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 thepyruvate dehydrogenase complex (AMA-M2)；AMA-negative patients should be diagnosed asPBC with histologic evidence.

Exclusion Criteria:

1. patients who had been treated with UDCA, immunosuppressive medications within 3months.

2. patients who had evidence of extrahepatic biliary obstruction

3. patients coinfection with HBV or HCV

4. patients with one of the followings: 1) hemoglobin(HB): <11 g/dl in male, <10 g/dl infemale 2) white blood cell count <3000/mm3 3) neutrophile granulocyte <1500/mm3 4)platelet <50000/mm3; 5) serum albumin <3.3 g/dl 6) alanineaminotransferase(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) totalbilirubin ≥4×ULN; 9) prothrombin time (PT) prolong 3 seconds or more, or PTA ≦60%; 10)creatinine ≥4×ULN.

5. patients with evidence of decompensated liver disease(ascites, gastrointestinalbleeding, hepatic encephalopathy et al.)

6. 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.

7. Body Mass Index >28 kg/m2

8. drug or alcohol abuse.

9. patient with severe disease of heart, lung, kidney, alimentary canal, neural system,autoimmune disease or tumor

10. patient had or on the scheduled of organ transplantation;

11. patient for whom the follow-up is considered impossible

12. pregnant or nursing woman