Article(id=1321425584522121574, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.07.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1747152000000, acceptedDateStr=2025-05-14, onlineDate=1792982010249, onlineDateStr=2026-10-26, pubDate=1776182400000, pubDateStr=2026-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982010249, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982010249, creator=13701087609, updateTime=1792982010249, updator=13701087609, issue=Issue{id=1321425569611362746, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='7', pageStart='673', pageEnd='784', issueExtLink='null', onlineDate='null', pubDate='1776182400000', pubDateStr='2026-04-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982006695, creator='13701087609', updateTime=1792983136833, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430309837587328, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430309837587329, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=764, endPage=771, ext={EN=ArticleExt(id=1321425584958329191, articleId=1321425584522121574, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Signal mining of drug-related thyroid abnormalities using the FAERS database, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To identify and analyze disproportionality signals of drug-related thyroid adverse reactions, summarize potentially high-risk drugs, and provide references for clinical medication safety.
Methods: Reports of thyroid adverse events from the US Food and Drug Administration Adverse Event Reporting System (FAERS) between January 2004 and December 2024 were retrieved. Disproportionality analysis was used to assess drug-thyroid adverse event associations, with further evaluation of demographics, time to onset, and patient outcomes.
Results: Among 1 261 drugs, 80 exhibited signals of thyroid adverse reactions, including 39 antineoplastic agents (48.75%), 7 anti-infectives (8.75%), 6 cardiovascular drugs (7.5%), and 9 neurologic agents (11.25%). Amiodarone (2 537 cases), pembrolizumab (1 953 cases), and nivolumab (1 748 cases) were the most frequently reported agents. The strongest thyroid signal intensities (by ROR) were observed for biotin (ROR=164.57), amiodarone (ROR=61.51), bexarotene (ROR=46.85), and benzophenylamine (ROR=35.26). Females showed higher susceptibility (female-to-male ratio: 1∶2.33), particularly in individuals aged 18~64 years (18 352 cases, 59.12%). Thyroid abnormalities associated with antineoplastic drugs had a shorter time to onset. Higher proportions of fatal outcomes were associated with digoxin, sorafenib, pembrolizumab, and nivolumab.
Conclusion: Numerous drugs are associated with the risk of thyroid dysfunction, warranting vigilant monitoring. Females, especially those aged 18~64, represent a high-risk population for frug-related thyroid abnormalities. For antineoplastic agents, the first 60 days of treatment constitute a critical monitoring period; long-term medications demand regular surveillance.
, authors=Jian-qun ZHAO
1, 2, 3, Yu-pei WU
2, 3, Yan-shuo SHI
2, 3, Zeng-fang YU
2, 3, Yin-ling MA
2, 3, *, authorsList=Jian-qun ZHAO, Yu-pei WU, Yan-shuo SHI, Zeng-fang YU, Yin-ling MA, authorCompany=null, correspAuthors=Yin-ling MA, 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=1321425585772024169, articleId=1321425584522121574, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=基于FAERS数据库的药物相关甲状腺异常信号挖掘, columnId=1236331163573342670, journalTitle=中国新药杂志, columnName=药物安全与合理应用, runingTitle=null, highlight=null, articleAbstract=
目的： 对药物相关甲状腺不良反应的异常信号进行挖掘与分析，总结有潜在风险的药物，为临床安全用药提供参考。
方法： 检索美国FDA不良事件报告系统（FDA Adverse Event Reporting System, FAERS）中2004年1月—2024年12月甲状腺异常报告，采用比例失衡法探究药物与甲状腺异常信号的关系，并分析人口学信息、发生时间和患者结局。
结果： 从1 261个药物中筛选出药物相关甲状腺不良反应异常信号的药物80个，其中抗肿瘤药物39种（48.75%），抗感染药物7种（8.75%），心血管系统药物6种（7.5%），神经系统药物9种（11.25%）等。胺碘酮（2 537例）、帕博利珠单抗（1 953例）、纳武利尤单抗（1 748例）报告例数最多；生物素[报告比值比（reporting odds ratio, ROR）=164.57]、胺碘酮（ROR=61.51）、贝沙罗汀（ROR=46.85）、苄非他明（ROR=35.26）信号强度最强。药物相关甲状腺异常信号中，女性占比更多，男女比例为1∶2.33，尤其在18~64岁（18 352例，59.12%）人群中更显著。抗肿瘤药物引起的甲状腺异常发生时间较早，地高辛、索拉非尼、帕博利珠单抗、纳武利尤单抗死亡报告比例较高。
结论： 引起甲状腺功能异常风险的药物较多，临床应用时应保持谨慎，注意监测甲状腺功能。女性是药物相关甲状腺异常的高危人群，尤其在18~64岁人群中。对于抗肿瘤药物，药物治疗前60 d是重点监测时期；对于需长期服用的药物，应规律监测。
, authors=赵建群
1, 2, 3, 吴玉佩
2, 3, 石岩硕
2, 3, 于泽芳
2, 3, 马银玲
2, 3, *, authorsList=赵建群, 吴玉佩, 石岩硕, 于泽芳, 马银玲, authorCompany=null, correspAuthors=马银玲, authorNote=
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1, 2, 3, address=
1Graduate School, Hebei Medical University, Shijiazhuang 050051, China
2Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China
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1, 2, 3, address=
1河北医科大学研究生学院，石家庄 050051
2河北省人民医院药学部，石家庄 050051
3河北省临床药学重点实验室，石家庄 050051, bio={"content":"
赵建群，女，本科，主管药师，主要从事医院药学研究。E-mail: 18233172877@163.com。
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赵建群，女，本科，主管药师，主要从事医院药学研究。E-mail: 18233172877@163.com。
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3河北省临床药学重点实验室，石家庄 050051)])]), Author(id=1321425589127467391, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425589240713602, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, authorId=1321425589127467391, language=EN, stringName=Yu-pei WU, firstName=Yu-pei, middleName=null, lastName=WU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China
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2, 3, address=
2河北省人民医院药学部，石家庄 050051
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2Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China), AuthorCompanyExt(id=1321425588015976818, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, companyId=1321425587995005296, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2河北省人民医院药学部，石家庄 050051)]), AuthorCompany(id=1321425588296995187, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, xref=3, ext=[AuthorCompanyExt(id=1321425588313772404, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, companyId=1321425588296995187, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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2, 3, address=
2Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China
3Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang 050051, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425590398341513, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, authorId=1321425589706281349, language=CN, stringName=石岩硕, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
2, 3, address=
2河北省人民医院药学部，石家庄 050051
3河北省临床药学重点实验室，石家庄 050051, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1321425587995005296, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, xref=2, ext=[AuthorCompanyExt(id=1321425588007588209, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, companyId=1321425587995005296, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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2, 3, address=
2Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China
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2, 3, address=
2河北省人民医院药学部，石家庄 050051
3河北省临床药学重点实验室，石家庄 050051, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1321425587995005296, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, xref=2, ext=[AuthorCompanyExt(id=1321425588007588209, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, companyId=1321425587995005296, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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3河北省临床药学重点实验室，石家庄 050051)])]), Author(id=1321425592239640977, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=maling-shz@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1321425592323527060, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425584522121574, authorId=1321425592239640977, language=EN, stringName=Yin-ling MA, firstName=Yin-ling, middleName=null, lastName=MA, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China
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