与抗凝剂相关的出血:基于现实数据的药物监测和出血管理的见解
Xia Hong1, Qun Wei1, Zi-Lian Wang1
1Department of Obstetrics and Gynecology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
International journal of surgery (London, England)
|December 17, 2025
概括
抗凝血药物在出血风险方面存在显著差异,老年患者和早期开始治疗的风险更高. 这项研究绘制了这些风险图,以指导更安全的抗血栓治疗选择.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 抗凝血药物对于血栓性疾病的管理至关重要,但会增加出血风险.
- 选择合适的抗凝剂需要评估患者特定的血栓和缺血因素.
研究的目的:
- 建立与抗凝剂治疗相关的出血风险的综合图谱.
- 识别和描述药物特定的出血信号和危险因素.
主要方法:
- 综合性定性文献审查和对FDA不良事件报告系统 (FAERS) 数据 (2004-2024) 的定量分析.
- 使用不成比例分析 (ROR,PRR,BNN,EBGM) 来检测出血信号.
- 对顶部出血信号的解剖分析和用于风险因素分析的后勤回归.
主要成果:
- 分析了110,701份与抗凝剂相关的出血报告;老年患者 (≥65) 占63.2%.
- 脊柱下皮层出血显示了最高的信号;胃/肠道出血常见于口服抗凝剂;后皮层出血与肝素.
- 贝特里克萨班在创伤性和内出血方面显示出极端的ROR;每个药物都确定了不同的出血概况.
结论:
- 这项研究提供了最广泛的抗凝剂相关出血信号图谱.
- 显著的药物间异质性和长期风险需要个性化的抗凝剂选择和监测.
- 通过个性化治疗策略,可以在抗血栓治疗中改善安全性-疗效平衡.
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