Development And Clinical Application Of A Diagnostic Scale For Kidney Yang Deficiency Syndrome In Diabetic Nephropath

Objective:According to literature search,although there are established TCM syndrome scales related to diabetic kidney disease,they are mostly developed solely on the basis of expert experience,which lacks objectivity.Or by simply browsing literature,books to determine the scale items,more rigid dogmatic;Some scales only judge "yes" or "no" for each item,and determine whether it is diagnosed as kidney-yang deficiency syndrome by the total number of "yes" items,without distinguishing between mild,moderate and severe of the four diagnosis items.Some scales have unified division of mild,moderate and severe scores,such as mild(1 point),moderate(3 points)and severe(5 points).However,according to the actual clinical situation,there are significant differences in the contribution of different four diagnosis information items to the diagnosis and diagnosis of TCM syndromes.Therefore,the accuracy of such scales has been improved to a certain extent,but there are still defects.In addition,although there are universal syndromic scales for all diseases and clinical scales specifically for diabetic nephropathy,in addition to the above problems,for each specific syndrome type of diabetic nephropathy,there are still problems of not being targeted enough for a single syndrome,and the diagnosis process of some scales is too complicated and cumbersome.There are many problems such as lack of convenience in clinical or scientific application.In order to promote the clinical standardized diagnosis and treatment of kidney Yang deficiency syndrome of diabetic kidney disease and related scientific research,this topic uses a variety of statistical methods,through literature review and expert consultation,and combined with the four clinical case diagnosis information,to complete a diagnostic scale for kidney Yang deficiency syndrome of diabetic kidney disease.The reliability,validity and small sample clinical validation were evaluated.Finally,the collected clinical data were analyzed retrospectively with the scale obtained in this project.To provide support for clinical syndrome diagnosis and syndrome study of this disease syndrome type,and provide ideas and reference for TCM clinical diagnosis and treatment.Methods:According to the process and method of the standardized scale,this study carried out literature retrieval,expert consultation and clinical cross sectional research,developed a "Diagnostic Scale for Kidney Yang Deficiency Syndrome of diabetes Kidney Disease" by combining subjective and objective methods,evaluated the reliability and validity of the scale,and carried out small sample clinical verification,and then used the existing data to analyze the clinical application of Kidney Yang Deficiency Syndrome.The specific steps are as follows:1.Determine the research purpose and content,and establish a working group;2.Build an item pool by consulting books and literature;3.Delphi expert argumentation method for screening entries;4.Scale development:133 patients with diabetes and kidney disease were included,and four diagnostic information was collected.Frequency analysis method,correlation coefficient method,discrimination method and Klumbach method were used a The coefficient method was used to screen the items,the factor analysis method was used to give weight to the items,the ROC curve was used to determine the diagnostic threshold of the scale,and the quartile method was used to determine the grading standard of kidney yang deficiency integral,so as to obtain a "diagnostic scale of kidney yang deficiency syndrome in diabetes";5.Evaluate the reliability and validity of the scale,with reliability evaluation including homogeneity reliability and split half reliability,and validity evaluation including content validity and structural validity;6.Verification of the scale:51 patients with diabetes and kidney disease were re included with the same inclusion criteria.The "3+1 verification model" of the TCM syndrome diagnosis scale was used.A syndrome differentiation team was composed of three experts and one graduate student.Three experts independently judged the patient’s syndrome,and two or more of them agreed to be the "gold standard" for diagnosis,which was compared with the syndrome differentiation results of the scale developed by this topic;7.Retrospective clinical application analysis of the scale:133 patients included in the combined development of the scale and 51 patients included in the verification stage of the scale were scored using the scale developed in this study.According to the scoring results,they were divided into kidney yang deficiency syndrome group and non kidney yang deficiency syndrome group.The kidney yang deficiency syndrome group was further divided into mild group,moderate group,and severe group.Gender,age,course of disease,BMI index,highest systolic blood pressure,and highest diastolic blood pressure were compared between each group And the number of people in each stage and classification of diabetes nephropathy.Results:1.A total of 13 items related to the four diagnostic scales of kidney yang deficiency syndrome of diabetes kidney disease were obtained by combining subjective and objective screening methods:"sore waist and knees","chilly limbs","frequent urination at night","clear and long urination","edema of lower limbs","fatigue","shortness of breath","listlessness","pale