Article(id=1292130367197172244, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.07.015, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1770048000000, receivedDateStr=2026-02-03, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997486161, onlineDateStr=2026-08-06, pubDate=1776355200000, pubDateStr=2026-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997486161, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997486161, creator=13701087609, updateTime=1785997486161, 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=996, endPage=1001, ext={EN=ArticleExt(id=1292130367557882391, articleId=1292130367197172244, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Risk signal mining of adverse events in drug-induced pseudomembranous colitis based on the US FAERS database, columnId=1292126489844151289, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Adverse Drug Reactions, runingTitle=null, highlight=null, articleAbstract=
Objective Based on the adverse event reporting system (FAERS) database of the US Food and Drug Administration (FDA), drugs related to pseudomembranous colitis (PMC) were identified to provide a reference for clinical safe medication.
Methods Extract the reports of drug-related adverse events (AEs) of PMC from the FAERS database for the period from the first quarter of 2004 to the fourth quarter of 2024. Risk signal detection was performed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods. Analysis was conducted on the top 20 drugs in terms of the number of reports and the top 20 drugs in terms of signal values.
Results A total of 18 356 cases of drug induced PMC were retrieved, and 485 drugs with positive risk signals were identified. The proportion of females was the highest, accounting for 52.09% (9 562 cases/18 356 cases). The number of patients over 60 years old was the largest, accounting for 36.88% (6 769 cases/18 356 cases). Among drug-related diagnoses, Crohn’s disease accounted for 5.67% (1 040 cases/18 356 cases) and ulcerative colitis for 5.53% (1 016 cases/18 356 cases), with a larger number of cases. Among the patient outcomes, the hospitalization-initial or prolonged rate was the highest, accounting for 50.43% (9 257 cases/18 356 cases). Among the top 20 drugs by number of reports, infliximab ranked first. According to the ATC classification, antineoplastic and immunomodulating agents and anti-infectives for systemic use were the most numerous, each accounting for 30% (6 varieties/20 varieties), among which vedolizumab was not mentioned PMC in the label. In the top 20 drugs ranked by ROR signal intensity, anti-infective drugs accounted for the highest proportion of 60% (12 varieties/20 varieties), and belladonna was not mentioned in relation to PMC in the label.
Conclusion A variety of drugs can cause PMC. Clinicians should remain vigilant, promptly perform diagnostic evaluations, discontinue the offending drugs, and initiate appropriate treatment to ensure medication safety.
, authors=Jie ZHU, Si-xuan ZHAO, Ying BAI, authorsList=Jie ZHU, Si-xuan ZHAO, Ying BAI, authorCompany=null, correspAuthors=Ying BAI, 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=1292130368430297626, articleId=1292130367197172244, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于美国FAERS数据库的药源性伪膜性结肠炎不良事件风险信号挖掘, 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（FDA）不良事件报告系统（FAERS）数据库，挖掘与伪膜性结肠炎（PMC）相关的药品，为临床安全用药提供参考。
方法 提取FAERS数据库2004年第1季度至2024年第4季度数据中药源性PMC不良事件（AEs）报告，通过报告比值比（ROR）法和比例报告比值比（PRR）法筛选符合风险信号检测的药品，对报告数量前20位及信号值前20位药品进行分析。
结果 获取18 356例与药源性PMC有关数据，筛选出风险信号药品485种。女性比例最高，占52.09%（9 562例/18 356例），>60岁患者数量最多，占36.88%（6 769例/18 356例），药物相关诊断中，克罗恩病占5.67%（1 040例/18 356例）、溃疡性结肠炎占5.53%（1 016例/18 356例），病例数较多，患者转归中住院治疗或住院时间延长比例最高，占50.43%（9 257例/18 356例）。报告数量前20位的药品中英夫利西单抗报告数量最多，按照解剖学治疗学及化学（ATC）分类，抗肿瘤药和免疫机能调节药及系统用抗感染药数量较多，各占30%（6种/20种），其中维得利珠单抗在说明书中未提及PMC。ROR值信号强度排序前20位药品中，系统用抗感染药物占60%（12种/20种），比例最高，颠茄在说明书中未提及PMC。
结论 多种药品可发生PMC，临床需关注，及时进行检查、停用相关药物并治疗，保障用药安全。
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祝洁（1988-），女，主管药师，主要从事医院药学相关工作
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