用于延长引起静脉血栓塞的治疗
Gregory Piazza1,2, Behnood Bikdeli1,2,3, Arvind K Pandey2
1Thrombosis Research Group, Brigham and Women's Hospital-Harvard Medical School, Boston.
The New England journal of medicine
|September 1, 2025
概括
在引起静脉血栓塞栓症和持续风险因素的患者中,使用阿皮克萨班的扩展抗凝剂显著降低了复发性静脉血栓塞栓症 (VTE). 这种治疗显示出严重出血事件的风险较低.
科学领域:
- 心脏病学
- 血液学
- 临床试验
背景情况:
- 在患有过渡性诱发因子和持久性风险因子的患者中,对静脉血栓塞栓症 (VTE) 治疗的最佳持续时间存在不确定性.
- 引起的静脉突发症需要谨慎管理,以平衡复发风险和出血并发症.
研究的目的:
- 评估长期治疗阿皮克萨班的疗效和安全性,以预防引起VTE和持久风险因素的患者复发VTE.
- 在阿皮克萨班和安慰剂组中比较症状复发性静脉动脉突和严重出血的风险.
主要方法:
- 一个单中心,双盲,随机试验,涉及600名成年人VTE过渡性诱发因素和至少一个持久的风险因素.
- 在最初的3个月抗凝期后,参与者接受了口服阿皮克萨班 (每天两次2.5毫克) 或安慰剂12个月.
- 主要结局包括症状复发的静脉瘤和根据国际血栓学会和血液静止学标准定义的重大出血事件.
主要成果:
- 在阿皮克萨班组中,有1. 3%的患者出现症状性复发性静脉突发症,而在安慰剂组中为10. 0% (危险比率为0. 13;P< 0. 001).
- 一名接受阿皮克萨班治疗的患者出现严重出血,而没有接受安慰剂治疗的患者. 临床相关的非重大出血发生频率更高 (4. 8% 对比 1. 7%).
- 在这两组中都没有死于心血管或出血原因.
结论:
- 持续12个月的低强度阿皮克萨班治疗显著降低了症状复发性静脉突发症和持久风险因素患者的风险.
- 观察到较低的严重出血风险支持在该患者群中使用延长的阿皮克萨班治疗.
- 来自HI-PRO试验 (NCT04168203) 的结果为优化静脉血栓炎治疗策略提供了有价值的证据.
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