Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
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DOI：
10.1016/j.ijid.2019.03.036
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发表时间：
2019-06-01
影响因子：
8.4
通讯作者：
Zignol, Matteo
中科院分区：
文献类型：
--
作者：
Akkerman, Onno;Aleksa, Alena;Zignol, Matteo
世界卫生组织发起了一项名为aDSM（主动结核病药物安全性监测和管理）的全球倡议，以更好地描述耐药结核病（TB）新治疗方案在现实世界中的安全性。然而，在一些国家很难实施全面监测。该项目的目的是证明实施国家aDSM登记的可行性，并描述与接触新型抗结核药物相关的不良事件（AE）的类型和频率。继2016年开展的试点研究之后，寻求结核病参考中心/国家正式参与该项目，并连续招募了接受含贝达喹啉和/或地拉曼尼方案治疗的病例。前瞻性收集AE，确保根据已知的安全性特征将AE归因于特定药物。来自27个国家的41个中心共报告了309例病例（65%为男性; 268例接受贝达喹啉治疗，20例接受德拉马尼治疗，在参与国承诺到2019年第一季度报告的估计781例病例中，有21例同时使用两种药物。(C)2019由Elsevier Ltd代表国际传染病学会发布。
The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries.The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs.Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile.A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019. (C) 2019 Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.