低分子肝素与未分离肝素作为桥接治疗心房颤动栓塞性卒中患者的疗效、安全性和耐受性研究

Farnia Feiz, Reyhane Sedghi, Alireza Salehi, Nahid Hatam, Jamshid Bahmei, Afshin Borhani-Haghighi
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引用次数: 0

摘要

背景:调整剂量华法林抗凝治疗是一种广泛接受的预防房颤患者卒中复发的治疗方法。同时,在华法林开始抗凝治疗之前使用肝素或类肝素桥接治疗是一个有争议的问题。我们比较了低分子肝素(LMWH)和未分离肝素(UFH)作为桥接方法在近期房颤缺血性卒中患者中的安全性、有效性和耐受性。方法:本研究是一项随机单盲对照试验,在符合接受华法林治疗条件的心房颤动急性缺血性卒中患者中,随机每12小时皮下注射60毫克(mg)的低分子肝素(依诺肝素),或1000单位/小时连续静脉注射肝素。主要疗效终点是新发缺血性卒中、心肌梗死和/或死亡的复发。主要安全终点是中枢神经系统和/或全身性出血。结果:共招募74名受试者。两组患者的基线人口学特征和临床特征相匹配。UFH组随访期间新发缺血性卒中、心肌梗死和/或死亡10例(27.03%),低分子肝素组4例(10.81%)(p值:0.136)。UFH组7例(18.9%)、4例(10.8%),低分子肝素组5例(13.5%)、3例(8.1%)(p值分别为0.754、0.751),随访期间均出现出血和中枢神经系统(CNS)症状。未见任何患者出现退出和肝素诱导的血小板减少症和药物过敏等重大不良反应。结论:依诺肝素是一种安全、有效的UFH桥接治疗方案。
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Study of the Efficacy, Safety and Tolerability of Low-Molecular-Weight Heparin vs. Unfractionated Heparin as Bridging Therapy in Patients with Embolic Stroke due to Atrial Fibrillation.

Background: Anticoagulation with adjusted dose warfarin is a well-accepted treatment for the prevention of recurrent stroke in patients with atrial fibrillation. Meanwhile, using bridging therapy with heparin or heparinoids before warfarin for initiation of anticoagulation is a matter of debate. We compared safety, efficacy, and tolerability of low-molecular-weight heparin (LMWH) and unfractionated heparin (UFH) as a bridging method in patients with recent ischemic stroke due to atrial fibrillation.

Method: This study was a randomized single-blind controlled trial in patients with acute ischemic stroke due to atrial fibrillation who were eligible for receiving warfarin and were randomly treated with 60 milligrams (mg) of LMWH (enoxaparin) subcutaneously every 12 h, or 1000 units/h of continuous intravenous heparin. The primary efficacy endpoints were recurrence of new ischemic stroke, myocardial infarction and/or death. The primary safety endpoint was central nervous system and/or systemic bleeding.

Results: Seventy-four subjects were recruited. Baseline demographic and clinical characteristics of two groups were matched. Composite endpoint outcome of new ischemic stroke, myocardial infarction, and/or death in follow-up period was seen in 10 subjects (27.03%) in UFH group and in four subjects (10.81%) in LMWH group (p value: 0.136). All hemorrhages and symptomatic central nervous system (CNS) hemorrhages in follow-up period were in 7 (18.9%) and 4 (10.8%) patients in UFH group, in 5 (13.5%), and 3 (8.1%) patients in LMWH group (p values: 0.754 and 0.751), respectively. Drop out and major adverse-effects such as heparin-induced thrombocytopenia and drug hypersensitivity were not seen in any patient.

Conclusion: Enoxaparin can be a safe and efficient alternative for UFH as bridging therapy.

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