用于剂量方案个体化的模型指导精准给药软件工具：一项范围综述
Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review.
作者信息
Del Valle-Moreno Paula, Suarez-Casillas Paloma, Mejías-Trueba Marta, Ciudad-Gutiérrez Pablo, Guisado-Gil Ana Belén, Gil-Navarro María Victoria, Herrera-Hidalgo Laura
机构信息
Department of Pharmacy, University Hospital Virgen del Rocío, 41013 Seville, Spain.
Department of Infectious Diseases, Microbiology and Parasitology, Infectious Diseases Research Group, Institute of Biomedicine of Seville, University of Seville/Spanish National Research Council/University Hospital Virgen del Rocio, 41013 Seville, Spain.
出版信息
Pharmaceutics. 2023 Jul 1;15(7):1859. doi: 10.3390/pharmaceutics15071859.
BACKGROUND
Pharmacokinetic nomograms, equations, and software are considered the main tools available for Therapeutic Drug Monitoring (TDM). Model-informed precision dosing (MIPD) is an advanced discipline of TDM that allows dose individualization, and requires a software for knowledge integration and statistical calculations. Due to its precision and extensive applicability, the use of these software is widespread in clinical practice. However, the currently available evidence on these tools remains scarce.
OBJECTIVES
To review and summarize the available evidence on MIPD software tools to facilitate its identification, evaluation, and selection by users.
METHODS
An electronic literature search was conducted in MEDLINE, EMBASE, OpenAIRE, and BASE before July 2022. The PRISMA-ScR was applied. The main inclusion criteria were studies focused on developing software for use in clinical practice, research, or modelling.
RESULTS
Twenty-eight software were classified as MIPD software. Ten are currently unavailable. The remaining 18 software were described in depth. It is noteworthy that all MIPD software used Bayesian statistical methods to estimate drug exposure and all provided a population model by default, except NONMEN.
CONCLUSIONS
Pharmacokinetic software have become relevant tools for TDM. MIPD software have been compared, facilitating its selection for use in clinical practice. However, it would be interesting to standardize the quality and validate the software tools.
背景
药代动力学列线图、方程和软件被认为是治疗药物监测（TDM）可用的主要工具。模型指导的精准给药（MIPD）是TDM的一个先进学科，它允许剂量个体化，并且需要一个用于知识整合和统计计算的软件。由于其精准性和广泛的适用性，这些软件在临床实践中得到了广泛应用。然而，目前关于这些工具的现有证据仍然很少。
目的
回顾和总结关于MIPD软件工具的现有证据，以方便用户对其进行识别、评估和选择。
方法
2022年7月之前在MEDLINE、EMBASE、OpenAIRE和BASE中进行了电子文献检索。应用了PRISMA-ScR。主要纳入标准是专注于开发用于临床实践、研究或建模的软件的研究。
结果
28种软件被归类为MIPD软件。其中10种目前无法获取。对其余18种软件进行了深入描述。值得注意的是，除了NONMEN之外，所有MIPD软件都使用贝叶斯统计方法来估计药物暴露，并且默认都提供了一个群体模型。
结论
药代动力学软件已成为TDM的相关工具。已对MIPD软件进行了比较，便于在临床实践中选择使用。然而，对软件工具的质量进行标准化和验证将是很有意义的。
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