Evaluate the Efficacy And Safety Of TUDCA Compare UDCA In The Treatment Of Cholestatic Liver Disease-PBC by A Randomized,Double-Blind,Double Dummy,Parallel-Controlled,Multicenter Trial and The Consecutive Treatment By TUDCA

Date de début de l'étude : 1 août 2009

Inclusion Criteria: 1 Ages Eligible for Study: 18 Years to 70 Years 2 Alkaline phosphatase (ALP) ≥ 2 times the Upper Limits of Normal (ULN); 3 Anti mitochondrial antibody (AMA) positive and / or anti-mitochondrial antibody subtype M2 (AMA-M2) positive; if the AMA and AMA-M2 were negative, need liver biopsy confirmed pathological changes in PBC. Exclusion Criteria: 1．in the 3 months before screening received UDCA, hormones, immunosuppressive therapy; 2．with extrahepatic biliary obstruction; 3．accompanied by hepatitis B virus (HBV) and hepatitis C virus (HCV) infection; 4．laboratory screening examination : hemoglobin (HB): male< 11 g/dL, female <10 g/dL < g/dL; the total white blood cell (WBC) count < 3000/mm3; the absolute neutrophil count (ANC) <1500/mm3; platelet (PLT) count <50000/mm3; serum albumin <3.3g/dL; alanine aminotransferase (ALT) ≥ 10 ULN and / or aspartate aminotransferase (AST) ≥ 10ULN; ALT ≥ 5 ULN and / or AST ≥ 5 ULN with immunoglobulin G (IgG) ≥ 2ULN; total bilirubin (T-Bil) ≥ 4 ULN; prothrombin time (PT) prolonged ≥ 3 seconds (limit reference value based on) or PTA ≤ 60%; the serum creatinine (Cr) ≥ 1.5ULN. 5．patients with esophageal variceal or bleeding, ascites, hepatic encephalopathy or other evidence of hepatic decompensation; 6．diagnosed with liver cancer, suspected to have liver cancer, AFP > 100ng/ml. As the AFP in 2 times the upper limit of normal to 100ng/ml, need re-check in 2 weeks, if their AFP > 100ng/ml can not be included 7．body mass index >28 (Kg/m2); 8．alcohol or drug abusers within the recent year; 9．there is a serious heart, lung, kidney, digestive, nervous, mental disease, autoimmune diseases or malignant tumor 10．drug-induced liver injury; 11. plan to transplant or have had organ transplants; 12． are unable or unwilling to provide informed consent or fails to comply with the test requirements; 13．pregnant, lactating women.