全口服贝达喹啉方案治疗儿童耐多药/利福平耐药结核病的疗效和安全性：一项多中心、回顾性、队列研究。

Efficacy and safety of the all-oral bedaquiline-containing regimen as treatment for pediatric multidrug/rifampicin-resistant tuberculosis: a multicenter, retrospective, cohort study.

机构信息

Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai, China.

Department of Tuberculosis, Chengdu Public Health Center, Chengdu, Sichuan Province, China.

出版信息

Expert Rev Anti Infect Ther. 2024 Apr;22(4):219-227. doi: 10.1080/14787210.2023.2285917. Epub 2023 Nov 22.

DOI:10.1080/14787210.2023.2285917

PMID:37982155

Abstract

OBJECTIVE

The study aimed to observe the efficacy and safety of an all-oral bedaquiline (BDQ)-containing regimen for pediatric multidrug/rifampicin-resistant tuberculosis (MDR/RR-TB) through a multicenter, retrospective study in China.

METHODS

In the study, pediatric patients receiving all-oral BDQ-containing regimen (BDQ group) with clinical matched control group were included, the control group received an injection-containing regimen. The treatment outcomes and the incidence of adverse events (AEs) were compared and analyzed.

RESULTS

79 pediatric patients were enrolled, including 37 cases in BDQ group and 42 cases in the control group, the median age was 12 {8-16} and 11 {9-15} in both groups respectively. Favorable treatment outcome and cure rate in BDQ group were significantly higher than those in control group (100%vs 83.3%, p 0.03; 94.6%vs 63.3%, p 0.00). Median time of sputum culture conversion in BDQ group was significantly shorter than that in the control group (4 weeks vs 8 weeks, p 0.00). The incidence of AEs in the BDQ group was significantly less than that in the control group (48.6% vs 71.4%, p 0.03). No AEs leading to treatment discontinuation of BDQ occurred.

CONCLUSIONS

The all-oral BDQ-containing regimens may be effective and safe in the Chinese pediatric population.

摘要

目的

本研究旨在通过中国多中心回顾性研究，观察全口服贝达喹啉（BDQ）方案治疗儿童耐多药/利福平耐药结核（MDR/RR-TB）的疗效和安全性。

方法

本研究纳入了接受全口服 BDQ 方案（BDQ 组）和临床匹配对照组（对照组）的儿科患者，对照组接受注射剂方案。比较并分析了两组的治疗结局和不良事件（AE）发生率。

结果

共纳入 79 例儿科患者，BDQ 组 37 例，对照组 42 例，两组患者的中位年龄分别为 12 岁[8-16 岁]和 11 岁[9-15 岁]。BDQ 组的治疗结局和治愈率明显高于对照组（100%vs 83.3%，p=0.03；94.6%vs 63.3%，p=0.00）。BDQ 组痰培养转阴的中位时间明显短于对照组（4 周 vs 8 周，p=0.00）。BDQ 组的 AE 发生率明显低于对照组（48.6%vs 71.4%，p=0.03）。BDQ 组无因 AE 导致治疗中断的情况。