Construction And Application Of Individualized Efficacy Evaluation Indicators Of Treatment Based On Syndrome Differentiation Of Traditional Chinese Medicine

Objective:1.To clarify the research status quo,existing problems and challenges of the individual efficacy evaluation indicators of treatment based on syndrome differentiation of traditional Chinese medicine(TCM),and to point out the research direction for constructing the individual efficacy evaluation indicators of treatment based on syndrome differentiation of TCM.2.To explore the individual efficacy evaluation indicators and their construction ideas and methods that can reflect the characteristics of TCM,so as to further enrich and improve the methodological research system of clinical efficacy evaluation of TCM.3.Taking chronic heart failure(CHF),which is the dominant disease of TCM,as an example,to construct the individual efficacy evaluation indicators of treatment on CHF based on syndrome differentiation of TCM,and to carry out clinical verification and application,so as to provide the methodological demonstration for the construction of the individual efficacy evaluation indicators of other diseases.At the same time,it also provides evidence-based medical evidence for the intervention of TCM in CHF.Method:1.The systematic evaluation was made on the related studies of individual efficacy evaluation of TCM by the methods of literature review and bibliometrics.2.Based on the current research status,existing problems and challenges of individual efficacy evaluation of TCM,this paper systematically expounds the ideas and methods of constructing the individual efficacy evaluation indicators which can reflect the characteristics of the combination of disease and syndrome and treatment based on syndrome differentiation of TCM.3.Taking CHF as an example,through literature investigation,Delphi and expert consensus meeting,this paper constructing the individual efficacy evaluation indicators of treatment based on syndrome differentiation of TCM and the syndrome evaluation scale,and the individual curative effect was evaluated comprehensively by analytic hierarchy process and fuzzy comprehensive evaluation method.4.TCM syndrome evaluation scale of chronic heart failure was scientifically assessed through prospective clinical studies to verify its feasibility,reliability,validity and responsiveness.5.The clinical application of the individual efficacy evaluation indicators of chronic heart failure was carried out through the prospective cohort study design,and the individual efficacy of TCM in the treatment of chronic heart failure was comprehensively evaluated.Results:1.At present,there are few researches on the individual evaluation of TCM,among which there are some problems,such as insufficient application of TCM syndrome indicators,more application of composite indicators and non-standard evaluation methods,and so on,which cannot reflect the characteristics of treatment based on syndrome differentiation of TCM.It is proposed to focus on the subjective and individualized characteristics of treatment based on syndrome differentiation of TCM,give full play to the advantages of TCM diagnosis and treatment,innovate the methods and techniques of clinical efficacy evaluation of TCM,and construct the individual efficacy evaluation indicators of treatment based on syndrome differentiation of TCM.it is a key scientific problem to be solved urgently at present.2.It is pointed out that the construction of the individual efficacy evaluation indicators of treatment based on syndrome differentiation of TCM should follow the diagnosis and treatment mode of combination of disease and syndrome and treatment based on syndrome differentiation of TCM,to solve the contradiction between standardization and individualization in the evaluation of clinical curative effect of TCM,and to combine individualization and standardization,to integrate TCM and western medicine,to construct a multi-dimensional evaluation indicators set including western medicine disease indicators,TCM syndrome indicators,quality of life scale and so on.And the construction methods of individualized efficacy evaluation indicators are described in the whole process,including the methods of indicator list,indicator selection,model construction,clinical verification and so on.3.Construction of individual efficacy evaluation indicators of CHF.Firstly,based on literature investigation,Delphi and expert consensus meeting,we formed a set of disease efficacy evaluation indicators of CHF: U={re-admission of heart failure,NYHA classification,left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVEDD),left ventricular end-systolic diameter(LVESD),aminoterminal B-type natriuretic peptide precursor(NT-pro BNP),TCM syndrome efficacy evaluation scale,the Minnesota living with heart failure questionnaire(MLHFQ),incidence of adverse reactions}.Secondly,based on literature investigation,semi-structured expert interview,Delphi and expert consensus meeting,TCM syndrome efficacy