巴西应用线探针检测和 Xpert® MTB/RIF 检测对疑似耐药结核病进行诊断的临床影响：一项实用临床试验。
Clinical Impact of the Line Probe Assay and Xpert® MTB/RIF Assay in the Presumptive Diagnosis of Drug-Resistant Tuberculosis in Brazil: A Pragmatic Clinical Trial.
机构信息
Universidade Federal do Rio de Janeiro, Faculdade de Medicina, Programa Acadêmico de Tuberculose, Rio de Janeiro, RJ, Brasil.
Universidade Federal de Ouro Preto, Escola de Farmácia, Departamento de Análises Clínicas, Ouro Preto, MG, Brasil.
出版信息
Rev Soc Bras Med Trop. 2022 Feb 25;55:e0191. doi: 10.1590/0037-8682-0191-2021. eCollection 2022.
BACKGROUND
Rapid molecular methods such as the line probe assay (LPA) and Xpert® MTB/RIF assay (Xpert) have been recommended by the World Health Organization for drug-resistant tuberculosis (DR-TB) diagnosis. We conducted an interventional trial in DR-TB reference centers in Brazil to evaluate the impact of the use of LPA and Xpert.
METHODS
Patients with DR-TB were eligible if their drug susceptibility testing results were available to the treating physician at the time of consultation. The standard reference MGITTM 960 was compared with Xpert (arm 1) and LPA (arm 2). Effectiveness was considered as the start of the appropriate TB regimen that matched drug susceptibility testing (DST) and the proportions of culture conversion and favorable treatment outcomes after 6 months.
RESULTS
A higher rate of empirical treatment was observed with MGIT alone than with the Xpert assay (97.0% vs. 45.0%) and LPA (98.2% vs. 67.5%). Patients started appropriate TB treatment more quickly than those in the MGIT group (median 15.0 vs. 40.5 days; p<0.01) in arm 1. Compared to the MGIT group, culture conversion after 6 months was higher for Xpert in arm 1 (90.9% vs. 79.3%, p=0.39) and LPA in arm 2 (80.0% vs. 83.0%, p=0.81).
CONCLUSIONS
In the Xpert arm, there was a significant reduction in days to the start of appropriate anti-TB treatment and a trend towards greater culture conversion in the sixth month.
背景
快速分子检测方法，如线探针检测（LPA）和 Xpert® MTB/RIF 检测（Xpert），已被世界卫生组织推荐用于耐药结核病（DR-TB）诊断。我们在巴西的 DR-TB 参考中心进行了一项干预性试验，以评估使用 LPA 和 Xpert 的影响。
方法
如果在咨询时治疗医生可以获得药敏试验结果，则将 DR-TB 患者纳入研究。将标准参考 MGITTM 960 与 Xpert（臂 1）和 LPA（臂 2）进行比较。有效性定义为开始使用与药敏试验（DST）相符的合适 TB 方案，以及在 6 个月后培养转换和治疗结果良好的比例。
结果
MGIT 单独使用的经验性治疗率高于 Xpert 检测（97.0% vs. 45.0%）和 LPA（98.2% vs. 67.5%）。与 MGIT 组相比，臂 1 中的患者更快开始接受合适的 TB 治疗（中位数 15.0 天 vs. 40.5 天；p<0.01）。与 MGIT 组相比，臂 1 中的 Xpert 检测（90.9% vs. 79.3%，p=0.39）和 LPA 检测（80.0% vs. 83.0%，p=0.81）在 6 个月时的培养转换率更高。
结论
在 Xpert 臂中，开始适当抗 TB 治疗的时间显著缩短，第六个月时培养转换率呈增加趋势。
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