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口服凝血酶抑制剂预防脑卒中试验(SPORTIF)中非瓣膜性心房颤动女性患者的抗凝治疗 被引量:1

Anticoagulation in women with non-valvular atrial fibrillation in the stroke prevention using an oral thrombin inhibitor(SPORTIF) trials
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摘要 目的:女性心房颤动(AF)患者脑卒中的风险高于男性。华法林可预防脑卒中,但是由治疗引起的出血在女性中比男性中更多见。方法与结果:SPORTIF III试验(公开标记,n=3410)和SPORTIF V试验(双盲,n=3922)共纳入2257例伴有至少一个脑卒中危险因素的女性AF患者,受试者被随机分配到华法林治疗组[目标国际标准化比值(INR)2.0~3.0]或希美加群组(36m g,2次/d)。主要终点事件为所有脑卒中(包括缺血性和出血性)和全身性栓塞事件。女性患者的平均年龄较男性大(73.4±8.0岁vs69.8±9.0岁,P【0.0001)。 Aims: The risk of stroke is greater among women with atrial fibrillation (AF) than men. Warfarin protects against stroke, but treatment-related bleeding occurs more often in women than in men. Methods and results: SPORTIF III(open label, n=3410) and V (double-blind, n=3922) included 2257 women with AF and one or more stroke risk factors randomized to warfarin[target international normalized ratio (INR) 2.0-3.0] or ximelagatran (36 mg twice daily). Primary outcomes were all stroke(ischaemic/haemorrhagic) and systemic embolic event. Women were older, on average, than men, 73.4±8.0 vs. 69.8±9.0 years (P< 0.0001). More women were >75-years old and women had more risk factors than men had(P< 0.0001). The INR on warfarin (mean 2.5±0.7) was within target range for 67%of follow-up regardless of gender. Women more often developed primary events[2.08%/year, 95%confidence interval (CI) 1.60-2.56%/year vs. 1.44%/year, 95%CI 1.18-1.71%/year in men; P=0.016]. Major bleeding rates were similar(P=0.766)but women experienced more overall(major/minor) bleeding (P< 0.001). Warfarin was associated with more overall bleeding in both genders and more major bleeding in women than in men (P=0.001). Conclusion: When compared with men with AF, women in these studies were older and had more stroke risk factors. Women were more prone to anticoagulant-related bleeding; the higher rate of thrombo-embolism among women was related to more frequent interruption of anticoagulant therapy.
机构地区 Department of Medicine
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