Suggestions for Model-Informed Precision Dosing to Optimize Neonatal Drug Therapy.
Suggestions for Model-Informed Precision Dosing to Optimize Neonatal Drug Therapy.
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DOI：
10.1002/jcph.1315
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发表时间：
2019-03
影响因子：
2.9
通讯作者：
Akinbi HT
中科院分区：
文献类型：
--
作者：
Euteneuer JC;Kamatkar S;Fukuda T;Vinks AA;Akinbi HT
用于治疗新生儿的大多数药物的剂量、有效性和安全性的证据很少。因此，剂量通常通过体重或体表面积缩放的成人和儿科药理学数据外推得出。这可能导致不安全或无效的药物给药。然而，正在开发和研究新的策略来给危重新生儿用药。能够快速分析药物水平的质谱技术是现成的。将群体药代动力学和药效学与来自新生儿的稀疏样本的数据整合在一起的软件允许及时调整剂量以达到预期效果，同时最大限度地减少不良结果。一些影响新生儿药物反应的遗传多态性也有报道。这篇综述强调了药物反应的各个方面以及它是如何受到早产的影响，评估了新生儿的药物基因组学研究，并提出了创新的药代动力学/药效学模型为基础的方法，结合联合收割机人口或生理为基础的药理学数据，贝叶斯分析和电子决策支持工具，在新生儿精确给药的建议，同时举例说明这种方法可用于优化新生儿的药物治疗。还讨论了在新生儿中实施精确给药的障碍以及如何克服这些障碍。
Evidence for dosing, efficacy, and safety of most medications used to treat neonates is sparse. Thus, dosing is usually derived by extrapolation from adult and pediatric pharmacologic data with scaling by bodyweight or body surface area. This may lead to drug dosing that is unsafe or ineffective. However, new strategies are being developed and studied to dose medications in critically ill neonates. Mass spectroscopy technology capable of quickly analyzing drug levels is readily available. Software that integrates population pharmacokinetics and pharmacodynamics with data from sparse samples from neonates allows for timely adjustments of dosing to achieve the desired effect while minimizing adverse outcomes. Some genetic polymorphisms that affect drug response in neonates have also been reported. This review highlights aspects of drug response and how it is impacted by prematurity, assesses pharmacogenomic studies in neonates, and offers suggestions for innovative pharmacokinetic/pharmacodynamic model-based approaches which combine population or physiology-based pharmacology data, Bayesian analysis, and electronic decision support tools for precision dosing in neonates while illustrating examples where this approach can be used to optimize medical therapy in neonates. Barriers to implementing precision dosing in neonates and how to overcome them are also discussed.
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