Einhäupl Karl
Department of Neurology, Medical School, Charité, Berlin, Germany.
Curr Med Res Opin. 2007 Feb;23(2):271-3. doi: 10.1185/030079906X167291.
Evidence is needed to guide therapeutic decisions on patients who had ischaemic cerebral events. The recently published European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT), an open-label randomised controlled study, compared long-term treatment of patients randomised to aspirin 30-325 mg daily with (n = 1363) or without (n = 1376) dipyridamole 200 mg twice daily. The study found the combination to be superior to aspirin alone (13% vs. 16% events in a composite endpoint of vascular death, non-fatal stroke, non-fatal myocardial infarction, or major bleeding; hazard ratio 0.8; 95% confidence interval 0.66-0.98). In the interpretation of the results, criticism has been raised related to the study design (open-label, change during the study), the study conduct (half of the aspirin patients underdosed, 33% drop-out rate in the combination group, missing information on potential confounders such as protective concomitant medication), and the outcomes (lack of differences in the efficacy outcomes between the intent-to-treat and the on-treatment populations, lack of differences in minor bleedings between treatment groups, borderline statistical significance of primary study endpoint). Further studies are needed to determine the place of aspirin/dipyridamole combinations in the secondary prevention of stroke.
需要证据来指导对发生缺血性脑事件患者的治疗决策。最近发表的欧洲/澳大利亚可逆性缺血性中风预防试验（ESPRIT）是一项开放标签随机对照研究，比较了随机接受每日30 - 325毫克阿司匹林治疗的患者（n = 1363）联合或不联合每日两次200毫克双嘧达莫治疗的长期效果。该研究发现联合用药优于单独使用阿司匹林（在血管性死亡、非致命性中风、非致命性心肌梗死或大出血的复合终点中，事件发生率分别为13%和16%；风险比0.8；95%置信区间0.66 - 0.98）。在对结果的解读中，有人对研究设计（开放标签、研究期间的改变）、研究实施（一半阿司匹林患者剂量不足、联合用药组33%的脱落率、缺乏关于潜在混杂因素如保护性伴随用药的信息）以及结果（意向性治疗人群和实际治疗人群之间疗效结果无差异、治疗组之间轻微出血无差异、主要研究终点的统计学意义接近临界值）提出了批评。需要进一步的研究来确定阿司匹林/双嘧达莫联合用药在中风二级预防中的地位。
