National Referral Unit for Tropical and Travel Medicine, Department of Internal Medicine, University Hospital La Paz-Carlos III, IdiPAZ, Madrid, Spain.
National Referral Centre for Tropical Diseases, Infectious Diseases Department, University Hospital Ramón y Cajal, IRYCIS, Madrid, Spain.
Clin Microbiol Infect. 2018 Dec;24(12):1344.e1-1344.e4. doi: 10.1016/j.cmi.2018.06.006. Epub 2018 Jun 12.
To describe the tolerability and rate of nifurtimox discontinuation when administered as a second-line treatment to patients with previous treatment interruptions due to adverse reactions with benznidazole.
We studied a prospective cohort study of adult patients with chronic Chagas disease in a referral centre in Spain treated from July 2007 to July 2017. We analysed the tolerability profile and treatment interruption rate due to adverse reactions (ARs) to nifurtimox in patients previously incompletely treated (less than 30 days) with benznidazole due to ARs.
A total of 472 patients initiated treatment with benznidazole during the study period. Of these, 118 (25%) developed ARs that led to treatment discontinuation before 30 days of therapy. Fifty-three (44.9%) of 118 initiated nifurtimox as second-line treatment; most were women (79.3%), were of Bolivian origin (98.1%) and had a median age of 37.3 years (interquartile range, 29.8-43.2). The most common ARs with nifurtimox were cutaneous hypersensitivity (24.1%), digestive disorders (22.2%), fever (12.9%), neurologic disturbances (11.1%), depression, anxiety or insomnia (9.2%), dyspnoea (7.4%), myalgia (5.5%), and dizziness, asthenia or malaise (7.4%). Twenty-six (49.1%) of 53 patients discontinued nifurtimox due to ARs, all of them before the required minimal therapy duration of 60 days. There were no deaths.
Treatment of chronic Chagas disease relies on two drugs with a poor tolerability profile. In our cohort, 12.3% of the patients who initiated benznidazole and subsequently nifurtimox in case of nontolerance developed ARs that led to permanent treatment discontinuation. Most were women of childbearing age, a group for whom therapy has the added benefit of interrupting vertical transmission.
描述在因不良反应（AR）而中断贝那唑嗪治疗的患者中，作为二线治疗药物使用硝呋替莫的耐受性和停药率。
我们对西班牙一家转诊中心的慢性恰加斯病成年患者进行了一项前瞻性队列研究，这些患者于 2007 年 7 月至 2017 年 7 月接受治疗。我们分析了因不良反应而中断贝那唑嗪治疗（不到 30 天）的患者中，使用硝呋替莫的耐受性和因不良反应导致的停药率。
在研究期间，共有 472 例患者开始使用贝那唑嗪治疗。其中，118 例（25%）因 AR 而中断治疗。在这 118 例患者中，有 53 例（44.9%）开始使用硝呋替莫作为二线治疗；大多数为女性（79.3%），来自玻利维亚（98.1%），中位年龄为 37.3 岁（四分位距 29.8-43.2）。使用硝呋替莫最常见的不良反应是皮肤过敏（24.1%）、消化系统疾病（22.2%）、发热（12.9%）、神经紊乱（11.1%）、抑郁、焦虑或失眠（9.2%）、呼吸困难（7.4%）、肌肉痛（5.5%）、头晕、乏力或不适（7.4%）。在 53 例患者中，有 26 例（49.1%）因不良反应而停止使用硝呋替莫，所有患者都在所需的 60 天最小治疗疗程之前停药。没有死亡病例。
慢性恰加斯病的治疗依赖于两种耐受性较差的药物。在我们的队列中，12.3%的患者在使用贝那唑嗪不耐受后开始使用硝呋替莫，他们发生的不良反应导致了永久性停药。大多数为育龄妇女，这一人群的治疗还可以中断垂直传播。
