【摘要】 通过回顾中医临床大数据知识工程学的起源及其40年发展历程，厘清了各研究阶段的重大事件和研究成果，阐述了基于病案的真实世界中医临床研究思路与方法，强调了从数据驱动向数据与知识双驱动模式转换，推动真实世界中医临床研究模式变革与创新的重要性，明确了模式变革与创新的基础是将中医临床病例数据库知识属性化重构，使隐性知识显性化，实现知识的完整表达，构建中医临床病例知识库。以病例数据知识化、知识编码及知识图谱为示例，重点展示了中医临床大数据知识工程的关键技术和核心环节，充分证实了大数据知识工程是真实世界中医临床研究的必由之路。在国家中医药高质量发展战略指引下，未来应培育中医临床研究新质生产力，形成具有新发展理念的中医临床研究新业态为目标，构建大数据知识工程技术平台和中医临床知识仓库，为开展中医临床领域大模型研究提供技术平台和知识资源，促进中医临床智能化和中医药事业高质量发展。更多还原

【Abstract】 Through a systematic review of the origin and 40 years of development of Traditional Chinese Medicine(TCM) big data knowledge engineering, we clariffy the major events and research achievements in each stage of the research, expound the ideas and methods of real world TCM clinical study based on medical records, emphasize the importance of transforming from data driven mode to data and knowledge driven mode to promote the innovation of the real world TCM clinical study model, and argue that the basis of model transformation and innovation is to reconstruct the knowledge attributes of TCM clinical case data base, make tacit knowledge explicit, realize full expression of knowledge, and build a TCM clinical case knowledge base. Taking case data knowledge, knowledge coding and knowledge mapping as examples, we highlight the key technologies and core links of TCM big data knowledge engineering, and fully confirm that big data knowledge engineering is the only way for real world TCM clinical study. Under the guidance of the national high-quality development strategy of TCM, with the goal of cultivating new quality productivity and forming a new business form of clinical research of TCM with new development concepts, we will build a big data knowledge engineering technology platform and a warehouse of TCM clinical knowledge, provide a technical platform and knowledge resources for carrying out large-scale model research in the field of TCM, and promote the clinical intelligence and high-quality development of TCM.更多还原