Adverse reactions to benznidazole in the treatment of Chagas’ Disease: a systematic review of randomized and controlled trials

Abstract Background In Brazil, the only drug available for the treatment of Trypanosoma cruzi, which causes Chagas' Disease (CD), is the Benznidazole (BZN) whose the adverse reactions might lead to treatment dropout. Objective The objective of this study is to quantify the proportion of occurrence of adverse effects, to describe them and to identify the risk factors associated with this occurrence. Method This is a systematic review conducted through the standards established by the Preferred Reporting Items in Systematic Reviews and Metanalyses (PRISMA). Only randomized controlled trials were included. Results Five of 134 studies were included. The sample size ranged from 77 to 2854 people, and the age range of the participants ranged from zero to 75 years old. All included studies reported adverse reactions to BZN use. The frequency of adverse reaction was 38% and the most common reaction was the skin rash. The treatment dropout caused by the adverse reactions was cited in three studies and was ranging from 6.4% to 13.4%. Conclusion The adverse reactions caused by the use of BZN varied with the age of patients and the therapeutic scheme of dose and time adopted. Therefore, medical knowledge is imperative for the safe use of BZN and adherence to treatment.

背景：在巴西，治疗引发恰加斯病（Chagas' Disease, CD）的病原体克氏锥虫（Trypanosoma cruzi）的唯一可用药物为苯硝唑（Benznidazole, BZN），其引发的不良反应可能导致患者中断治疗。研究目的：本研究旨在量化不良反应的发生比例、描述其临床特征，并明确与不良反应发生相关的危险因素。研究方法：本研究遵循《系统评价与荟萃分析优先报告条目》（Preferred Reporting Items in Systematic Reviews and Meta-analyses, PRISMA）制定的标准开展，仅纳入随机对照试验（Randomized Controlled Trial, RCT）。研究结果：最终从134项研究中纳入5项，样本量范围为77至2854例受试者，参与者年龄跨度为0至75岁。所有纳入研究均报道了使用BZN后的不良反应，不良反应总发生率为38%，最常见的不良反应为皮疹。3项研究提及了由不良反应导致的治疗中断率，其范围为6.4%至13.4%。研究结论：BZN所致不良反应随患者年龄及所采用的剂量-时间治疗方案而异。因此，掌握相关医学专业知识对于安全使用BZN及提高治疗依从性至关重要。