complexion","pale tongue","tooth marked tongue","white coated tongue","weak pulse ";2.The weight values of the scale items in descending order are:fatigue(11),fear of cold limbs(10),shortness of breath(10),listlessness(10),lower limb edema(8),pale complexion(8),pale tongue(8),tooth marked tongue(8),weak pulse(8),white coated tongue(7),frequent urination at night(5),clear and long urination(5),sore waist and knees(3);3.Determine the scale threshold as 55.5,that is,when the scale score is greater than or equal to 55.5,the case of diabetes kidney disease is diagnosed as kidney yang deficiency syndrome;4.Use the quartile method to classify the diagnosis into mild,moderate,and severe grades.55.5 ≤ total score<74 indicates mild kidney yang deficiency syndrome,74 ≤total score<106 indicates moderate,and total score≥ 106 indicates severe.5.The reliability and validity evaluation results of the scale showed good results.6.The clinical validation results of 6.51 small samples showed that the sensitivity of the scale was 89.29%,specificity was 100%,and accuracy was 94.12%.7.A retrospective clinical application analysis was conducted on the included case data using the final scale(133+51=184 cases).According to the evaluation criteria of the scale,there were 98 cases in the kidney yang deficiency syndrome group and 86 cases in the non kidney yang deficiency syndrome group.The statistical results showed that:(1)the mean BMI of the kidney yang deficiency syndrome group was relatively high,and the difference in BMI between the two groups was statistically significant;(2)The number of males in both groups is higher than that of females,but there is no difference in the gender composition ratio between the two groups;(3)There was no statistically significant difference in age,course of disease(year),maximum systolic blood pressure,and maximum diastolic blood pressure between the two groups;(4)In different stages of diabetes nephropathy,the proportion of kidney yang deficiency syndrome:Ⅴ>Ⅳ>Ⅲ,the difference between the groups was statistically significant(P<0.05).(5)The frequency and score of each item in the Kidney Yang Deficiency Syndrome group can be seen.The items with the highest frequency of occurrence are "fatigue","frequent urination at night",and "fear of cold limbs".The items with the highest total score are "fatigue","fear of cold limbs",and "lower limb edema",while the items with the highest unweighted score are "fatigue","frequent urination at night",and "lower limb edema".The results showed that there was a significant correlation between the proportion of kidney yang deficiency syndrome and the stage of diabetes kidney disease.It was speculated that the degree of kidney yang deficiency was aggravated with the progress of diabetes kidney disease,or because the degree of kidney yang deficiency increased,the condition of diabetes kidney disease continued to deteriorate and progress.Compared with the grading of the degree of kidney yang deficiency syndrome in each stage of diabetes nephropathy,the difference between the groups was not statistically significant(P>0.05).This result may be related to the large number of statistical groups and small sample size,which needs to be further verified in the future clinical practice.Conclusion:1.This study developed a targeted and clinically applicable diagnostic scale for kidney yang deficiency of diabetes kidney disease by combining subjective and objective research methods;2.The clinical validation results of its small sample showed that the sensitivity of the scale was 89.29%,specificity was 100%,and accuracy was 94.12%.3.The retrospective clinical application of the scale showed that:(1)The proportion of kidney yang deficiency syndrome in different stages of diabetes nephropathy was stage Ⅴ(78.6%)>stage Ⅳ(53.5%)>stage Ⅲ(42.0%),indicating that the proportion of kidney yang deficiency increased with the progress of diabetes nephropathy stages;(2)The BMI of patients with kidney yang deficiency syndrome in diabetes patients with kidney disease is higher than that of patients without kidney yang deficiency syndrome.It can be seen that there is a significant correlation between obesity and kidney yang deficiency syndrome in this disease;(3)However,there was no statistically significant difference in age,course of disease,maximum systolic blood pressure,and maximum diastolic blood pressure between the kidney yang deficiency syndrome group and the non kidney yang deficiency syndrome group;(4)There was no statistically significant difference in the light to moderate degree of kidney yang deficiency syndrome in each stage of diabetes nephropathy;(5)The clinical characteristics of each item are different,and the specificity in diagnosis also varies.A high frequency means that the item is common and universal in patients with kidney yang deficiency syndrome.The higher the weight,the greater the significance of the item for the diagnosis of kidney yang deficiency syndrome.From the weight,"frequent urination at night" ranks third to last among all items,indicating that the item appears frequently in this disease,However,the diagnostic value of kidney yang deficiency syndrome for this disease is average.To sum up,this scale establishes the unified and quantitative diagnostic criteria for kidney yang deficiency syndrome of diabetes kidney disease,provides support for clinical syndrome diagnosis and syndrome research,and provides ideas and basis for clinical treatment.