与三重抗血栓治疗相关的出血风险:一个专注的现实世界药物监督不成比例分析研究
Kannan Sridharan1, Gowri Sivaramakrishnan2
1Department of Pharmacology & Therapeutics, College of Medicine & Health Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain. skannandr@gmail.com.
BMC cardiovascular disorders
|March 15, 2025
概括
三重抗血栓治疗 (TAT) 增加了出血风险,特别是与里瓦洛克萨班. 阿皮克萨班似乎更安全,在现实数据中显示出较低的出血和死亡率. 为了验证,需要进行进一步的试验.
科学领域:
- 药监和药物安全 药监和药物安全
- 心血管血栓形成的原因是心血管血栓.
- 临床药理学 临床药理学
背景情况:
- 三重抗血栓治疗 (TAT),结合双抗血小板治疗 (DAPT) 和口服抗凝剂,是急性冠状动脉综合征/穿皮冠状动脉干预患者的标准.
- TAT会增加出血风险,因此需要对不同口服抗凝剂进行安全性比较数据.
- 现实世界的药监数据对于评估TAT出血风险至关重要.
研究的目的:
- 评估和比较与TAT中使用的各种口服抗凝剂相关的现实出血风险.
- 为了确定特定的口服抗凝剂,当与DAPT结合时,它们会增加或降低出血风险.
- 分析TAT疗法中死亡,残疾和住院等相关结果.
主要方法:
- 利用了USFDA不良事件报告系统 (AERS) 的数据,从2004年3月到2024年6月.
- 采用病例非病例不成比例分析来检测出血的安全信号.
- 使用频率学和贝叶斯信号检测算法分析了TAT组合 (DAPT + 口服抗凝剂).
主要成果:
- 里瓦罗克萨班与DAPT结合显示出最高的出血信号 (ROR: 82.84),而阿皮克萨班则是最低的 (ROR: 13.11).
- 其他抗凝血剂显示出不同的出血风险:华法林 (15.96),达比加特兰 (27.32) 和阿诺库马罗 (43.98).
- 里瓦洛克萨班与评估的TAT疗法中最高的死亡率有关.
结论:
- TAT显著增加出血风险,而里瓦洛克萨班组合是最令人担忧的.
- 在TAT疗法中,阿皮克萨班在出血和死亡率方面显示出潜在的更安全的特征.
- 临床实践应包括对TAT的出血风险进行谨慎监测,特别是在使用里瓦洛克萨班时,等待进一步的试验验证.
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