利用生理学基础的药动力学模型来支持中国老年人群的理性药物治疗
Xiaofei Wu1, Ziyang Wang1, Shupeng Liu1
1Clinical Pharmacology Research Center, Peking Union Medical College Hospital, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical PK & PD Investigation for Innovative Drugs, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, People's Republic of China.
对中国老年人的50种药物开发了生理学基础的药理动力学 (PBPK) 模型,解决了理性药物治疗的数据缺口. 这种方法支持个性化药物治疗和治疗药物监测 (TDM),以改善患者的治疗结果.
科学领域:
- 药理动力学 药理动力学
- 老年医学 老年医学
- 计算建模 计算建模
背景情况:
- 中国面临着人口快速老龄化,老年人越来越依赖药物.
- 合理的药物管理在老年人中至关重要,但受到有限的药理动力学 (PK) 数据的阻碍.
- 现有的老年人PK研究很少,复杂,阻碍了个性化治疗.
研究的目的:
- 为了解决中国老年人群中缺乏PK数据的问题.
- 开发和验证常见处方药物的生理学基础药理动力学 (PBPK) 模型.
- 探索PBPK模型在神经精神病药物治疗药物监测 (TDM) 中的应用.
主要方法:
- 使用临床试验数据对50种成年药物进行验证的PBPK模型.
- 在中国老年人群中开发和应用四种特定药物的PBPK模型 (蒂卡格勒罗,里瓦洛克萨班,阿尔普拉佐拉姆,米达佐拉姆).
- 模拟药物度-时间概况,并与观察数据进行比较.
主要成果:
- 对于四种测试药物,PBPK模型与中国老年人观察到的PK数据有很强的一致性.
- 在50种药物中,在老年人和年轻人之间没有观察到显著的PK差异.
- 为老年人提供了四种神经精神药物的基于证据的剂量建议.
结论:
- PBPK模型成功地解决了中国老年人50种药物的数据差距.
- 为老年人制定了量身定制的药物计划,为个性化和理性的药物治疗提供了一种新的方法.
- 在老年人群中,PBPK建模为个性化药物治疗实践提供了有价值的工具.
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