Effect of introducing ethambutol and integrating drugs into fixed-dose tablets on mortality in tuberculosis patients.

IF 1.5 4区医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Transactions of The Royal Society of Tropical Medicine and Hygiene Pub Date : 2025-09-22 DOI:10.1093/trstmh/traf100

Fredi Alexander Diaz-Quijano, Patricia Bartholomay, Kleydson Bonfim Andrade, Daniele Maria Pelissari, Denise Arakaki-Sanchez, Fernanda Dockhorn Costa, Rejane Sobrino Pinheiro

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引用次数: 0

Abstract

Background: In response to increasing primary resistance to isoniazid, the Brazilian Ministry of Health modified the tuberculosis (TB) treatment regimen at the end of 2009. The changes included adding ethambutol to the intensive phase, using fixed-dose combination tablets and adjusting isoniazid and pyrazinamide dosages. This study aimed to estimate the effect of the regimen change on all-cause mortality and, secondarily, on TB-specific mortality, treatment success and loss to follow-up.

Methods: We analysed cohorts of individuals ≥10 y of age who initiated TB treatment before (n = 145 528) and after (n = 161 264) the regimen change. Data were obtained from the national notifiable disease and mortality information systems. Missing data were imputed and effects were estimated using multilevel logistic regression models with states as the clustering level. Covariates were selected using a directed acyclic graph.

Results: The regimen change was not associated with all-cause mortality (relative risk [RR] 1.01 [95% confidence interval {CI} 0.98 to 1.04]) or TB-specific mortality (RR 0.98 [95% CI 0.95 to 1.02]). The treatment success rate was lower, and loss to follow-up was higher during the modified regimen period compared with the previous one. However, sensitivity analyses suggest that changes in the handling of transfers and missing outcome data may partly explain these findings.

Conclusion: We concluded that the modified regimen did not adversely affect survival among TB patients.

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引入乙胺丁醇并将药物整合到固定剂量片中对结核病患者死亡率的影响。

背景：为应对异烟肼原发性耐药性的增加，巴西卫生部于2009年底修改了结核病治疗方案。这些变化包括在强化期加入乙胺丁醇、使用固定剂量联合片以及调整异烟肼和吡嗪酰胺的剂量。本研究旨在评估方案改变对全因死亡率的影响，其次是对结核病特异性死亡率、治疗成功率和随访损失的影响。方法：我们分析了在方案改变之前（n = 145 528）和之后（n = 161 264）开始结核病治疗的≥10岁个体的队列。数据来自国家应通报疾病和死亡率信息系统。用状态作为聚类水平的多级逻辑回归模型对缺失数据进行输入和效果估计。使用有向无环图选择协变量。结果：方案改变与全因死亡率（相对危险度[RR] 1.01[95%可信区间{CI} 0.98 ~ 1.04]）或结核病特异性死亡率（RR 0.98[95%可信区间{CI} 0.95 ~ 1.02]）无关。改良方案期治疗成功率较前一方案低，随访失踪率较高。然而，敏感性分析表明，转移处理的变化和结果数据的缺失可能部分解释了这些发现。结论：我们的结论是改良方案对结核病患者的生存没有不利影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Transactions of The Royal Society of Tropical Medicine and Hygiene 医学-公共卫生、环境卫生与职业卫生

CiteScore

4.00

自引率

9.10%

发文量

115

审稿时长

4-8 weeks

期刊介绍： Transactions of the Royal Society of Tropical Medicine and Hygiene publishes authoritative and impactful original, peer-reviewed articles and reviews on all aspects of tropical medicine.