通过母乳养来确定母亲药物暴露:UmbrelLACT研究协议 - - 来自ConcepTION项目的一项贡献
Martje Van Neste1,2, Nina Nauwelaerts3, Michael Ceulemans1,2,4
1Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
这项研究收集了关于母亲药物转移到母乳中的数据,以评估婴儿暴露和安全性. 它还评估了基于生理学的药理动力学 (PBPK) 模型,用于预测母乳养婴儿的药物水平.
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:
- 许多产后妇女需要药物治疗,但母乳养期间药物转移的数据有限.
- 这种知识差距使得关于药物使用的明智决策变得复杂,可能导致不必要的停止母乳养或不理想的治疗.
- 雨LACT研究通过收集有关母亲药物暴露和婴儿结果的关键数据来解决这个问题.
研究的目的:
- 量化母亲药物转移到母乳中的数量,并估计婴儿的暴露.
- 评估基于生理学的药理动力学 (PBPK) 模型对哺乳期药物度的预测准确度.
- 为哺乳母亲提供更安全的药物治疗决策提供证据.
主要方法:
- 从各种医疗机构招募使用药物治疗的母乳养母亲.
- 收集母乳和可选的母/婴血样,用于药物度分析.
- 估计婴儿药物摄入量和全身暴露,并与PBPK模型预测进行比较.
主要成果:
- 将生成关于母乳中药物度和婴儿暴露的数据.
- 将根据观察到的数据评估PBPK模型的预测性能.
- 这将告知PBPK模型在哺乳期预测药物转移的可靠性.
结论:
- 这项UmbrelLACT研究将提高对母亲药物转移和婴儿暴露的理解.
- 它将验证PBPK模型在母乳养期间管理药物治疗中的实用性.
- 研究结果将支持基于证据的临床实践,用于需要药物治疗的母乳养母亲.
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