Enhancing Recovery After Acute Ischemic Stroke with Donepezil as an Adjuvant Therapy to Standard Medical Care: Results of a Phase IIa Clinical Trial
Enhancing Recovery After Acute Ischemic Stroke with Donepezil as an Adjuvant Therapy to Standard Medical Care: Results of a Phase IIa Clinical Trial
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DOI：
10.1016/j.jstrokecerebrovasdis.2010.12.009
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发表时间：
2011-05-01
影响因子：
2.5
通讯作者：
Meschia, James F.
中科院分区：
文献类型：
--
作者：
Barrett, Kevin M.;Brott, Thomas G.;Meschia, James F.
背景资料：我们的目的是评估早期多奈哌齐给药的安全性、耐受性和有效性信号，以促进不同急性缺血性卒中人群的恢复。研究方法：这是一项多中心、单组、国家神经疾病和卒中研究所重组组织纤溶酶原激活剂试验对照、改良的2阶段适应性临床试验，在美国2家三级护理医院进行。纳入症状发作后24小时内接受治疗的缺血性卒中成人患者。研究的干预是多奈哌齐5 mg/天，持续30天，然后增加到10 mg/天，持续60天。我们的主要结果指标包括治疗相关的不良事件和副作用。主要有利结局是90天的国立卫生研究院卒中量表（NIHSS）评分
Background: Our aim was to assess the safety, tolerability, and efficacy signal of early donepezil administration with regard to enhancing recovery in a diverse acute ischemic stroke population. Methods: This was a multicenter, single-arm, National Institute of Neurological Disorders and Stroke Recombinant Tissue Plasminogen Activator trial controlled, modified 2-stage adaptive clinical trial set in 2 tertiary care hospitals in the United States. Adults with ischemic stroke treated within 24 hours after onset of symptoms were included. The intervention studied was donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days. Our main outcome measures included treatment-related adverse events and side effects. The primary favorable outcome was a 90-day National Institutes of Health Stroke Scale (NIHSS) score