中国临床药理学与治疗学2025，Vol.30Issue(8)：1067-1075,9.DOI:10.12092/j.issn.1009-2501.2025.08.007
基于生理药代动力学模型的维生素D个体化给药方案研究
Individualized dosage study of vitamin D3 based on physiologically-based pharmacokinetic modeling
摘要
Abstract
AIM:To establish a physiologically-based pharmacokinetic(PBPK)model for vitamin D in adults,aiming to provide guidance for the ratio-nal clinical use of vitamin D in individuals with vita-min D deficiency.METHODS:Relevant literature and databases were reviewed to obtain the physi-cochemical properties and pharmacokinetic param-eters of vitamin D3.The PBPK model for adult whole-body vitamin D was constructed,optimized,and predicted using PK-Sim® software.The model's predictive performance was evaluated using confi-dence intervals,goodness of fit,and fold error(FE).The effectiveness of commonly used clinical dosing regimens was assessed based on the final opti-mized model,and personalized dosing recommen-dations were provided.RESULTS:The established adult whole-body PBPK model for vitamin D had a goodness of fit R2 of 0.961,approaching 1,and the FE values for AUC0-∞ and Cmax were both within the range of 0.5 and 2,indicating that the constructed PBPK model possesses good data predictive capa-bility.CONCLUSION:A successful PBPK model for oral vitamin D3 in adults has been established,showing good predictive performance for single oral doses of vitamin D3.Single oral doses of vita-min D3(7 500 μg and 15 000 μg)are safe and effec-tive dosing regimens for improving vitamin D insuf-ficiency or deficiency in Asian adults.Regular moni-toring of vitamin D levels before and during treat-ment is recommended to achieve the optimal out-comes of personalized therapy.关键词
维生素D3/PK-Sim®/PBPK/药代动力学/拟合优度/剂量预测Key words
vitamin D3/PK-Sim®/PBPK/pharma-cokinetics/goodness of fit/dose prediction分类
医药卫生引用本文复制引用
魏园园,马涛,唐跃洲,李琥波,田晓瑜,党云洁,周旭..基于生理药代动力学模型的维生素D个体化给药方案研究[J].中国临床药理学与治疗学,2025,30(8):1067-1075,9.基金项目
国家自然科学基金面上项目(81973251) （81973251）
国家自然科学基金面上项目(81973469) （81973469）
河北省自然科学基金资助项目(H2025206694) （H2025206694）
河北省卫生健康委医学科学研究课题(20240242) （20240242）
