The BENEFIT trial: testing the hypothesis that trypanocidal therapy is beneficial for patients with chronic Chagas heart disease
The BENEFIT trial: testing the hypothesis that trypanocidal therapy is beneficial for patients with chronic Chagas heart disease
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DOI：
10.1590/s0074-02762009000900042
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发表时间：
2009-07-01
期刊：
影响因子：
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通讯作者：
Rassi, Anis
中科院分区：
文献类型：
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作者：
Marin-Neto, J Antonio;Rassi Jr, Anis;Rassi, Anis
在南美锥虫病慢性期的病理生理紊乱中，寄生虫持续存在可能是慢性南美锥虫病心肌病患者心肌损伤的主要机制。克氏锥虫在心脏中的存在引起低度但无情的炎症过程并诱导心肌自身免疫损伤。这些事实表明，杀锥虫治疗可能对慢性恰加斯病心脏病患者的临床病程产生积极影响。然而，现有的实验和临床证据不足以支持这些患者常规使用病因治疗。BENEFIT项目-苄硝唑中断锥虫病的评价-是一项国际性、多中心、双盲、安慰剂对照试验，研究慢性恰加斯心脏病患者使用苄硝唑进行杀锥虫治疗。该项目实际上由两项研究组成。该初步研究调查了病原学治疗是否显着降低寄生虫负担，通过基于聚合酶链反应的技术进行评估，并确定了杀锥虫药物在这种类型的锥虫病人群中的安全性和耐受性。这项全面研究确定了苯并咪唑抗锥虫治疗是否能降低慢性恰加斯心脏病患者的死亡率和其他主要心血管临床结局。
Among the pathophysiological derangements operating in the chronic phase of Chagas disease, parasite persistence is likely to constitute the main mechanism of myocardial injury in patients with chronic chagasic cardiomyopathy. The presence of Trypanosoma cruzi in the heart causes a low-grade, but relentless, inflammatory process and induces myocardial autoimmune injury. These facts suggest that trypanocidal therapy may positively impact the clinical course of patients with chronic Chagas heart disease. However, the experimental and clinical evidence currently available is insufficient to support the routine use of etiologic treatment in these patients. The BENEFIT project - Benznidazole Evaluation for Interrupting Trypanosomiasis - is an international, multicenter, double-blind, placebo-controlled trial of trypanocidal treatment with benznidazole in patients with chronic Chagas heart disease. This project is actually comprised of two studies. The pilot study investigates whether etiologic treatment significantly reduces parasite burden, as assessed by polymerase chain reaction-based techniques and also determines the safety and tolerability profile of the trypanocidal drug in this type of chagasic population. The full-scale study determines whether antitrypanosomal therapy with benznidazole reduces mortality and other major cardiovascular clinical outcomes in patients with chronic Chagas heart disease.