Research On The Development Of Type2Diabetes Mellitus TCM Syndrome Elements Diagnostic Scale And Preliminary Application

Objective1、 Establish type2diabetes mellitus TCM syndrome elements diagnostic scale using procedures and current recognized scale development to explore TCM syndrome normalization and objection methods.2、 Investigate symptom distribution of TCM syndromes and correlation between the syndrome elements and clinical indicators based of the developed scale.Methods1、 Determine TCM four diagnostic information and syndrome elements of type2diabetes mellitus using literature investigation and expert consultation. Collected179cases of type2diabetes mellitus patients’four diagnostic information and general information by means of multi-centre clinical epidemiological investigation, bolted syndrome elements items with correlation analysis、 stepwise regression and factor analysis means,assigned four diagnostic information items with logistic regression analysis,determined syndrome elements diagnostic threshold with ROC curve, and established type2diabetes mellitus TCM syndrome elements diagnostic scale. Then texted the clinical authentication reliability、 validity of scale using another dataset of70patients.2、 Differentiation of TCM symptoms and signs of249cases of type2diabetes mellitus patients using developed scale which get through clinical epidemiological survey,investigate symptoms distribution and analyze demographic data.On the basis of the symptoms distribution, normalize treatment group of249cases type2diabetes mellitus patients’clinical conventional indicators, investigate the relevance between symptoms and clinical indicators using t test、 correlation analysis and decision tree analytical tools.Results1、 Scale research results(1) Type2diabetes mellitus TCM syndrome elements diagnostic scale includes nine syndrome elements, the extreme items、 assignment and diagnostic threshold show that:Qi deficiency syndrome:mental fatigue is4scores feeble is3score、 shortness of breath is8score、 palpitations is3score、 spontaneous sweating is2score, diacritic liminal value is11score;Yin deficiency syndrome:emaciation is2score、 night sweats is5score、 five upset dryness-heat is3score、 dry mouth is1score、 insomnia is3score、 constipation is6score, diacritic liminal value is9score; Dampness syndrome:obesity is4score、 abdominal distention is2score、 sicchasia is2score、 joint and muscle pain is3score、 mouth sticky is5 score、 somnolence is2score、 large and fat tongue is2score, diacritic liminal value is8score; Dryness-heat syndrome:thirsty is2score、 thirsting for cold is6score、 consumer valley is3score、 emaciation is2score、 reddish complexion is2score、 dry mouth is2score、 yellow or dryness coated tongue is3score、 rapid pulses is2score, diacritic liminal value is13score;Yang deficiency syndrome:thirsting for warm is4score、 chilly is8score、 waist and knee weak is1score、 cold extremities is3score、 frequency and much nocturnal urine is4score, diacritic liminal value is8score; Blood stasis syndrome:lividity face and lip is2score、 chest complaint is6score、 dull purple tongue is8score、 sublingual varicose veins is3score, diacritic liminal value is10score; Body fluid loss syndrome:thirst is3score、 sweating is4score、 asteatosis cutis is6score、 constipation is2score、 dry tongue (old tongue) is4score, diacritic liminal value is12score; Phlegm syndrome:dizziness is4score、 abdominal distention5score、 mouth sticky is4score、 greasy coated tongue is6score, diacritic liminal value is7score;Qi stagnation syndrome:depression is4score、 costa inflation is5score、costalgia is7score、abdominal distention is3score, diacritic liminal value is4score.(2) Results of scale assessment:the split half reliability coefficient of scale is0.878, the Cronbach’s a coefficient is0.844, extract3common divisors for factor analysis that cumulative variance contribution rate69.123%,the coefficient correlation is0.471-0.794.2、 Results of249cases clinical cross-sectional study results show that more men than women in all patients accounted for60.64%,50-59age group most patients accounted for43.37%, course of disease of5-10years accounted for41.77%.The proportion of overweight and obesity accounted for40.16%and20.08%respectively. Complications are follows: peripheral neuropathy, retinopathy, peripheral angiopathy, diabetic nephropathy.The results of the use of scale dialectical:yin deficiency and qi deficiency syndrome are the most syndrome accounting for50.60%and48.99%,followed by phlegm, dampness、 yang deficiency, dryness-heat、 body fluid loss syndrome, while blood stasis syndrome and qi stagnation syndrome are the least syndrome. There are single syndrome and nine syndrome combinations. The most common syndrome combination are two and three syndrome combinations,then single syndrome and four syndrome combinations. Qi and yin deficiency syndrome and Qi and yin deficiency syndrome affiliate other syndrome are the most main syndrome combinations.3、 Studies of syndrome and clinical indicators have shown that:qi deficiency syndrome element was related with2hPBG、 C-P、 APOA I、 TBA、 MONO%、 MONO、 MCHC and the decision tree model of qi deficiency contained LPa、 FT4、 APOA I.Yin deficiency syndrome element was related with APOA I, LYM%、 NE%、 PT,、INR、 FT3、 ALT、 BUN、 Cr、 UA、 RBC、 HCT.The decision tree mode of yin deficiency contained Cr、 HbAlc、 TT、 RBC、 LYM、 TC. Yang deficiency syndrome element was related with HAblc、 APTT、 MCV、 MCH、 MCHC、 FINS、 TG、FT3、 ALT、 GGT、 TBIL、 DBIL、 Cr、 LYM、 RBC、 mALB.The decision tree mode of yang deficiency contained LPa、 FT3、 TSH、 FINS、 PDW、 HCT、 TT. Dampness syndrome element was related with APTT、 AST、 MCV、 MCH、 MPV、 HDL、 PT、 BUN、 Cr, The decision tree mode of dampness syndrome element wasn’t established. Phlegm syndrome element was related with FINS、2hPBG、 hs-CRP、TSH、 MCV、 TG、 HDL、 FT3、 FT4、 BUN、 Cr、UA、 RBC.The decision tree mode of Phlegm contained BUN、 WBC、 MCV、 hs-CRP、 RBC、 T4.ConclusionType2diabetes mellitus TCM syndrome elements diagnostic scale included9syndrome elements which have better reliability and validity. Preliminary applicantion studies have shown that the scale can provide normalization standard for differentiation of symptoms and signs of type2diabetes mellitus clinic,described symptom distribution rulesy, described the relationship between symptom and clinical indicators. The scale can be used to differentiate TCM symptoms and signs normalization of type2diabetes mellitus in clinic and basic research, and provide new ideas and methods for TCM symptom normalization research.