evaluation scale of CHF is formed,which mainly involves 25 items of 6 syndrome elements:blood stasis syndrome,water drinking syndrome,phlegm-turbid syndrome,Qi deficiency syndrome,Yin deficiency syndrome and Yang deficiency syndrome.Thirdly,the structure model of individual efficacy evaluation of CHF is constructed based on the analytic hierarchy process,including six dimensions of secondary indicators: end-point event indicators,cardiac function indicators,physical and chemical examination indicators,TCM syndrome indicators,quality of life indicators,and safety indicators,and nine tertiary indicators.Through the pairwise comparison matrix of indicators,the normalized weight coefficient and combined weight coefficient of each indicator are determined.The normalized weight coefficient of secondary indicators end-point event indicators,cardiac function indicators,physical and chemical examination indicators,TCM syndrome indicators,quality of life indicators,and safety indicators were 0.2901,0.2901,0.2051,0.1088,0.0653 and 0.0405 respectively.The normalized weight coefficient and combined weight coefficient of the three-level indicators re-admission of heart failure was 1,0.2901,NYHA classification was 1,0.2901,LVEF was 0.4167、0.0855,LVEDD was 0.0833、0.0171,LVESD was 0.0833、0.0171,NT-pro BNP was 0.4167 、 0.0855,TCM syndrome efficacy evaluation scale was 1,0.1088,MLHFQ was 1,0.0653,and adverse reaction rate was 1,0.0405.Finally,the evaluation matrix and weight vector of each indicator are fuzzy synthesized by fuzzy comprehensive evaluation method and weighted average operator,and the final comprehensive evaluation result is obtained.4.The TCM syndrome efficacy evaluation scale of CHF was evaluated scientifically by prospective clinical study.A total of 141 CHF patients were included.The feasibility analysis showed that the acceptance and completion rate of the scale were 100%,and the average completion time of the single scale was about 15 minutes,which was feasible.The reliability analysis show that in the two measurements,the correlation of the scale total score and the correlation of each dimension scores of are more than 0.7,the test-retest reliability is stable,the Cronbach α coefficient is greater than 0.7,and the internal consistency reliability is high.The validity analysis show that each item had a good correlation with each dimension,each dimension and the total scale(p < 0.05),and the content validity was good.The verification factor analysis show that the goodness-of-fit index was 0.980,the standardized factor loading value was more than 0.6,the construct validity was good,AVE was more than 0.5,CR was more than0.7.the polymerization validity is better.5.A prospective cohort study was designed to evaluate the clinical application of individual efficacy evaluation indicators of treatment based on syndrome differentiation of TCM for CHF.191 hospitalized patients with CHF were divided into exposure group(n = 94)and nonexposure group(n = 97)according to whether they were treated with TCM injection or not.The results show that the exposed group was superior to the non-exposed group in the improvement of heart failure readmission,NYHA classification,LVEF,LVEDD,LVESD,NT-pro BNP,TCM syndrome efficacy evaluation scale,MLHFQ,and the incidence of adverse reactions.The results of the individual comprehensive evaluation model based on fuzzy comprehensive evaluation method showed that the fuzzy comprehensive evaluation vector B of exposure group was(0.79,0.19,0.02),and the comprehensive score was 2.77.In the non-exposure group,the fuzzy comprehensive evaluation vector B was(0.63,0.32,0.05),and the comprehensive score was 2.58.Conclusion:1.Under the diagnosis and treatment mode of combination of disease and syndrome and treatment based on syndrome differentiation of TCM,we should further improve the study of individual efficacy evaluation of TCM,and innovate the techniques and methods of individual efficacy evaluation of treatment based on syndrome differentiation of TCM.2.The ideas and methods for constructing the individual efficacy evaluation indicators of treatment based on syndrome differentiation of TCM were preliminarily established.3.The individual efficacy evaluation indicators of treatment based on syndrome differentiation of TCM for CHF include 6 evaluation dimensions,which are end-point event indicators,cardiac function indicators,physical and chemical examination indicators,TCM syndrome indicators,quality of life indicators and safety indicators,and 9specific evaluation indicators.4.The preliminarily established TCM syndrome efficacy evaluation scale of CHF has good feasibility,reliability,validity and responsiveness,and can be applied to the curative effect evaluation of TCM syndrome of CHF.5.The individual efficacy evaluation indicators of treatment based on syndrome differentiation of TCM for CHF have been verified and proved to be practical in clinic,and the construction of fuzzy comprehensive evaluation model has guiding significance for clinical practice.