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ENGLISH ABSTRACT
基于液相色谱-串联质谱技术的治疗药物监测方法研究进展
李姿颖
谢洁
屈子裕
江游
张谛
禹松林
马晓丽
邱玲
戴新华
方向
俞晓平
作者及单位信息
·
DOI： 10.3760/cma.j.cn114452-20230915-00144
Advances in therapeutic drug monitoring methods based on liquid chromatography-tandem mass spectrometry
Li Ziying
Xie Jie
Qu Ziyu
Jiang You
Zhang Di
Yu Songlin
Ma Xiaoli
Qiu Ling
Dai Xinhua
Fang Xiang
Yu Xiaoping
Authors Info & Affiliations
Li Ziying
Institute of Inspection and Quarantine, College of Life Sciences, China Jiliang University, Hangzhou 310018, China
Xie Jie
Technology Innovation Center of Mass Spectrometry for State Market Regulation, Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China
Qu Ziyu
Technology Innovation Center of Mass Spectrometry for State Market Regulation, Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China
Jiang You
Technology Innovation Center of Mass Spectrometry for State Market Regulation, Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China
Zhang Di
Technology Innovation Center of Mass Spectrometry for State Market Regulation, Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China
Yu Songlin
Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China
Ma Xiaoli
Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China
Qiu Ling
Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China
Dai Xinhua
Technology Innovation Center of Mass Spectrometry for State Market Regulation, Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China
Fang Xiang
Technology Innovation Center of Mass Spectrometry for State Market Regulation, Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China
Yu Xiaoping
Institute of Inspection and Quarantine, College of Life Sciences, China Jiliang University, Hangzhou 310018, China
·
DOI： 10.3760/cma.j.cn114452-20230915-00144
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摘要

液相色谱-串联质谱技术具有高特异性、高通量的特点，因此在临床检验领域有快速的应用和发展，其在治疗药物监测中的应用可有效提升定量准确性与灵敏度，为患者制定个性化的最佳给药方案。但该技术目前仍面临一些挑战，自动化、质量控制、量值溯源等将是今后的发展方向。

色谱法，液相;串联质谱法;治疗药物监测;样本前处理;挑战
ABSTRACT

Liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology has the characteristics of high specificity and high throughput, making it rapidly applied and developed in the field of clinical testing. Its application in the monitoring of therapeutic drugs can effectively improve the quantitative accuracy and sensitivity, and formulate a personalized and optimal dosing plan for patients. However, this technology still faces some challenges, and automation, quality control, and quantitative traceability will be the future development direction.

Chromatography, liquid;Tandem mass spectrometry;Therapeutic drug monitoring;Sample pretreatment;Challenge
Yu Xiaoping, Email: nc.defudabe.uljcpxy
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引用本文

李姿颖,谢洁,屈子裕,等. 基于液相色谱-串联质谱技术的治疗药物监测方法研究进展[J]. 中华检验医学杂志,2024,47(03)：332-340.

DOI:10.3760/cma.j.cn114452-20230915-00144

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自20世纪90年代始，临床医学检验需求与技术快速发展，液相色谱-串联质谱（liquid chromatography-tandem mass spectrometry，LC-MS/MS）技术在治疗药物监测（therapeutic drug monitoring，TDM）领域的应用愈加广泛。
常用的TDM方法分为光谱法、色谱法和免疫分析法。光谱法检测成本低，但所需样本量大，且易受代谢物或结构相似化合物干扰。色谱法适用范围广、定量准确度和精密度高，主要分为气相色谱法和液相色谱法。气相色谱法与气质联用法用于测定在一定温度下可气化且不分解的物质，因此应用范围受限。高效液相色谱法的样品前处理步骤耗较长，超高效液相色谱法所需进样体积及溶剂消耗小，但前处理流程更为复杂。免疫法基于抗原抗体的特异性结合进行检测，其中酶放大免疫法和荧光偏振免疫分析法应用最广。该法操作流程简便、自动化程度高，多用于临床大批量样本的定量。但其测定物质单一、较高的检出限与检测成本极大程度地制约了临床中低浓度药物的定量和多药高通量检测的发展 ［ 1 ］ 。LC-MS/MS技术具有高准确度、高灵敏度的特点，可区分结构类似物，交叉反应较小 ［ 2 ］ ，已成为TDM分析的新选择。
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备注信息
A
俞晓平，Email： nc.defudabe.uljcpxy
B
李姿颖, 谢洁, 屈子裕, 等. 基于液相色谱-串联质谱技术的治疗药物监测方法研究进展[J]. 中华检验医学杂志, 2024, 47(3): 332-340. DOI: 10.3760/cma.j.cn114452-20230915-00144.
C
所有作者声明无利益冲突
D
国家重点研发计划 (2020YFF01014600)
国家自然科学基金 (21927812)
中国计量科学研究院基本业务费 (AKYZZ2325)
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