Article(id=1292126504209641658, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.02.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1742832000000, receivedDateStr=2025-03-25, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996565153, onlineDateStr=2026-08-06, pubDate=1769529600000, pubDateStr=2026-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996565153, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996565153, creator=13701087609, updateTime=1785996565153, updator=13701087609, issue=Issue{id=1292126409196064779, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1769529600000', pubDateStr='2026-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996542500, creator='13701087609', updateTime=1786014671444, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292202447569707674, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292202447569707675, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=237, endPage=242, ext={EN=ArticleExt(id=1292126504406773947, articleId=1292126504209641658, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=High performance liquid chromatography tandem mass spectrometry for the determination of methotrexate and 7-hydroxymethotrexate concentrations in human plasma, columnId=1246531413395263850, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Research Method, runingTitle=null, highlight=null, articleAbstract=
Objective To establish a high-performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) method for analyzing the concentrations of methotrexate (MTX) and its metabolite 7-hydroxymethotrexate (7-OH-MTX) in human plasma, and to use it for clinical drug monitoring, in order to explore the relationship between their concentrations and liver and kidney toxicity.
Methods Acetonitrile precipitation protein method was used to preprocess the samples, combined with HPLC-MS/MS detection. 369 blood samples from pediatric and adult patients who received high-dose methotrexate (HDMTX) chemotherapy were collected for methodological validation, and Spearman correlation analysis between concentration and hepatotoxicity and nephrotoxicity was performed using statistical software SPSS 27.
Results The linear relationship of MTX in human plasma was good within the concentration range of 0.005-2 μmol·L-1 (r=0.998 8), and the linear relationship of 7-OH-MTX was good within the concentration range of 0.05-20 μmol·L-1 (r=0.997 4). The intra batch and inter batch precision were all less than 10%, the extraction recovery rate reached 87.0-106.1%, and the coefficient of variation of matrix effect was less than 7%. The analysis of blood concentration measurements at 42 hours, 72 hours, and after HDMTX infusion showed that the concentration ratio of 7-OH-MTX/MTX was significantly negatively correlated with liver function indicators alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (P<0.01), while there was no significant correlation with renal function indicators creatinine (CR) and creatinine clearance rate (CCR) (P>0.05).
Conclusion The established method is simple, accurate, and sensitive, and is suitable for clinical drug therapy monitoring. By monitoring 7-OH-MTX/MTX, the occurrence of liver toxicity can be effectively predicted for timely clinical drug rescue.
, authors=Shuai-shuai GAO
1, Hao-ran LI
1, Ying LI
1, Fang-ting LI
1, De-qiang LI
1, Zheng-yang LIU
2, Wei-chong DONG
1, 2, authorsList=Shuai-shuai GAO, Hao-ran LI, Ying LI, Fang-ting LI, De-qiang LI, Zheng-yang LIU, Wei-chong DONG, authorCompany=null, correspAuthors=Wei-chong DONG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292126504662626492, articleId=1292126504209641658, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=高效液相色谱-串联质谱法测定人血浆中甲氨蝶呤和7-羟基甲氨蝶呤浓度, columnId=1246531413600784769, journalTitle=中国临床药理学杂志, columnName=研究方法, runingTitle=null, highlight=null, articleAbstract=
目的 建立高效液相色谱串联质谱法（HPLC-MS/MS）分析人血浆中甲氨蝶呤（MTX）及其代谢物7-羟基甲氨蝶呤（7-OH-MTX）的浓度，并用于临床治疗药物监测，以探讨其浓度与肝肾毒性的关系。
方法 采用乙腈沉淀蛋白的方法预处理样本，结合HPLC-MS/MS检测，收集临床采用大剂量甲氨蝶呤（HDMTX）化疗的儿童和成人患者血样369份用于方法学验证，并用统计学软件SPSS 27进行浓度与肝毒性和肾毒性的Spearman相关性分析。
结果 人血浆中MTX在0.005~2 μmol·L-1浓度范围内线性关系良好（r=0.998 8），7-OH-MTX在0.05~20 μmol·L-1浓度范围内线性关系良好（r=0.997 4），批内批间精密度均<10%，提取回收率达到87.0%~106.1%，基质效应变异系数（CV）<7%。在HDMTX输注后42 h、72 h及以后的血样浓度测定结果分析显示，浓度比7-OH-MTX/MTX与肝功能指标丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）均呈显著负相关（P<0.01），而与肾功能指标肌酐（CR）和肌酐清除率（CCR）则无明显相关性（P>0.05）。
结论 所建方法简便、准确、灵敏，适用于临床药物治疗监测，通过监测7-OH-MTX/MTX，可以有效预测肝毒性的发生，以便及时进行临床药物解救。
, authors=高帅帅
1, 李浩然
1, 李颖
1, 李芳婷
1, 李德强
1, 刘政阳
2, 董维冲
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高帅帅（2002-），男，硕士研究生，主要从事临床药学研究
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