A Study On The Efficacy Of Ursodeoxycholic Acid Combined Tongdan Decoction Treating 30 Patients With Primary Biliary Cirrhosis

Background and aim Primary biliary cirrhosis(PBC) is an organ-specific autoimmune disease that characterized by chronic,progressive destruction of small intrahepatic bile duct with periportal inflammation and ultimately fibrosis.The causation of this disease is unknown.With the development of study and diagnostic technique,the detection rate of PBC was also gradually higher these years in our country.UDCA was considered as a standard drug to treat PBC therapeutically,however,several studies suggested that UDCA as a standard drug was still need assessment,the main cause of this conclusion may relate to the stage and grade of this disease.There were reports of traditional Chinese medicine been applied to treat autoimmune disease and hepatic fibrosis,indicating that the application of herbs to treat those diseases were available.So,in this study we aim to observe the efficacy of Ursodeoxycholic acid(UDCA) combined Tongdan Decoction in the treatment of 30 patients with Primary Biliary Cirrhosis(PBC) whose clinical stage was in early metaphase.Methods All the patients at the authors' hospital from May 2002 to May 2007 were diagnosised PBC with reference to the guideline suggested by American Association for the Study of Liver Diseases(AASLD) in 2000.Select 60 patients whose clinical stage was inearly metaphase and met all the following criteria were randomly divided into control group(n=30) and treatment group(n=30), treated with UDCA and UDCA combined Tongdan Decoction respectively.All the drug granules of herbs inTongdan Decoction were supplied by Guangdong Yifang Pharmaceutical Co.,Ltd.which accredited to GMP conformity.If some patients had a abnormal ALT or AST,the base treatment was still needed.The clinical symptoms,hepatic function,immunology index and side effects were observed at 0,4,12 and 24wk after treatment,and the results would be estimate relate to corresponding standard then。Most patients would be followed up for 1-3years and be tested at 48,96 and 148wk.With regard to measurement data,between two or more independent groups using Mann-Whitney and Kruskal-Wallis ANOVA tests,to enumeration data,using x2 test,all the data was analysised by professional staff use d the SPSS package,a p value <0.05 at a two-tailed test was considered significant.Results 1),The results and end-results after treatment:After 24wk of treatment,83.3%(25/30) patients in the treatment group had a complete response,and only 56.3%(17/30) in control group,(P<0.05),but there was no difference at 48wk.(93%vs83.3%),all of patients in two groups responded after 48 wk of treatment.2),Clinical Symptoms:The clinical symptoms were both improved in 2 groups,especially in the treatment group after 4 wk(P <0.05).And over 90%patients had no clinical symptoms after 12 wk in the treatment group,but still 30%patients in control group had some clinical symptoms,until 24wk,there were still 10%,3),Serum biochemistry markers: after 4wk of treatment,the serum biochemistry markers of patients in 2 groups were ameliorated,and combined therapy was superior to UDCA monotherapy in lowering cholestasis and aminopherase(P<0.05).Over 80%patients' biochemistry markers except TBA were normal in treatment group at 24 wk.The data of follow-up study indicate that over 90%patients' serum biochemistry markers in treatment group were in normal range at 48wk.,and in control group, the level of ALP,GGT,ALT and AST approach to normal,but still 16.7%patients had no complete response at 48wk.4),immunology markers:The levels of IgA,IgM and IgG had a significantly change at 96wk post-therapy in treatment group(p<0.05),and also showed a significantly breakdown in control group except IgM(P=0.0856) at 148wk post-therapy.In the next 3 years of follow-up study,a bit of patients showed a seroconversion of AMA,M2 and M9,but there were no significant difference.5),Safety:The common side-effects were diarrhea and occasional pruritus induced by increased serum TBA level,which was alleviated by decreasing the dose of UDCA.In the course of this study, the change of Alb and AFP had no significantly difference in clinical,2 patients' splenomegaly took a favorable turn and 2 patients developed to splenomegaly,HCC was not found in all of patients.Conclusions 1),UDCA can effect to release the symptoms,biochemistry and immunology markers of PBC patients whose clinical stage in early metaphase; 2),UDCA combined Tongdan Decoction in treatment of PBC could raise the effectiveness of UDCA,especially in symptoms,signs and liver biochemical markers.3),UDCA combined Tongdan Decoction to treat PBC was a maintenance therapy,and had no definite course of treatment,so long-term study to evaluate the treatment of PBC is still needed.