Article(id=1291404839427235866, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.11.026, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1745942400000, receivedDateStr=2025-04-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824506860, onlineDateStr=2026-08-04, pubDate=1750089600000, pubDateStr=2025-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824506860, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824506860, creator=13701087609, updateTime=1785824506860, updator=13701087609, issue=Issue{id=1291404791758975909, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1750089600000', pubDateStr='2025-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824495496, creator='13701087609', updateTime=1785824495496, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1646, endPage=1650, ext={EN=ArticleExt(id=1291404841268535323, articleId=1291404839427235866, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Research progress on the safety of Janus kinase inhibitors, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Recent advancements in Janus kinase (JAK) inhibitors have highlighted their therapeutic potential in autoimmune diseases, yet safety concerns persist. Chinese pharmaceutical companies are advancing selective JAK inhibitor research and development, focusing on trials for rheumatoid arthritis (RA) patients failing biologic disease-modifying antirheumatic drugs (bDMARDs) and exploring superiority/non-inferiority against tumor necrosis factor (TNF) inhibitors. In the future, JAK inhibitors need to be combined with long-term real-world data to expand the applicable population. This article provides important evidence for new drug research and development, regulatory decisions, and rational clinical medication, with the aim of promoting the safer and more effective use of JAK inhibitors in the treatment of autoimmune diseases.

, authors=-Rigeleng SE, Xing AI, Yuan-hong LI, Tian ZHAO, Jian HOU, Jie ZHANG, authorsList=-Rigeleng SE, Xing AI, Yuan-hong LI, Tian ZHAO, Jian HOU, Jie ZHANG, authorCompany=null, correspAuthors=Jie 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=1291404842057064476, articleId=1291404839427235866, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=Janus激酶抑制药安全性的研究进展, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

Janus激酶（JAK）抑制药在自身免疫性疾病治疗中广泛应用，但非选择性JAK抑制药带来的安全性问题引发关注。目前，我国药企正加速布局选择性JAK抑制药研发，建议在生物类改善病情抗风湿药（bDMARDs）疗效不佳或不能耐受的类风湿关节炎（RA）人群中开展临床试验，并探索与肿瘤坏死因子（TNF）抑制药的优效性或非劣效性对比。未来JAK抑制药还需结合长期真实世界数据，拓展适用人群。本文为新药研发、监管决策以及临床合理用药提供了重要依据，以期推动JAK抑制药在自身免疫性疾病治疗中更安全、有效地使用。

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色日格楞（1980-），男，审评员，主要从事风湿免疫系统药物临床审评工作

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色日格楞（1980-），男，审评员，主要从事风湿免疫系统药物临床审评工作

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