【摘要】 目的梳理我国中医药伦理审查相关研究,揭示该领域的热点主题和发展趋势。方法以收录于国内数据库关于中医药伦理审查研究的学术论文为文献样本,借助书目共现分析系统(BICOMB)及SPSS22.0软件进行文献信息挖掘,并对高频关键词进行共词聚类和主题战略坐标分析。结果共检索到文献78篇,高频关键词17个,国内中医药伦理审查研究领域的4大热点为:机构建设及体系认证、GCP伦理优化、伦理原则性研究、试验方案设计与项目质量管理。结论近些年来,中医药伦理审查研究是一个热点,可结合目前薄弱领域加强进一步研究,以期提高中医药伦理审查的整体水平。更多还原

【Abstract】 Objective: To tease relevant research on the ethical review of Traditional Chinese medicine in China and reveal hot topics and trends in the field. Methods: Taking the academic papers included in the domestic database on ethical review of Traditional Chinese medicine as literature samples,the BICOMB and SPSS22. 0 software were used for document information mining,and the high-frequency keywords were analyzed used co-word clustering and thematic strategic diagram. Results: A total of 78 documents were retrieved,and 17 high-frequency keywords were used. The four major hotspots in the field of ethical review of Traditional Chinese medicine included: institution building and system certification,GCP ethics optimization,ethical principle research,trial scheme design and project quality management. Conclusion: In recent years,the ethical review of Traditional Chinese medicine has been explored by scholars and institutions in China from multiple perspectives,and further research can be strengthened combined with the current weak areas,in order to increase the overall level of ethical review of Traditional Chinese Medicine.更多还原