贝达喹啉和德拉马尼序贯治疗耐多药结核病患者的中期治疗结局。

Interim treatment outcomes in multidrug-resistant tuberculosis patients treated sequentially with bedaquiline and delamanid.

机构信息

Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.

出版信息

Int J Infect Dis. 2020 Sep;98:478-485. doi: 10.1016/j.ijid.2020.07.001. Epub 2020 Jul 5.

DOI:10.1016/j.ijid.2020.07.001

PMID:32640367

Abstract

OBJECTIVES

The objective of this study was to evaluate the efficacy and safety of the sequential use of bedaquiline (Bdq) and delamanid (Dlm) in patients with multidrug-resistant tuberculosis (MDR-TB) and limited treatment options.

METHODS

This study evaluated 74 MDR-TB patients treated between March 2016 and December 2018 with Bdq followed by Dlm (n = 22), or vice versa (n= 52), combined with optimized background regimens.

RESULTS

The mean age of the participants was 49.0 ± 15.8 years. Fifty-one (68.9%) of the participants were male. Fluoroquinolone resistance was identified in 54 (72.9%) patients, including 20 (27.0%) with extensively drug-resistant TB. Of the 47 (63.5%) patients with positive cultures at the commencement of the first new drug, culture conversion occurred in 44 (93.6%). The interim treatment outcome after 12 months was favourable in 68/74 patients (91.9%). Twenty-four weeks of treatment were completed in 137 of 148 episodes of new drug use (92.3%). Regarding the 11 early discontinuation events, six patients stopped using a new drug due to adverse drug reactions that were not life-threatening, including one (1.4%) who stopped Bdq due to QT-prolongation.

CONCLUSIONS

Sequential use of the two new drugs appears to be an effective and safe option for MDR-TB patients with few treatment options.

摘要

目的

本研究旨在评估贝达喹啉（Bdq）和德拉马尼（Dlm）序贯疗法在治疗耐多药结核病（MDR-TB）且治疗选择有限的患者中的疗效和安全性。

方法

本研究评估了 2016 年 3 月至 2018 年 12 月间 74 例接受 Bdq 序贯 Dlm（n=22）或反之（n=52）治疗的 MDR-TB 患者，联合优化背景治疗方案。

结果

参与者的平均年龄为 49.0±15.8 岁，51 例（68.9%）为男性。54 例（72.9%）患者存在氟喹诺酮类耐药，其中 20 例（27.0%）为广泛耐药结核。47 例（63.5%）起始新药物治疗时培养阳性患者中，44 例（93.6%）培养转阴。12 个月时的中期治疗结局在 68/74 例（91.9%）患者中良好。148 个新药物治疗疗程中有 137 个（92.3%）完成了 24 周的治疗。在 11 例早期停药事件中，6 例因非危及生命的药物不良反应停止使用新药物，其中 1 例（1.4%）因 QT 延长停止使用 Bdq。