Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China: focus on the safety

作者：Jingtao Gao, Juan Du, Guihui Wu, Yi Pei, Mengqiu Gao, Leonardo Martínez, Lin Fan, Wei Chen, Li Xie, Yu Chen, Hua Wang, Long Jin, Guobao Li, Peilan Zong, Yu Xiong, Qianhong Wu, Mingwu Li, Xiaofeng Yan, Yanfang Miao, Qingshan Cai, Xinjie Li, Dapeng Bai, Shu-Jun Geng, Guoli Yang, Peijun Tang, Yi Zeng, Xiao-Hong Chen, Tong-Xia Li, Cui Cai, Yun Zhou, Zhuo Ma, Jianyun Wang, Wen‐Long Guan, Lin Xu, Jichan Shi, Wei Shu, Lili Cheng, Fei Teng, Yu-Jia Ning, Shiheng Xie, Yuxian Sun, Lijie Zhang, Yuhong Liu · 发表于：Infectious Diseases of Poverty · 年份：2021 · DOI：10.1186/s40249-021-00819-2 · 被引用次数：36 · 研究领域：Tuberculosis Research and Epidemiology、Pharmacovigilance and Adverse Drug Reactions、Drug-Induced Hepatotoxicity and Protection

BACKGROUND: World Health Organization recommends countries introducing new drug and short treatment regimen for drug resistant tuberculosis (DR-TB) should develop and implement a system for active pharmacovigilance that allows for detection, reporting and management of adverse events. The aim of the study is to evaluate the frequency and severity of adverse events (AEs) of bedaquiline-containing regimen in a cohort of Chinese patients with multidrug-resistant (MDR)/extensively drug-resistant (XDR)-TB based on active drug safety monitoring (aDSM) system of New Drug Introduction and Protection Program (NDIP). METHODS: AEs were prospectively collected with demographic, bacteriological, radiological and clinical data from 54 sites throughout China at patient enrollment and during treatment between February, 2018 and December, 2019. This is an interim analysis including patients who are still on treatment and those that have completed treatment. A descriptive analysis was performed on the patients evaluated in the cohort. RESULTS: By December 31, 2019, a total of 1162 patients received bedaquiline-containing anti-TB treatment. Overall, 1563 AEs were reported, 66.9% were classified as minor (Grade 1-2) and 33.1% as serious (Grade 3-5). The median duration of bedaquiline treatment was 167.0 [interquartile range (IQR): 75-169] days. 86 (7.4%) patients received 36-week prolonged treatment with bedaquiline. The incidence of AEs and serious AEs was 47.1% and 7.8%, respectively. The most...