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比较基因型诊断算法对埃塞俄比亚阿姆哈拉地区耐药结核病患者治疗开始时间和治疗结局的影响。

Comparing the impact of genotypic based diagnostic algorithm on time to treatment initiation and treatment outcomes among drug-resistant tuberculosis patients in Amhara region, Ethiopia.

机构信息

Department of Epidemiology and Biostatistics, Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.

出版信息

PLoS One. 2021 Feb 18;16(2):e0246938. doi: 10.1371/journal.pone.0246938. eCollection 2021.

Abstract

BACKGROUND

To end Tuberculosis (TB) by 2030, early detection and timely treatment of Drug-Resistant Tuberculosis (DR-TB) is vital. The role of rapid, accurate, and sensitive DR-TB diagnostic tool is indispensable to accelerate the TB control program. There are evidence breaks in the time difference and its effect on treatment outcomes among different DR-TB diagnostic tools in Ethiopia. This article aimed to compare the different DR-TB diagnostic tools with time pointers and evaluate their effect on the treatment outcomes.

METHOD

We performed a retrospective chart review of 574 DR-TB patients from September 2010 to December 2017 to compare the impact of molecular DR-TB diagnostic tests (Xpert MTB/RIF, Line Probe Assay (LPA), and solid culture-based Drug Susceptibility Testing (DST)) on time to diagnosis, treatment initiation, and treatment Outcomes. Kruskual-Wallis test was employed to assess the presence of a significant difference in median time among the DR-TB diagnostic tests. Chi-Square and Fisher exact tests were used to test the presence of relations between treatment outcome and diagnostic tests.

RESULT

The data of 574 DR-TB patients were included in the analysis. From these, 321, 173, and 80 patients were diagnosed using Xpert MTB/RIF, Line Probe Assay (LPA), and solid culture-based DST, respectively. The median time in a day with (Interquartile range (IQR)) for Xpert MTB/RIF, LPA, and solid culture-based DST was from a first care-seeking visit to diagnosis: 2(0, 9), 4(1, 55), and 70(18, 182), from diagnosis to treatment initiation: 3(1, 8), 33(4, 76), and 44(9, 145), and from a first care-seeking visit to treatment initiation: 4(1, 11), 3(1, 12) and 76(3.75, 191) respectively. The shorter median time was observed in the Xpert MTB/RIF followed by the LPA, and this was statistically significant with a p-value <0.001. There was no statistically significant difference concerning treatment outcomes among the three DST tests.

CONCLUSION

Xpert MTB/RIF can mitigate the transmission of DR-TB significantly via quick diagnosis and treatment initiation followed by LPA as equating to the solid culture base DST, particularly in smear-positive patients. However, we didn't see a statistically significant impact in terms of treatment outcomes. Xpert MTB/RIF can be used as the first test to diagnose DR-TB by further complimenting solid culture base DST to grasp the drug-resistance profile.

摘要

背景

要在 2030 年终结结核病(TB),早期发现和及时治疗耐药结核病(DR-TB)至关重要。快速、准确、灵敏的 DR-TB 诊断工具对于加速结核病控制计划是不可或缺的。在不同的 DR-TB 诊断工具之间,存在着时间差异及其对治疗结果的影响的证据差距。本文旨在比较不同的 DR-TB 诊断工具与时间指标,并评估它们对治疗结果的影响。

方法

我们对 2010 年 9 月至 2017 年 12 月的 574 例 DR-TB 患者进行了回顾性图表审查,以比较分子 DR-TB 诊断测试(Xpert MTB/RIF、线性探针分析(LPA)和基于固体培养的药物敏感性测试(DST))对诊断、治疗开始和治疗结果的影响。采用 Kruskual-Wallis 检验评估 DR-TB 诊断测试之间中位数时间是否存在显著差异。采用卡方检验和 Fisher 确切概率法检验治疗结果与诊断测试之间的关系。

结果

纳入了 574 例 DR-TB 患者的数据进行分析。其中,321、173 和 80 例患者分别使用 Xpert MTB/RIF、LPA 和固体培养 DST 进行诊断。Xpert MTB/RIF、LPA 和固体培养 DST 从首次就诊到诊断的中位数时间为 2(0,9)、4(1,55)和 70(18,182);从诊断到治疗开始的中位数时间为 3(1,8)、33(4,76)和 44(9,145);从首次就诊到治疗开始的中位数时间为 4(1,11)、3(1,12)和 76(3.75,191)。Xpert MTB/RIF 的中位数时间最短,其次是 LPA,具有统计学意义(p 值<0.001)。三种 DST 测试在治疗结果方面没有统计学差异。

结论

Xpert MTB/RIF 通过快速诊断和治疗开始,可以显著减轻 DR-TB 的传播,随后是 LPA,与固体培养基础 DST 相当,特别是在涂片阳性患者中。然而,我们没有看到在治疗结果方面有统计学意义的影响。Xpert MTB/RIF 可作为诊断 DR-TB 的首选测试,进一步补充固体培养基础 DST 以掌握耐药谱。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5712/7891731/3f820551d701/pone.0246938.g001.jpg

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