Clinical Value of Emerging Bioanalytical Methods for Drug Measurements: A Scoping Review of Their Applicability for Medication Adherence and Therapeutic Drug Monitoring.

Clinical Value of Emerging Bioanalytical Methods for Drug Measurements: A Scoping Review of Their Applicability for Medication Adherence and Therapeutic Drug Monitoring.
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DOI:
10.1007/s40265-021-01618-7
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发表时间:
2021-11
期刊:
影响因子:
11.5
通讯作者:
van Boven JFM
van Boven JFM
中科院分区:
医学1区
文献类型:
--
作者:
Zijp TR;Izzah Z;Åberg C;Gan CT;Bakker SJL;Touw DJ;van Boven JFM

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药物浓度的直接定量允许药物依从性监测(MAM)和治疗药物监测(TDM)。近年来开发了多种侵入性较小的方法:干血斑(DBS),唾液和毛发分析。概述了MAM和TDM的新兴药物定量方法,重点介绍了慢性药物治疗患者中方法的临床验证。通过在涵盖2000-2020年期间的三个电子数据库中进行系统检索,进行了范围界定审查。由Rayyan的两名独立审查员进行筛选和入选。这些文章的数据汇总在REDCap数据库中。主要结果是基于研究样本量、交叉验证方法和方法描述的方法的临床有效性。按矩阵、治疗领域和应用(MAM和/或TDM)报告结局。共确定了4590项研究,最终纳入了175篇文章; 57篇关于DBS,66篇关于唾液,55篇关于毛发分析。大多数报告涉及神经系统疾病(37%)、传染病(31%)和移植(14%)。生成所有测量药物的临床验证概述。共62种药物检测用于MAM,131种药物检测用于TDM。MAM和TDM在没有传统侵入性血液采样的情况下越来越有可能:DBS,唾液和毛发的优势和局限性不同,但都有可能进行有效和更方便的药物监测。为了加强未来证据的质量和可比性,建议对方法的临床验证进行标准化。在线版本包含补充材料,可通过10.1007/s40265-021-01618-7获得。
Direct quantification of drug concentrations allows for medication adherence monitoring (MAM) and therapeutic drug monitoring (TDM). Multiple less invasive methods have been developed in recent years: dried blood spots (DBS), saliva, and hair analyses. To provide an overview of emerging drug quantification methods for MAM and TDM, focusing on the clinical validation of methods in patients prescribed chronic drug therapies. A scoping review was performed using a systematic search in three electronic databases covering the period 2000–2020. Screening and inclusion were performed by two independent reviewers in Rayyan. Data from the articles were aggregated in a REDCap database. The main outcome was clinical validity of methods based on study sample size, means of cross-validation, and method description. Outcomes were reported by matrix, therapeutic area and application (MAM and/or TDM). A total of 4590 studies were identified and 175 articles were finally included; 57 on DBS, 66 on saliva and 55 on hair analyses. Most reports were in the fields of neurological diseases (37%), infectious diseases (31%), and transplantation (14%). An overview of clinical validation was generated of all measured drugs. A total of 62 drugs assays were applied for MAM and 131 for TDM. MAM and TDM are increasingly possible without traditional invasive blood sampling: the strengths and limitations of DBS, saliva, and hair differ, but all have potential for valid and more convenient drug monitoring. To strengthen the quality and comparability of future evidence, standardisation of the clinical validation of the methods is recommended. The online version contains supplementary material available at 10.1007/s40265-021-01618-7.
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