Abstract: Objective To evaluate the clinical efficacy of ursodeoxycholic acid （UDCA） and prednisolone combination in the treatment of patients with primary biliary cirrhosis （PBC） and to investigate effective method of treating PBC. Methods 106 patients with PBC in our hospital between January 2010 and December 2015 were randomly divided into two groups. Fifty-three patients with PBC in the control group were treated with oral administration of ursodeoxycholic acid at dose of 13~15 mg·kg^-1·d^-1,and fifty- three patients with PBC in the observation group received oral prednisolone on the basis of UDCA at same dose as in the control group. At presentation and 3 months,6 months and 12 months after treatment,the clinical manifestations of the patients were observed and serum ALP,albumin,and bilirubin levels and serum IgM,IgG and IgA were measured routinely. Results The clinical symptoms improved both in the observation group and control group after treatment,and the patient's fatigue and skin itching significantly improved in the combination group;serum ALP,GGT and bilirubin levels in the two groups were significantly improved after treatment（P<0.05）,and the above indexes decreased rapidly in the two groups after 3 months,and the improvement in the observation group was significantly better than in the control group （P<0.05）;at 6 months and 12 months of treatment,the improvement in the two groups was not obviously different（P>0.05）;There was no significant difference in blood albumin levels between the two groups（P>0.05）;blood IgM levels in both groups significantly decreased after treatment（P<0.05）,and there was a significant difference between the observation group and the control group at 3 months（P<0.05）,while there was no significant difference as respect to blood IgM between the two groups at 6 months and 12 months（P>0.05）;There was no significant difference as respect to blood IgA and IgG levels between the two groups before and after treatment at any time point （P>0.05）. Conclusion The combination of UDCA and prednisolone can in the short term improve the clinical manifestation,the main biochemical indexes and decrease serum IgM levels in PBC patients,which needs further investigation.

Key words: Primary biliary cirrhosis, Ursodeoxycholic acid, Prednisolone, Efficacy