| Background:Chronic Kidney Disease(CKD)is one of the common chronic diseases and one of the main causes of end-stage kidney disease,which characterized by high morbidity and low awareness,while there are few specific treatment options.The incidence rate of CKD is increasing year by year,which seriously threatens human health and poses huge challenges and difficulties to global health.A lot of researches have confirmed that traditional Chinese medicine(TCM)plays an extremely important role in the prevention and treatment of CKD.Whether TCM is effective in the course of treatment depends on the accuracy of syndrome differentiation and treatment,with the characteristics of ambiguity and subjectivity in this process.Quantitative research on TCM syndrome differentiation methods is an effective measure for the development of TCM.Professor Lyu Renhe,developed his own unique syndrome differentiation method for Qi deficiency and blood stasis syndrome of CKD during clinical procedures,and achieved extremely therapeutic effects in clinical practice.Therefore,appropriate methods should be used to dig deeply into Professor Lyu Renhe’s method of distinguishing and treating CKD.Therefore a scientific,objective,and easy-topromote syndrome differentiation scale for CKD with Qi deficiency and blood stasis syndrome should be formed based on this Quantitative research to promote the popularization of Chinese medicine for the prevention and treatment of this disease and improve the effectiveness of clinical diagnosis and treatment,which is also so important to the development of TCM.Objective:To develop Professor Lyu Renhe’s Qi Deficiency and Blood Stasis Syndrome Differentiation Scale In Chronic Kidney Disease,and to select appropriate statistical methods to evaluate the scale from the aspects of reliability,validity,authenticity and reliability,and to explore the standardized research on TCM syndrome diagnosis methods.Methods:Based on the qualitatively interview method,the scale items will be initially screened.Subsequently,expert questionnaire consultation and cross-sectional study will be conducted.After that,the discrete degree,internal consistency,representativeness,resolution and independence of the scale items are evaluated according to the discrete trend method,Cronbach a coefficient method,factor analysis method,resolution coefficient,correlation coefficient method and discrimination analysis method and other aspects.According to the corresponding results,the items which do not meet the conditions are eliminated,and start formal examination with revised scale.Conducting a cross-sectional study,which can evaluate the reliability and validity of the scale.By using the weighting coefficient method to assign values to the scale entries.And then select the ROC curve to determine the diagnostic threshold of the scale,and establish the diagnosis model and the degree of symptoms will be graded based on this.All in all,basing on the above results,the diagnostic criteria and conduct clinical diagnostic tests will be determined.Then evaluate the authenticity and reliability of the scale.Results:The study has determined Professor Lyu Renhe’s Qi Deficiency and Blood Stasis Syndrome Differentiation Scale In Chronic Kidney Disease.The reliability of the scale was measured from the aspects of retest reliability,scorer’s reliability,consistency reliability,and split-half reliability.The validity of the rating scale in terms of degree,differentiation validity and structural validity.All the results obtained meet the requirements and standards of the scale.Assigning values to the scale items,the diagnostic formula of the scale is Y=11 fatigue and weakness+8 shortness of breath and sloth+4 easy to catch cold or repeated cold+ 6 Spontaneous sweating+10 weakness of urination+5 weakness of lower limbs+ 8 weakness of lumbago+2 edema of face or lower limbs or the whole body+9 weakness of lumbago+10 eye weeks,dark circles of eyes+10 lips and purple darkness+10 dark complexion+4 tongue ecchymosis,thick and distended sublingual veins+3 Thready pulse or feeble pulse or weak veins+2 Uneven pulse.Established the quantitative diagnostic criteria for Professor Lyu Renhe’s CKD of Qi deficiency and blood stasis syndrome,and finally determined the diagnostic threshold to be 195.5.And the diagnosis is graded,if 195.5≤syndrome score<293 belongs to mild range;293≤syndrome score<383 belongs to moderate range;syndrome score≥383 belongs to severe.Evaluation of the authenticity and reliability of the scale shows that the scale has a sensitivity of 92.77%,a false negative rate of 0.07,a specificity of 94.8%,a false positive rate of 0.07,and a positive likelihood ratio of 17.86,The negative likelihood ratio was 0.08,the Youden index was 0.876,and the Kappa value was 0.875.It can be concluded that the evaluation results of the authenticity and reliability of the scale are good enough.Conclusion:Professor Lyu Renhe’s Chronic Kidney Disease of Qi Deficiency and Blood Stasis Syndrome Differentiation Scale,developed by this research institute,is feasible,and the scale has high diagnostic accuracy and good performance such as sensitivity and specificity of the scale.It has a certain scientific value and is worthy of further promotion and application,but it also needs to be repeatedly verified,revised,and improved in clinical practice. |