Koldeweij Charlotte, Freriksen Jolien J M, de Wildt Saskia N
Radboudumc, divisie Farmacologie en Toxicologie, afd. Farmacie, Nijmegen.
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Ned Tijdschr Geneeskd. 2024 Feb 8;168:D7931.
Most women use medication during pregnancy. The disposition of drugs may be altered due to changes in pregnant women's bodies. This may call for pregnancy-adjusted doses for certain medications. However, in the face of scarce evidence, such doses are generally lacking, potentially contributing to an increased risk of treatment failure or toxicity in pregnant women and their unborn children. By integrating physiological and/or population data, pharmacokinetic models can be used to determine appropriate medication dosages among pregnant women and their unborn children, as well as other patient groups for which evidence-based doses may be lacking such as children, elderly or obese patients. In order to translate model predictions into clinically usable doses, a number of conditions must be met, including careful model validation, an assessment of evidence from pharmacokinetic modelling alongside available clinical studies by multidisciplinary experts, as well as transparent communication towards end-users on the considerations for determining appropriate medication doses.
大多数女性在孕期会使用药物。由于孕妇身体的变化,药物的处置情况可能会改变。这可能需要对某些药物调整孕期剂量。然而,面对证据稀缺的情况,此类剂量通常并不存在,这可能会增加孕妇及其未出生胎儿治疗失败或中毒的风险。通过整合生理和/或人群数据,药代动力学模型可用于确定孕妇及其未出生胎儿以及其他可能缺乏循证剂量的患者群体(如儿童、老年人或肥胖患者)的合适用药剂量。为了将模型预测转化为临床可用剂量,必须满足一些条件,包括仔细的模型验证、多学科专家对药代动力学建模证据与现有临床研究证据的评估,以及与终端用户就确定合适用药剂量的考量进行透明沟通。