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Article(id=1236678237414289654, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236678235866583092, 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=1668700800000, acceptedDateStr=2022-11-18, onlineDate=1772776668169, onlineDateStr=2026-03-06, pubDate=1688054400000, pubDateStr=2023-06-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772776668169, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772776668169, creator=13701087609, updateTime=1772776668169, updator=13701087609, issue=Issue{id=1236678235866583092, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='12', pageStart='1177', pageEnd='1280', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772776667801, creator=13701087609, updateTime=1772776891082, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236679172442092503, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236678235866583092, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236679172442092504, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236678235866583092, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1201, endPage=1205, ext={EN=ArticleExt(id=1236678237678530808, articleId=1236678237414289654, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Research on core assessment indicators for human use experience of traditional Chinese medicine based on Delphi method, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To scientifically construct the evaluation indicators for human use experience of traditional Chinese medicine (TCM) and provide reference for the formation of "triple combination" registration review evidence system.

Methods:

Based on the Delphi method, after literature research and expert investigation, two rounds of expert consultation were carried out, and the expert consultation results were evaluated by the mean, variation index, coordination coefficient, etc., and the core indicators for human use experience evaluation of TCM were further screened and optimized.

Results:

22 experts in various fields were selected to conduct a questionnaire survey. The participation rates of experts in the 2 rounds of consultation were 100% and 95.46%, and the authority indicators of involved experts were 0.852 and 0.865. According to the mean value and coefficient of variation of the indicators, combined with the revision suggestions of experts, the core indicators of human use experience evaluation including 4 first-level indicators and 22 second-level indicators were finally formed.

Conclusion:

The core indicators for human use experience evaluation of TCM could guide the standardized collection and summary of human use experience data, promote the formation of high-quality and evaluable human use experience evidence, and support the research and development of new TCM products.

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目的：

科学构建中药人用经验评估指标，为“三结合”注册审评证据体系的形成提供参考。

方法：

基于德尔菲法，在文献研究和专家调查的基础上，开展2轮专家咨询，从均数、变异指数、协调系数等角度对专家咨询结果进行评价，进一步筛选和优化中药人用经验评估核心指标。

结果：

选取各领域专家共22名进行问卷调查，2轮咨询的专家积极性系数分别为100%，95.46%，专家权威程度分别为0.852，0.865，根据指标均值和变异系数，结合专家修改建议，最终形成包含4个一级指标、22个二级指标的人用经验评估核心指标。

结论：

中药人用经验评估核心指标可引导人用经验数据资料的规范收集和总结，促进形成高质量、可评价的人用经验证据，推进中药新药研发。

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党海霞，女，研究员，主要从事中医药政策研究。联系电话：(010)64089693，E-mail: 。
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智恺，女，主治医师，主要从事中医药政策研究。联系电话：(010)64089686，E-mail: 。

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智恺，女，主治医师，主要从事中医药政策研究。联系电话：(010)64089686，E-mail: 。

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智恺，女，主治医师，主要从事中医药政策研究。联系电话：(010)64089686，E-mail: 。

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基于德尔菲法的中药人用经验评估核心指标研究
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智恺 1 , 苏鹏丽 2 , 刘骏 2 , 于亚南 2 , 李兵 3 , 许海玉 4 , 李耿 5 , 申春悌 6 , 廖星 2 , 党海霞 1
中国新药杂志 | 新药述评与论坛 2023,32(12): 1201-1205
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中国新药杂志 | 新药述评与论坛 2023, 32(12): 1201-1205
基于德尔菲法的中药人用经验评估核心指标研究
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智恺1 , 苏鹏丽2, 刘骏2, 于亚南2, 李兵3, 许海玉4, 李耿5, 申春悌6, 廖星2, 党海霞1
作者信息
  • 1中国中医科学院，北京 100700
  • 2中国中医科学院中医临床基础医学研究所，北京 100700
  • 3中国中医科学院中药研究所，北京 100700
  • 4中国中医科学院中药监管科学研究中心，北京 100700
  • 5中国医学科学院药用植物研究所，北京 100193
  • 6南京中医药大学，南京 210023

    • 智恺，女，主治医师，主要从事中医药政策研究。联系电话：(010)64089686，E-mail: 。

通讯作者:

