University of Groningen, University Medical Centre Groningen, Department of Clinical Pharmacy and Pharmacology, Groningen, the Netherlands.
Interdisciplinary Centre for Health Studies (CIESAL), Universidad de Valparaíso, Valparaíso, Chile.
Clin Microbiol Infect. 2020 Aug;26(8):1008-1016. doi: 10.1016/j.cmi.2020.03.008. Epub 2020 Mar 21.
Therapeutic drug monitoring (TDM) is a tool to personalize and optimize dosing by measuring the drug concentration and subsequently adjusting the dose to reach a target concentration or exposure. The evidence to support TDM is however often ranked as expert opinion. Limitations in study design and sample size have hampered definitive conclusions of the potential added value of TDM.
We aim to give expert opinion and discuss the main points and limitations of available data from antibiotic TDM trials and emphasize key elements for consideration in design of future clinical studies to quantify the benefits of TDM.
The sources were peer-reviewed publications, guidelines and expert opinions from the field of TDM.
This review focuses on key aspects of antimicrobial TDM study design: describing the rationale for a TDM study, assessing the exposure of a drug, assessing susceptibility of pathogens and selecting appropriate clinical endpoints. Moreover we provide guidance on appropriate study design.
This is an overview of different aspects relevant for the conduct of a TDM study. We believe that this paper will help researchers and clinicians to design and conduct high-quality TDM studies.
治疗药物监测（TDM）是一种通过测量药物浓度并随后调整剂量以达到目标浓度或暴露水平来实现个体化和优化给药的工具。然而，支持 TDM 的证据通常被归类为专家意见。研究设计和样本量的限制妨碍了 TDM 潜在附加值的明确结论。
我们旨在提供专家意见，并讨论抗生素 TDM 试验中现有数据的要点和局限性，并强调在未来临床研究中设计以量化 TDM 益处时需要考虑的关键要素。
这些来源是来自 TDM 领域的同行评议出版物、指南和专家意见。
本综述重点介绍了抗菌药物 TDM 研究设计的关键方面：描述 TDM 研究的基本原理、评估药物的暴露情况、评估病原体的敏感性以及选择适当的临床终点。此外，我们还提供了关于适当研究设计的指导。
这是对进行 TDM 研究相关的不同方面的概述。我们相信，本文将有助于研究人员和临床医生设计和进行高质量的 TDM 研究。
