Efficacy and safety of the all-oral bedaquiline-containing regimen as treatment for pediatric multidrug/rifampicin-resistant tuberculosis: a multicenter, retrospective, cohort study.
Wen-Wen Sun, Ming Yang, Xiao-Hong Chen, Li-Chao Fan, Hao-Yu Wu, Shao-Jun Zhang, Yu Chen, Lin Fan
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引用次数: 0
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.
目的:通过在中国开展的一项多中心回顾性研究,观察含贝达喹啉(BDQ)全口服方案治疗小儿耐多药/利福平结核病(MDR/RR-TB)的疗效和安全性。方法:采用全口服含BDQ方案的患儿(BDQ组)和临床匹配的对照组,对照组采用含注射方案。比较分析两组患者的治疗效果及不良事件(ae)发生率。结果:纳入79例患儿,其中BDQ组37例,对照组42例,两组中位年龄分别为12{8-16}和11{9-15}。BDQ组患者的良好疗效和治愈率均显著高于对照组(100%vs 83.3%, p 0.03;94.6%vs 63.3%, p 0.00)。BDQ组痰培养转化的中位时间显著短于对照组(4周vs 8周,p < 0.05)。BDQ组不良事件发生率明显低于对照组(48.6% vs 71.4%, p 0.03)。未发生导致BDQ停药的不良事件。结论:含bdq全口服方案在中国儿童人群中可能是安全有效的。
期刊介绍:
Expert Review of Anti-Infective Therapy (ISSN 1478-7210) provides expert reviews on therapeutics and diagnostics in the treatment of infectious disease. Coverage includes antibiotics, drug resistance, drug therapy, infectious disease medicine, antibacterial, antimicrobial, antifungal and antiviral approaches, and diagnostic tests.