含贝达喹啉新方案治疗耐药肺结核的疗效与安全性研究

doi:10.19871/j.cnki.xfcrbzz.2021.04.008

摘要/Abstract

摘要： 目的评价含贝达喹啉方案治疗耐药肺结核的疗效与安全性,为临床合理安全用药提供指导。方法回顾性分析2020年1月至2020年8月深圳市第三人民医院收治的使用含贝达喹啉方案治疗的44例耐药结核病患者的临床资料,包括耐多药结核（MDR-PTB）和广泛耐药结核（XDR-TB）患者,对含贝达喹啉方案的有效性和安全性进行评价。结果 44例患者含贝达喹啉方案治疗24周,抗酸杆菌涂片转阴率97.4%(38/39);结核分枝杆菌培养转阴率为92.9%(26/28)。不良事件共计49件,其中,心电图QTc（代表心室去极化和复极化过程总时间）延长18件,占36.7%,肝脏毒性10件,占20.4%;在18件QTc延长的不良事件中,明确与贝达喹啉单因素相关的3件,占总不良事件中的6.1%;4例患者因QTc延长中断治疗,其中1例与贝达喹啉单因素相关。结论含贝达喹啉的方案治疗耐多药、广泛耐药结核病疗效良好,有较高的安全性,但使用过程中仍需密切监测不良反应,特别需要关注QTc延长的发生。

关键词: 肺结核, 耐药结核, 贝达喹啉, 回顾性研究, 疗效

Abstract: Objective To evaluate the efficacy and safety of bedaquiline (BDQ)in patients with drug resistant pulmonary tuberculosis (DR-PTB)and to provide guidance for clinical rational and safe drug use. Methods We retrospectively reviewed 44 DR-TB patients (including multi-drug resistant pulmonary tuberculosis, MDR-PTB and extensively-drug-resistant TB (XDR-TB) treated with bedaquiline-containing regimen between January 2020 and August 2020 in the Third People's Hospital of Shenzhen. Results The conversion rate of acid-fast bacilli smear was 97.4%(38/39) and the culture conversion rates was 92.9%(26/28) at 24 weeks. There were 49 adverse events in total, including 18 cases of prolonged QTc interval (36.7%) and 10 cases of liver toxicity (20.4%). Among the 18 QTc prolonged adverse events, 3 were clearly related to bedaquiline, accounting for 6.1% of the total adverse events. Treatment was halted in four patients because of prolonged corrected QTc interval, one of which was associated with a single factor of bedaquiline. Conclusion Bedaquiline-containing regimen was effective and safe for patients with pulmonary DR-TB. But it was still necessary to closely monitor adverse reactions, especially the occurrence of prolonged QTc interval.

Key words: Pulmonary tuberculosis, Drug-resistant tuberculosis, Bedaquiline, Retrospective studies, Efficacy

杨梁梓, 任坦坦, 傅向东, 刘智, 罗蓝, 张培泽. 含贝达喹啉新方案治疗耐药肺结核的疗效与安全性研究[J]. 新发传染病电子杂志, 2021, 6(4): 302-305.

Yang Liangzi, Ren Tantan, Fu Xiangdong, Liu Zhi, Luo Lan, Zhang Peize. Bedaquiline in the treatment of pulmonary drug-resistant tuberculosis: safety and efficacy[J]. Electronic Journal of Emerging Infectious Diseases, 2021, 6(4): 302-305.

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