Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis

Inclusion criteria

• written informed consent
• aged 18-70 years
• increase in alkaline phosphatase for 2 folds or more
• positive anti-mitochondrial antibody (AMA) with presence of antibodies against the pyruvate dehydrogenase complex (AMA-M2)；AMA-negative patients should be diagnosed as PBC with histologic evidence.

Exclusion criteria

• patients who had been treated with UDCA, immunosuppressive medications within 3 months.
• patients who had evidence of extrahepatic biliary obstruction
• patients coinfection with HBV or HCV
• patients with one of the followings: 1) hemoglobin(HB): <11 g/dl in male, <10 g/dl in female 2) white blood cell count <3000/mm3 3) neutrophile granulocyte <1500/mm3 4) platelet <50000/mm3; 5) serum albumin <3.3 g/dl 6) alanine aminotransferase(ALT)≥10×ULN and/or aspartate aminotransferase(ALT)≥10×ULN; 7) ALT≥5×ULN and/or AST≥5×ULN coexisting with immunoglobulin G (IgG) ≥2×ULN; 8) total bilirubin ≥4×ULN; 9) prothrombin time (PT) prolong 3 seconds or more, or PTA ≦60%; 10) creatinine ≥4×ULN.
• patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.)
• definitely diagnosed as hepatocellular carcinoma(HCC), probable HCC, AFP>100ng/ml.Patients with AFP>2×ULN while <100ng/ml should re-test 2 weeks later.
• Body Mass Index >28 kg/m2
• drug or alcohol abuse.
• patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor
• patient had or on the scheduled of organ transplantation;
• patient for whom the follow-up is considered impossible
• pregnant or nursing woman