Department of Pediatrics, University of Iowa, College of Pharmacy, 115 S. Grand Ave., Iowa City, IA 52242, USA.
Drug Metab Dispos. 2011 Jul;39(7):1214-20. doi: 10.1124/dmd.110.036855. Epub 2011 Apr 1.
The primary objective of this work was to determine the optimal time for administration of an erythropoietin (Epo) dose to maximize the erythropoietic effect using a simulation study based on a young sheep pharmacodynamic model. The dosing optimization was accomplished by extending a Hb production pharmacodynamic model, which evaluates the complex dynamic changes in the Epo receptor (EpoR) pool from the changes in Epo clearance. Fourteen healthy 2-month-old sheep were phlebotomized to Hb levels of 3 to 4 g/dl. Epo clearance was evaluated longitudinally in each animal by administering tracer doses of (125)I-recombinant human Epo multiple times during the experiment. Kinetic parameters were estimated by simultaneously fitting to Hb data and Epo clearance data. The phlebotomy caused a rapid temporary increase in the endogenous Epo plasma level. The Hb began to increase after the increased in the Epo level with a lag time of 1.13 ± 0.79 days. The average correlation coefficients for the fit of the model to the Hb and clearance data were 0.953 ± 0.018 and 0.876 ± 0.077, respectively. A simulation study was done in each sheep with fixed individual estimated model parameters to determine the optimal time to administer a 100 U/kg intravenous bolus Epo dose. The optimal dose administration time was 11.4 ± 6.2 days after phlebotomy. This study suggests that the Hb produced from Epo administration can be optimized by considering the dynamic changes in the EpoR pool.
本研究的主要目的是通过基于年轻绵羊药效动力学模型的模拟研究,确定给予促红细胞生成素 (Epo) 剂量以最大程度发挥促红细胞生成作用的最佳时间。通过扩展 Hb 生成药效动力学模型来实现剂量优化,该模型评估了从 Epo 清除率变化中 Epo 受体 (EpoR) 池的复杂动态变化。14 只健康的 2 月龄绵羊被放血至 Hb 水平为 3 至 4 g/dl。通过在实验过程中多次给予(125)I-重组人 Epo 示踪剂量,在每个动物中纵向评估 Epo 清除率。通过同时拟合 Hb 数据和 Epo 清除数据来估计动力学参数。放血导致内源性 Epo 血浆水平迅速暂时升高。Hb 在 Epo 水平增加后开始增加,滞后时间为 1.13 ± 0.79 天。模型对 Hb 和清除数据的拟合平均相关系数分别为 0.953 ± 0.018 和 0.876 ± 0.077。在每只绵羊中进行了一项模拟研究,使用固定的个体估计模型参数来确定给予 100 U/kg 静脉推注 Epo 剂量的最佳时间。最佳剂量给药时间是放血后 11.4 ± 6.2 天。本研究表明,通过考虑 EpoR 池的动态变化,可以优化 Epo 给药产生的 Hb。