| Objective:To observe the clinical efficacy and safety of Gandouling tablet combined with swallowing function training on treating the dysphagia of Wilson diease(WD)with phlegm-blood stasis interjunction syndrome.To explore the mechanism of Gandouling tablet in the treatment of WD dysphagia of this type.To provide the basis for this kind of patients using the integrated traditional Chinese and western medicine treatment scheme in clinical which has higher long-term compliance,can be continued after discharge,and put forward a new idea for the treatment of WD dysphagia with Chinese patent medicine.Methods:(1)The collected 90 patients who met the criteria randomly divided into DMPS group(group A),DMPS+swallowing function training group(group B),and DMPS+swallowing function training+Gandouling tablet group(group C),each group consisted of 30 people.Group A was only given the DMPS basic copper removal treatment plan,while group B was given the swallowing function training(Including cold stimulation,empty swallowing training,phonation training,tongue movement training,feeding training,and orofacial muscle group training)on the basis of the basic copper removal treatment plan,and the group C was given Gandouling tablets and swallowing function training(The method is the same as group B)in addition to the basic copper removal treatment plan.The subjects in each group were treated for 4 courses with 8 days as a course.(2)All the enrolled patients completed Water Swallow Test,modified Young scale,Unified Wilson Disease Rating Scale,Standardized Swallowing Assessment,Eating assessment questionnaire,Swallowing Quality-of-Life Questionnaire,TCM syndrome accumulation scale,and the 24 h urinary copper content and safety-related indicators detections 1 day before treatment and at the end of fourth course of treatment.After all treatments,the overall clinical effective rate and the incidence of adverse reactions were compared among the three groups.Results:(1)Comparison of the overall clinical efficacy:It was 53.33% in group A,66.67% in group B and 93.33% in group C.They were significantly different(P<0.01),and then Bonferroni method was used for pairwise comparison,withα’=0.0167 as the adjusted test level.The results showed that there was no statistical difference between group A and group B(P>0.0167),while the clinical effective rate of group C was significantly higher than that of group B and group A(P<0.0167).(2)Comparison of the related scale indicators: There was no significant difference in the scores of each scale among the three groups before treatment(P>0.05).The scores of modified Young scale,UWDRSⅠ,SSA,EAT-10 and SWAL-QOL in group A after treatment was improved compared with that before treatment(P<0.05).In group B,the modified Young scale,UWDRSⅠ,SWAL-QOL scores were improved(P <0.05),and SSA,EAT-10 scores were significantly decreased after treatment(P<0.01).The scores of all scales in group C after treatment were significantly better than those before treatment(P < 0.01).Comparison between two groups after treatment:The score of EAT-10 in group B was lower than that in group A(P < 0.05),while there was no significant difference in the scores of modified Young scale,UWDRSⅠ,SSA and SWAL-QOL(P > 0.05).The scores of SSA and EAT-10 were statistically different between group C and group B(P < 0.05),and the scores of modified Young scale,UWDRSⅠand SWAL-QOL were significantly different(P<0.01).The scores of each scale in group C were significantly better than those in group A(All P<0.01).(3)Comparison of TCM syndrome scores: Before treatment,There was no statistical difference among the three groups(P>0.05).Compared before and after treatment,no statistical difference were observed in group A or B(P>0.05),but the score of group C decreased significantly(P<0.01).After treatment,The difference between group A and group B was not statistically significant(P >0.05),while the score of group C was significantly lower than that in the other two groups(P<0.01).(4)Comparison of 24 h urinary copper content:Before treatment,There was no statistical difference among the three groups(P>0.05).While after four courses of treatment it was significantly higher than before in each group(P < 0.01).After treatment,the difference between group B and group A was not obvious(P > 0.05),while the 24 h urinary copper content of group C was significantly higher than that of the other two groups(P<0.01).(5)Comparison of safety and incidence of adverse reactions:No patient in each group showed significant deterioration of relevant safety indicators during the study.The incidence of adverse reactions was 13.33% in group A,16.67% in group B and 13.33%in group C.There was no significant difference among the three groups(P>0.05).Conclusion:(1)Swallowing function training can improve the swallowing function of patients to a certain extent,but its effect on improving the neurological function and quality of life is not obvious,and there is little difference between the effect of using DMPS alone.(2)Compared with the basic copper excretion therapy of DMPS or single combination of swallowing function training in the treatment of dysphagia of Wilson disease patients with phlegm-blood stasis interjunction syndrome,the treatment plan of Gandou ling tablet combined with swallowing function training can obtain more obvious clinical efficacy,which can significantly increase the excretion of urinary copper,improve the neurological function,swallowing function,quality of life and TCM syndrome score of patients.There was no statistical difference in the safety indicators and incidence of adverse reactions among the three treatment regimens,and Gandouling tablet were safe.(3)Gandouling tablet combined with swallowing function training is a scientific and advisable treatment plan,which is simple,easy to operate and less painful.After discharge,patients can also carry on independently for a long time,which is consistent with the characteristics of the disease requiring lifelong maintenance treatment,worthy of clinical popularization. |
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