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治疗药物监测Everolimus使用体积吸收微量抽样和量化干血斑点方法与LC-MS/MS在成年固体器官移植接受者的治疗药物监测:分析和临床比较研究

Arkadiusz Kocur¹, Bartosz Olkowski², Mateusz Moczulski¹

¹Department of Drug Chemistry, Pharmaceutical and Biomedical Analysis, Medical University of Warsaw, Banacha 1, 02-097 Warsaw, Poland.

Molecules (Basel, Switzerland)

|August 14, 2025

概括

一种新的LC-MS/MS方法使用微采样设备准确地测量毛细血管血液中的常利 (EVE). 这支持移植受体的方便,以患者为中心的治疗药物监测.

科学领域:

药理学药理学是指药理学的学科.
分析化学分析化学
移植医学移植医学

背景情况:

作为一种mTOR抑制剂的Everolimus (EVE) 需要在固体器官移植 (SOT) 中进行治疗药物监测 (TDM),因为其治疗窗口狭窄且具有可变性.
精确的EVE测量对于优化免疫抑制和SOT患者的结果至关重要.

研究的目的:

开发和验证一种可靠的液体染色学-并联质谱法 (LC-MS/MS) 方法来测量EVE水平.
为了评估微采样设备 (MitraTM VAMS和Capitainer® qDBS) 对EVE TDM的性能,与静脉全血相比.

主要方法:

根据EMA和IATDMCT指南进行LC-MS/MS方法开发和验证.
验证包括线性,选择性,准确性,精度,矩阵效应,恢复,稳定性,并进行样本再分析.
临床验证使用来自33名SOT接受者的66个匹配样本.

主要成果:

LC-MS/MS方法在静脉全血,VAMS和qDBS矩阵中显示出高准确度和精度.
在微量采样方法和静脉参考方法之间观察到很好的一致性,血红素效应可以忽略不计.
该研究提供了Mitra和Capitainer设备用于EVE监控的首次全面验证.

结论:

经过验证的LC-MS/MS微采样方法为EVE TDM寻找常规血液采样提供了可靠的替代方案.
这种方法可以实现分散的,以患者为中心的监测,提高移植护理的便利性和遵守性.

关键词:

这是LC-MS/MS.这是VAMS的VAMS.这是Everolimus.qDBSBS 在线观看实体器官移植移植实体器官移植

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