Safety of treatment regimens for drug-resistant TB over a 15-year period: a scoping review.

IJTLD open Pub Date : 2026-04-13 eCollection Date: 2026-04-01 DOI:10.5588/ijtldopen.25.0728

M Amiri, M Cheraghi, M J Nasiri, D R Silva, G Sotgiu, L D'Ambrosio, R Centis, I Kontsevaya, H K Gandhi, D Oberdhan, V Girbinger, M Dara

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Abstract

Background: A previous review summarised the evolution and efficacy of the regimens to treat rifampicin-resistant/multidrug-resistant TB (RR/MDR-TB), underscoring the persistent need for efficacious shorter treatments. The aim of this scoping review was to explore safety, quality of life (QoL), and unmet needs associated with RR/MDR-TB in studies published between 2009 and 2024.

Methods: We searched PubMed/MEDLINE, Embase, Cochrane CENTRAL, Scopus, and Web of Science for studies reporting safety, QoL, and unmet needs in the last 15 years.

Results: Fifty-seven studies including 9,874 patients were identified, with significant variation in geographic distribution, sample size, and other core variables. The overall proportion of serious adverse events (AEs) ranged between 0.2% and 10.1% in retrospective studies, 1.0%-72.4% in prospective cohorts, and 20.0%-25.0% in experimental studies, with no data on QoL. Almost all studies containing linezolid (LZD) reported gastrointestinal and haematological AEs. In studies based on individual patient data, AEs associated with bedaquiline (1.7%-2.4%) and fluoroquinolones (3%-4%) were less frequent than those associated with LZD (14.1%-17.2%). The World Health Organization 95% credible interval range was 10.1%-27.0%.

Conclusion: While efficacious RR/MDR-TB regimens are recommended, individual drugs still cause AEs potentially leading to decreased adherence. New efficacious treatments with improved safety/tolerability profiles are needed.

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15年期间耐药结核病治疗方案的安全性：范围审查。

背景：之前的一篇综述总结了治疗利福平耐药/耐多药结核病（RR/MDR-TB）方案的演变和疗效，强调了对有效的短期治疗的持续需求。本综述的目的是探讨2009年至2024年间发表的研究中与耐药/耐多药结核病相关的安全性、生活质量（QoL）和未满足的需求。方法：我们检索PubMed/MEDLINE、Embase、Cochrane CENTRAL、Scopus和Web of Science，检索过去15年报告安全性、生活质量和未满足需求的研究。结果：共纳入了57项研究，包括9874例患者，在地理分布、样本量和其他核心变量方面存在显著差异。在回顾性研究中，严重不良事件（ae）的总比例为0.2% - 10.1%，在前瞻性队列中为1.0%-72.4%，在实验研究中为20.0%-25.0%，没有关于生活质量的数据。几乎所有含有利奈唑胺（LZD）的研究都报告了胃肠道和血液学不良反应。在基于个体患者数据的研究中，与贝达喹啉（1.7%-2.4%）和氟喹诺酮类药物（3%-4%）相关的ae发生率低于与LZD相关的ae发生率（14.1%-17.2%）。世界卫生组织95%可信区间范围为10.1%-27.0%。结论：虽然推荐有效的耐药/耐多药结核病治疗方案，但个别药物仍可能导致不良反应，从而降低依从性。需要新的有效治疗方法，提高安全性/耐受性。

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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IJTLD open

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