剂塔克罗利斯人口药理动力学和有限抽样策略评估在老年脏移植接受者
Jasper Kamp1, Tom C Zwart1, Soufian Meziyerh2,3
1Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands.
Pharmaceutics
|January 26, 2024
概括
一个人口的药理动力学模型被开发为老年移植接受者在化剂的tacrolimus. 这种模型和有限的采样策略可以帮助个性化塔克罗利斯剂量,以获得更好的患者结果.
科学领域:
- 药理学 药理学是指药理学的学科.
- 腎臟病學 (nephrology) 是一種醫學專業.
- 移植医学 移植医学
背景情况:
- 溶剂塔克罗利斯 (Envarsus®) 旨在持续暴露,这是由于塔克罗利斯治疗窗口狭窄而至关重要的.
- 接受脏移植的老年人群需要了解老年接受者改变的塔克罗利斯药理动力学 (PK).
- 老年人的生理变化可能会影响塔克罗利斯的新陈代谢和疗效.
研究的目的:
- 为年长的移植接受者开发一个人群PK模型.
- 建立和验证有限采样策略 (LSS) 以估计塔克罗利斯AUC.
- 为了支持这个特定的患者群体的个性化塔克罗利斯剂量.
主要方法:
- 分析了34名年龄≥65岁的移植接受者接受溶剂塔克罗利斯治疗的PK数据.
- 使用非线性混合效应建模用于PK数据分析.
- 获得了八点全血和缩写干血斑点 (DBS) AUC0-24h样本.
主要成果:
- 一个有三个过境区的两间隔间模型和一个用于口服吸收的混合物模型最好地描述了PK数据.
- 在T = 0,2,6小时确定了最佳的三样LSS.
- 在T = 0,2,6,8h和T = 0,1,6,8h时确定了最佳的四个样本LSS.
结论:
- 开发的人口PK模型准确地反映了老年移植接受者的塔克罗利斯PK.
- 该模型和LSS有效地估计了塔克罗利斯的暴露.
- 这些工具可以帮助优化老年患者的塔克罗利斯剂量个性化.
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