Objective:To establish a TCM syndrome quantitative diagnostic model and diagnostic criteria for idiopathic membranous nephropathy with spleen-deficiency syndrome,and to provide a standard for clinical differentiation of idiopathic membranous nephropathy with spleen-deficiency syndrome.Methods:Through literature review,group discussion and other steps,the Chinese medicine disease name of idiopathic membranous nephropathy was determined.The identified disease names were used as keywords to search the ancient and modern literature,and the information of four diagnosis were extracted and sorted out to construct a pool of alternative items.According to the standard steps of Delphi method,with the item pool as the source of questionnaire content,the Delphi expert consultation form was made and presented to the clinical experts of TCM to complete the summary and collation of expert opinions.In this study,by referring to the survey results of the consultation table and the form of group discussion,the retained items were optimized and screened again,and the first edition of the "diagnostic scale of spleen deficiency syndrome in idiopathic membranous nephropathy" was formulated.The first version of the scale was used as a tool to collect clinical case data,and statistical methods were used to analyze the collecteddata.According to the statistical results,a "second version of the scale" with better overall quality and the quality of each item was constructed.To ensure the scientific validity of the scale.According to the results of comprehensive weight coefficient assignment,the total syndrome score of spleen deficiency syndrome of patients was calculated.Then the receiver operating characteristic curve(ROC curve)was used to analyze the syndrome score,so as to determine the best diagnostic threshold of syndrome and the evaluation criteria of each degree of classification.Finally,a retrospective and prospective clinical diagnostic experiment was carried out to evaluate the clinical application value of the scale,and finally the establishment of the syndrome diagnostic model and diagnostic criteria of idiopathic membranous nephropathy with spleen deficiency syndrome was completed.Results:After standardized and rigorous development,this study finally formulated the "diagnosis scale of spleen deficiency syndrome in idiopathic membranous nephropathy".The results of multiple statistical methods showed that the reliability and validity of the scale could meet the requirements of the standard.Finally,the optimal diagnostic threshold of syndrome differentiation was determined to be 201.5,and the quantitative diagnostic criteria of TCM syndromes of idiopathic membranous nephropathy with spleen deficiency syndrome was established.The clinical diagnostic test results of the scale also proved that it responded well in terms of sensitivity and specificity.Conclusion:After determining the TCM disease name,collecting and sorting out the four diagnosis items,and summarizing the opinions of clinical experts,the scale has preliminary theoretical support,and then undergoes statistical methods to analyze and test,and carries out clinical practical application tests to ensure its scientification.The development process is standardized and rigorous,and has feasibility and practicability.The final diagnostic model and diagnostic criteria of spleen deficiencysyndrome of idiopathic membranous nephropathy provide a standardized standard for the clinical syndrome evaluation of this disease. |