Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO; Division of Mycobacterial and Respiratory Infections, National Jewish Health, Denver, CO.
Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.
Chest. 2017 Oct;152(4):800-809. doi: 10.1016/j.chest.2017.04.175. Epub 2017 May 5.
Clofazimine is an antimicrobial agent that has activity in vitro against mycobacteria. Increasingly, it has been used for the treatment of nontuberculous mycobacteria (NTM), despite limited data supporting its use in this setting. The objective of this study was to evaluate the safety, tolerability, and clinical outcomes associated with clofazimine in patients with NTM infection.
This observational-cohort study assessed clofazimine as used for pediatric and adult cystic fibrosis (CF) and non-CF patients with pulmonary and extrapulmonary NTM infection as part of a multidrug regimen from 2006 to 2014. Treatment regimens and adverse drug reactions (ADRs) were captured.
A total of 112 patients were included (median age, 62 years); 24 patients (21%) had CF. Eighty-seven (78%) had refractory disease with failure of previous therapy. Fifty-four patients (48%) had Mycobacterium abscessus complex, 41 (37%) had Mycobacterium avium complex, and 16 (14%) had two NTM species. The median duration of clofazimine use was 383 days (range, 3-2,419 days). Sixteen patients (14%) stopped clofazimine due to an ADR after a median of 101 days (95% CI, 63-119). Forty-one of 82 patients (50%) with pulmonary disease converted to negative NTM cultures within 12 months.
Clofazimine was a safe, reasonably tolerated, and active oral drug for NTM infection in our heterogeneous population of pediatric and adult CF and non-CF patients. It should be considered as an alternative drug for treatment of NTM disease.
氯法齐明是一种具有抗微生物活性的药物，体外对分枝杆菌具有活性。尽管其在这种情况下的使用数据有限，但它越来越多地被用于治疗非结核分枝杆菌（NTM）。本研究的目的是评估氯法齐明在 NTM 感染患者中的安全性、耐受性和临床结局。
这项观察性队列研究评估了氯法齐明在 2006 年至 2014 年期间，作为多药方案的一部分，用于儿科和成人囊性纤维化（CF）和非 CF 患者肺部和肺外 NTM 感染的安全性、耐受性和临床结局，纳入了接受氯法齐明治疗的儿童和成人 CF 和非 CF 患者，这些患者患有肺部和肺外 NTM 感染，作为多药治疗方案的一部分。记录治疗方案和药物不良反应（ADR）。
共纳入 112 例患者（中位年龄 62 岁）；24 例（21%）为 CF。87 例（78%）为难治性疾病，先前治疗失败。54 例（48%）为脓肿分枝杆菌复合体，41 例（37%）为鸟分枝杆菌复合体，16 例（14%）为两种 NTM 物种。氯法齐明的中位使用时间为 383 天（范围 3-2419 天）。16 例（14%）患者因 ADR 在中位 101 天后（95%CI，63-119）停止使用氯法齐明。82 例肺部疾病患者中有 41 例（50%）在 12 个月内转为 NTM 培养阴性。
在我们儿科和成人 CF 和非 CF 患者的异质性人群中，氯法齐明是一种安全、耐受性良好且有效的 NTM 感染口服药物。它应被视为治疗 NTM 疾病的替代药物。
