Matías-Guiu J, Dávalos A, Picó M, Monasterio J, Vilaseca J, Codina A
Department of Neurology, Hospital Vall D'Hebron, Barcelona, Spain.
Acta Neurol Scand. 1987 Dec;76(6):413-21. doi: 10.1111/j.1600-0404.1987.tb03596.x.
A total of 243 patients who had reversible ischemic attacks (RIA) were submitted to clinical trial to determine whether dipyridamole (400 mg/day) (D) or aspirin (100 mg/48 hours) + dipyridamole (300 mg/day) (ASA + D) would produce significant reduction in the subsequent occurrence of RIA and completed stroke. One hundred and fifteen were selected for Group ASA + D and 71 were treated with dipyridamole only. The treatment groups were similar in relation to age, sex, risk factors, duration and presumed vascular territory of RIA, incidence of alterations of arterial supra-aortic trunks, cerebral infarct (CT scan), and platelet function. Patients were followed for a mean time of 21 months. At the end of the study, 21.7% of the ASA + D group and 19.7% in the D group had suffered new episodes of RIA or completed stroke (p = 0.88). Frequency of stroke (reversible ischemic neurologic deficit or completed stroke) was 7.8% in the ASA + D patients and 9.8% in the D patients (p = 0.83). Subgroup analysis did not show significant differences either. It is concluded that ASA + D has no significantly greater beneficial effect than that observed with D alone in the secondary prevention of atherothrombotic cerebral ischemia. However, a statistical Type II error cannot be excluded by the reduced number of recurrences.
共有243例可逆性缺血性发作(RIA)患者参与了一项临床试验,以确定双嘧达莫(400毫克/天)(D)或阿司匹林(100毫克/48小时)+双嘧达莫(300毫克/天)(ASA + D)是否能显著降低随后RIA和完全性卒中的发生率。115例患者被选入ASA + D组,71例仅接受双嘧达莫治疗。治疗组在年龄、性别、危险因素、RIA的持续时间和推测的血管区域、主动脉弓上干改变的发生率、脑梗死(CT扫描)以及血小板功能方面相似。患者平均随访21个月。研究结束时,ASA + D组有21.7%的患者以及D组有19.7%的患者出现了新的RIA发作或完全性卒中(p = 0.88)。ASA + D组患者的卒中发生率(可逆性缺血性神经功能缺损或完全性卒中)为7.8%,D组患者为9.8%(p = 0.83)。亚组分析也未显示出显著差异。结论是,在动脉粥样硬化性血栓形成性脑缺血的二级预防中,ASA + D并不比单独使用D具有显著更大的有益效果。然而,由于复发次数减少,不能排除Ⅱ型统计错误。