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[意大利心房颤动研究(SIFA):现状报告]

[Italian Study on Atrial Fibrillation (SIFA): status report].

作者信息

Amabile G, Matteoli S, Fattapposta F, Lavezzari M, Trappolini M, Heiman F, Morocutti C

机构信息

Istituto Clinica Malattie Nervose e Mentali, Università degli Studi La Sapienza, Roma.

出版信息

Cardiologia. 1993 Dec;38(12 Suppl 1):327-32.

PMID:8020032
Abstract

Non-valvular atrial fibrillation increases the risk of stroke by a factor of 5 and is present in about 15% of patients with acute stroke. Its prevalence in the general population increases from 0.5% at 50-59 years to > 10% at 80-99 years. In patients with non-valvular atrial fibrillation the risk of stroke increases with age, blood pressure and other evidence of cardiac disease. In addition, non-valvular atrial fibrillation is associated with a greater early mortality and a greater risk of recurrent stroke. The anticoagulant therapy to prevent early recurrent embolism is likewise controversial. Anticoagulant therapy appears to reduce this risk, but there is the danger of accentuating hemorrhagic infarction, especially in patients with large strokes. The effectiveness of antiplatelet drugs in patients with cardioembolic stroke is also not defined. The Studio Italiano Fibrillazione Atriale (SIFA) is a multicentric, randomized trial to assess the efficacy and safety of anticoagulant, warfarin, versus antiplatelet treatment, indobufen, a reversible inhibitor of platelet cyclo-oxygenase, in the prevention of recurrent cerebral ischemia and other systemic embolisms in non-valvular atrial fibrillation patients. Patients of both sexes, aged > 30 years with non-valvular atrial fibrillation, who have presented in the last 2 weeks an ischemic cerebral event (transitory ischemic attack or non-disabling stroke) and who have given their informed consent, were eligible. Patients with hemorrhagical diseases or contraindications to anticoagulant therapy were excluded. Patients were randomly given either indobufen (400 mg/die) or oral warfarin to an international normalized ratio of 2.0-3.5. The primary end-points were: recurrence of cerebral ischemia, systemic embolisms, intracranial or fatal hemorrhage, acute myocardial infarction, vascular death.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

非瓣膜性心房颤动使中风风险增加5倍,约15%的急性中风患者存在该病症。其在普通人群中的患病率从50 - 59岁时的0.5%增至80 - 99岁时的超过10%。在非瓣膜性心房颤动患者中,中风风险随年龄、血压及其他心脏病证据增加。此外,非瓣膜性心房颤动与更高的早期死亡率及复发性中风风险相关。预防早期复发性栓塞的抗凝治疗同样存在争议。抗凝治疗似乎可降低此风险,但有加重出血性梗死的危险,尤其是在大面积中风患者中。抗血小板药物在心源性栓塞性中风患者中的有效性也未明确。意大利心房颤动研究(SIFA)是一项多中心随机试验,旨在评估抗凝药物华法林与抗血小板药物吲哚布芬(一种血小板环氧化酶可逆抑制剂)在预防非瓣膜性心房颤动患者复发性脑缺血及其他全身性栓塞方面的疗效和安全性。年龄大于30岁、患有非瓣膜性心房颤动、在过去2周内发生过缺血性脑事件(短暂性脑缺血发作或非致残性中风)且已签署知情同意书的男女患者符合条件。患有出血性疾病或有抗凝治疗禁忌证的患者被排除。患者被随机给予吲哚布芬(400毫克/天)或口服华法林,使国际标准化比值达到2.0 - 3.5。主要终点为:脑缺血复发、全身性栓塞、颅内或致命性出血、急性心肌梗死、血管性死亡。(摘要截断于250字)

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