含贝达喹啉方案治疗耐多药/广泛耐药结核病中期疗效前瞻性队列研究
作者:
作者单位:

1.南华大学附属长沙中心医院结核病诊疗中心, 湖南 长沙 410007;2.郴州市二医院结核科, 湖南 郴州 423000

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通讯作者:

施利  E-mail: 124463122@qq.com

中图分类号:

R521

基金项目:

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)


Interim efficacy of bedaquiline-containing regimen in treatment of MDR/XDR-TB: a prospective cohort study
Author:
Affiliation:

1.Department of Tuberculosis Diagnosis and Treatment, Changsha Central Hospital, University of South China, Changsha 410007, China;2.Department of Tuberculosis, Chenzhou Second People's Hospital, Chenzhou 423000, China

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    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。

    Abstract:

    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.

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裴异,陈检才,封文军,等.含贝达喹啉方案治疗耐多药/广泛耐药结核病中期疗效前瞻性队列研究[J]. 中国感染控制杂志,2021,(12):1102-1108. DOI:10.12138/j. issn.1671-9638.20211484.
Yi PEI, Jian-cai CHEN, Wen-jun FENG, et al. Interim efficacy of bedaquiline-containing regimen in treatment of MDR/XDR-TB: a prospective cohort study[J]. Chin J Infect Control, 2021,(12):1102-1108. DOI:10.12138/j. issn.1671-9638.20211484.

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  • 收稿日期:2021-05-27
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  • 在线发布日期: 2024-04-26
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