摘要
目的评估含贝达喹啉(BDQ)方案治疗耐多药结核病(MDR-TB)/广泛耐药结核病(XDR-TB)的有效性和安全性,为中国耐药结核病患者使用BDQ提供临床数据支持。方法收集2018年3月—2019年9月某院接受含BDQ治疗方案的结核病患者临床资料,分析患者治疗期间的疗效及不良反应。结果共纳入69例患者,其中10例(14.5%)为XDR-TB;63例(91.3%)完成24周含BDQ治疗,2例在治疗期间分别死于心脏骤停、呼吸衰竭,3例退组,1例失访。39例(56.5%)患者报告了108次不良事件,大部分不良事件被归为1级或2级(75次,69.4%),最常见的3级及以上不良事件为QT间期延长。治疗基线痰培养阳性29例(46.0%),第8、12、24周痰培养阴转率分别为93.1%(27例)、100.0%(29例)、93.1%(27例),2例患者痰培养于24周时复阳;痰培养阴转中位时间为24 d(四分位间距:14~61 d)。52例合并肺部空洞患者中,48例(92.3%)完成24周含BDQ治疗,12、24周空洞闭合率分别为37.5%、64.6%。结论与传统治疗方案相比,24周含BDQ的治疗方案可以提高MDR/XDR-TB患者痰培养阴转率和空洞闭合率,但需重视QT间期的监测管理。
Objective To evaluate the efficacy and safety of bedaquiline(BDQ-containing)regimen for the treatment of multidrug-resistant tuberculosis(MDR-TB)/extensively drug-resistant tuberculosis(XDR-TB),and provide clinical data for the use of BDQ in drug-resistant TB patients in China.Methods Clinical data of tuberculosis patients receiving BDQ-containing regimen in a hospital from March 2018 to September 2019 were collected,efficacy and adverse reactions during treatment were analyzed.Results Sixty-nine patients were enrolled,10(14.5%)of whom had XDR-TB,63 cases(91.3%)completed 24 weeks of BDQ-containing treatment,two patients died of cardiac arrest and respiratory failure during treatment,three were transferred,one was lost to follow-up,39 patients(56.5%)reported 108 times of adverse events,most adverse events were classified as grade 1 or grade 2(75 times,69.4%),and the most common grade 3 and above adverse events were QT interval prolongation.29 cases(46.0%)were positive in sputum culture at baseline,the negative conversion rates of sputum culture at week 8,12 and 24 were 93.1%(27 cases),100.0%(29 cases)and 93.1%(27 cases)respectively,sputum culture of 2 patients returned to positive at week 24;the median time of negative conversion of sputum culture was 24 days(interquartile interval:14-61 days).Among 52 patients with pulmonary cavity,48(92.3%)completed 24 weeks of BDQ-containing treatment,the cavity closure rates at week 12 and 24 were 37.5%and 64.6%respectively.Conclusion Compared with the traditional treatment regimen,BDQ-containing treatment regimen for 24 weeks can improve the negative conversion rate of sputum culture and cavity closure rate in patients with MDR/XDR-TB,but attention should be paid to the monitoring and management of QT interval.
作者
裴异
陈检才
封文军
杨晓云
黄云辉
何芳
胡羽萌
雷丽萍
施利
PEI Yi;CHEN Jian-cai;FENG Wen-jun;YANG Xiao-yun;HUANG Yun-hui;HE Fang;HU Yu-meng;LEI Li-ping;SHI Li(Department of Tuberculosis Diagnosis and Treatment, Changsha Central Hospital, University of South China, Changsha 410007, China;Department of Tuberculosis, Chenzhou Second People’s Hospital, Chenzhou 423000, China)
出处
《中国感染控制杂志》
CAS
CSCD
北大核心
2021年第12期1102-1108,共7页
Chinese Journal of Infection Control
基金
长沙市科技计划项目(kq1801145)
湖南省卫生健康委科研计划项目(20201439)。
关键词
贝达喹啉
肺结核
耐多药结核病
广泛耐药结核病
不良事件
bedaquiline
pulmonary tuberculosis
multidrug-resistant tuberculosis
extensively drug-resistant tuberculosis
adverse event
