Trajman Anete, Durovni Betina, Saraceni Valeria, Menezes Alexandre, Cordeiro-Santos Marcelo, Cobelens Frank, Van den Hof Susan
Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; McGill University, Montreal, Canada.
Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; Rio de Janeiro City Health Secretariat, Rio de Janeiro, Brazil.
PLoS One. 2015 Apr 27;10(4):e0123252. doi: 10.1371/journal.pone.0123252. eCollection 2015.
The impact on treatment outcomes of XpertMTB/RIF, a molecular-based test that provides rapid diagnosis of tuberculosis (TB) and rifampicin resistance with high accuracy, has not been reported despite its adoption in a few countries. We here report treatment outcomes in a step-wedged cluster randomized trial for patients diagnosed with XpertMTB/RIF compared to patients diagnosed with sputum smear examination in public health facilities in Brazil.
Treatment outcome data were added to the trial database of patients diagnosed from 4 February to 4 October 2012, and crosschecked with data from the national mortality and the drug-resistant TB registers. Treatment outcomes in the intervention (n=2232) and baseline (n=1856) arms were compared using a multilevel regression model.
Unfavourable outcomes were frequent in both arms, mainly due to loss to follow-up (16%). Overall unfavourable outcomes were not reduced in the intervention arm (29.6% versus 31.7%, OR=0.93; 95%CI=0.79-1.08). However, the overall TB-attributed death rate was lower in the intervention arm (2.3% vs. 3.8%). Adjusted for HIV status, age group and city, the intervention resulted in a 35% decrease in TB-attributed deaths (OR=0.65, 95%CI=0.44-0.97).
The proportion of patients successfully treated did not increase with Xpert MTB/RIF implementation, with high loss to follow-up rates in both arms. We did observe a 35% reduction in TB-related mortality, which we hypothesize may be explained by less advanced disease among the smear-negative patients diagnosed by Xpert. In conclusion, XpertMTB/RIF introduction did not improve TB treatment outcomes in Brazil.
clinicaltrials.gov NCT01363765.
尽管Xpert MTB/RIF这一基于分子技术的检测方法已在一些国家采用，该方法能快速、准确地诊断结核病（TB）和利福平耐药情况，但尚未有关于其对治疗结果影响的报道。我们在此报告一项阶梯式整群随机试验的治疗结果，该试验将巴西公共卫生机构中经Xpert MTB/RIF诊断的患者与经痰涂片检查诊断的患者进行了对比。
将治疗结果数据添加到2012年2月4日至10月4日诊断患者的试验数据库中，并与国家死亡率和耐药结核病登记数据进行交叉核对。使用多水平回归模型比较干预组（n = 2232）和基线组（n = 1856）的治疗结果。
两组的不良结果都很常见，主要原因是失访（16%）。干预组的总体不良结果并未减少（29.6%对31.7%，OR = 0.93；95%CI = 0.79 - 1.08）。然而，干预组的总体结核病归因死亡率较低（2.3%对3.8%）。在对HIV状态、年龄组和城市进行调整后，干预使结核病归因死亡减少了35%（OR = 0.65，95%CI = 0.44 - 0.97）。
随着Xpert MTB/RIF的实施，成功治疗的患者比例并未增加，两组的失访率都很高。我们确实观察到结核病相关死亡率降低了35%，我们推测这可能是因为经Xpert诊断的涂片阴性患者中疾病进展程度较低。总之，在巴西引入Xpert MTB/RIF并未改善结核病的治疗结果。
clinicaltrials.gov NCT01363765。
