三结合体系下“中医理论”古代文献检索的关键技术与证据评价要素

Key technologies and evidence evaluation elements for retrieval of ancient documents of“traditional Chinese medicine theory”under the triple-combination system

建立“三结合”的中药注册审评证据体系,中医理论证据评价体系的形成至关重要。现有的中医理论证据体系尚不成熟,对于古代文献的检索缺乏规范的检索步骤且证据的评价要素不够全面,为此对古代文献的检索环节进行规范,提出DSPMRE六要素以明确检索问题和需求,在证据评价方面创新性提出文献的完整性,将文献来源、文献的共识性共同提炼为证据评价要素,初步形成中医理论证据等级推荐意见,以此完善文献检索、分析评价、分级推荐3个关键环节,构建“三结合”体系下支撑中药新药研发和注册审批的中医理论证据体系。

To establish a“three-in-one”traditional Chinese medicine registration review evidence system,the formation of a traditional Chinese medicine theoretical evidence evaluation system is crucial.The existing traditional Chinese medicine theory evidence system is still immature,lack of standardized retrieval steps for the retrieval of ancient documents,and the evaluation elements of the evidence are not comprehensive enough.So the retrieval process of ancient documents was standardized in this study.Propose six elements of DSPMRE to clarify retrieval issues and needs,and the integrity of the documents,the source and consensus of literature were innovatively proposed to be the three elements of evidence evaluation.Recommendations were made on the level of traditional Chinese medicine theoretical evidence to improve the three key links,i.e.,literature retrieval,analysis and evaluation,and classified recommendation,thus to build a traditional Chinese medicine theoretical evidence system that supports the research and development and registration approval of new Chinese medicines under the triple-combination system.