Article(id=1291404934633746523, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404875351449891, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.09.023, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1731168000000, receivedDateStr=2024-11-10, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824529559, onlineDateStr=2026-08-04, pubDate=1747411200000, pubDateStr=2025-05-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824529559, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824529559, creator=13701087609, updateTime=1785824529559, updator=13701087609, issue=Issue{id=1291404875351449891, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='9', pageStart='1201', pageEnd='1350', issueExtLink='null', onlineDate='null', pubDate='1747411200000', pubDateStr='2025-05-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824515426, creator='13701087609', updateTime=1785824515426, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1329, endPage=1334, ext={EN=ArticleExt(id=1291404934814101596, articleId=1291404934633746523, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Considerations on the clinical pharmacology of small interfering RNA drugs, columnId=1246531408630534361, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Review, runingTitle=null, highlight=null, articleAbstract=

Small interference RNA (siRNA) drugs have unique characteristics in molecular structure, mechanism of action and pharmacokinetic characteristics, presenting numerous challenges during the clinical research phase. This paper mainly presents the clinical pharmacology study of six siRNA drugs, that have been approved by the U.S. Food and Drug Administration, from the pharmacokinetic characteristics, drug-drug interactions, the special population with liver or kidney dysfunction, immunogenicity and cardiac safety etc. By the comprehensive overview of the early clinical pharmacology evaluation method of siRNA drugs, we hope to provide references for the design of early clinical trials and the translation of clinical research of siRNA drugs.

, authors=Jiang-shuo LI1, 2, Jian-xiong ZHANG1, 2, Hang YIN1, 2, Rui-hua DONG1, 2, Jing-yi MA3, Shu-jie LIU3, Chun-min WEI3, Rui-rui HE3, authorsList=Jiang-shuo LI, Jian-xiong ZHANG, Hang YIN, Rui-hua DONG, Jing-yi MA, Shu-jie LIU, Chun-min WEI, Rui-rui HE, authorCompany=null, correspAuthors=Rui-rui HE, 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=1291404935191588957, articleId=1291404934633746523, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=关于小干扰RNA类药物临床药理学研究的考虑, columnId=1246531408819278046, journalTitle=中国临床药理学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

小干扰RNA(siRNA)药物具有独特的分子结构、作用机制和药代动力学特征,在临床研究阶段面临较多挑战。本文主要结合美国食品药品监督管理局已批准上市的6款siRNA药物在临床药理学研究方面的新药研究实例,从药代动力学、药物-药物相互作用、肝肾功能不全的特殊人群、免疫原性和心脏安全性等方面综合概述了siRNA药物的早期临床药理评价方法,对siRNA药物的临床药理研究提出几点思考,以期为siRNA药物的早期临床试验设计及临床研究转化提供参考。

, authors=李江硕1, 2, 张健雄1, 2, 尹航1, 2, 董瑞华1, 2, 马婧怡3, 刘淑洁3, 魏春敏3, 贺锐锐3, authorsList=李江硕, 张健雄, 尹航, 董瑞华, 马婧怡, 刘淑洁, 魏春敏, 贺锐锐, authorCompany=null, correspAuthors=贺锐锐, authorNote=

李江硕(1993-),女,主管药师,主要从事临床药理学方向研究

, correspAuthorsNote=
贺锐锐,副主任药师 Tel: (010)80995837 E-mail:
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关于小干扰RNA类药物临床药理学研究的考虑
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李江硕 1, 2 , 张健雄 1, 2 , 尹航 1, 2 , 董瑞华 1, 2 , 马婧怡 3 , 刘淑洁 3 , 魏春敏 3 , 贺锐锐 3
中国临床药理学杂志 | 综述 2025,41(9): 1329-1334
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中国临床药理学杂志 |综述 2025 , 41 (9) : 1329 -1334
关于小干扰RNA类药物临床药理学研究的考虑
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李江硕1, 2, 张健雄1, 2, 尹航1, 2, 董瑞华1, 2, 马婧怡3, 刘淑洁3, 魏春敏3, 贺锐锐3
作者信息
  • 1.首都医科大学 附属北京友谊医院 研究型病房,北京 100050
  • 2.核酸类产品与细胞治疗早期临床评价北京市重点实验室,北京 100050
  • 3.国家药品监督管理局 药品审评中心,北京 100022
通讯作者:
贺锐锐,副主任药师 Tel: (010)80995837 E-mail:
作者简介:

