同时使用抗凝剂和易布鲁替尼的出血风险:基于人口的嵌套病例对照研究
Marion Allouchery1,2,3, Cécile Tomowiak4,5, Allison Singier3
1Pharmacologie Clinique et Vigilances, CHU de Poitiers, Poitiers, France.
British journal of haematology
|July 24, 2023
概括
与抗凝剂结合的易布鲁替尼在现实患者群体中显著增加了临床相关出血 (CRB) 风险的2.5倍. 这一发现凸显了与这些药物同时使用的关键安全考虑因素.
科学领域:
- 药物监督 药物监督 药物监督
- 血液学 血液学 血液学
- 在瘤学瘤学.
背景情况:
- 关于将易布鲁替尼与抗凝固剂结合使用的安全性的现实数据有限.
- 评估临床相关出血 (CRB) 的风险对于患者安全至关重要.
研究的目的:
- 为了评估与抗凝药同时使用易布鲁替尼的患者中CRB的风险.
- 为了在不同的抗凝剂类别中比较出血风险.
主要方法:
- 使用全国数据库进行了嵌套病例控制研究.
- 614个CRB病例与多达2407个对照进行了匹配.
- 条件后勤回归模型被用来估计调整的赔率比率 (aOR).
主要成果:
- 接受易布鲁替尼和抗凝剂的患者患有CRB的风险增加了2.54倍 (aOR2.54,95%CI [1.94; 3.32]).
- 观察到所有抗凝剂类别的风险增加:VKAs (aOR 1.99),DOACs (aOR 2.48) 和亲肠道抗凝剂 (aOR 3.40).
结论:
- 同时使用易布鲁替尼和抗凝剂在现实环境中与显著更高的CRB风险有关.
- 增加的出血风险适用于各种抗凝剂类型,强调需要仔细监测.
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