Article(id=1292130361417421293, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.06.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1742140800000, receivedDateStr=2025-03-17, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997484782, onlineDateStr=2026-08-06, pubDate=1774627200000, pubDateStr=2026-03-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997484782, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997484782, creator=13701087609, updateTime=1785997484782, updator=13701087609, issue=Issue{id=1292130360968630762, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='6', pageStart='751', pageEnd='900', issueExtLink='null', onlineDate='null', pubDate='1774627200000', pubDateStr='2026-03-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997484675, creator='13701087609', updateTime=1786014452071, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201527440068743, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201527440068744, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=840, endPage=849, ext={EN=ArticleExt(id=1292130361778131439, articleId=1292130361417421293, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Data mining of adverse event risk signals for dupilumab based on FAERS database, columnId=1246531412438966969, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Reader’s Field, runingTitle=null, highlight=null, articleAbstract=
Objective To analyze adverse drug event (ADE) signals associated with dupilumab based on the date from the U.S. Food and Drug Administration Adverse Event Reporting System(FAERS), and to provide insights for rational medication use in clinical settings.
Methods ADE reports of dupilumab as the primary suspected drug were obtained by collecting the data of FAERS database from the first quarter 2017 to the third quarter 2024. ADE signals were analyzed by joint reporting odds ratio (ROR) method and bayesian confidence interval progressive neural network (BCPNN) method.
Results After data cleaning, 669 761 reports of dupilumab-related ADEs were collected, involving 264 882 patients. A total of 461 ADE signals were detected across 18 system-organ classes (SOC), which had a good coincidence with the adverse reactions in the current Chinese and English drug instructions, and also found some new high-intensity positive signals that were not included in the instructions. Including ocular hyperaemia, erythema of eyelid, eyelid exfoliation, periorbital irritation, skin fissures, neurodermatitis, injection site exfoliation, cutaneous T-cell lymphoma, etc. The median time to onset of ADE reported by patients <18 years old, 18-65 years old, and ≥65 years old was 75 days, 98 days, and 110.5 days, respectively (P<0.000 1 according to Log-rank test). Weibull distribution test was performed on time to onset of 20 ADE signals that were not included in the manual. It was found that cutaneous T-cell lymphoma, hyposmia, parosmia, and sinus headache, occurred continuously over time, and the incidence of the others decreased gradually over time.
Conclusion When clinically using dupriumab, it is essential to controll the indications and conduct a thorough medication assessment. Monitoring should be strengthened near the time window of adverse events. The latent ADEs that are not mentioned in the instructions should be noticed to ensure safe medication.
, authors=Guan-dong ZHANG, Yu YANG, Rui-ling ZHAO, authorsList=Guan-dong ZHANG, Yu YANG, Rui-ling ZHAO, authorCompany=null, correspAuthors=Rui-ling ZHAO, 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=1292130362247893488, articleId=1292130361417421293, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于美国FAERS数据库的度普利尤单抗不良事件风险信号挖掘, columnId=1246531414020219657, journalTitle=中国临床药理学杂志, columnName=读者园地, runingTitle=null, highlight=null, articleAbstract=
目的 基于美国FDA不良事件报告系统（FAERS）挖掘真实世界的度普利尤单抗不良事件（ADE）信号，为临床安全用药提供参考。
方法 检索美国食品药品管理局不良事件报告系统（FAERS）数据库中2017年第1季度至2024年第3季度以度普利尤单抗为首要怀疑药物的ADE报告，采用报告比值比法（ROR）和贝叶斯置信区间递进神经网络法（BCPNN）进行ADE信号挖掘。
结果 经数据清洗后，共收集到669 761例次与度普利尤单抗相关的ADE报告，涉及患者264 882例，2种统计方法共识别出461个ADE信号，涉及18个系统/器官分类（SOC），与度普利尤单抗现行版中英文药品说明书中药物不良反应重合度较好，也发现了说明书未收录的新的高强度阳性信号，包括眼充血、眼睑红斑、眼睑脱落、眶周刺激症状、皮肤皲裂、神经性皮炎、注射部位表皮剥脱、皮肤T细胞淋巴瘤等。ADE报告诱发时间在90天内占比达48.33%，<18岁患者ADE报告诱发时间中位数为75天，18~65岁患者ADE报告诱发时间中位数为98天，≥65岁患者ADE报告诱发时间中位数为110.5天（P<0.0001）。选择20个未载入说明书的ADE信号诱发时间进行韦伯分布检验，发现皮肤T细胞淋巴瘤、嗅觉减退、嗅觉异常、窦性头痛随着时间的推移不断地发生，其余ADE信号的发生率随着时间的推移逐渐下降。
结论 临床使用度普利尤单抗时应控制适应证，做好用药评估，在不良事件发生的时间窗附近加强监测，还应关注未被说明书记载的潜在ADE，以确保用药安全。
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张冠东（1982-），女，副主任药师，主要从事医院药学、临床试验质量控制方面的工作
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