Diabetic Nephropathy Qi And Yin Deficiency, Blood Stasis, Dampness Turbidity Research Specification Of Clinical Trials Of New Drug Of Tcm Syndrome

Objective1.To establish the measuring scale of syndrome of qi-yin deficiency,blood stasis anddamp pathogen on diabetic nephropathy.Besides,to explore the ideas and methods on the research of TCM syndromes specification about Chinese medicine clinical trials of new drugs.2.To provide a standardized scale for further in-depth scientific research on syndrome of qi-yin deficiency,blood stasis and turbid damp on diabetic nephropathy.Moreover,toimprove the credibility of the scientific conclusions of the research.3.The research ideas and methods used will provide reference for other researches onTCM syndromes specification.Furthermore,toexplore the scientific and feasible research model on research of TCM syndromes specification and standardization.MethodsThe research is based on the ideas of combination of disease,syndrome and symptoms and rely on the national12th five-year-plan of major scientific and technologicalprojects on technical platform of new drug’s clinical evaluation(project number:2011ZX09302-006-01).The research includes three parts:The first part.Distribution regules on syndrone of diabetic nephropathy.Retrieve the literatures in the China Journal Full-text Database(2003.01.01-2012.06.30),then sort out and analyze the literatures.That means,collect all the literatures which involve the syndrometypes.The second part:Formulation of the syndrome differentiation scale about the syndrome of QI and YIN deficiency,blood stasis and turbid damp on diabetic nephropathy.Based on literature research and expert consutation,screen out the scale items.The main objectivescreening methods are:entry distribution investigation method, discrete trend method, the method of Krone Bach coefficient, correlation coefficient method, factor analysis and cluster analysis.Then,formulate the measuring scaleinitially.In the end,assess the reliability, validity and responsiveness of it and formulate the final measuring scale.The third partClinical trial on new Chinese drugs of QI-YIN deficiency,blood stasis and damp pathogen syndrome on diabetic nephropathy.Using the measuring scale that has formed before the clinical trial,and adoping the stratified,randomized and controlled clinical trial.By carrying on the clinical trial to analyse the efficacy evaluation of maidishen-shenxiao capsule.ResultsThe first part:19of them are meet the requirements,and DN Syndromes were up to39kinds of types,involving5197cases.By summering, the syndromes were27kinds of types.The top four TCM syndromes were:qi-yin deficiency type(29.36%), blood stasis type(13.10%),spleen-kidney qi-yang deficiency type(11.14%) and yin-yang deficiency type (7.43%).The second part:①By searching and sorting modern medical records and diagnostic criterias,it has formed the symptoms of item pool which including30items.②After two rounds of subjective screening method (Delphi method), the measuring scale formed initially, including four dimensions,16items.③By means of using objective screening methods(entry distribution investigation method, discrete trend method, the method of Krone Bach coefficient, correlation coefficient method, factor analysis and cluster analysis),the final measuring scale formed.④In total,98patients were enrolled in this study.After assessing the reliability,validity and responsiveness of the measuring seale,it can be found that:the test-retest reliability coefficients were all above0.837, the split-half reliability coefficient is above0.891, the correlation coefficient is greater than0.469, the Krone Bach coefficient was0.815and the inter-rater reliability coefficient was0.867.Meanwhile,the content validity correlation coefficients was between0.544and0.918, the cumulative contribution factor structure validity rate is69.099%.And the scale effect was0.54.The third part:①In early-stage of diabetic nephropathy:Before and after treatment,the comparison of the treatment group on FPG,PPG2and HbA1C were:P<0.05. thecomparison ofthe control group on FPG was P>0.05.PPG2and HbA1C were:P<0.05; The comparison of the treatment group on UACR and24-Hour ptoteinuria quantitative were:P<0.05,the comparison of the control group onUACR and24-Hour ptoteinuria quantitative were:P<0.05;The comparison of the treatment group on Cr,BUN and GFR were:P>0.05,the comparison of the control group onCr,BUN and GFR were:P>0.()5;The comparison ofthe treatment group onsyndrome integral was:P<0.05, The comparison ofthe control group on syndrome integral was:P>0.05.②In clinical-stage of diabetic nephropathy:Before and after treatment,the comparison of the treatment group on FPG was:P>0.05,PPG2and HbAlC were:P<0.05, the comparison of the control group on FPG and HbAlC were:P>0.05,PPG2was:P<0.05;The comparison of the treatment group on UACR and24-Hour ptoteinuria quantitative were:P<0.05, the comparison of the control group on UACR was P>0.05.24-Hour ptoteinuria quantitative was:P<0.05;The comparison of the treatment group on Cr,BUN and GFR were:P>0.05, the comparison of the control group on Cr and BUN were: P>0.05,GFR was:P<0.05; The comparison of the treatment group on syndrome integral was:P<0.05. The comparison of the control group on syndrome integral was:P>0.05.Conclusions:1.Diabetic nephropathyis a kind of disease that deficiency in origin and excess in superficiality.In all the syndromes of DN,Qi-yin deficiency type,spleen-kidney qi deficiency type,spleen-kidney yang deficiency type and yin-yang deficiency type basically represent the clinical characteristics of deficiency in origin, and blood stasis is the most important one in all the excess in superficialit syndromes. 2.①Using the scale methodology on the research of standardization about TCM syndromes and the quantification of the symptoms.It can overcome the defect of fuzzy diagnosis of subjectivity and syndromes.Besides,it can provide the scientific ideas and methods on research,diagnosis and treatment about syndromatology of TCM.②Delphi method is an important method which can seek the expert consensus, extract expert experience scientifically and gives full play to the personal opinions of experts by questionnaire investigation, and is an effective way of scientific TCM syndrome-disease research.③Using a variety of objective screening methods to analyze the scale entry can supplement the lack of subjective screening method. And it can make results of the research more in line with the clinical practical.④Testing the feasibility, reliability, validity and responsiveness of the scale in order to evaluat the acceptance, stability, accuracy and validityneed of it.The results confirmed that thescale hashigh feasibility, stability, reliabilityand internal consistency.Moreover, the content validity,construct validity and the reactivity of the scale are all well.3.Maidishen-shenxiao Capsulewere significantly better than the control group on blood glucose control, reduce proteinuria and improve the patientsymptoms.And it proves that standardization of syndrome of traditional Chinese medicine can effectively guide clinical trials of new drugs.