| ObjectType 2 diabetes mellitus and diabetic kidney disease are common clinical diseases,and microalbuminuria stage of diabetic kidney disease is the earliest stage of clinical diagnosis.Urinary microprotein not only impairs renal function,but also impairs heart and other blood vessels.However,this period is reversible.If no intervention is taken,the disease will progress to clinical proteinuria stage,which is irreversible.Therefore,predicting the microalbuminuria stage of diabetic kidney disease is a key point in the prevention and treatment of diabetes mellitus and diabetic kidney disease.Risk factors affecting the development of diabetic kidney disease can be found from general information,laboratory index information and TCM syndromes in order to find out early and treat ear ly.Based on the previous TCM syndromes evaluation form,the guide and tutor’s experience,this study developed a TCM syndromes diagnosis scale for diabetes mellitus.Combining basic information,laboratory index information and TCM syndromes diagnosis,this study developed a risk prediction model for type 2 diabetes mellitus progression to microalbuminuria stage ofdiabetic kidney disease.So we can provide a risk prediction model,which is reliable,simple and scientific,to the clinical practice.Methods1 Development of Diabetes TCM Syndrome Diagnosis Scale:722 patients with type 2 diabetes and diabetic kidney disease in microalbuminuria stage were included,which were divided into training set and test set.The training focused on collecting the information of the four diagnostic methods of TCM,selecting the four diagnostic items by frequency method and systematic cluster analysis,combining the distribution of syndrome types in the Guidelines for the Prevention and Treatment of Diabetic Chinese Medicine and the Guidelines for the Prevention and Treatment of Diabetic Kidney Disease in TCM,and the core pathogenesis,kidney essence deficiency syndrome,of essencetheoretical hypothesis of"deficiency of kidney essence and obstruction of collaterals of the kidney syndrome" of the tutor for diabetic kidney disease,to determine the corresponding relationship between syndrome types and symptoms.Through binary logistic regression analysis and correlation analysis,the subordinate relationship between syndrome types and symptom items was further screened,and the symptoms were assigned according to binary logistic regression analysis.Finally,the diagnostic threshold of confirmatory type was determined by the ROC curve.Finally,the reliability and validity of the scale were evaluated by the test set,and the sensitivity,specificity,accuracy,Youden index and Kappa value of the scale were verified.2 Development of risk prediction equation for type 2 diabetes mellitus progressing to microalbuminuria stage of diabetic kidney disease:563type 2 diabetic patients were divided into training set and test set.The training set was divided intoDM group,n=291,[ACR<2.5 mg/mmol(male)or<3.5 mg/mmol(female)]and DKD group,n=217[2.5 mg/mmol<ACR<30.0mg/mmol(male)Or 3.5 mg/mmol<ACR<30.0 mg/mmol(female)].Single-factor logistic regression analysis was used to identify risk factors from general information,laboratory indicators and characteristics of TCM syndromes.After eliminating confounding factors by multi-factor logistic regression,independent risk factors affecting the progression of type 2 diabetes mellitus to microalbuminuria stage of diabetic kidney disease were determined,and prediction equation was established.The diagnostic threshold was determined by ROC curve.The sensitivity,specificity,accuracy,Youden index and Kappa value of the model were validated by test set.Results1 Development of Diabetes TCM Syndrome Diagnosis Scale:In this study,35 valid items were selected from 61 TCM four diagnostic items,and 10 TCM syndromes were extracted to establish the TCM syndrome diagnosis scale of type 2 diabetes,which were liver-stomach qi stagnation syndrome,stomach-intestine excess heat syndrome,damp-heat internal obstruction syndrome,phlegm turbidity internal retention syndrome,stagnation of blood stasis syndrome,liver-kidney yin deficiency syndrome,qi-yin deficiency syndrome,qi-blood deficiency syndrome,spleen-kidney yang deficiency syndrome and kidney essence deficiency syndrome.The diagnostic thresholds of syndrome types were 20 points,25 points,18 points,25 points,15 points,37 points,33 points,26 points,25 points and 20 points,respectively.The sensitivity,specificity,accuracy,Youden index and Kappa value of the syndromes were 74%-100%,85.31%-100%,85%-98.89%,63.23%-97.1%and 0.608-0.976 respectively.2 Development of risk prediction model for type 2 diabetes mellitus progressing to microalbuminuria stage ofdiabetic kidney disease:After reducing the influence of confounding factors through multivariate logistic regression analysis,independent risk factors were screened out as follows:stomach-intestine excess heat syndrome(OR=2.010,95%CI1.928-2.095,P=0.035),spleen-kidney yang deficiency syndrome(OR=2.184,95%CI 2.085-2.288,P=0.035),uric acid(UA)≥420umol/L(male)/360umol/L(female),(OR=2.784,95%CI2.643-2.934,P=0.014).A predictive equation for the progress of integrated traditional Chinese and Western medicine was established,P＝exp(-3.306+0.698×stomach-intestine excess heat syndrome+0.781× spleen-kidney yang deficiency syndrome+1.024× UA+0.911× age+0.042× course of disease)/[1+ exp(-3.306+0.698× stomach-intestine excess heat syndrome+0.781× spleen-kidney yang deficiency syndrome+1.024× UA+0.911×age+0.042× course of disease)].The diagnostic threshold was 0.66.The area under the ROC curve of the equation is 0.747(95%CI:0.687-0.808).The sensitivity and specificity of the model were 64.3%and 74%respectively.The sensitivity,specificity,accuracy,Youden index and Kappa value of the model were 70%,93.33%,89.09%,63.33%and 0.633 respectively.The area under ROC curve was 0.914(95%CI:0.738-1.000).ConclusionsCombining the characteristics of syndromes with the TCM guidelines and theoretical hypothesis of my tutor,the TCM syndromes diagnostic scale for type 2 diabetes mellitus developed has good diagnostic efficacy and can be applied to the clinical practice.The scale may provide a basis for the objective study of TCM syndromes for diabetes mellitus.Then,the risk prediction modelof type2 diabetes mellitus progression to microalbuminuria stage ofdiabetic kidney disease,which is integrated the characteristics of traditional Chinese and Western medicine,was establishedand its diagnostic efficiency is good.The simple,reliable and scientific prediction model is convenient for clinical use,and good to the type2diabetes patients to pretending from the early kidney damage by early prevention,early detection and early treatment. |
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