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华法林与阿司匹林预防非瓣膜性心房颤动患者血栓栓塞的随机对照研究 被引量:149

The randomized study of efficiency and safety of antithrombotic therapy in nonvalvular atrial fibrillation: warfarin compared with aspirin
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摘要 目的 通过前瞻性、随机、多中心研究比较阿司匹林与调整剂量华法林预防非瓣膜性心房颤动(房颤)患者发生血栓栓塞的有效性和安全性.方法 在18个中心,根据入选标准将非瓣膜性房颤患者随机分配至阿司匹林组(150~160 mg/d)和调整剂量华法林组(初始剂量2 mg/d),目标国际标准化比值(INR)为2.0~3.0(年龄≥75岁者的INR为1.6~2.5).常规门诊随访,调整华法林剂量并记录两组患者的终点事件和不良反应发生情况.主要终点事件为缺血性脑卒中和死亡,次要终点事件包括短暂性脑缺血发作、腔隙性脑梗死、外周动脉栓塞、急性心肌梗死和严重出血.结果 共704例患者进入分析,阿司匹林组369例,华法林组335例.男性420例(59.7%),平均年龄(63.3±9.9)岁,两组患者基线特征(包括合并疾病和伴随用药)差异无统计学意义.随访时间中位数19个月(2~24个月).与阿司匹林比较,调整剂量华法林明显降低主要终点事件发生率[2.7%比6.0%,P=0.03,OR 0.44,95%可信区间(CI)为0.198~0.960],相对危险下降54%;缺血性脑卒中的相对危险下降62%(1.8%比4.6%,P=0.04,OR 0.38,95% CI为0.147~0.977);总血栓栓塞事件相对危险下降52%(10.6%比5.4%,P=0.01,OR 0.48,95% CI为0.269~0.858).次要终点事件两组间差异无统计学意义.华法林组轻微出血和严重出血发生率均高于阿司匹林组(P<0.05).华法林组总死亡率低于阿司匹林组[4例(1.2%)比8例(2.2%)],但差异无统计学意义(P>0.05);包括主要和次要终点的联合终点事件华法林组低于阿司匹林组(8.4%比13.0%,P=0.047). 结论 与阿司匹林相比,华法林可明显降低国人非瓣膜性房颤患者脑卒中的发生率,华法林组出血的发生率高于阿司匹林组,但多数出血并发症发生在INR>3.0.严密监测(INR 2.0~3.0)下的调整剂量华法林安全有效. Objective To investigate whether warfarin is more effective and superior to aspirin for the prevention of thrombeembolism in nonvalvular atrial fibrillation in Chinese. Methods In a multicenter randomized trial, the patients diagnosed as nonvalvular atrial fibrillation were randomized to receive aspirin 150 mg- 160 mg once daily or adjusted-dose warfarin (international normalized ratio, 2.0 - 3.0). We compared the effect of the two therapy on the primary end point of ischemic stroke or death from any cause and on the combined end-point (stroke, death, peripheral arteries embolism, TIA, acute myocardial infarction, serious bleeding) during a median follow-up period of 19 months. Results Of the 704 patients, 420 (59.7%) were male. The average patient age was (63.3 ±9.9) years. The median follow-up period is 19 months. The mean dose of warfarin was (3.2 ±0.7) rag. Compared with aspirin, the primary end point of death or ischemic stroke was reduced by warfarin (2.7% vs 6.0% , P =0.03, OR 0. 44,95% CI 0. 198 -0.960) and the relative risk decreased by 56%. The thrombeembolism event in the aspirin group was significantly higher than that in warfarin group ( 10.6% vs 5.4%, P = 0. 01, OR 0. 48,95% CI 0. 269 - 0.858). There was no significant differences of the mortality rate between the two groups( 1.2% vs 2.2%,P 〉0.05). The secondary end point was nonsignificantly reduced in warfarin group than that in aspirin group, while the combined end point is statistically decreased by adjusted-dose warfarin(8.4% vs 13.0% , P =0. 047). Warfarin treatment was associated with increased bleeding rate compared to aspirin (6.9% vs 2.4%, P 〈 0.05 ), although the major bleeding rate is rather low (1.5%). All the major bleeding events occurred with INR above 3.0. Conclusions Randomized control study demonstrated that anticoagulation with adjusted-dosed warfarin ( INR 2.0 - 3.0) can significantly reduced the risk of thromboembolism event with slightly increased hemorrhage, compared to as
作者 胡大一 张鹤萍 孙艺红 姜立清 HU Da-yi, ZHANG He-ping, SUN Yi-hong, JIANG Li- qing , on behalf of the Antithrombotic Therapy in Atrial Fibrillation Study Group. Department of Cardiology, People's Hospital, Peking University, Beijing 100044, China
出处 《中华心血管病杂志》 CAS CSCD 北大核心 2006年第4期 295-298,共4页 Chinese Journal of Cardiology
基金 卫生部科技专项心房颤动的抗栓研究项目基金(WKZ-2001-1-18)
关键词 心房颤动 华法林 阿司匹林 脑血管意外 颅内出血 Atrial fibrillation Warfarin Aspirin Cerebrovascular accident Intracranial hemorrhages
作者简介 通讯作者:胡大一,北京大学人民医院心内科,100044,Email: dayi.hu@medmail.com.cn
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参考文献11

