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为何基于模型的精准给药尚未成为普遍的临床现实?从过去吸取的经验教训以及未来的路线图。

Why has model-informed precision dosing not yet become common clinical reality? lessons from the past and a roadmap for the future.

作者信息

Darwich A S, Ogungbenro K, Vinks A A, Powell J R, Reny J-L, Marsousi N, Daali Y, Fairman D, Cook J, Lesko L J, McCune J S, Knibbe Caj, de Wildt S N, Leeder J S, Neely M, Zuppa A F, Vicini P, Aarons L, Johnson T N, Boiani J, Rostami-Hodjegan A

机构信息

Centre for Applied Pharmacokinetic Research, Division of Pharmacy and Optometry, University of Manchester, Manchester, UK.

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.

出版信息

Clin Pharmacol Ther. 2017 May;101(5):646-656. doi: 10.1002/cpt.659. Epub 2017 Apr 4.

Abstract

Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model-informed precision dosing (MIPD) may improve treatment outcomes by achieving the optimal dose for an individual patient. There is, however, relatively little published evidence of large-scale utility and impact of MIPD, where it is often implemented as local collaborative efforts between academia and healthcare. This article highlights some successful applications of bringing MIPD to clinical care and proposes strategies for wider integration in healthcare. Considerations are brought up herein that will need addressing to see MIPD become "widespread clinical practice," among those, wider interdisciplinary collaborations and the necessity for further evidence-based efficacy and cost-benefit analysis of MIPD in healthcare. The implications of MIPD on regulatory policies and pharmaceutical development are also discussed as part of the roadmap.

摘要

容易出现多药联用情况的患者群体以及特殊亚群易受到治疗不充分的影响。在特殊人群中进行精准给药对于改善治疗反应和/或降低毒性风险至关重要。基于模型的精准给药(MIPD)可通过为个体患者实现最佳剂量来改善治疗结果。然而,关于MIPD大规模应用和影响的已发表证据相对较少,MIPD通常是作为学术界与医疗保健机构之间的地方合作努力来实施的。本文重点介绍了将MIPD应用于临床护理的一些成功案例,并提出了在医疗保健中更广泛整合的策略。本文提出了一些需要解决的问题,以便MIPD成为“广泛的临床实践”,其中包括更广泛的跨学科合作以及对MIPD在医疗保健中的循证疗效和成本效益进行进一步分析的必要性。作为路线图的一部分,还讨论了MIPD对监管政策和药物研发的影响。

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