在膝关节置换后用于血栓预防的阿皮克萨班与埃诺沙巴林 (ADVANCE-2):一项随机双盲试验
Michael Rud Lassen1, Gary E Raskob, Alexander Gallus
1Department of Orthopaedics, Spine Clinic, Clinical Trial Unit, Hørsholm Hospital, University of Copenhagen, Hørsholm, Denmark. mirula@noh.regionh.dk
Lancet (London, England)
|March 9, 2010
概括
阿皮克萨班是一种更有效的口服替代品,用于预防膝关节置换后静脉血栓栓塞,具有类似的出血风险. 这种口服的XA因子抑制剂为接受重大关节手术的患者提供了一个方便的选择.
科学领域:
- 整形外科手术 整形外科手术
- 药理学 药理学是指药理学的学科.
- 血管医学 血管医学
背景情况:
- 低分子量肝素,如埃诺沙巴林,是主要关节置换后静脉瘤预防的标准.
- 艾皮克萨班是一种口服的XA因子抑制剂,是一种潜在的替代品,在有效性,安全性和易用性方面可能具有优势.
研究的目的:
- 为了比较阿皮克萨班与埃诺沙巴林在选择性全膝关节置换 (TKR) 后对静脉瘤预防的疗效和安全性.
主要方法:
- ADVANCE-2是一项3期,随机,双盲,多中心试验,涉及3057名接受TKR的患者.
- 患者接受口服阿皮克萨班2.5毫克每天两次或皮下埃诺沙巴林40毫克每天一次,持续10-14天.
- 主要结局是VTE (深静脉血栓塞,肺栓塞) 和在治疗期间因任何原因死亡的组合.
主要成果:
- 阿皮克萨班显示出更高的疗效,与埃诺沙巴林相比,在主要结局中相对降低了38%的相对风险 (15%与24%,p<0.0001).
- 对于阿皮克萨班的初级结果,绝对降低风险为9.3%.
- 在4%的阿皮克萨班接受者和5%的埃诺沙巴林接受者 (p=0.09) 中发生了重大或临床相关的非重大出血,这表明没有显著差异.
结论:
- 口服阿皮克萨班2.5毫克每天两次是一种更有效和更方便的替代品,用于TKR后的VTE预防.
- 在这种患者群体中,阿皮克萨班在出血风险方面与埃诺沙巴林提供了可比的安全性.
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