Article(id=1292130423853839101, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.07.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1742313600000, receivedDateStr=2025-03-19, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997499668, onlineDateStr=2026-08-06, pubDate=1776355200000, pubDateStr=2026-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997499668, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997499668, creator=13701087609, updateTime=1785997499668, updator=13701087609, issue=Issue{id=1292130366320562708, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='7', pageStart='901', pageEnd='1050', issueExtLink='null', onlineDate='null', pubDate='1776355200000', pubDateStr='2026-04-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997485952, creator='13701087609', updateTime=1786014433453, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201449350516861, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201449350516862, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=990, endPage=995, ext={EN=ArticleExt(id=1292130424088720126, articleId=1292130423853839101, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Signal mining and analysis of tepotinib adverse events based on the US FAERS database, columnId=1292126489844151289, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Adverse Drug Reactions, runingTitle=null, highlight=null, articleAbstract=
Objective To conduct data mining on tepotinib-associated adverse drug events (ADEs) using the US FDA Adverse Event Reporting System (FAERS) database, providing evidence for its clinical safety.
Methods ADE reports for tepotinib from FAERS (Q1 2021 to Q4 2024) were analyzed. Signal detection methods included the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Multi-item Gamma Poisson Shrinker (MGPS). Sex-based differences in ADE signals were assessed using Fisher’s exact test with Bonferroni correction.
Results A total of 523 ADE reports identified tepotinib as the primary suspect drug, revealing 37 positive Preferred Terms (PT) across 14 System Organ Classes (SOCs). Notably, ADEs involving the ear and labyrinth disorders, infections and infestations, and nervous system disorders were not documented in the drug label. Several PTs—including malignant pleural effusion, infectious pleural effusion, central nervous system metastasis, pneumothorax, deafness, pericardial effusion, and dysgeusia—were newly identified as potential risks. Sex-stratified analysis showed higher diarrhea risk in women and a stronger appetite loss association in men. Importantly, interstitial lung disease (ILD) exhibited a significant signal in men (ROR=16.28, ROR025=8.71) but not in women, suggesting sex may be a key risk factor for tepotinib-induced ILD.
Conclusions Clinicians should prioritize monitoring high-frequency, high-signal, and newly detected ADEs during tepotinib therapy. The drug label should be updated to include sex-specific ILD risk warnings.
, authors=Mao-lin SUN, Zhen TIAN, Jian-ping ZHANG, authorsList=Mao-lin SUN, Zhen TIAN, Jian-ping ZHANG, authorCompany=null, correspAuthors=Jian-ping ZHANG, 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=1292130424331989759, articleId=1292130423853839101, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于美国FAERS数据库的特泊替尼不良事件信号挖掘与分析, columnId=1292126489986757627, journalTitle=中国临床药理学杂志, columnName=药物不良反应, runingTitle=null, highlight=null, articleAbstract=
目的 基于美国食品药品监督管理局不良事件报告系统（FAERS）对特泊替尼相关不良事件（ADE）进行数据挖掘，为其临床安全使用提供参考。
方法 收集2021年第一季度至2024年第四季度FAERS中特泊替尼的药物不良事件（ADE）报告数据，采用报告比值比（ROR）法、比例报告比（PRR）法和多项伽玛泊松分布缩减（MGPS）法进行ADE信号检测，通过Fisher精确检验及Bonferroni校正开展性别相关阳性信号差异检测。
结果 以特泊替尼为首要怀疑药物的ADE报告共523份，首选术语（PT）阳性信号37个，累及14个系统器官分类（SOC）。耳及迷路类、感染及侵染类、各类神经系统疾病SOC未被药品说明书提及。恶性胸腔积液、感染性胸腔积液、中枢神经系统转移、气胸、耳聋、心包积液、味觉障碍多个PT未在说明书中记载。性别相关差异分析提示，女性腹泻风险升高及男性食欲减退关联性突出。男性患者间质性肺疾病（ILD）信号显著（ROR=16.28，ROR025=8.71），而女性未检测出阳性信号，提示性别可能是特泊替尼ILD的重要风险因素。
结论 临床在使用特泊替尼时，应对发生频次较高、信号强度较强及新发的ADE予以重视和监护，建议说明书中补充ILD的性别风险警示。
, authors=孙茂林, 田珍, 张建萍, authorsList=孙茂林, 田珍, 张建萍, authorCompany=null, correspAuthors=张建萍, authorNote=
孙茂林（1998-），女，硕士研究生，主要从事药物合理应用及药物不良反应监测方面的研究
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孙茂林（1998-），女，硕士研究生，主要从事药物合理应用及药物不良反应监测方面的研究
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