Shah Ira, Gandhi Dhruv N, Ansari Ramsha, Warse Himanshu, Kalawadia Sachi, Yangchen Tsering, Shah Daksha, Puri Varsha, Mattoo Sanjay, Bodhanwala Minnie
Pediatric DR-TB State Centre of Excellence, Department of Pediatric Infectious Diseases, BJ Wadia Hospital for Children, Mumbai, Maharashtra, India.
Department of Pediatrics, Seth GS Medical College, Mumbai, Maharashtra, India.
Lung India. 2025 Jul 1;42(4):330-336. doi: 10.4103/lungindia.lungindia_609_24. Epub 2025 Jun 27.
This study evaluates the treatment outcomes and adverse drug reactions (ADRs) of longer oral bedaquiline (BDQ)-based (without delamanid) antitubercular therapy (ATT) regimens in children aged 5-18 years.
A retrospective study was conducted between June 2021 and February 2024. We included 105 children diagnosed with drug-resistant tuberculosis (DR-TB) and treated with longer oral BDQ-based regimens. Duration of treatment was based on clinico-radiological resolution and multiple ADRs. Data on demographics, clinical features, resistance patterns, treatment regimens, outcomes, and adverse effects were analyzed.
Mean age was 11.29 ± 3.20 years, with a male-to-female ratio of 0.42:1. Prior ATT exposure was reported in 61 (58.1%), with previous treatment failure in 34 (55.7% of those with prior exposure) patients. BDQ was administered for a median duration of 6 months, with 14 (13.33%) requiring extension. BMLCC (bedaquiline-moxifloxacin-linezolid-cycloserine-clofazimine) regimen was received by 61 (58.1%), and BLCC ± additional drugs (bedaquiline-linezolid-clofazimine-cycloserine) regimen was received by 30 (28.6%) patients. Treatment completion was achieved in 75 (71.43%) patients with a mean duration of 22.50 ± 7.50 months, of which 35 (46.67%) required treatment for 18 months, 32 (42.67%) required treatment for more than 18 months, and 8 (10.67%) patients required treatment stoppage before 18 months in view of multiple ADRs. Fifty-one (48.6%) patients had ADRs, including QTc prolongation in 25 (23.8%), psychosis 11 (10.5%), and vomiting 7 (6.7%).
BDQ-based regimens are effective in treating pediatric DR-TB, with high treatment completion rates. However, the duration of treatment is 18 months or longer in most patients based on clinico-radiological resolution. ADRs, particularly QTcF prolongation, warrant close monitoring and follow-up.
本研究评估了在5至18岁儿童中，基于较长疗程口服贝达喹啉（BDQ）（不含地拉曼德）的抗结核治疗（ATT）方案的治疗效果和药物不良反应（ADR）。
于2021年6月至2024年2月进行了一项回顾性研究。我们纳入了105例被诊断为耐药结核病（DR-TB）并接受基于较长疗程口服BDQ方案治疗的儿童。治疗持续时间基于临床影像学缓解情况和多种ADR。分析了人口统计学、临床特征、耐药模式、治疗方案、治疗效果和不良反应的数据。
平均年龄为11.29±3.20岁，男女比例为0.42:1。61例（58.1%）报告有先前ATT暴露史，其中34例（先前暴露者的55.7%）有先前治疗失败史。BDQ的中位给药持续时间为6个月，14例（13.33%）需要延长疗程。61例（58.1%）接受了BMLCC（贝达喹啉-莫西沙星-利奈唑胺-环丝氨酸-氯法齐明）方案，30例（28.6%）患者接受了BLCC±其他药物（贝达喹啉-利奈唑胺-氯法齐明-环丝氨酸）方案。75例（71.43%）患者完成了治疗，平均疗程为22.50±7.50个月，其中35例（46.67%）需要治疗18个月，32例（42.67%）需要治疗超过18个月，8例（10.67%）患者因多种ADR在18个月前停止治疗。51例（48.6%）患者出现ADR，包括25例（23.8%）QTc延长、11例（10.5%）精神病和7例（6.7%）呕吐。
基于BDQ的方案在治疗儿童DR-TB方面有效，治疗完成率高。然而，根据临床影像学缓解情况，大多数患者的治疗持续时间为18个月或更长。ADR，尤其是QTcF延长，需要密切监测和随访。