  • 1Arboix A,Lluis GE,Massons JB,et al.Atrial fibrillation and stroke:clinical presentation of cardioembolic versus atherothrombotic infarction.Int J Cardiol,2000,73:33-42. 被引量:1
  • 2胡大一,孙艺红,周自强,李奎宝,倪永斌,杨光,孙淑红,李蕾.中国人非瓣膜性心房颤动脑卒中危险因素的病例-对照研究[J].中华内科杂志,2003,42(3):157-161. 被引量:328
  • 3周自强 ,胡大一 ,陈捷 ,张仁汉 ,李奎宝 ,赵秀丽 .中国心房颤动现状的流行病学研究[J].中华内科杂志,2004,43(7):491-494. 被引量:1213
  • 4Petersen P,Boysen G,Godtfredsen J,et al.Placebo controlled,randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation.Lancet,1989,338:175-179. 被引量:1
  • 5European Atrial Fibrillation Trial Study Group.Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke.Lancet,1993,342:1255-1262. 被引量:1
  • 6Stroke Prevention in Atrial Fibrillation Investigators.Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation:stroke prevention in atrial fibrillation Ⅱstudy.Lancet,1994,343:687-691. 被引量:1
  • 7Gullov AL,Koefoed BG,Petersen P,et al.Fixed mini-dose warfarin and aspirin alone and in combination versus adjusted-dose warfarin for stroke prevention in atrial fibrillation:Second Copenhagen Atrial Fibrillation,Aspirin,and Anticoagulation Study.Arch Intern Med,1998,158:1513-1521. 被引量:1
  • 8戚文航.中国部分地区心房颤动住院病例回顾性调查[J].中华心血管病杂志,2003,31(12):913-916. 被引量:323
  • 9张学义,张薇,郑兆通,钟明,黎莉,张运.非瓣膜性心房颤动并发缺血性脑卒中的防治[J].中华急诊医学杂志,2004,13(9):592-594. 被引量:19
  • 10Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia.The European Atrial Fibrillation Trial Study Group.N Engl J Med,1995,333:5-10. 被引量:1

二级参考文献17

  • 1Goldstein LB, Adams R, Becker K, et al. Primary prevention of ischemic stroke: a statement for healthcare professionals from the stroke council of the American Heart Association. Circulation, 2001, 103:163-182. 被引量:1
  • 2Laupacis A, Albers G, Dalen J, et al. Antithrombotic therapy in atrial fibrillation. Chest, 1998,114(5 Suppl):5795-5895. 被引量:1
  • 3Yamaguchi T. Optimal intensity of warfarin therapy for secondary prevention of stroke in patients with non-valvular atrial fibrillation. A multicenter, prospective, randomized trial. Stroke, 2000, 31:817-821. 被引量:1
  • 4Levy S, Brelthardt G, Campbell RW, et al. Atrial fibrillation: current knowledge and recommendations for management. Working Group on Arrhythmias of the European Society of Cardiology. Eur Heart J, 1998, 19:1294-1320. 被引量:1
  • 5Antiplatelet Trialists Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Br Med J, 2000, 324:71-86. 被引量:1
  • 6Hsievert H, Lesh MD, Trepels T, et al. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation, 2002, 105:1887-1891. 被引量:1
  • 7Ezekowita MD, Levine JA. Preventing stoke in patients with atrial fibrillation. JAMA, 1999, 281: 1830-1835. 被引量:1
  • 8Fuster V, Ryden LE, Asinger RW, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary. A Report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines and the 被引量:1
  • 9Hirsh J, Dalen J, Anderson DR, et al. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest, 2001,119(1 Suppl):8S-21S. 被引量:1
  • 10Levine MN, Raskob G, Landefeld S, et al. Hemorrhagic complications of anticoagulant treatment. Chest, 2001,119(1 Suppl):108S-121S. 被引量:1

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