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非ST段抬高急性冠脉综合征患者随机应用依诺肝素或普通肝素抗凝治疗的疗效和出血并发症:系统综述

Efficacy and Bleeding Complications Among Patients Randomized to Enoxaparin or Unfractionated Heparin for Antithrombin Therapy in Non-ST-Segment Elevation Acute Coronary Syndromes: A Systematic Overview
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摘要 背景:抗凝疗法已成为急性冠脉综合征(acute coronary syndrome,ACS)治疗指南推荐的标准疗法。但是,最近某些试验在ACS患者中对依诺肝素(enoxaparin)与普通肝素(unfractionated heparin)的应用进行了比较,发现这些抗凝疗法的疗效及安全性并不及既往试验结果。目的:有6项随机对照试验对依诺肝素与普通肝素治疗ACS患者进行了比较,对其终点(即全因死亡及非致死性心肌梗死)、输血与大出血进行系统评估。资料来源:从杜克临床研究所(Duke Clinical Research Institute)获取ESSENCE、A to Z及SYNERGY试验的原始数据。由TIMI 11B、ACUTEⅡ及INTERACT研究的主要研究人员提供各自的基线特征和事件发生频率。研究选取:在非ST段抬高ACS患者中比较依诺肝素与普通肝素的6项随机对照试验均人选进行分析。数据提取:从全部试验人群和随机分组前未接受抗凝治疗的亚人群中获取疗效终点和安全性终点。数据综合:应用随机效应经验性贝叶斯模型(random—effects empirical Bayes model),系统评估21946例患者的结果。依诺肝素与普通肝素30天死亡率无显著差异(3.0%比3.0%,优势比[odds ratio,OR],1.00;95%可信区间[confidence interval,CI],0.85~1.17)。在所有试验人群中,依诺肝素与普通肝素相比,30天死亡或非致死性心肌梗死(myocardial infarction,MI)联合终点显著下降,具有统计学差异(10.1%比11.0%;OR,0.91;95%CI,0.83~0.99;所需治疗例数107)。随机分组前未接受抗凝治疗的依诺肝素组患者30天死亡或MI联合终点亦显著下降,具有统计学差异(8.0%比9.4%;OR,0.81;95%CI,0.70~0.94;所需治疗例数72)。随机分组后第7天,总体安全人群或者随机分组前未接受抗凝治疗的人群输血(OR,1.01;95%CI,0.89~1.14)或大出血的发生率(OR,1.04;95%CI,0.83~1.30)无显著差异。结论:对近22000例各类ACS患者进行系统回顾发现,在预防死亡或MI联合终点方面依诺肝素较普通肝素更有效。
出处 《美国医学会杂志(中文版)》 2005年第4期209-216,共8页 The Journal of the American Medical Association(Chinese Edition)
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