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华法林与阿司匹林预防慢性心房颤动血栓栓塞并发症的安慰剂对照随机试验。哥本哈根AFASAK研究。

Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study.

作者信息

Petersen P, Boysen G, Godtfredsen J, Andersen E D, Andersen B

机构信息

Department of Neurology, University Hospital, Copenhagen, Denmark.

出版信息

Lancet. 1989 Jan 28;1(8631):175-9. doi: 10.1016/s0140-6736(89)91200-2.

DOI:10.1016/s0140-6736(89)91200-2
PMID:2563096
Abstract

From November, 1985, to June, 1988, 1007 outpatients with chronic non-rheumatic atrial fibrillation (AF) entered a randomised trial; 335 received anticoagulation with warfarin openly, and in a double-blind study 336 received aspirin 75 mg once daily and 336 placebo. Each patient was followed up for 2 years or until termination of the trial. The primary endpoint was a thromboembolic complication (stroke, transient cerebral ischaemic attack, or embolic complications to the viscera and extremities). The secondary endpoint was death. The incidence of thromboembolic complications and vascular mortality were significantly lower in the warfarin group than in the aspirin and placebo groups, which did not differ significantly. 5 patients on warfarin had thromboembolic complications compared with 20 patients on aspirin and 21 on placebo. 21 patients on warfarin were withdrawn because of non-fatal bleeding complications compared with 2 on aspirin and none on placebo. Thus, anticoagulation therapy with warfarin can be recommended to prevent thromboembolic complications in patients with chronic non-rheumatic AF.

摘要

从1985年11月至1988年6月,1007例慢性非风湿性心房颤动(AF)门诊患者进入一项随机试验;335例接受华法林公开抗凝治疗,在一项双盲研究中,336例接受每日一次75毫克阿司匹林治疗,336例接受安慰剂治疗。每位患者随访2年或直至试验终止。主要终点是血栓栓塞并发症(中风、短暂性脑缺血发作或内脏及四肢的栓塞并发症)。次要终点是死亡。华法林组的血栓栓塞并发症发生率和血管死亡率显著低于阿司匹林组和安慰剂组,后两组之间无显著差异。接受华法林治疗的5例患者出现血栓栓塞并发症,而接受阿司匹林治疗的有20例,接受安慰剂治疗的有21例。接受华法林治疗的21例患者因非致命性出血并发症退出试验,而接受阿司匹林治疗的有2例,接受安慰剂治疗的无一例。因此,对于慢性非风湿性AF患者,可推荐使用华法林进行抗凝治疗以预防血栓栓塞并发症。

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