基于液相色谱-质谱联用技术治疗药物监测在精准医学中的研究进展

doi:10.19803/j.1672-8629.20250383

摘要/Abstract

摘要： 目的探讨基于液相色谱-质谱联用（LC-MS）技术的治疗药物监测（TDM）在精准医学中的研究进展,为临床开展精准医疗提供参考。方法通过检索2011年6月1日至2025年5月31日中国知网、中华医学期刊网、万方数据以及PubMed相关文献,概述特定患者的TDM应用,阐述基于LC-MS技术的TDM应用前景和面临挑战。结果基于TDM并进行实时药物剂量调整,可以确保药物有效性最大化,同时减少药品不良反应（ADR）的发生。LC-MS技术因具有较高的灵敏度、特异性和准确度,促使其在TDM领域得到了应用。结论 TDM是一种关键的临床工具,能够科学评价药物的临床疗效与安全性。基于LC-MS技术的TDM可以制订适合患者的个体化给药方案,助力临床精准医学的发展。

关键词: 液相色谱-质谱联用, 治疗药物监测, 药物剂量, 个体化治疗, 精准医学

Abstract: Objective To summarize the research progress in therapeutic drug monitoring (TDM) based on liquid chromatography-mass spectrometry (LC-MS) technology in precision medicine so as to provide a reference for clinical precision medicine. Methods By searching China National Knowledge Infrastructure (CNKI), Chinese Medical Journal Network, Wanfang Database, and PubMed for related literature that was published between June 1, 2011 and May 31, 2025, this study summarized the applications of TDM among specific patients and described the prospects of and challenges to TDM based on LC-MS technology. Results TDM and real-time adjustment of doses of drugs could maximize efficacy of drugs and help prevent adverse drug reaction(ADR). LC-MS technology was widely used in the field of TDM due to its high sensitivity, specificity and accuracy. Conclusion TDM is a key clinical tool that can accurately evaluate the clinical efficacy and safety of drugs. TDM based on LC-MS technology can formulate individualized drug delivery schemes for patients and boost advances in clinical precision medicine.

Key words: Liquid Chromatography-Mass Spectrometry, Therapeutic Drug Monitoring, Drug Dosage, Individualized Therapy, Precision Medicine

中图分类号:

R965
R917

刘学, 黄甫静, 范玲, 谢星星, 余志刚. 基于液相色谱-质谱联用技术治疗药物监测在精准医学中的研究进展[J]. 中国药物警戒, 2026, 23(4): 476-480.

LIU Xue, HUANG Fujing, FAN Ling, XIE Xingxing, YU Zhigang. Research Progress in Therapeutic Drug Monitoring Based on Liquid Chromatography-Mass Spectrometry Technology in Precision Medicine[J]. Chinese Journal of Pharmacovigilance, 2026, 23(4): 476-480.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20250383

