years, 75.2% were previously treated for TB, 59.4% were resistant only to isoniazid and rifampicin and 18.1% resistant to fluoroquinolones. Culture conversion at Month 2 and 6 showed similar PPV while specificity was much higher for culture conversion at Month 2: 91.3% (95%CI 86.1-95.1). PPV of culture conversion at Month 2 did not vary strongly according to patients' characteristics, while specificity was slightly higher among patients with fluoroquinolone-resistant strains. Culture conversion at Month 2 is an acceptable prognostic marker for MDR-TB treatment. Considering the advantage of using an earlier marker, further evaluation as a surrogate marker is warranted to shorten TB trials.
确定结核病(TB)治疗反应的良好预后标志物是寻找替代标志物以缩短 TB 试验持续时间的必要步骤。我们对 6 个耐药结核病(DRTB)项目中常规收集的数据进行了回顾性分析。评估了培养物转化,定义为连续两次阴性培养物,并探讨了第 2 个月和第 6 个月的培养物转化对预测治疗成功的作用。为了探索与阳性预测值(PPV)和培养物转化特异性相关的因素,拟合了多项逻辑回归。这项研究包括 634 名患者:68.5%为男性;中位年龄为 35 岁,75.2%曾接受过结核病治疗,59.4%仅对异烟肼和利福平耐药,18.1%对氟喹诺酮类耐药。第 2 个月和第 6 个月的培养物转化具有相似的 PPV,而第 2 个月的培养物转化特异性要高得多:91.3%(95%CI 86.1-95.1)。第 2 个月培养物转化的 PPV 与患者特征的相关性不强,而耐氟喹诺酮类药物的患者特异性略高。第 2 个月的培养物转化是 MDR-TB 治疗的一种可接受的预后标志物。考虑到使用早期标志物的优势,进一步评估作为替代标志物以缩短 TB 试验是有必要的。