Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
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DOI：
10.1183/13993003.01522-2019
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发表时间：
2019-12-01
影响因子：
24.3
通讯作者：
Migliori, Giovanni Battista
中科院分区：
文献类型：
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作者：
Borisov, Sergey;Danila, Edvardas;Migliori, Giovanni Battista
世界卫生组织（WHO）建议各国实施药物警戒，并收集有关主动药物安全性监测（aDSM）和不良事件管理的信息。这项前瞻性研究的目的是评估一组连续接受新型抗结核药物治疗的结核病患者中抗结核药物不良事件的频率和严重程度。（即贝达喹啉、德拉马尼）和改变用途的药物（即氯法齐明、利奈唑胺）。在归因于特定药物后，前瞻性地收集不良事件以及诊断时和治疗期间的人口统计学、细菌学、放射学和临床信息。在全球范围内，来自26个国家/地区的45个中心报告了658例患者（68.7%为男性，4.4%为HIV合并感染者）接受以下治疗：87.7%接受贝达喹啉治疗，18.4%接受地拉马尼治疗（6.1%同时接受两种治疗），81.5%接受利奈唑胺治疗，32.4%接受氯法齐明治疗。总体而言，报告了504起不良事件：447起（88.7%）被归类为轻微（1-2级），57起（11.3%）被归类为严重（3-5级）。55例患者报告的57起严重不良事件中的大多数（51/57，89.5%）最终消退。在报告严重不良事件的患者中，一些负责的药物被停用：0.35%的患者（577例中的2例）停用贝达喹啉，0.8%的患者（121例中的1例）停用地拉曼，1.9%的患者（536例中的10例）停用利奈唑胺，1.4%的患者（213例中的3例）停用氯法齐明。阿米卡星治疗的患者中有6.9%（131例中有9例）报告了严重不良事件，乙硫异烟胺/丙硫异烟胺治疗的患者中有0.4%（221例中有1例）报告了严重不良事件，利奈唑胺治疗的患者中有2.8%（536例中有15例）报告了严重不良事件，环丝氨酸/特立齐酮治疗的患者中有1.8%（498例中有8例）报告了严重不良事件。
The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV coinfected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1-2) and 57 (11.3%) as serious (grade 3-5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.