Evandro Chagas National Institute of Infectious Diseases (INI)-Oswaldo Cruz Foundation (Fiocruz), Manguinhos, Rio de Janeiro, Brazil.
Médecins Sans Frontières (MSF), Operational Center Barcelona (OCBA), 08001 Barcelona, Spain.
J Antimicrob Chemother. 2017 Sep 1;72(9):2596-2601. doi: 10.1093/jac/dkx180.
Up to half of patients with Chagas' disease under benznidazole treatment present adverse drug reactions (ADRs) and up to one-third do not complete standard treatment.
To verify the incidence and possible factors associated with the suspension of benznidazole treatment in a large cohort of patients.
We included 2075 patients treated with benznidazole during the projects managed by the medical humanitarian organization Doctors Without Borders (Médecins Sans Frontières) in Bolivia from 2009 to 2013. Benznidazole treatment was provided two or three times per day for ∼60 days at 5-7.5 mg/kg/day. A multiple logistic regression model was developed to evaluate the factors associated with permanent suspension of benznidazole treatment.
Permanent benznidazole treatment suspension occurred in 211 patients (10.2%) and the average time until permanent treatment suspension was 23 days. Multifactorial analysis revealed that female sex (adjusted OR = 1.70), moderate ADRs (adjusted OR = 10.57), mild ADRs (adjusted OR = 1.69) and skin disorders (adjusted OR = 4.18) were significantly associated with the permanent suspension of benznidazole treatment. Women with mild or moderate skin ADRs presented a probability of treatment interruption of 18.6% and 59.0%, respectively.
Benznidazole treatment was safe and a large proportion of patients were able to complete a full course of benznidazole treatment under close treatment surveillance. Female sex, skin disorders and mild and moderate ADRs were independently associated with the permanent suspension of benznidazole treatment. In particular, women with moderate skin ADRs had the highest risk of benznidazole treatment interruption.
在接受苯并咪唑治疗的恰加斯病患者中，多达一半会出现药物不良反应（ADR），多达三分之一的患者无法完成标准治疗。
在一个大型患者队列中验证苯并咪唑治疗中断的发生率和可能相关因素。
我们纳入了 2075 名 2009 年至 2013 年期间由无国界医生组织（Médecins Sans Frontières）在玻利维亚管理的项目中接受苯并咪唑治疗的患者。苯并咪唑的治疗方案为每天 2 至 3 次，持续约 60 天，剂量为 5-7.5mg/kg/天。采用多因素逻辑回归模型评估与苯并咪唑治疗永久停药相关的因素。
211 名（10.2%）患者永久停止苯并咪唑治疗，平均停药时间为 23 天。多因素分析显示，女性（校正比值比 [OR] = 1.70）、中度 ADR（校正 OR = 10.57）、轻度 ADR（校正 OR = 1.69）和皮肤疾病（校正 OR = 4.18）与苯并咪唑治疗的永久停药显著相关。有轻度或中度皮肤 ADR 的女性中断治疗的概率分别为 18.6%和 59.0%。
苯并咪唑治疗安全，大多数患者在密切治疗监测下能够完成全疗程治疗。女性、皮肤疾病以及轻度和中度 ADR 与苯并咪唑治疗的永久停药独立相关。特别是有中度皮肤 ADR 的女性中断苯并咪唑治疗的风险最高。
