Effects of missed anti-tuberculosis therapy doses on treatment outcome: a multi-center cohort study

IF 7 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Americas Pub Date : 2025-06-25 DOI:10.1016/j.lana.2025.101162

Isabella B.B. Ferreira , Rodrigo C. Menezes , Mariana Araújo-Pereira , Valeria C. Rolla , Afrânio L. Kritski , Marcelo Cordeiro-Santos , Timothy R. Sterling , Cody Staats , Gustavo Amorim , Anete Trajman , Bruno B. Andrade

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引用次数: 0

Abstract

Background

Tuberculosis (TB) remains a leading cause of infectious disease mortality globally. Although directly observed therapy (DOT) has been widely implemented to improve adherence, nonadherence continues to compromise treatment success rates, especially in real-world settings. Therefore, this study aims to assess the impact of missed doses on TB treatment outcomes.

Methods

Prospective study that followed adults with drug-sensitive TB for two years after TB treatment initiation at five clinical centers of the RePORT-Brazil cohort between June 2015 and June 2019. Participants not in DOT or followed for less than 30 days were excluded. Nonadherence was defined as the percentage of missed doses relative to the prescribed regimen, monitored daily through DOT. The primary composite outcome comprised treatment failure, disease recurrence, drug resistance, death, or loss to follow-up (LTFU) after 30 days of treatment. Associations were assessed with multivariable logistic regression.

Findings

Among the 578 participants analyzed, 218 (37·7%) experienced unfavorable outcomes. Overall, 23% of participants missed more than 10% of prescribed doses, and this group had an 81·2% likelihood of experiencing unfavorable outcomes, compared to only 21·6% among those with complete adherence. A significant association was observed between the percentage of missed doses and unfavorable outcomes (adjusted OR: 1·11, 95% CI: 1·07–1·14, p-value < 0·0001).

Interpretation

Even minor nonadherence in TB treatment was associated with an increased risk of unfavorable outcomes, highlighting the role of adherence in successful TB care.

Funding

Fundação Oswaldo Cruz, Fundação José Silveira, Departamento de Ciência e Tecnologia, US National Institute of Allergy and Infectious Diseases.

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错过抗结核治疗剂量对治疗结果的影响：一项多中心队列研究

结核病（TB）仍然是全球传染病死亡的主要原因。尽管直接观察疗法（DOT）已被广泛应用于提高依从性，但不依从性继续影响治疗成功率，特别是在现实环境中。因此，本研究旨在评估错过剂量对结核病治疗结果的影响。方法前瞻性研究，在2015年6月至2019年6月期间，在报告-巴西队列的五个临床中心对药物敏感性结核病成人患者进行了为期两年的结核病治疗。没有参加DOT或随访少于30天的参与者被排除在外。不依从性被定义为相对于规定方案的错过剂量的百分比，每天通过DOT监测。主要综合结局包括治疗失败、疾病复发、耐药、死亡或治疗30天后失去随访（LTFU）。用多变量逻辑回归评估相关性。在578名参与者中，218名（37.7%）经历了不良结果。总体而言，23%的参与者错过了超过10%的处方剂量，这一组有81.2%的可能性出现不良结果，而完全依从的患者只有21.6%。漏给剂量百分比与不良结局之间存在显著关联(调整后OR: 1.11, 95% CI: 1.07 - 1.14， p值<；0·0001)。解释：即使在结核病治疗中轻微的不依从性也与不良结果的风险增加有关，这突出了依从性在成功的结核病治疗中的作用。美国国家过敏和传染病研究所Ciência电子技术部，fundingfundal o Oswaldo Cruz, fundal o josise Silveira。

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来源期刊

Lancet Regional Health-Americas Multiple-

CiteScore

8.00

自引率

0.00%

发文量

期刊介绍： The Lancet Regional Health – Americas, an open-access journal, contributes to The Lancet's global initiative by focusing on health-care quality and access in the Americas. It aims to advance clinical practice and health policy in the region, promoting better health outcomes. The journal publishes high-quality original research advocating change or shedding light on clinical practice and health policy. It welcomes submissions on various regional health topics, including infectious diseases, non-communicable diseases, child and adolescent health, maternal and reproductive health, emergency care, health policy, and health equity.