Development and validation of the diagnostic scale of traditional Chinese medicine syndrome elements for diabetic kidney disease
Min Jiang, Xi-En Lou, Xianhui Zhang, Qian Nan, Xue Gao, Hongfang Liu
Abstract
BACKGROUND: To construct a traditional Chinese medicine (TCM) syndrome elements diagnostic scale for diabetic kidney disease (DKD). METHODS: A total of 492 DKD patients were included in the study. TCM symptoms, signs and tongue manifestation information of the patients were collected, which constituted the items of the TCM syndrome elements diagnostic scale. Frequency dominance method was used to screen the core items. Cluster analysis and factor analysis method were used to identify the syndrome elements. Correlation coefficient and regression analysis were used to determine the syndrome elements. Regression coefficient was used to determine the scale items, and the diagnostic threshold was established by receiver operating characteristic curve. By using the above statistical methods , TCM syndrome elements diagnostic scale was constructed, and confirmed via diagnostic tests of 150 patients. RESULTS: There were 61 items of TCM diagnostic descriptions, and we kept the most useful 32 after filtering. After extracting the syndrome elements, a TCM syndrome elements diagnostic rating scale for DKD containing 9 syndrome elements was constructed, which were qi deficiency syndrome, blood deficiency syndrome, yin deficiency syndrome, yang deficiency syndrome, excessive heat syndrome, qi stagnation syndrome, damp heat syndrome, blood stasis syndrome and phlegm turbidity syndrome. A small-sample clinical validation test of the scale showed sensitivity of 78.8-100%, specificity of 84.3-100%, and accuracy of 82.7-100%. CONCLUSIONS: We constructed a TCM syndrome elements diagnostic rating scale for DKD, providing a basis for the standardized study of TCM syndromes.