12个月的爱多克萨班与3个月的癌症患者与隔离的远距离深静脉血栓 (ONCO DVT研究):一个开放的,多中心的,随机临床试验
Yugo Yamashita1, Takeshi Morimoto2, Nao Muraoka3
1Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (Y. Yamashita, Y. Yoshikawa).
Circulation
|August 28, 2023
概括
在癌症患者中,与3个月的治疗相比,12个月的EDOXABAN治疗显著降低了复发性静脉血栓栓塞 (VTE) 事件,并具有类似的重大出血率.
科学领域:
- 血液学
- 癌症学
- 临床试验
背景情况:
- 在癌症患者中,隔离远静脉血栓 (DVT) 的最佳抗凝治疗持续时间尚不清楚.
- 长期治疗可能会预防血栓形成,但会增加出血风险.
研究的目的:
- 在癌症患者中比较12个月和3个月的EDOXABAN治疗的疗效和安全性.
- 在12个月后评估复发性静脉血栓塞栓症 (VTE) 或与VTE相关的死亡的主要终点.
主要方法:
- 一个多中心的随机临床试验,涉及601名患有偏远DVT的癌症患者.
- 患者接受了12个月或3个月的edoxaban治疗.
- 主要终点:综合性复发性静脉突发症或与静脉突发症相关的死亡;次要终点:严重出血.
主要成果:
- 12个月的爱多克萨班显著降低了症状性复发性VTE或与VTE相关的死亡 (1. 0%与7. 2%相比; OR,0. 13; 95% CI,0. 03- 0. 44).
- 在12个月 (9. 5%) 和3个月 (7. 2%) 组中,主要出血率相似 (OR,1. 34;95% CI,0. 75-2.41).
结论:
- 12个月的埃多克萨班治疗比预防3个月的复发性静脉瘤或与静脉瘤相关的癌症患者的死亡更好.
- 在这种患者群体中,使用EDOXABAN延长抗凝药似乎是安全的.
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