对于P2Y12抑制剂的种群药理动力学/药理动力学模型:使用暴露模拟进行系统审查和临床评估
Jingcheng Chen1,2,3, Yuchen Qu4, Muhan Jiang2
1Department of Cardiology, Peking University Third Hospital, Beijing, 100191, China.
Clinical pharmacokinetics
|January 20, 2024
概括
血中的P2Y12抑制剂度会影响出血风险. 在老年,体重小的亚洲女性中,调整蒂卡格勒勒剂量为每天两次60毫克,可以减少出血,而不会增加缺血事件.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
- 药物新陈代谢 药物新陈代谢
背景情况:
- 血中的P2Y12抑制剂度与临床事件相关,特别是出血.
- 影响P2Y12抑制剂血水平的因素需要研究以优化治疗结果.
研究的目的:
- 总结克洛皮多格雷尔,普拉苏格雷尔和提卡格雷尔的群体药理动力学/药理动力学 (PopPKPD) 模型.
- 通过分析影响P2Y12抑制剂血度的因素,评估特定患者群体的出血风险.
主要方法:
- 根据包含/排除标准收集并总结了PopPKPD模型.
- 在模拟中复制模型以评估对血度的共变量影响.
- 将特殊人群的模拟结果与治疗窗口进行比较,以预测出血风险.
主要成果:
- 女性性别,体重和年龄等共变量显著影响P2Y12抑制剂暴露,特殊人群暴露高达179%以上.
- 剂量调整可以使特殊人群的血液度正常化,达到一般人群暴露的±20%.
- 对于特定人群,建议将提卡格勒勒维护剂量从每天90毫克降低到每天60毫克.
结论:
- 将提卡格雷勒维持剂量降低到每隔两天60毫克有效降低出血风险.
- 这种剂量调整在老年,体重小的亚洲女性中并没有显著增加血栓性心脏病发作风险.
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