用阿司匹林,西布拉菲班或两者的随机试验,用于急性冠状动脉综合征后的二次预防
Circulation
|April 3, 2001
概括
将低剂量西布拉菲班添加到阿司匹林并没有改善急性冠状动脉综合征患者的结局和增加出血. 高剂量西布拉菲班显示死亡率增加的趋势.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 之前的试验表明,西布拉菲班与阿司匹林相比,对于二次预防后急性冠状动脉综合征没有益处.
- 第二个SYMPHONY试验调查了低剂量西布拉菲班加阿司匹林 (LDS+A) 和高剂量西布拉菲班 (HDS) 与单独的阿司匹林.
研究的目的:
- 评估低剂量或高剂量西布拉菲班与阿司匹林结合用于急性冠状动脉综合征患者的二次预防的疗效和安全性.
- 为了比较LDS+A和HDS疗法与阿司匹林单一治疗的结果.
主要方法:
- 由于初步结果,第二个SYMPHONY试验在6671名患者后过早终止.
- 平均治疗持续时间为90天.
- 主要终点:死亡,心肌梗塞 (MI) 或严重的复发性缺血. 二级终点包括死亡率和心脏病发作率,以及重大出血事件.
主要成果:
- 在阿司匹林 (9.3%) 和LDS+A (9.2%) 之间的主要终点没有显著差异.
- 高剂量西布拉菲班 (HDS) 显示,主要终点 (10.5%) 的非显著增加.
- 与阿司匹林单独 (4.0%) 相比,LDS+A (5.7%) 的重大出血显著增加. HDS没有显示出出血显著增加 (4.6%).
- 高硬化症与明显更多的死亡或心脏病发作 (OR 1.43) 和单独较高的死亡率 (OR 1.83) 相关.
结论:
- 将低剂量西布拉菲班与阿司匹林结合使用,不会改善急性冠状动脉综合征后的二次预防结果,并增加出血风险.
- 高剂量西布拉菲班显示死亡率增加的趋势,死亡或心脏病发作显著增加.
- 目前的证据不支持在急性冠状动脉综合征患者中使用西布拉菲班与阿司匹林联合使用.
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