Observational Study Of Gandouling Tablet In The Treatment Of Liver Fibrosis In Wilson’s Disease With Syndrome Of Phlegm And Blood Stasis

Objective:To explore the clinical efficacy of Gandouling tablet(GDL)combined with Dimercaptosuccinic Acid Capsules(DAC)on liver fibrosis in Wilson’s disease(WD)patients,which is expected to provide vital support for traditional Chinese medicine(TCM)and enrich the theoretical strategy for patients of WD’s liver fibrosis.Methods:(1)WD patients with liver fibrosis in neurology center of the First Affiliated Hospital of Anhui University of Chinese Medicine were enrolled based on the advanced inclusion and exclusion standards,which were selected from February 2019 to March2020;(2)Participants were randomly divided into treatment group and control group.interventions of GDL combined with DAC were given to participants in the treatment group,while the control group were treated with single DAC.The treatment duration were carried out seriously for 48 weeks.(3)TCM syndrome score scale,liver transaminase indicators,liver fibrin markers,liver stiffness measurement(LSM),AST to PLT ratio index(APRI)and FIB-4 index were measured at baseline,week of 24,and48.Results:(1)At 24 weeks:(1)TCM syndrome score scale,there were significant differences in two groups after treatment(P<0.01),but there were no differences between the two groups(P>0.05);(2)Liver transaminase indicators,there were significant differences in Alanine aminotransferase(ALT)and Aspartate aminotransferase(AST)in two groups after treatment(P<0.01),but there were no differences between two groups(P>0.05).(3)Liver fibrin markers,there were significant differences in LSM,APRI score and FIB-4 index between two groups after treatment(P<0.05),but no significant differences were showed in the two groups(P>0.05).(2)At 48 weeks:(1)TCM syndrome score scale,there were significant differences in two groups after 48 weeks of treatment(P<0.05),and there were significant differences between two group in TCM syndrome score scale(P<0.05).(2)There were significant differences on ALT and AST in two groups after 48 weeks of treatment(P<0.05),and there were significant differences on ALT and AST between two groups(P<0.05).(3)Liver fibrin markers,a significant differences were received in two groups on Hyaluronic acid(Hyaluronic acid,HA),Laminin(Laminin,LN),Type III collagen peptide before(Type III procollagen N peptide,PIIINP),and Type IV collagen(Type IV collagen,C-IV)level(P< 0.01);and compared with control group,the indicators of HA and PIIINP were significantly decreased(P<0.05);(4)There were significant differences on LSM,APRI score and FIB-4 index in two groups after 48 weeks of treatment(P<0.05),while there were significant differences in LSM between two groups(P<0.05).Conclusion:In our study showed there no significance differences on liver fibrosis between Gandouling Tablet combined with Dimcaptosuccinic acid capsule and single Dimcaptosuccinic acid capsule in short-termed duration,however,WD patients could receive better clinical efficacy in long-termed duration,,proving that Gandoulin Tablet play vital roles and provide the theoretical strategy for the treatment of WD’s liver fibrosis.