| Purpose:1.Based on literature research and relevant guidelines,the expert questionnaire of WD efficacy evaluation indicators was developed,and the indicators were weighted by Delphi method;2.Based on the clinical research data,the single index efficacy evaluation study was carried out by using TCM syndrome differentiation treatment intervention for hepatolenticular degeneration;3.Analytic Hierarchy Process(AHP)and fuzzy comprehensive evaluation were used to comprehensively evaluate the clinical efficacy of the treatment plan,and to find a suitable method for the comprehensive efficacy evaluation of multi-dimensional outcome indicators of traditional Chinese medicine.Methods:1.Based on the literature study and thematic discussion,a questionnaire for WD efficacy evaluation was developed and distributed to 20 experts in the field of neurology for expert consultation,and the Delphi method was used to evaluate the degree of positivity,authority and coordination of experts,and the percent weighting method was used to assign weights to the efficacy evaluation indexes.2,92 patients with WD were randomly divided into control group(DMPS group)and observation group(TCM identification therapy combined with DMPS therapy),outcome evaluation indexes The main evaluation indexes included unified Wilson’s disease rating scale,modified Goldstein classification,24h urine copper,serum liver fibrosis,quality of life indexes,treatment cost,etc.,and the efficacy evaluation of single indexes was conducted by statistical methods Research.Based on the data of multidimensional outcome indicators of clinical research,we select suitable comprehensive efficacy evaluation methods and construct comprehensive evaluation models.Results:1.Results of the expert questionnaire.The positive coefficient of experts in this expert consultation survey is 100.0%.The degree of expert authority was>0.8;the coordination coefficient of expert opinion was0.797,which was statistically significant by X~2test(X~2=95.646,p<0.01),and the degree of expert coordination of all indicators was good;the weight coefficients were determined according to the size of the mean value of the expert scores of each outcome indicator,and in descending order,they were TCM evidence score,modified Goldstein classification,UWDRS 24h urine copper,quality of life,serum liver fibrosis,and medical costs.2.Single index efficacy evaluation results.(1)Chinese medicine symptom score:the clinical Chinese medicine symptom scores of patients in both groups were significantly lower than those before treatment(p<0.01),and the trend of decreasing symptom scores of patients in the observation group was more significant(p<0.05).(2)Modified Goldstein classification:The total effective rate of the observation group was 82.9%,including 14 cases with significant effect,27 cases with effective effect,6cases with ineffective effect and 0 cases with aggravation;the total effective rate of the control group was 71.1%,with 7 cases with significant effect,25 cases with improvement,10 cases with ineffective effect and 3 cases with aggravation.The results of the comparison between the two groups were significantly different by Ridit test(p<0.05).(3)UWDRS scores:1)UWDRS I scores decreased significantly after treatment in both groups,and the decreasing trend of scores in the observation group was more significant(p<0.01);2)UWDRS II scores decreased significantly after treatment in both groups,and the decreasing trend of scores in the observation group was more significant(p<0.01);3)UWDRS III scores decreased significantly after treatment in both groups,and the decreasing trend of scores in the observation group was more significant(p<0.01);(4)Serum liver fibrosis:before treatment,no significant differences were seen in PⅢNP,C-IV,LN and HA between the observation group and the control group(p>0.05);after treatment,no significant differences were seen in PⅢNP,C-IV,LN and HA between the two groups(p>0.05).(5)24h urine copper:there was no significant difference in 24h urine copper between the2 groups before treatment;at the end of 2,4 and 6 courses of treatment,the 24h urine copper value in the observation group was significantly greater than that in the control group,and the difference was statistically significant(p<0.01).(6)Quality of life:1)HAMD scores decreased significantly in both groups after treatment(p<0.01),and the decrease was greater in the observation group(p<0.01);2)HAMA scores decreased significantly in both groups after treatment(p<0.01),and the decrease was greater in the observation group(p<0.01);3)Barthel scores increased significantly in both groups after treatment(p<0.01),and the increased was greater in the observation group(p<0.05).(7)Medical costs:there was no significant difference between groups in laboratory,examination and treatment costs(p>0.05),the cost of drugs and total costs were higher in the observation group than in the control group(p<0.05),and incremental analysis showed that the cost required for each additional unit of effect was￥30.16.3.WD comprehensive efficacy evaluation.(1)AHP method:According to the mean score of each outcome index in the expert questionnaire survey,the recursive hierarchy of WD comprehensive efficacy evaluation was constructed,two-by-two comparisons of each level of evaluation index were made,index weights of each level were calculated and consistency tests were conducted,index combination weights were obtained by the method of concatenation of index weights of each level,and passed consistency tests;according to the mean value of each outcome index data in the clinical study,the comprehensive score index was calculated(2)Fuzzy comprehensive evaluation method:The treatment group=1.1072>control group=0.894,the observation group is better than the control group.(2)Fuzzy comprehensive evaluation method:the set of factors for the evaluation object of this study included Goldstein classification,UWDRS score,TCM evidence score,and quality of life;the evaluation set was divided into four categories:significant,effective,effective and aggravation;based on the research data of each outcome index,the frequency distribution table of each outcome index evaluation set was established and the fuzzy evaluation matrix was constructed;based on the relative weights of the four indexes;the Zadeh operator was used for fuzzy relationship operation,and the judgment was made according to the maximum subordination principle.The comprehensive clinical efficacy of both groups was"effective",0.568 in the observation group and 0.498 in the control group,and the observation group was better than the control group.Conclusion:1,WD efficacy evaluation index weighting expert questionnaire survey:the positive coefficient and authority degree of experts is high,expert opinions are concentrated,and the coordination coefficient is good,each index is ranked according to the weighting:Chinese medicine evidence score,modified Goldstein classification,unified Wilson’s disease assessment scale,24h urine copper,serum liver fibrosis,quality of life indicators,and treatment cost,which initially established the WD efficacy The framework of WD efficacy evaluation index system was initially established.2,WD TCM treatment program has certain clinical efficacy:reduce TCM evidence points,improve clinical symptoms such as neurological,psychiatric symptoms,liver damage,promote the excretion of copper in the body,improve the ability of daily life,depression,anxiety;has a good health economics effect.3,WD TCM clinical efficacy results have multidimensional properties.The clinical efficacy of WD TCM treatment protocols was evaluated using the AHP method and fuzzy comprehensive evaluation method,and it was concluded that WD TCM treatment protocols have certain comprehensive efficacy advantages over Western medicine treatment alone. |
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