Clinical Observation Of Modified Xiaoyaosan Combined With Ursodeoxycholic Acid In The Treatment Of Primary Biliary Cirrhosis

Objective:To observe the clinical efficacy and safety of modified xiaoyaosan ccombined with ursodeoxycholic acid in the treatment of primary biliary cirrhosis,and to provide a theoretical basis for the clinical treatment of primary biliary cirrhosis.Method:Forty-five patients with primary biliary cholangitis who visited the outpatient clinics of Hepatology Department of Shandong University of Traditional Chinese Medicine,Tai’an City Hospital of Traditional Chinese Medicine,Weifang City Hospital of Traditional Chinese Medicine and Jinan Infectious Diseases Hospital from 2016 to 2018 were observed and analyzed.The patients were divided into control group(20 cases)and experimental group(25 cases).The control group was treated with ursodeoxycholic acid,while the experimental group was treated with ursodeoxycholic acid on the basis of the control group.Jiawei Xiaoyao Powder was added for routine treatment.After 24 weeks,according to the changes of TCM syndrome score,serum biochemistry,liver fibrosis,immunology and safety after treatment,the two groups of patients were analyzed statistically.Results:1.Total response rate:The total response rate of biochemical indicators was 56.00%in the experimental group,which was significantly better than 35.00%in the control group.2.Serum biochemical indicators:After treatment,the two groups can improve the serum biochemical indicators of patients,with statistical difference(P<0.05);comparing the improvement of alanine aminotransferase(ALT),alkaline phosphatase(ALP),gamma-glutamyltransferase(GGT),total bilirubin(TBiL),direct bilirubin(DBiL)indicators between the two groups,the experimental group was significantly better than the control group,and the difference between the two groups was statistically significant.There was no significant difference in AST,TBA and ALB(P<0.05).3.TCM syndromes:integral comparison:both groups improved after treatment,with statistical difference(P<0.05);the experimental group was better than the control group,with statistical difference(P<0.05).Curative effect comparison:After treatment,14 cases were markedly effective in the experimental group,9 cases were effective,2 cases were ineffective,and the total effective rate was 92.00%.In the control group,5 cases were markedly effective,6 cases were effective and 9 cases were ineffective,The total effective rate was 55.00%.The total effective rate of the experimental group was better than that of the control group.4.Four indicators of liver fibrosis:after treatment,hyaluronic acid(HA)and type Ⅳ collagen(Ⅳ-c)were improved in both groups,with statistical difference(P<0.05);laminin(LN),type Ⅲ procollagen(PC-Ⅲ)had no statistical difference;the experimental group of hyaluronic acid(HA),type Ⅳ collagen(Ⅳ-c)was significantly better than the control group,with statistical difference(P<0.05);There was no significant difference in type N and type Ⅲ procollagen(PC-Ⅲ).5.Immunological indicators:There was no significant difference between the anti-nuclear antibody(ANA)and anti-mitochondrial antibody M2 subtype(AMA-M2)groups.6.Safety:During the treatment period,there was 1 case of slight nausea in the experimental group,no other obvious adverse reactions occurred,and the safety was good.In the control group,1 case of slight dizziness could be alleviated by itself,and no other adverse reactions occurred.Conclusions:1.Modified xiaoyaosan combined with ursodeoxycholic acid in the treatment of primary biliary cirrhosis can significantly improve the clinical symptoms and laboratory indicators of patients.2.It has obvious superiority and safety compared with western medicine alone.3.Explain that liver depression and spleen deficiency is one of the main pathogenesis of PBC,soothing liver and relieving depression is one of the effective treatments for PBC.