Article(id=1322125557656043884, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, articleNumber=null, orderNo=null, doi=null, 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=1622995200000, acceptedDateStr=2021-06-07, onlineDate=1793148896849, onlineDateStr=2026-10-28, pubDate=1638201600000, pubDateStr=2021-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793148896849, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793148896849, creator=13701087609, updateTime=1793148896849, updator=13701087609, issue=Issue{id=1322125552731927464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='22', pageStart='2017', pageEnd='2120', issueExtLink='null', onlineDate='null', pubDate='1638201600000', pubDateStr='2021-11-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793148895675, creator='13701087609', updateTime=1793149501548, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128094022971944, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128094022971945, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2059, endPage=2063, ext={EN=ArticleExt(id=1322125557828010349, articleId=1322125557656043884, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Considerations on clinical value of new traditional Chinese medicines from the view of TCM practice, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Clinical value is the core value of a drug on the market, and reflects the needs of medical staff and patients for drugs. By defining the characteristics of traditional Chinese medicine (TCM) and the needs of patients and clinic for medication, it is concluded that no matter what perspective is used to evaluate the clinical value of new TCM, the core content should be focused on the core clinical advantages of traditional Chinese medicine, such as advantage diseases of TCM treatment and patients' subjective feelings, the needs of patients for medical treatment, unmet clinical medication needs, and druggability. Comprehensive analysis of these four dimensions is also consistent with the characteristics of new TCM approved for marketing in the past five years.

, authors=Na AN, Ling HAN, authorsList=Na AN, Ling HAN, authorCompany=null, correspAuthors=Ling HAN, 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=1322125558041919854, articleId=1322125557656043884, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=基于中医实践浅谈对中药新药临床价值的思考, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

临床价值是药物上市的核心价值,主要体现了医务人员和患者对药物的需求。明确中药新药临床价值,对于体现中药的临床优势、满足临床用药需求、提高我国中药行业原创能力以及促进中药产业发展均具有重大战略意义。通过分析中医实践经验、患者和临床用药需求等,总结出中药新药临床价值的关键内容,包括中医药治疗优势病种、患者感受等中药临床核心优势、中医药理论和临床实践的支持性、与已上市中药产品的比较优势、成药性分析这4个维度,这也与近5年获批上市的中药新药特点相符合。

, authors=安娜, 韩玲, authorsList=安娜, 韩玲, authorCompany=null, correspAuthors=韩玲, authorNote=

安娜,女,博士,副研究员,主要从事中药新药临床审评工作。联系电话:(010)85242951,E-mail:。

, correspAuthorsNote=
韩玲,女,博士,主任药师,主要从事中药新药审评工作。联系电话:(010)85243109,E-mail:。
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安娜,女,博士,副研究员,主要从事中药新药临床审评工作。联系电话:(010)85242951,E-mail:。

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安娜,女,博士,副研究员,主要从事中药新药临床审评工作。联系电话:(010)85242951,E-mail:。

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基于中医实践浅谈对中药新药临床价值的思考
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安娜 , 韩玲
中国新药杂志 | 新药注册与审评技术 2021,30(22): 2059-2063
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中国新药杂志 |新药注册与审评技术 2021 , 30 (22) : 2059 -2063
基于中医实践浅谈对中药新药临床价值的思考
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安娜 , 韩玲
作者信息
  • 国家药品监督管理局药品审评中心,北京 100022
通讯作者:
韩玲,女,博士,主任药师,主要从事中药新药审评工作。联系电话:(010)85243109,E-mail:。
作者简介:

安娜,女,博士,副研究员,主要从事中药新药临床审评工作。联系电话:(010)85242951,E-mail:。

Considerations on clinical value of new traditional Chinese medicines from the view of TCM practice
Na AN , Ling HAN
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
出版时间: 2021-11-30
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临床价值是药物上市的核心价值,主要体现了医务人员和患者对药物的需求。明确中药新药临床价值,对于体现中药的临床优势、满足临床用药需求、提高我国中药行业原创能力以及促进中药产业发展均具有重大战略意义。通过分析中医实践经验、患者和临床用药需求等,总结出中药新药临床价值的关键内容,包括中医药治疗优势病种、患者感受等中药临床核心优势、中医药理论和临床实践的支持性、与已上市中药产品的比较优势、成药性分析这4个维度,这也与近5年获批上市的中药新药特点相符合。

中药新药  /  临床价值  /  中药特点  /  临床优势与特色  /  成药性

Clinical value is the core value of a drug on the market, and reflects the needs of medical staff and patients for drugs. By defining the characteristics of traditional Chinese medicine (TCM) and the needs of patients and clinic for medication, it is concluded that no matter what perspective is used to evaluate the clinical value of new TCM, the core content should be focused on the core clinical advantages of traditional Chinese medicine, such as advantage diseases of TCM treatment and patients' subjective feelings, the needs of patients for medical treatment, unmet clinical medication needs, and druggability. Comprehensive analysis of these four dimensions is also consistent with the characteristics of new TCM approved for marketing in the past five years.

new traditional Chinese medicines  /  clinical value  /  characteristics of traditional Chinese medicines  /  clinical advantages and characteristics  /  druggability
安娜, 韩玲. 基于中医实践浅谈对中药新药临床价值的思考. 中国新药杂志, 2021 , 30 (22) : 2059 -2063 .
Na AN, Ling HAN. Considerations on clinical value of new traditional Chinese medicines from the view of TCM practice[J]. Chinese Journal of New Drugs, 2021 , 30 (22) : 2059 -2063 .

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  • 首发时间:2026-10-28
  • 出版时间:2021-11-30
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    国家药品监督管理局药品审评中心,北京 100022

通讯作者:

韩玲,女,博士,主任药师,主要从事中药新药审评工作。联系电话:(010)85243109,E-mail:。
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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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