摘要
目的:汇总分析2013-2022年国内外儿童药物临床试验相关文献,探讨该领域的研究动态和热点,旨在为我国政府、医疗机构、企业等协同推进儿童药物临床试验的创新发展提供参考.方法:检索Web of Science核心数据库和中国知网数据库的相关文献,检索时间为2013年1月1日-2022年12月31日.采用CiteSpace 6.2R2软件对文献进行关键词、发文国家、研究机构和作者分析,并建立知识图谱;采用Excel 2021软件对文献发文量进行描述性统计并制图.结果:共纳入英文文献6825篇,发文量总体呈增长趋势;中文文献436篇,发文量呈波动增长趋势.英文文献中出现频次较高的关键词为有效性(550次)、疗法(535次);研究热点主要为儿童肾脏相关疾病、儿童慢性病;研究趋势为精准医学(强度13.09);美国发文量最多(3004篇),发文量最多的机构为哈佛大学(472篇);研究团队数量较多.中文文献中出现频次较高的关键词为儿童用药(104次)、药品说明书(27次);研究热点主要为中药研发、知情同意;研究趋势为中药研发(强度2.41);发文量最多的机构为国家药品监督管理局药品审评中心(37篇);研究团队数量较少、规模较小.结论:儿童药物临床试验研究热点存在差异,英文文献侧重于特定疾病/药物研究,中文文献侧重于体系建设及儿童用中药研究.英文文献研究主体合作较为密切,中文文献研究主体合作有待加强.基于儿童药物临床试验现状和未来发展预期目标,监管部门的重视、各类研究主体及学者间的合作、企业的积极参与、法律法规体系的完善均不可或缺,促进我国儿童药物临床试验研究成果的科学合理应用需要达成各方共识.
Abstract
Objective:To analyze the literature related to pediatric drug clinical trials domestically and internationally from 2013 to 2022,and to explore the research trends and hotspots in this field,so as to provide reference for the innovative development of collaborative promotion in pediatric drug clinical trials by the Chinese government,medical institutions,enterprises,etc.Meth-ods:Retrieving journal literature from the Web of Science core collection and China National Knowledge Infrastructure by using subject words from January 1,2013 to December 31,2022,this paper used CiteSpace 6.2R2 software to analyze literature on key-words,countries,institutions,authors and establish a knowledge graph,and used Excel 2021 software to descriptive statistics anal-ysis and mapping of the publication volume of literature.Results:A total of 6825 English literature were included,and the overall publication volume showed an increasing trend.A total of 436 Chinese literature were included,and the publication volume showed a fluctuating growth trend.The keywords that appear frequently in English literature are efficacy(frequency 550)and therapy(fre-quency 535).The research hotspots mainly include kidney related diseases in children and chronic diseases in children.The re-search trend is precision medicine(intensity 13.09).The country with the highest publication volume is the United States(3004 ar-ticles),and the institution is Harvard University(472 articles).There is a large number of research teams.The keywords that ap-pear frequently in Chinese literature are pediatric drug(frequency 104)and drug instructions(27 times).The research hotspots mainly include traditional Chinese medicine and informed consent.The research trend is research and development of traditional Chinese medicine(strength 2.41).The institution with the highest number of publications is the Drug Evaluation Center of the Na-tional Medical Products Administration(37 articles).The research team has a small number and scale.Conclusion:There are differences in the research hotspots of pediatric drug clinical trials.English literature focuses on specific disease/drug research,while Chinese literature focuses on system construction and research on traditional Chinese medicine for children.The cooperation between English literature research subjects is relatively close,while the cooperation between Chinese literature research subjects needs to be strengthened.Based on the current situation and expected future development goals of pediatric drug clinical trials,the attention of regulatory authorities,cooperation between various research subjects and scholars,active participation of enterprises,and the improvement of legal and regulatory system are all indispensable.To promote the scientific and rational application of re-search results in pediatric drug clinical trials in China,consensus needs to be reached among all parties.
基金项目
省局(江苏省人民政府、国家中医药管理局)共建二期项目(SJGJ01763)
南京中医药大学江苏省"十四五"公共管理重点学科药品管理与政策子方向项目()
2021年江苏省大学生创新创业训练计划省级项目(202110315106Y)
维普
万方数据