Article(id=1322245735614104006, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, 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=1612195200000, acceptedDateStr=2021-02-02, onlineDate=1793177549508, onlineDateStr=2026-10-28, pubDate=1622304000000, pubDateStr=2021-05-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177549508, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177549508, creator=13701087609, updateTime=1793177549508, updator=13701087609, issue=Issue{id=1322245734427112160, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='10', pageStart='865', pageEnd='960', issueExtLink='null', onlineDate='null', pubDate='1622304000000', pubDateStr='2021-05-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177549225, creator='13701087609', updateTime=1793177686658, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322246311269740715, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322246311269740716, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=898, endPage=901, ext={EN=ArticleExt(id=1322245735823819207, articleId=1322245735614104006, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Investigation and considerations about clinical position and effect evaluation system and criterion suited for traditional Chinese medicine, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Clinical position and effect evaluation are the key points of new drug research and development. Traditional Chinese medicine (TCM) clinical research often have problems such as unclear clinical position, effect evaluation not targeted, or do not tally with the characteristics of drug and so on. Recently, extensive investigation has been carried out with questionnaire on the revision of “the general principle of clinical research of new drug of TCM” on “how to determine the clinical position with characteristics of TCM” and “how to build effect evaluation system and evaluation standard with characteristics of TCM”, and participate experts give constructive advices. This article summarizes and analyzes experts' opinions, and discusses the author's opinion of TCM clinical position and effect evaluation system.

, authors=Cai-mei SONG, Bing-lin LIU, Fei-ran XUE, Ling HAN, authorsList=Cai-mei SONG, Bing-lin LIU, Fei-ran XUE, 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=1322245736125809096, articleId=1322245735614104006, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=关于中药临床定位及疗效评价体系和标准的调研及思考, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

临床定位和疗效评价均是新药研发的关键点，中药临床研究中往往存在临床定位不清、疗效评价没有针对性或与药物作用特点不符等问题。近期，在一项关于《中药新药临床研究一般原则》修订的调查问卷中也对“如何确定具有中药特点的临床定位”和“如何构建具有中药特点的疗效评价体系和评价标准”进行了广泛调研，参与专家均给出了具有建设性的意见。本文对专家意见进行总结分析，并浅谈笔者对中药临床定位和疗效评价体系的思考。

, authors=宋彩梅, 刘炳林, 薛斐然, 韩玲, authorsList=宋彩梅, 刘炳林, 薛斐然, 韩玲, authorCompany=null, correspAuthors=韩玲, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=X/p9wOBHYrxDH0JixBG92A==, magXml=yKhAc1M9WlwFaO7zbtx/dQ==, pdfUrl=null, pdf=Efqfm+Be1eGw2aAlVnVixg==, pdfFileSize=803117, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=zfJgXNoXKVWbR1TCPuCslg==, mapNumber=null, fund=null)}, authors=[Author(id=1322245738038411725, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735614104006, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=songcaimei@126.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322245738109714895, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735614104006, authorId=1322245738038411725, language=EN, stringName=Cai-mei SONG, firstName=Cai-mei, middleName=null, lastName=SONG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322245738168435152, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735614104006, authorId=1322245738038411725, language=CN, stringName=宋彩梅, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京　100022, bio={"content":"

宋彩梅，女，审评员，主要从事中药新药临床技术审评工作。E-mail：songcaimei@126.com。

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宋彩梅，女，审评员，主要从事中药新药临床技术审评工作。E-mail：songcaimei@126.com。

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