党海霞，女，研究员，主要从事中医药政策研究。联系电话：(010)64089693，E-mail: 。
Research on core assessment indicators for human use experience of traditional Chinese medicine based on Delphi method
Kai ZHI1 , Peng-li SU2, Jun LIU2, Ya-nan YU2, Bing LI3, Hai-yu XU4, Geng LI5, Chun-di SHEN6, Xing LIAO2, Hai-xia DANG1
Affiliations
  • 1China Academy of Chinese Medical Sciences, Beijing 100700, China
  • 2Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • 3Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • 4Research Center of Drug Regulatory Science, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • 5Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Beijing 100193, China
  • 6Nanjing University of Chinese Medicine, Nanjing 210023, China
出版时间: 2023-06-30
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摘要
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目的：

科学构建中药人用经验评估指标，为“三结合”注册审评证据体系的形成提供参考。

方法：

基于德尔菲法，在文献研究和专家调查的基础上，开展2轮专家咨询，从均数、变异指数、协调系数等角度对专家咨询结果进行评价，进一步筛选和优化中药人用经验评估核心指标。

结果：

选取各领域专家共22名进行问卷调查，2轮咨询的专家积极性系数分别为100%，95.46%，专家权威程度分别为0.852，0.865，根据指标均值和变异系数，结合专家修改建议，最终形成包含4个一级指标、22个二级指标的人用经验评估核心指标。

结论：

中药人用经验评估核心指标可引导人用经验数据资料的规范收集和总结，促进形成高质量、可评价的人用经验证据，推进中药新药研发。

中药  /  人用经验  /  评估指标  /  德尔菲法
Objective:

To scientifically construct the evaluation indicators for human use experience of traditional Chinese medicine (TCM) and provide reference for the formation of "triple combination" registration review evidence system.

Methods:

Based on the Delphi method, after literature research and expert investigation, two rounds of expert consultation were carried out, and the expert consultation results were evaluated by the mean, variation index, coordination coefficient, etc., and the core indicators for human use experience evaluation of TCM were further screened and optimized.

Results:

22 experts in various fields were selected to conduct a questionnaire survey. The participation rates of experts in the 2 rounds of consultation were 100% and 95.46%, and the authority indicators of involved experts were 0.852 and 0.865. According to the mean value and coefficient of variation of the indicators, combined with the revision suggestions of experts, the core indicators of human use experience evaluation including 4 first-level indicators and 22 second-level indicators were finally formed.

Conclusion:

The core indicators for human use experience evaluation of TCM could guide the standardized collection and summary of human use experience data, promote the formation of high-quality and evaluable human use experience evidence, and support the research and development of new TCM products.

traditional Chinese medicine  /  human use experience  /  evaluation indicators  /  Delphi method
智恺, 苏鹏丽, 刘骏, 于亚南, 李兵, 许海玉, 李耿, 申春悌, 廖星, 党海霞. 基于德尔菲法的中药人用经验评估核心指标研究. 中国新药杂志, 2023 , 32 (12) : 1201 -1205 .
Kai ZHI, Peng-li SU, Jun LIU, Ya-nan YU, Bing LI, Hai-yu XU, Geng LI, Chun-di SHEN, Xing LIAO, Hai-xia DANG. Research on core assessment indicators for human use experience of traditional Chinese medicine based on Delphi method[J]. Chinese Journal of New Drugs, 2023 , 32 (12) : 1201 -1205 .
基金
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  • 中国中医科学院科技创新工程重大攻关项目(CI2021A04701)
  • 国家中医药管理局中医药标准化资助项目(GZY-FJS-2020-206)
2023年第32卷第12期
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  • 首发时间：2026-03-06
  • 出版时间：2023-06-30
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  • 录用日期：2022-11-18
基金
中国中医科学院科技创新工程重大攻关项目(CI2021A04701)
国家中医药管理局中医药标准化资助项目(GZY-FJS-2020-206)
作者信息
    1中国中医科学院，北京 100700
    2中国中医科学院中医临床基础医学研究所，北京 100700
    3中国中医科学院中药研究所，北京 100700
    4中国中医科学院中药监管科学研究中心，北京 100700
    5中国医学科学院药用植物研究所，北京 100193
    6南京中医药大学，南京 210023

通讯作者:

党海霞，女，研究员，主要从事中医药政策研究。联系电话：(010)64089693，E-mail: 。
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2种不同金属材料的力学参数
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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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