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在斯威士兰,贝达喹啉和地拉曼德在结核病患者中导致不良结局的发生率较低。

Bedaquiline and delamanid result in low rates of unfavourable outcomes among TB patients in Eswatini.

作者信息

Vambe D, Kay A W, Furin J, Howard A A, Dlamini T, Dlamini N, Shabangu A, Hassen F, Masuku S, Maha O, Wawa C, Mafukidze A, Altaye K, Sikhondze W, Gwitima T, Keus K, Simelane T, Kerschberger B

机构信息

Eswatini National Tuberculosis Control Programme, Manzini, Eswatini.

Baylor College of Medicine, Houston, TX, USA, Baylor Children´s Foundation, Mbabane, Eswatini.

出版信息

Int J Tuberc Lung Dis. 2020 Oct 1;24(10):1095-1102. doi: 10.5588/ijtld.20.0082.

Abstract

Since 2015, Eswatini has been scaling up bedaquiline (BDQ) and delamanid (DLM) based drug-resistant TB treatment regimens under programmatic conditions. Identification of factors associated with treatment outcomes in patients receiving BDQ and/or DLM either as a new treatment initiation or drug substitution. This is a retrospective cohort study of patients receiving BDQ and/or DLM in Eswatini between March 2015 and October 2018. We describe factors associated with unfavourable treatment outcomes (death, lost to follow-up, treatment failure and amplification of resistance) and culture conversion using multivariable flexible parametric survival and competing-risks regression analyses. Of 352 patients receiving BDQ and/or DLM, 7.8% and 21.2% had an unfavourable treatment outcome at 6 and 24 months, respectively. Predictors were age ≥ 60 years (adjusted hazard ratio aHR 4.49, 95%CI 1.61-12.57) vs. age 20-39 years, and a treatment regimen combining both drugs (aHR 4.49, 95%CI 1.61-12.57) vs. BDQ only. The probability of culture conversion was increased for two health facilities and patients with a poly resistance profile (adjusted sub-hazard ratio 2.01, 95%CI 1.13-3.59) vs. multidrug resistance. Single use of BDQ or DLM was associated with low rates of unfavourable outcomes, suggesting that these medications may be effectively adopted at scale under routine programmatic conditions. Combined use of BDQ and DLM was a risk factor for unfavourable outcomes and should prompt for collection of more data on the combined use of these medications.

摘要

自2015年以来,斯威士兰一直在按照项目条件扩大基于贝达喹啉(BDQ)和地拉米啶(DLM)的耐多药结核病治疗方案。确定在将BDQ和/或DLM作为新的治疗起始用药或药物替代用药的患者中与治疗结果相关的因素。这是一项对2015年3月至2018年10月期间在斯威士兰接受BDQ和/或DLM治疗的患者进行的回顾性队列研究。我们使用多变量灵活参数生存分析和竞争风险回归分析来描述与不良治疗结果(死亡、失访、治疗失败和耐药性增强)以及培养转化相关的因素。在352例接受BDQ和/或DLM治疗的患者中,分别有7.8%和21.2%在6个月和24个月时出现不良治疗结果。预测因素包括年龄≥60岁(调整后风险比aHR 4.49,95%置信区间CI 1.61 - 12.57)与20 - 39岁相比,以及联合使用两种药物的治疗方案(aHR 4.49,95%CI 1.61 - 12.57)与仅使用BDQ相比。两个医疗机构以及具有多耐药特征的患者(调整后亚风险比2.01,95%CI 1.13 - 3.59)与耐多药患者相比,培养转化的概率增加。单独使用BDQ或DLM与不良结果发生率较低相关,这表明这些药物在常规项目条件下可以有效地大规模采用。联合使用BDQ和DLM是不良结果的一个风险因素,应促使收集更多关于这些药物联合使用的数据。

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