齐米拉加特兰与华法林用于预防非膜心房的患者中风:一项随机试验
Gregory W Albers1, Hans-Christoph Diener, Lars Frison
1Stanford Stroke Center, Palo Alto, Calif, USA.
JAMA
|February 11, 2005
概括
固定剂量西米拉加特兰在预防心房患者中风和栓塞方面表现出与华法林相当的疗效. 虽然有效,但潜在的肝毒性需要对这种抗凝固剂治疗进行进一步的研究.
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:
- 华法林在预防非膜心房的缺血性中风方面是有效的,但有局限性,包括剂量调整,凝血监测和出血风险.
- 新型口服抗凝剂正在研究,以克服华法林的局限性.
研究的目的:
- 为了比较口服直接血栓激素抑制剂西米拉加特兰与华法林在非膜动患者中进行中风和全身栓塞预防的疗效和安全性.
主要方法:
- 一个双盲,随机,多中心试验,涉及3922名患有非膜心房动和中风风险因素的患者.
- 患者接受了调整剂量的华法林 (目标INR2.0-3.0) 或固定剂量的西米拉加特兰 (每天两次36毫克).
- 主要终点是所有中风和全身栓塞事件,分析非劣质性.
主要成果:
- 齐米拉加特兰显示主要事件发生率为每年1.6%,而华法林为每年1.2%,符合非劣质假设 (P<.001).
- 使用西米拉加特兰的总出血事件显著降低 (37%vs47%每年;P<.001).
- 肝毒性,以高氨酸转移酶水平为指标,发生在6.0%的Ximelagatran接受者中,罕见的严重肝损伤病例.
结论:
- 固定剂量西米拉加特兰有效预防心房患者的血栓栓塞,为华法林提供了不需要凝血监测的替代品.
- 克西米拉加特兰诱导的肝毒性潜力需要仔细考虑和进一步调查.
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