Safety Profile of Nifurtimox for Treatment of Chagas Disease in the United States
Safety Profile of Nifurtimox for Treatment of Chagas Disease in the United States
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DOI：
10.1093/cid/ciw477
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发表时间：
2016-10-15
影响因子：
11.8
通讯作者：
Meymandi, Sheba K.
中科院分区：
文献类型：
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作者：
Forsyth, Colin J.;Hernandez, Salvador;Meymandi, Sheba K.
背景。硝呋替莫是治疗恰加斯病（CD）仅有的两种药物之一，也是目前在美国唯一可用的药物，但其安全性和耐受性尚未得到广泛研究。这是第一个评估美国cd患者对硝呋替莫耐受性的研究。本研究评估了53例乳化病患者的副作用，这些患者均为拉丁美洲移民，从2008年3月至2012年7月接受尼福替莫（8- 10mg /kg，每日3次，持续12周）治疗。记录不良事件发生的频率和严重程度。共记录435例ae；93.8%为轻度，3.0%为中度，3.2%为重度。患者平均经历8.2次不良事件；最常见的是厌食症（79.2%）、恶心（75.5%）、头痛（60.4%）、健忘症（58.5%）和体重减轻（52.8%）。11例患者（20.8%）无法完成治疗。经历中度或重度AE(优势比[or]， 3.82
Background. Nifurtimox is 1 of only 2 medications available for treating Chagas disease (CD) and currently the only drug available in the United States, but its safety and tolerance have not been extensively studied. This is the first study to evaluate tolerance of nifurtimox in US patients with CD.Methods. This investigation assessed side effects in a sample of 53 patients with CD, all Latin American immigrants, who underwent treatment with nifurtimox (8-10 mg/kg in 3 daily doses for 12 weeks) from March 2008 to July 2012. The frequency and severity of adverse events (AEs) was recorded.Results. A total of 435 AEs were recorded; 93.8% were mild, 3.0% moderate, and 3.2% severe. Patients experienced a mean of 8.2 AEs; the most frequent were anorexia (79.2%), nausea (75.5%), headache (60.4%), amnesia (58.5%), and >5% weight loss (52.8%). Eleven patients (20.8%) were unable to complete treatment. Experiencing a moderate or severe AE (odds ratio [OR], 3.82; P