Objective: To explore the efficacy and safety of Shugan Lidan Tang combined ursodeoxycholic acid in treatment of early and mid-term primary biliary cirrhosis hygroscopic blood stasis syndrome. Method: A total of 171 cases primary biliary cirrhosis patients were randomly divided into the traditional Chinese medicine(TCM) group

the chemical medicine group and the combined group

with 57 cases in each group. The TCM group was treated with Shugan Lidan Tang

ursodesoxycholic acid was applied in the chemical medicine group

Shugan Lidan Tang and ursodesoxycholic acid was provided to the combined group. A course of treatment was 48 weeks. The changes of clinical symptom

serum fibrosis

liver function and immunological indicators were observed before and after treatment. To compare the complete response and safety index in three groups. Result: The total response rate in combined group in the 24th

48th weeks was higher than that of the TCM group and the combined group (P<0.05). There was no significant difference between the TCM group and the western medicine group. The clinical symptoms

serum fibrosis

liver function

immunoglobulin G (IgG)

immunoglobulin M (IgM)

immunoglobulin A (IgA)

anti-mitochondrial antibody (AMA) were superior to those in TCM group and the chemical medicine groups in the 48th week (P<0.05). The order of the groups in terms of adverse reactions and blood and urine routine was the TCM groupP<0.05). Conclusion: Shugan Lidan Tang has the effect in the treatment of early and mid-term primary biliary cirrhosis. Compared with ursodesoxycholic acid

there is no obvious difference

with a better safety index. Shugan Lidan Tang combined with ursodeoxy-cholic acid has a remarkable efficacy in treating early and mid-term primary biliary cirrhosis hygroscopic blood stasis syndrome.