测量母乳中的母乳度及其在母乳养婴儿中的使用 婴儿暴露预测
Cindy H T Yeung1, Julie Autmizguine2,3, Pooja Dalvi1
1Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children, Toronto, ON, Canada.
Clinical pharmacokinetics
|January 26, 2024
概括
使用ezetimibe的哺乳期母亲可以母乳养,因为母乳中的药物水平对婴儿来说不是治疗性的. 这项研究测量了乳中的ezetimibe及其代谢物,通过PBPK建模预测婴儿暴露的最小程度.
科学领域:
- 药理学 药理学是指药理学的学科.
- 儿科 儿科 儿科
- 哺乳期研究 哺乳期研究
背景情况:
- 哺乳期母亲使用抗高脂剂ezetimibe,面临着关于母乳养的决定.
- 有限的数据存在于人类母乳中以谢胺及其代谢物 (ezetimibe-glucuronide).
研究的目的:
- 为了量化人类母乳中的埃泽胺和埃泽胺-葡萄化物.
- 为了预测婴儿通过母乳养接触ezetimibe.
- 评估母乳养婴儿的安全性,这些婴儿的母亲正在服用ezetimibe.
主要方法:
- 开发并验证了一种液体染色学-并发质谱法 (LC-MS/MS) 测定乳汁中埃泽胺和埃泽胺-葡萄胺的测定方法.
- 从接受ezetimibe治疗的哺乳母亲收集的母乳样本.
- 利用儿科生理学基础的药理动力学 (PBPK) 模型来预测婴儿暴露,并计算曲线比率 (UAR) 下的上方区域.
主要成果:
- 测量到的埃泽提米布度在0.17-1.02 ng/mL之间,而埃泽提米布-葡萄化物在0.42-2.65 ng/mL之间.
- 该PBPK模型表明成人治疗暴露和模拟婴儿暴露 (AUC24) 之间的重叠是最小的.
- 在婴儿年龄组中计算的UAR值在0.0015到0.0026.5之间.
结论:
- 根据PBPK模型的预测,母乳养的婴儿接受了对ezetimibe及其代谢物的非治疗性暴露.
- 这些发现支持母亲正在服用ezetimibe的婴儿母乳养的安全性.
- 建议进行进一步的"母婴对研究",以确认婴儿血度.
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