Study On Evaluation Method Of TCM Therapeutic Effect Of Perimenopausal Syndrome Based On Measuring Whole Health State

Purpose:Constructing a theoretical framework for evaluation of TCM curative effect in perimenopausal syndrome based on whole health status measurement,to solve the problems which can not be reflected in TCM syndrome differentiation in the previous evaluation methods of TCM efficacy.To develop a PMS TCM PRO scale of efficacy evaluation and to establish a method for evaluating the whole efficacy of TCM in perimenopausal syndrome,which to provide basis for clinical evaluation of PMS.Validated for comprehensive evaluation method of PMS TCM effect,Preliminary discussion of the possibilities of TCM whole curative effect evaluation method,to provide methodological support for PMS clinical research in TCM.Methods:1.To evaluate the efficacy of TCM evaluation methods and the current status of efficacy evaluation of PMS.Take the existing problems as the starting point,put forward the theoretical framework of PMS TCM efficacy evaluation methods.2.Based on the principle of grading(first-level indicators,second-level indicators)and classification(disease evaluation,evaluation of TCM Syndrome,patient report outcome,doc tor report outcome),Established the method(2X-4Y)of PMS efficacy evaluation based on whole status measurement.Based on previous research-After three rounds of expert consultations,subjective screening of PMS curative evaluation scale items was conducted.After objective preclinical investigation,objective item optimization and language debugging were completed.and the formulation of PMS curative effect rating scale was completed.To collect clinical data and establish a database using the universal PRO Scale,PMS special disease PRO Scale,common CRO Scale,and PMS specialized CRO scale.Cronbach's a coefficient was used to evaluate the reliability of each scale,and validity of the scale was evaluated in terms of construct validity and discriminant validity.3.Through two rounds of delphi expert consultation method,the calculation method and index weight of each evaluation index in the PMS efficacy evaluation system were established,and the PMS TCM efficacy evaluation method system was constructed.4.Targeting 85 patients with PMS(liver-qi stagnation syndrome,liver depression transforming into fire syndrome and kidney yin deficiency syndrome)as subjects,a validated experimental study of PMS TCM efficacy evaluation methods based on whole status measurement was conducted.The feasibility of the whole curative effect evaluation method was verified by comparison analysis with the conventional PMS efficacy evaluation method(modified kupperman score method).Results:1.The theoretical framework of PMS TCM efficacy evaluation method(2X-4Y)based on whole health status measurement was established.The measurement includes:(1)Level 1 indicators:Measurement of the outcome of life,including frequency indicators and time indicators,such as remission rate,cure rate,etc;(2)Level 2 indicators:measurement of whole status,with emphasis on the quality of life includes the evaluation of the efficacy of the disease,the evaluation of the efficacy of the syndrome,the evaluation of the PRO,and the evaluation of the CRO.2.A universal PRO scale including 36 items in four dimensions:physiological.psychological,social,and satisfaction and a PMS disease-specific PRO scale with 56 items were formed;A preliminary table of general CRO with 15 dimensions,validity,safety,and satisfaction,and a preliminary list of CRO for PMS special disease with 10 dimensions including physical signs,physical and chemical indicators,and 10 items were also formed.3.Scale assessment:The cronbach's a coefficients of the psychological and satisfaction dimensions of the newly diagnosed general purpose PRO scale were above 0.8,and the cronbach's a coefficient of the physiologic and social dimensions ranged from 0.7 to 0.8,suggesting that the general PRO scale has a high degree of internal consistency.The cronbach's a coefficients of the newly diagnosed and re-diagnosed PMS PRO scales were above 0.9,suggesting that the PRO scale has a high degree of consistency.The cronbach's a coefficient of the security dimension of the general CRO scale is above 0.9,and the cronbach's a coefficient of the validity dimension is above 0.8.This suggests that most items in the general CRO scale have high consistency,and only the satisfaction dimension is poor.Research can further optimize and filter the entries.The cronbach's a coefficient of the special disease CRO scale is 0.7-0.8,and the physical dimension is more than 0.6,suggesting that the CRO scale has a high degree of consistency.The discriminant validity test results of general PRO and special disease PRO scales indicated that the two PRO scale scores were statistically different before and after treatment.which can distinguish the newly diagnosed and re-diagnosed patients with perimenopausal syndrome.The two PRO scale have a good ability to distinguish.Factorial analysis was used in the evaluation of construct validity,and 9 common factors were extracted based on the principle of eigenvalue greater than 1.After the analysis of the results,the three dimensions of the universal PRO scale are intersected with each other:physiological,psychological,and social dimensions.The physiological dimensions are relatively independent,and the satisfaction dimension is completely independent.It can be seen that the factor analysis of the universal PRO scale is basically consistent with the structure of the theoretical concept,suggesting that the scale has certain structural validity.According to the results,the validity and safety dimensions of the general CRO scale are relatively independent,and the degree of satisfaction is more dispersed,indicating that the scale has certain structural validity.The dimensions of physical signs and physical and chemical indicators of the special disease CRO scale are relatively independent,indicating that the scale has a good structural validity.4.After two rounds of expert consultation,the calculation method of each index in the clinical efficacy evaluation system of PMS and the weight of each index were determined.It was concluded that in the whole efficacy results,the proportion of the disease evaluation was 30%,and the proportion of the efficacy of the certificate was 30%,PRO evaluation accounted for 20%,CRO evaluation accounted for 20%.5.85 cases of PMS patients were collected for clinical observation,and the efficacy evaluation method was verified.The results showed that the efficacy evaluation method can well evaluate the efficacy of the disease,but also can reflect the dynamic changes in the efficacy of the certificate.Thro ugh the correlation analysis of each efficacy index,it was found that the whole curative effect was significantly related to the efficacy of the disease,the efficacy of the syndrome,and the efficacy of PRO.There was also a certain correlation between the curative effect and the curative effect.Thro ugh the comparison of the differences in the efficacy indices,it was found that there were significant differences between the PRO index and each efficacy.and there were significant differences between the CRO index and each efficacy.Conclusion:1.Through the literature research,a multi-angle whole measurement PMS comprehensive efficacy evaluation index system was established based on the principle of grading and classification.2.Through the literature research and Delphi expert consultation method,a comprehensive evaluation of the PMS TCM efficacy rating scale was developed,including the general PRO scale,the PMS special disease PRO scale,the general CRO scale,and the PMS specific disease CRO scale.Through clinical investigation,it is verified that the scale has a certain degree of scientific.3.Thro ugh expert consultation,a PMS TCM efficacy evaluation system based on whole status measurement was constructed.The whole efficacy of PMS was evaluated by rating the disease,evaluating the syndrome,and evaluating PRO and CRO.4.Through clinical trials,it has been found that the total efficacy evaluation method can reflect the combination of the evaluation of PMS disease and cardiology and the combination of the patient's point of view and the doctor's point of view,The efficacy evaluation method can be used to evaluate the whole efficacy of PMS.