| 1 Objectives1.1 To map knowledge domains of traditional Chinese medicine(TCM)in the treatment of Wilson’s disease,using Cite Space6.1.R6 software,take the literature data published by China National Knowledge Infrastructure(CNKI)as the research object.Visualized analysis of the domestic research field of TCM in the treatment of Wilson’s disease,to show the research status,hot spots and future research trends of TCM in the treatment of Wilson’s disease,in order to provide reference for the development of TCM in the field of Wilson’s disease.1.2 To observe the clinical efficacy and early renal injury indexes changes of Gan Dou Fu Mu Decoction combined with western medicine in the treatment of early renal injury in patients with phlegm and stasis type Wilson’s disease,and then to explore the efficacy and safety of Gan Dou Fu Mu Decoction in the treatment of early renal injury of phlegm and stasis type Wilson’s disease,so as to provide effective clinical basis for the treatment of early renal injury of phlegm and stasis type Wilson’s disease with TCM.2 Methods2.1 Analysis of mapping knowledge domains of Wilson’s disease treated by TCM Through searching the database of CNKI,all the published literatures about the treatment of Wilson’s disease with TCM were retrieved.Formulate clear inclusion criteria and exclusion criteria,and screen all retrieved documents.Read all the included documents,complete the data collation and standardize the document data.Using the method of scientific metrology and the visualization software Cite Space 6.1.R6,the knowledge map of TCM for Wilson’s disease was constructed through literature clustering analysis,keyword co-occurrence analysis and other technologies.2.2 Clinical intervention study of Gan Dou Fu Mu Decoction on early renal injury in phlegm and stasis type Wilson’s disease2.2.1 From October 2021 to October 2022,60 patients with Wilson’s disease in the Encephalopathy Center of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine,selected with phlegm and stasis type Wilson’s disease who meet the criteria,were randomly divided into treatment group and control group.30 healthy persons from the Physical Examination Center of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine were collected as the healthy physical examination group.In treatment,the control group was given low-copper and high-protein diet,copper-expelling therapy with Sodium Dimercaptopropane Sulfonate Injection(intermittent for 2 days after 6 days,8 days as a course of treatment),calcium gluconate injection as calcium supplement(intermittent calcium supplement,use on the 7th and 8th day of the course of treatment),and glutathione for liver protection(liver protection treatment lasted the whole course of treatment,uninterrupted)for a total of 4 courses.On the basis of treatment in the control group,the treatment group was given Gan Dou Fu Mu Decoction.2.2.2 The degree of early renal injury was evaluated by urinary retinol binding protein(URBP),urinary α 1 microglobulin(Uα1-MG),urinary β 2microglobulin(Uβ2-MG),urinary immunoglobulin G(UIg G),urinary transferrin(UTRF),urinary microalbumin(U-m Alb),urinary N-acetyl-β-D-glucosidase(UNAG),serum cystatin C(Cys C)and urinary albumin creatinine ratio(UACR).The clinical efficacy of patients with phlegm and stasis type Wilson’s disease was evaluated by TCM syndrome score,unified hepatolenticular degeneration scale Ⅲ and 24-hour urine copper.Analyze and compare the early renal injury index between patients with phlegm and stasis type Wilson’s disease and healthy subjects,and observe the clinical effect of Gan Dou Fu Mu Decoction on early renal injury in patients with phlegm and stasis type Wilson’s disease and early renal injury indexes.3 Results3.1 Analysis of mapping knowledge domains of Wilson’s disease treated by TCM Finally,308 literatures were included and 6 knowledge graphs were drawn.From the point of view of the number of articles,although the total number is small,it shows an upward trend as a whole,indicating that there are broad research prospects in the field of TCM for Wilson’s disease.From the perspective of cooperation,Anhui University of Traditional Chinese Medicine and its affiliated hospitals are mainly core institutions,but there is a lack of cross-institutional and cross-regional cooperation.From the perspective of research hotspots,phlegm and blood stasis syndrome and internal dampness-heat syndrome are common TCM syndrome types in clinic,and they are also the focus of TCM syndrome type research on Wilson’s disease.Gan Dou Fu Mu Decoction,Gan Dou Decoction and Gan Dou Ling are more effective compound prescriptions of TCM,and the research is also relatively rich.The discussion of liver fibrosis,hypersplenism,cognitive impairment and mental symptoms has become the focus of clinical research.Data mining has also become a new research direction in recent years.3.2 Clinical intervention study of Gan Dou Fu Mu Decoction on early renal injury in phlegm and stasis type Wilson’s disease3.2.1 Comparison of early renal injury indexes between patients with phlegm and stasis type Wilson’s disease and healthy subjectsIndexes of early renal injury