Objective:The evaluation of curative effect is a key link in the modernization of traditional Chinese medicine.The evaluation of curative effect in traditional Chinese medicine is mostly empirical and subjective summary,with low repeatability and difficult to quantify.At present,to provide the best evidence of TCM clinical efficacy,experts and scholars often by conducting a series of clinical trials to prove the efficacy and safety of traditional Chinese medicine treating diseases,with the rapid development of epidemiology and evidence-based medicine and application of class of traditional Chinese medicine colleges and universities across the country have to carry out the evidence-based research of traditional Chinese medicine,Chinese medicine clinical trials literature has been a significant increase in number,But they are far less recognized.In our opinion,in addition to the lack of strict design of prospective experimental studies,there are many TCM schools in different regions and most of them are handed down from teachers to families,resulting in various and inconsistent naming of TCM symptoms,syndromes and etiology,mostly in natural language.Ontology emphasizes normative concepts and semantic relations,and its construction purpose is mainly reflected in providing retrieval function through a unified concept set and simulating the human brain to construct knowledge system in the field,which can fully reflect the intricate conceptual relations in the field,and its ultimate purpose is to realize knowledge sharing.At present,most Chinese medicine domain ontology not give full play to the advantages and characteristics of ontology,the top ontology reuse is missing,single method of building ontology,ontology to improve and evaluate often easy to overlook,ontology application stage tend to focus on the knowledge representation,the term mapping is missing,focuses on the existing structured knowledge integration,not mining tacit knowledge.In order to realize the structured expression of knowledge of infertility TCM clinical trials,this study took infertility as an example,under the guidance of seven-step method and skeleton method,established normative glossary,term mapping rules and multiple semantic relationship model by Protege 5.5.0 software.Construct an open,clear and verifiable knowledge ontology of infertility TCM clinical trials.Meanwhile,on the basis of ontology construction,use data mining method to mine hidden laws to supplement and improve semantic relationships of knowledge ontology.Methods:Firstly,968 published TCM clinical trial literatures on infertility were taken as the main data source,and the relevant terminology concepts involved in each category in the standard ontology were collected by referring to the Chinese Traditional Chinese Medicine Glossary,TCM Clinical Diagnosis and Treatment Terms·Disease Part and CLASSIFICATION and Code of TCM Diseases and Syndromes(GB/T 15657-2021)and other standards.It includes seven categories of etiology and pathogenesis,disease syndromes,symptoms,operation/method,intervention drugs,diagnostic criteria and outcome indicators.Then,the top-level concepts involved in the knowledge ontology of TCM clinical trials of infertility are compared with BFO,GFO and TCMLS to determine the semantic network framework of reusable TCM language system.After that,Protege 5.5.0 software was used to determine the class and class hierarchy,define the relevant object attributes,numerical attributes and annotation attributes,and carry out term mapping to build a multivariate semantic relationship model,so as to better and accurately display semantic relationships,and initially generate the knowledge ontology of infertility TCM clinical trials.Since ontology construction is mainly a list of knowledge concepts one by one without distinction,it is only an integration of existing knowledge and does not explore new knowledge and rules.Therefore,on the basis of the initial construction of knowledge ontology of infertility TCM clinical trials,frequency statistics,co-occurrence analysis and TF-IDF algorithm were used to find common outcome indicators,characteristic outcome indicators and common combinations of outcome indicators,common combinations of control measures and common combinations of intervention measures for common causes of infertility,so as to supplement and improve the ontology.Finally,inference machine is used to verify ontology consistency and evaluate ontology to ensure the quality of constructed ontology.Results:The ontology mainly uses the semantic network framework of Chinese Medicine Language System(TCMLS)to establish sterility related disease and syndrome terms mapping rules,and carries out coding cross mapping between sterility related terms in GB/T 15657-2021 and ICD-11,completing 51 sterility syndrome terms mapping.Data mining method was used to analyze the knowledge involved in 968 literatures,and 4 new data attributes were added.Finally,a total of 5804 axioms,1210 classes,8 object attributes,9 data attributes,4 annotation attributes and 865 multivariate semantic relations were constructed.Conclusion:The ontology building,infertility clinical trials of traditional Chinese medicine has been basically achieved the semantic mapping and structured expression of knowledge,to the late multi-angle knowledge retrieval,tagging,laying a foundation for knowledge extraction,clinicians can be executed in accordance with the relevant specifications and procedures to implement the infertility of clinical trials of traditional Chinese medicine knowledge browse retrieval,the retrieval results more accurate,comprehensive,Clinical standard researchers can refer to the ontology content to simplify the establishment process of core outcome index set of infertility TCM clinical trials.Meanwhile,this study also provides ideas for the construction of relevant ontology of TCM clinical trials at home and abroad and the construction of other ontologies. 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