李江硕(1993-),女,主管药师,主要从事临床药理学方向研究

Considerations on the clinical pharmacology of small interfering RNA drugs
Jiang-shuo LI1, 2, Jian-xiong ZHANG1, 2, Hang YIN1, 2, Rui-hua DONG1, 2, Jing-yi MA3, Shu-jie LIU3, Chun-min WEI3, Rui-rui HE3
Affiliations
  • 1.Department of Research Ward, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100050, China
  • 2.Beijing Key Laboratory of Early Clinical Evaluation of Nucleic Acid Products and Cell Therapy, Beijing 100050, China
  • 3.Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
出版时间: 2025-05-17 doi: 10.13699/j.cnki.1001-6821.2025.09.023
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小干扰RNA(siRNA)药物具有独特的分子结构、作用机制和药代动力学特征,在临床研究阶段面临较多挑战。本文主要结合美国食品药品监督管理局已批准上市的6款siRNA药物在临床药理学研究方面的新药研究实例,从药代动力学、药物-药物相互作用、肝肾功能不全的特殊人群、免疫原性和心脏安全性等方面综合概述了siRNA药物的早期临床药理评价方法,对siRNA药物的临床药理研究提出几点思考,以期为siRNA药物的早期临床试验设计及临床研究转化提供参考。

小干扰RNA  /  N-乙酰半乳糖胺  /  药代动力学  /  临床药理

Small interference RNA (siRNA) drugs have unique characteristics in molecular structure, mechanism of action and pharmacokinetic characteristics, presenting numerous challenges during the clinical research phase. This paper mainly presents the clinical pharmacology study of six siRNA drugs, that have been approved by the U.S. Food and Drug Administration, from the pharmacokinetic characteristics, drug-drug interactions, the special population with liver or kidney dysfunction, immunogenicity and cardiac safety etc. By the comprehensive overview of the early clinical pharmacology evaluation method of siRNA drugs, we hope to provide references for the design of early clinical trials and the translation of clinical research of siRNA drugs.

small interference RNA  /  N-acetylgalactosamine  /  pharmacokinetics  /  clinical pharmacology
李江硕, 张健雄, 尹航, 董瑞华, 马婧怡, 刘淑洁, 魏春敏, 贺锐锐. 关于小干扰RNA类药物临床药理学研究的考虑. 中国临床药理学杂志, 2025 , 41 (9) : 1329 -1334 . DOI: 10.13699/j.cnki.1001-6821.2025.09.023
Jiang-shuo LI, Jian-xiong ZHANG, Hang YIN, Rui-hua DONG, Jing-yi MA, Shu-jie LIU, Chun-min WEI, Rui-rui HE. Considerations on the clinical pharmacology of small interfering RNA drugs[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (9) : 1329 -1334 . DOI: 10.13699/j.cnki.1001-6821.2025.09.023
  • 药品监管科学全国重点实验室第二批课题基金资助项目(2024SKLDRS0231)
  • 北京市卫生健康科技成果和适宜技术推广基金资助项目(BHTPP2024090)
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2025年第41卷第9期
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doi: 10.13699/j.cnki.1001-6821.2025.09.023
  • 接收时间:2024-11-10
  • 首发时间:2026-08-04
  • 出版时间:2025-05-17
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  • 收稿日期:2024-11-10
基金
药品监管科学全国重点实验室第二批课题基金资助项目(2024SKLDRS0231)
北京市卫生健康科技成果和适宜技术推广基金资助项目(BHTPP2024090)
作者信息
    1.首都医科大学 附属北京友谊医院 研究型病房,北京 100050
    2.核酸类产品与细胞治疗早期临床评价北京市重点实验室,北京 100050
    3.国家药品监督管理局 药品审评中心,北京 100022

通讯作者:

贺锐锐,副主任药师 Tel: (010)80995837 E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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