https://zgywjj.magtechjournal.com/CN/Y2026/V23/I4/476

参考文献

[1] FANG Z, ZHANG H, GUO J, et al.Overview of Therapeutic Drug Moni-toring and Clinical Practice[J]. Talanta, 2024, 266(Pt1): 124996.
[2] LI ZY, XIE J, QU ZY, et al.Advances in Therapeutic Drug Monitoring Methods Based on Liquid Chromatography-Tandem Mass Spectrometry[J]. Chin J Lab Med(中华检验医学杂志), 2024, 47(3): 332-340.
[3] RIVA N, GUIDO PC, IBAÑEZ J, et al. Therapeutic Monitoring of Pediatric Renal Transplant Patients with Conversion to Generic Cyclos-porin[J]. Int J Clin Pharm, 2014, 36(4): 779-786.
[4] LEMAITRE F, MONCHAUD C, WOILLARD JB, et al.Summary of the Recommendations of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) on the Therapeutic Drug Monitoring of Tacrolimus[J]. Therapie, 2020, 75(6): 681-685.
[5] MARITS P, LANDUCCI L, SUNDIN U, et al.Trough S-Infliximab and Antibodies Towards Infliximab in a Cohort of 79 IBD Patients with Maintenance Infliximab Treatment[J]. J Crohns Colitis, 2014, 8(8): 881-889.
[6] YANAI H, LICHTENSTEIN L, ASSA A, et al.Levels of Drug and Antidrug Antibodies Are Associated with Outcome of Interventions after Loss of Response to Infliximab or Adalimumab[J]. Clin Gastroenterol Hepatol, 2015, 13(3): 522-530.
[7] HIEMKE C, BERGEMANN N, CLEMENT HW, et al.Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017[J]. Pharmacopsychiatry, 2018, 51(1-2): 9-62.
[8] JOHANNESSEN LANDMARK C, SæTRE J, GOTTÅS A, et al. Pharmacokinetic Variability and Use of Therapeutic Drug Monitoring of Cannabidiol in Patients with Refractory Epilepsy[J]. Epilepsia, 2025 , 66(5): 1477-1491.
[9] Working Group on the Third Edition of China’s Guidelines for the Prevention and Treatment of Schizophrenia. Proposal of Chinese Clinical Practice Guidelines for the Prevention and Treatment of Schizop-hrenia, 3rd Edition[J]. Chin J Psychiatry(中华精神科杂志), 2023, 56(5): 331-335.
[10] AONUMA K, SHIGA T, ATARASHI H, et al.Guidelines for Therapeutic Drug Monitoring of Cardiovascular Drugs Clinical Use of Blood Drug Concentration Monitoring (Jcs 2015)-Digest Version[J]. Circ J, 2017, 81(4): 581-612.
[11] BALLA A, CHO KH, KIM YC, et al.Simultaneous Determination of Procainamide and N-Acetylprocainamide in Rat Plasma by Ultra-High-Pressure Liquid Chromatography Coupled with a Diode Array Detector and Its Application to a Pharmacokinetic Study in Rats[J]. Pharmaceutics, 2018, 10(2): 41.
[12] MILLET A, KHOUDOUR N, BROS P, et al.Quantification of Nivolumab in Human Plasma by LC-MS/HRMS and LC-MS/MS, Comparison with Elisa[J]. Talanta, 2021, 224: 121889.
[13] BULTS P, BISCHOFF R, BAKKER H, et al.LC-MS/MS-Based Monitoring of in vivo Protein Biotransformation: Quantitative Determination of Trastuzumab and Its Deamidation Products in Human Plasma[J]. Anal Chem, 2016, 88(3): 1871-1877.
[14] GASPAR VP, IBRAHIM S, SOBSEY CA, et al.Direct and Precise Measurement of Bevacizumab Levels in Human Plasma Based on Controlled Methionine Oxidation and Multiple Reaction Monitoring[J]. ACS Pharmacol Transl Sci, 2020, 3(6): 1304-1309.
[15] WILLEMAN T, JOURDIL JF, GAUTIER-VEYRET E, et al.A Multiplex Liquid Chromatography Tandem Mass Spectrometry Method for the Quantification of Seven Therapeutic Monoclonal Antibodies: Application for Adalimumab Therapeutic Drug Monitoring in Patients with Crohn’s Disease[J]. Anal Chim Acta, 2019, 1067: 63-70.
[16] DAI HR, GUO HL, WANG WJ, et al.From“Wet”Matrices to“Dry” Blood Spot Sampling Strategy: a Versatile LC-MS/MS Assay for Simultaneous Monitoring Caffeine and Its Three Primary Metabolites in Preterm Infants[J]. Clin Chem Lab Med, 2023, 62(1): 97-110.
[17] ROEDL K, FUHRMANN V.Liver Diseases in the Intensive Care Unit[J]. Med Klin Intensivmed Notfmed, 2024, 119(6): 449-457.
[18] LIU L, ZHANG L, ZHENG X, et al.LC-MS/MS-Based Multiplex Antibacterial Platform for Therapeutic Drug Monitoring in Intensive Care Unit Patients[J]. Front Pharmacol, 2023, 14: 1116071.
[19] BARCO S, MESINI A, BARBAGALLO L, et al.A Liquid Chroma-tography-Tandem Mass Spectrometry Platform for the Routine Therapeutic Drug Monitoring of 14 Antibiotics: Application to Critically Ill Pediatric Patients[J]. J Pharm Biomed Anal, 2020, 186: 113273.
[20] KILIANOVA Z, CIZMAROVA I, SPAGLOVA M, et al.Recent Trends in Therapeutic Drug Monitoring of Peptide Antibiotics[J]. J Sep Sci, 2024, 47(19): e202400583.
[21] CATTANEO D, GERVASONI C.Therapeutic Drug Monitoring of Antiretroviral Therapy: Current Progresses and Future Directions[J]. Expert Rev Clin Pharmacol, 2024, 17(7): 579-587.
[22] WANG F, EIKELAND E, REIDUNSDATTER RJ, et al.Quantification of Multiple Steroid Hormones in Serum and Human Breast Cancer Tissue by Liquid Chromatography-Tandem Mass Spectrometry Analysis[J]. Front Oncol, 2024, 14: 1383104.
[23] FARIHA R, DESHPANDE PS, ROTHKOPF E, et al.An In-Depth Analysis of Four Classes of Antidepressants Quantification from Human Serum Using LC-MS/MS[J]. Sci Rep, 2023, 13(1): 2115.
[24] HABLER K, KALLA AS, RYCHLIK M, et al.Therapeutic Drug Monitoring in Breast Cancer Therapy-LC-MS/MS Method for Quantification of the CDK4/6 Inhibitors Abemaciclib, Palbociclib, Ribociclib, and Major Metabolites Abemaciclib M20 and M2 in Human Serum[J]. J Pharm Biomed Anal, 2023, 225: 115211.
[25] KUSUMA MB, KASHIBHATTA R, GAVANDE A, et al.Bioanalytical Method Development and Validation of Highly Selective and Sensitive LC-MS/MS Method for Determination of Teriparatide (Parathyroid Hormone Fragment 1-34) in Human Serum Through Direct Detection of Intact Teriparatide Molecule[J]. J Chromatogr B Analyt Technol Biomed Life Sci, 2021, 1187: 123046.
[26] DA SA, RAASCH JR, VARGAS TG, et al.Simultaneous Determination of Fluoxetine and Norfluoxetine in Dried Blood Spots Using High-Performance Liquid Chromatography-Tandem Mass Spectrometry[J]. Clin Biochem, 2018, 52: 85-93.
[27] SURDU A, FOIA LG, LUCHIAN I, et al.Saliva as a Diagnostic Tool for Systemic Diseases-a Narrative Review[J]. Medicina (Kaunas), 2025, 61(2): 243.
[28] BECK O, SANDQVIST S, BÖTTCHER M, et al. Study on the Sampling of Methadone from Exhaled Breath[J]. J Anal Toxicol, 2011, 35(5): 257-263.
[29] POWELEIT EA, VINKS AA, MIZUNO T.Artificial Intelligence and Machine Learning Approaches to Facilitate Therapeutic Drug Management and Model-Informed Precision Dosing[J]. Ther Drug Monit, 2023, 45(2): 143-150.
[30] JAVID S, RAMYA K, GULZAR AHMED M, et al.Bioanalysis of Antihypertensive Drugs by LC-MS: a Fleeting Look at the Regulatory Guidelines and Artificial Intelligence[J]. Bioanalysis, 2025, 17(7): 471-487.