Ferreira Isabella B B, Menezes Rodrigo C, Araújo-Pereira Mariana, Rolla Valeria C, Kritski Afrânio L, Cordeiro-Santos Marcelo, Sterling Timothy R, Staats Cody, Amorim Gustavo, Trajman Anete, Andrade Bruno B
Escola Bahiana de Medicina e Saúde Pública, Pós-graduação em Medicina e Saúde Humana, Salvador, Brazil.
Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Institute, Salvador, Brazil.
Lancet Reg Health Am. 2025 Jun 25;48:101162. doi: 10.1016/j.lana.2025.101162. eCollection 2025 Aug.
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.
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.
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).
Even minor nonadherence in TB treatment was associated with an increased risk of unfavorable outcomes, highlighting the role of adherence in successful TB care.
Fundação Oswaldo Cruz, Fundação José Silveira, Departamento de Ciência e Tecnologia, US National Institute of Allergy and Infectious Diseases.
结核病仍是全球传染病死亡的主要原因。尽管直接观察治疗（DOT）已被广泛实施以提高依从性，但不依从性仍继续影响治疗成功率，尤其是在实际环境中。因此，本研究旨在评估漏服剂量对结核病治疗结果的影响。
前瞻性研究，在2015年6月至2019年6月期间，对巴西报告队列的五个临床中心开始结核病治疗后的成年药物敏感结核病患者进行了两年的随访。未接受DOT或随访少于30天的参与者被排除。不依从性定义为相对于规定疗程漏服剂量的百分比，通过DOT每日监测。主要复合结局包括治疗失败、疾病复发、耐药、死亡或治疗30天后失访（LTFU）。通过多变量逻辑回归评估相关性。
在分析的578名参与者中，218名（37.7%）出现不良结局。总体而言，23%的参与者漏服了超过10%的规定剂量，该组出现不良结局的可能性为81.2%，而完全依从者中这一比例仅为21.6%。观察到漏服剂量百分比与不良结局之间存在显著关联（调整后的OR：1.11，95%CI：1.07-1.14，p值<0.0001）。
即使是结核病治疗中轻微的不依从也与不良结局风险增加相关，突出了依从性在成功结核病治疗中的作用。
奥斯瓦尔多·克鲁兹基金会、若泽·西尔维拉基金会、科学技术部、美国国立过敏和传染病研究所。
