Division of Clinical Pharmacology, Children's National Hospital, Washington, DC, USA.
Division of Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
J Clin Pharmacol. 2021 Jun;61 Suppl 1:S141-S151. doi: 10.1002/jcph.1884.
In premature infants, effective and safe drug therapy depends on optimal dose selection and requires a thorough understanding of the underlying disease(s) of these fragile infants as well as the pharmacokinetics and pharmacodynamics of the drugs selected to treat their diseases. Differences in gestational and postnatal age or weight are the major determinants of the observed variability in drug disposition and effect in these infants. This article presents an outline on how to translate the results of a population pharmacokinetic/pharmacodynamic study into rational dosing regimens, and how physiologically based pharmacokinetic modeling, electronic health records, and the abundantly available data of vital functions of premature infants during their stay in the neonatal intensive care unit for evaluation of their pharmacotherapy can be used to tailor the most safe and effective dose in these infants.
在早产儿中,有效的和安全的药物治疗取决于最佳剂量选择,并需要深入了解这些脆弱婴儿的潜在疾病以及用于治疗其疾病的药物的药代动力学和药效动力学。胎龄和出生后年龄或体重的差异是导致这些婴儿药物处置和效应观察到变异性的主要决定因素。本文介绍了如何将群体药代动力学/药效动力学研究的结果转化为合理的给药方案,以及如何使用基于生理学的药代动力学建模、电子健康记录以及早产儿在新生儿重症监护病房期间大量可用的生命功能数据来评估其药物治疗,以调整这些婴儿的最安全和有效的剂量。