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目的比较阿司匹林联合双嘧达莫与华法林预防低危非瓣膜性心房颤动(NVAF)患者血栓栓塞的有效性和安全性。方法将确诊的125例低危NVAF患者,采用机械抽样法随机分为两组,分别给予调整剂量华法林抗凝治疗[华法林组,69例,目标国际标准化比值(INR)为2.0～3.O]和阿司匹林联合双嘧达莫抗血小板治疗(联合治疗组,56例,阿司匹林100mg 1次/d+双嘧达莫100mg 3次/d)。观察两组患者死亡、血栓栓塞事件(缺血性脑卒中和外周动脉栓塞)及各种出血的发生率。结果随访12～28个月。华法林组失访3例,发生缺血性脑卒中1例,严重出血1例,轻微出血3例;联合治疗组失访2例,发生缺血性脑卒中2例,周围动脉栓塞1例,轻微出血2例,无严重出血病例。与联合治疗组相比,华法林组血栓栓塞事件发生率具有降低趋势,但差异无统计学意义[1.5%(1/66)比5.6%(3/54),P=0.220];出血事件发生率呈现升高趋势,但差异也无统计学意义[6.1%(4/66)比3.7%(2/54),P=0.556]。结论无血栓栓塞高危因素的低危NVAF患者,阿司匹林联合双嘧达莫抗血小板治疗与口服华法林抗凝治疗的疗效相似。
Objective To compare the efficacy and safety of aspirin plus dipyridamole and warfarin in preventing thromboembolism in patients with low-risk nonvalvular atrial fibrillation (NVAF). Methods A total of 125 patients with low-risk NVAF were enrolled in this study. They were randomized into two groups by random sampling. Warfarin was given to patients in adjusted warfarin dose group (69 in warfarin group). The target international normalized ratio (INR) was 2.0-3. O] and aspirin combined with dipyridamole antiplatelet therapy (combination therapy group, 56 cases, aspirin 100mg 1 / d + dipyridamol 100mg 3 times / d). The incidence of death, thromboembolic events (ischemic stroke and peripheral arterial embolism) and various bleeding were observed in both groups. The results were followed up for 12 to 28 months. Warfarin group lost 3 cases, ischemic stroke in 1 case, severe bleeding in 1 case, mild bleeding in 3 cases; combined treatment group were lost in 2 cases, ischemic stroke in 2 cases, peripheral arterial embolization in 1 case , Mild bleeding in 2 cases, no serious bleeding cases. Compared with the combination therapy group, the incidence of thromboembolism in warfarin group tended to decrease, but the difference was not statistically significant (1.5% (1/66) vs. 5.6% (3/54), P = 0.220]; bleeding events The incidence showed an increasing trend, but the difference was not statistically significant [6.1% (4/66) vs 3.7% (2/54), P = 0.556]. Conclusions The antiplatelet effect of aspirin and dipyridamole is similar to that of oral warfarin in low-risk NVAF patients without risk of thromboembolism.