University of Groningen, University Medical Center Groningen, Tuberculosis Center Beatrixoord, Haren, The Netherlands; University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases & Tuberculosis, Groningen, The Netherlands.
Department of Phthisiology, Grodno State Medical University, GRCC "Phthisiology", Grodno, Belarus.
Int J Infect Dis. 2019 Jun;83:72-76. doi: 10.1016/j.ijid.2019.03.036. Epub 2019 Apr 3.
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.
世界卫生组织发起了一项全球倡议，称为 aDSM（活跃性结核病药物安全性监测和管理），以更好地描述在真实环境中治疗耐药结核病（TB）的新治疗方案的安全性概况。然而，在几个国家中全面监测是困难的。aDSM 项目的目的是展示实施国家 aDSM 登记册的可行性，并描述与接触新抗结核药物相关的不良事件（AE）的类型和频率。在 2016 年进行了一项试点研究之后，寻求了结核病参考中心/国家的正式参与，并连续招募了使用贝达喹啉和/或德拉马尼德方案治疗的病例。前瞻性地收集了 AE，以确保根据已知的安全性概况，将 AE 潜在地归因于特定药物。在估计有 781 例病例的情况下，共有来自 27 个国家的 41 个中心的 309 例病例得到了充分报告（65%为男性；268 例接受贝达喹啉治疗，20 例接受德拉马尼德治疗，21 例同时接受两种药物治疗），这些国家承诺在 2019 年第一季度之前报告。
