Study On The Evaluation Method Of Syndrome-based Chinese Medicine Efficacy Based On The Clinical Validation Of The Qi Deficiency And Blood Stasis Syndrome Evaluation Scal

The key point of clinical evaluation of TCM syndromes lies in the establishment of syndrome evaluation criteria,including syndrome evaluation indexes and standardization of syndrome evaluation methods.After the scale was introduced into the field of traditional Chinese medicine,it made the research results more scientific and credible in terms of clinical efficacy evaluation of traditional Chinese medicine.Taking qi deficiency and blood stasis syndrome as an example,this study conducted clinical verification and clinical application research on the previously developed evaluation scale of "Syndrome Evaluation Scale for Qi Deficiency And Blood Stasis ",providing technical support for clinical efficacy evaluation of TCM syndromes.ObjectiveEvaluate the effect of the "Syndrome Evaluation Scale for Qi Deficiency And Blood Stasis".Observe the relationship between syndrome improvement and disease effect improvement,and explore the efficacy evaluation method of TCM syndromes.MethodsIn this study,105 patients with qi deficiency and blood stasis syndrome were included,including three diseases including ischemic stroke convalescence,stable angina pectoris caused by coronary heart disease and diabetic peripheral neuropathy.The internal consistency of the scale was tested by reliability coefficient method.The 21 items of the scale were sorted by odd and even Numbers,and divided into odd and even groups.After the applicability test,factor analysis was used to evaluate the validity of the scale.The score of qi deficiency and blood stasis was ranked from low to high.The first 27%was low score,and the last 27%was high score.Mann-whitneyu test was used to compare the score of the two groups,and to evaluate the reactivity from the perspective of distinguishing the ability of different objects.Through a randomized controlled clinical trial,"Syndrome Evaluation Scale for Qi Deficiency And Blood Stasis "was applied to the clinical efficacy evaluation of TCM syndromes.The reactivity of the scale was verified from the perspective of time change by comparing the changes of the score of qi deficiency and blood stasis syndrome before and after treatment.Observe the relationship between syndrome improvement and disease effect improvement,and explore the efficacy evaluation method of TCM syndromes.ResultsThrough the reliability test,the Cronbach’s alpha is 0.705,and Half reliability Spearman correlation coefficient is 0.764.Through the validity analysis,13 items can be summarized into five dimensions:"qi deficiency syndrome","heavy qi deficiency syndrome","blood stasis syndrome","heavy blood stasis syndrome","qi deficiency and blood stasis syndrome".Through the reactivity analysis,mann-whitneyu test was used to compare the scores of qi deficiency and blood stasis in high and low groups,P=0.000<0.05,and the difference was statistically significant.In the randomized controlled clinical trial,response degree analysis was conducted on the evaluation scale of qi-deficiency and blood-stasis syndrome from the perspective of time change.The score difference of qi-deficiency and blood-stasis syndrome before and after treatment was statistically significant(P=0.029<0.05),and the effect scale was 0.59.Relationship between syndrome and disease:the correlation coefficient between the score of qi deficiency and blood stasis before treatment and the score of Toronto scale was 0.475,P=0.005<0.01,and the difference was statistically significant.The correlation coefficient between the score of qi deficiency and blood stasis after treatment and the score of Toronto scale was 0.629,P=0.000<0.01,and the difference was statistically significant.The correlation coefficient between the score difference of qi-deficiency and blood-stasis syndrome before and after treatment and that of the Toronto evaluation scale was 0.463,P=0.009<0.01,and the difference was statistically significant.conclusionsThe "Syndrome Evaluation Scale for Qi Deficiency And Blood Stasis" has good reliability,validity and reactivity.It’s good for evaluating the grade of qi deficiency and blood stasis syndrome,and can be used as a tool for the efficacy evaluation of qi deficiency and blood stasis syndrome.There is a certain correlation between syndrome improvement and disease improvement.