水蛭素合用阿司匹林与单用阿司匹林或氯吡格雷治疗短暂性脑缺血发作的随机对照研究

Aspirin and Clopidogrel Only Versus Hirudin plus Aspirin for Transient Ischemic Attack:A Randomized Controlled Study

目的:探讨水蛭素合用阿司匹林治疗短暂性脑缺血发作(TIA)的疗效和安全性。方法:89例TIA患者随机分为3组:(1)氯吡格雷组(n=29),口服氯吡格雷75mg/d;(2)阿司匹林组(n=30),口服阿司匹林100mg/d;(3)水蛭素合用阿司匹林组(n=30),口服水蛭素0.32g,3次/d,阿司匹林100mg/d。观察治疗后90d内TIA复发或进展为脑梗死的病例数,观察出血等不良事件发生率。结果:治疗后90d内总的脑梗死发生率为4.5%,3组之间无显著差异。水蛭素合用阿司匹林组和氯吡格雷组90d内的TIA复发风险分别较单用阿司匹林降低69%(P=0.0078)和65%(P=0.0170)。总的出血发生率为2.25%,均发生在水蛭素合用阿司匹林组。结论:水蛭素合用阿司匹林可降低90d内TIA复发率的效果优于单用阿司匹林,与单用氯吡格雷相似,但出血风险增高。

Objective： To investigate the efficacy and safety of hirudin plus aspirin in the treatment of transient ischemic attack （TIA）. Methods： Eighty-nine patients with TIA were randomly allocated into 3 groups： clopidogrel group （n =29） received clopidogrel 75 mg/d, aspirin group （n =30） received aspirin 100 mg/d, and hirudin plus aspirin group （n = 30） received hirudin 0.32 g, 3/d, and aspirin 100 mg/d. The numbers of patients with recurrent TIA or who developed cerebral infarction were observed within 90 days after the treatment.The adverse events, such as the incidence of cerebral hemorrhage, were observed. Results： The total incidence of cerebral infarction was 4.5 % within 90 days after the treatment, and there was no significant difference among the 3 groups. The risk of recurrent TIA within 90 days in the hirudin plus aspirin group and clopidogrel group reduced 69% （P = 0. 007 8） and 65% （P = 0. 017 0） respectively ascompared with the aspirin group,The total incidence of Needing was 2.25%, and they all occurred in the hirudin plus aspirin group. Conclusions： The efficacy of hirudin plus aspirin is better than aspirin only in reducing the recurrence rate of TIA within 90 days, which is similar to clopidogrel only, however, the risk of bleeding may increase.