in patients with phlegm and stasis type Wilson’s disease,URBP,U α 1-MG,U β 2-MG,UIg G,UTRF,U-m Alb,UNAG,Cys C and UACR,were significantly higher than those in healthy subjects(P<0.01).3.2.2 Comparative analysis of total clinical curative effectThe total effective rate of Gan Dou Fu Mu Decoction group was 93.33%,and that of western medicine treatment group was 66.67%.There was significant difference between the two groups(P<0.05).3.2.3 Comparative analysis of scores of TCM syndromeAfter 4 courses of copper excretion,the total score of TCM syndrome in both groups was significantly lower than that before(P < 0.01),and the total score of TCM syndrome in Gan Dou Fu Mu Decoction group was more significantly lower than that in western medicine treatment group(P<0.01).3.2.4 Comparative analysis of scores of unified hepatolenticular degeneration scale ⅢAfter 4 courses of copper excretion,the total score of UWDRS Ⅲ in both groups was significantly lower than that before(P<0.01),and the total score of UWDRS Ⅲ in Gan Dou Fu Mu Decoction group more significantly lower than that in western medicine treatment group(P<0.01).3.2.5 Comparative analysis of indexes of early renal injuryAfter 4 courses of copper excretion,the indexes of early renal injury,URBP,U α 1-MG,U β 2-MG,UIg G,UTRF,U-m Alb,Cys C and UACR,in Gan Dou Fu Mu Decoction group and western medicine treatment group were significantly lower than those before treatment(P < 0.01).The decrease in Gan Dou Fu Mu Decoction group was more obvious than that in western medicine group(P<0.01).The early renal injury index,UNAG,was not significantly lower than that before treatment(P>0.05),and there was no significant difference between the Gan Dou Fu Mu Decoction group and the western medicine treatment group(P>0.05).3.2.6 Comparative analysis of 24-hour urine copperAfter 2 courses of copper excretion,24-hour urine copper in Gan Dou Fu Mu Decoction group and western medicine treatment group was significantly higher than that before treatment(P < 0.01),and the increase in 24-hour urine copper in Gan Dou Fu Mu Decoction group was more significant than that in western medicine treatment group(P<0.01).After 4 courses of copper excretion,24-hour urine copper in Gan Dou Fu Mu Decoction group and western medicine treatment group was higher than that before treatment(P < 0.01),and the increase in 24-hour urine copper in Gan Dou Fu Mu Decoction group was more significant than that in western medicine treatment group(P<0.01).3.2.7 Comparative analysis of safety indexesAfter 4 courses of copper excretion,the values of WBC,RBC and PLT in Gan Dou Fu Mu Decoction group were slightly lower than those before treatment,and there was no significant difference(P > 0.05).The values of WBC,RBC and PLT in western medicine treatment group were significantly lower than those before treatment(P <0.05).The values of ALT and AST in Gan Dou Fu Mu Decoction group were significantly lower than those before treatment(P<0.05).The values of ALT and AST in the western medicine treatment group decreased slightly,but there was no statistical significance(P > 0.05).The values of BUN and Scr in Gan Dou Fu Mu Decoction group and western medicine treatment group decreased slightly,but there was no statistical significance(P>0.05).3.2.8 Comparative analysis of adverse reactionsAfter 4 courses of copper excretion,the incidence of adverse reactions was 6.67% in Gan Dou Fu Mu Decoction group and 26.67% in western medicine treatment group(P<0.05).4 Conclusions4.1 Analysis of mapping knowledge domains of Wilson’s disease treated by TCM4.1.1 The overall number of studies in the field of TCM treatment of Wilson’s disease showed a fluctuating growth trend.4.1.2 Anhui University of Traditional Chinese Medicine and its affiliated hospitals are active in the treatment of Wilson’s disease with TCM and have close cooperation.4.1.3 The research on the treatment of Wilson’s disease by TCM mainly focuses on three aspects: clinical medication research;TCM syndrome differentiation and treatment,and its theoretical study of TCM;clinical symptoms and pathological mechanism research.4.1.4 Data mining has become a new research hotspot in recent years.4.2 Clinical Intervention study of Gan Dou Fu Mu Decoction on early renal injury in phlegm and stasis type Wilson’s disease4.2.1 Patients with phlegm and stasis type Wilson’s disease have a certain degree of early renal injury.4.2.2.Gan Dou Fu Mu Decoction combined with western medicine can effectively improve the total clinical effective rate of phlegm and stasis type Wilson’s disease.4.2.3.Gan Dou Fu Mu Decoction combined with western medicine can effectively increase 24-hour urinary copper excretion,reduce TCM syndrome scores and UWDRSⅢ scores,and improve clinical symptoms in patients with phlegm and stasis type Wilson’s disease,which is better than that of western medicine alone.4.2.4 Gan Dou Fu Mu Decoction combined with western medicine can improve the related indexes of early renal injury in phlegm and stasis type Wilson’s disease,which is better than that of western medicine alone.4.2.5 Gan Dou Fu Mu Decoction has less adverse reactions and good safety in clinical use. |