Martí Massó J F, Lozano R
Department of Neurosciences, País Vasco University, San Sebastian, Spain.
Clin Ther. 1990 Jul-Aug;12(4):344-51.
Two hundred and sixty-four patients were included in an open, randomized, multicenter trial, with the aim of determining whether nicardipine can be useful in the prevention of cerebral infarction. The patients had experienced one or more transient ischemic attacks, reversible ischemic neurologic defect, or stroke with minor permanent neurological deficit in the 12 months before enrolling in the study. Each patient was randomly assigned to received 250 mg of aspirin once daily plus 20 mg of nicardipine thrice daily (n = 170) or 250 mg of aspirin once daily (n = 94) for 12 months. During the 12-month treatment period, 12% of the aspirin-plus-nicardipine group and 19% of the aspirin-only group experienced an ischemic cerebrovascular event; at six months, the cumulative incidence of events was significantly lower in the aspirin-plus-nicardipine group than in the aspirin-only group. One patient in each group died of a recurrent stroke. Aspirin-related side effects were dyspepsia (reported by four patients), heartburn (by seven), nausea and vomiting (by four), and melena (by five); nicardipine-related side effects were transient hypotension (by two), headache (by four), ankle edema (by three), and constipation (by four). Results indicate that the addition of nicardipine to antiplatelet treatment may safely prevent the recurrence of ischemic cerebrovascular events.
264名患者被纳入一项开放、随机、多中心试验，目的是确定尼卡地平是否有助于预防脑梗死。这些患者在入组研究前12个月内经历过一次或多次短暂性脑缺血发作、可逆性缺血性神经功能缺损或伴有轻度永久性神经功能缺损的中风。每位患者被随机分配接受每日一次250毫克阿司匹林加每日三次20毫克尼卡地平（n = 170）或每日一次250毫克阿司匹林（n = 94），持续12个月。在12个月的治疗期内，阿司匹林加尼卡地平组有12%的患者和仅服用阿司匹林组有19%的患者发生缺血性脑血管事件；在6个月时，阿司匹林加尼卡地平组的事件累积发生率显著低于仅服用阿司匹林组。每组各有一名患者死于复发性中风。与阿司匹林相关的副作用有消化不良（4名患者报告）、烧心（7名）、恶心和呕吐（4名）以及黑便（5名）；与尼卡地平相关的副作用有短暂性低血压（2名）、头痛（4名）、踝部水肿（3名）和便秘（4名）。结果表明，在抗血小板治疗中添加尼卡地平可安全预防缺血性脑血管事件的复发。
