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基于CiteSpace的中药新药临床研究现状及前沿热点变化趋势分析

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目的 探究中药新药临床研究领域的研究现状、前沿热点及变化趋势。方法 利用中国知网、万方数据知识服务平台检索2002年1月至2024年6月中药新药临床研究的文献,采用NoteExpress软件进行文献筛选和数据清洗,采用CiteSpace 6。1。1分析年发文量时间分布情况,并对作者、机构、关键词等节点进行共现分析,对关键词进行聚类分析、时线分析及突现分析。结果 纳入文献共412篇,年发文量整体呈现波动增长的总趋势。发文最高的3位作者依次为唐健元、胡思源、刘炳林,国家食品药品监督管理总局为发文最多的机构。排除与研究主题相同的关键词后,高频关键词包括"临床试验""人用经验""中药复方""中药制剂""临床价值"等;分析了 11个关键词聚类,并对其进行了时间线分析;突现分析显示了 13个关键词,突现强度排前3位的依次为"人用经验""中药""临床价值",近几年突现的关键词有"人用经验"。结论 2002年至今,中药新药临床研究领域经历了探索阶段、深入发展阶段及创新发展阶段,研究热点包括临床试验、人用经验、中药复方、临床价值等,人用经验和临床价值是近几年的研究前沿,该领域的研究变化趋势及热点前沿与国家政策和法律法规密切相关。
Analysis of the current status and trend of frontier hotspots in new drugs from traditional Chinese medicine based on CiteSpace
Objective To investigate the research statas,key focal points,and changing trends in clinical research on new drugs derived from traditional Chinese medicine.Methods CNKI and Wanfang Data were used to retrieve journal articles and dissertations on clinical research of new drugs from traditional Chinese medicine from January 2002 to June 2024.Literature screening and data cleaning were conducted using NoteExpress software.CiteSpace 6.1.1 was employed to analyze the annual distribution of publications,co-occurrence analysis of authors,institutions,and keywords,as well as clustering,timeline,and burst analysis of keywords.Results A total of 412 articles were included,showing a general trend of fluctuating growth in annual publications.Tang Jianyuan,Hu Siyuan,and Liu Bingling were the top three authors,the Drug Evaluation Center of the National Medical Products Administration was the top institutions.After excluding keywords related to the research topic,high-frequency keywords included"clinical trial","human use experience","traditional Chinese medicine compound","traditional Chinese medicine preparation",and"clinical value".Eleven keyword clusters were analyzed with timeline analysis.Burst analysis revealed 13 keywords,with"human use experience","traditional Chinese medicine",and"clinical value"ranking the top three in burst strength.In recent years,"Human Use Experience"has emerged as key keywords.Conclusion Since 2002,the clinical research field of new traditional Chinese medicine drugs has undergone an initial and standardized exploration stage,an in-depth scientific development stage,and an innovative development stage under new development concepts.The research hotspots include clinical trial,human use experience,traditional Chinese medicine compound,and clinical value.Recent years have witnessed heightened interest in human experience in clinical settings,highlighting these as forefront research areas.The evolving trends and focal points in this domain are intricately linked with national policies and pertinent regulations.

New drugs from traditional Chinese medicineClinical researchCiteSpaceVisualized analysisTraditional Chinese medicine regulations

谢磊、贺敬龙、徐阳美、张敏、钟思睿、成斌

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国家药品监督管理局药品审评检查大湾区分中心,广东 深圳 518000

中药新药 临床研究 CiteSpace 可视化分析 中药法规

2024

中国医药导报
中国医学科学院

中国医药导报

CSTPCD
影响因子:1.759
ISSN:1673-7210
年,卷(期):2024.21(27)