OBJECTIVE  To study the clinical effects, treatment efficacy, and safety of Jianpi Lidan Tongluo formula in the treatment of primary biliary cholangitis (PBC) with spleen deficiency and collateral obstruction syndrome.

  METHODS  A total of 60 PBC patients with spleen deficiency and collateral obstruction syndrome who met the inclusion criteria were randomly divided into the observation group and the control group, with 30 cases each. Both groups were given ursodeoxycholic acid capusule orally for three months, and the observation group added the Jianpi Lidan Tongluo formula on that basis. The changes of traditional Chinese medicine (TCM) symptoms in both groups were observed before and after treatment. In addition, we measured liver function Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Glutamyl transpeptidase (GGT), Total bilirubin (TB), Platelets (PLT), Liver Stiffness Measurement (LSM), CD4⁺, CD8⁺, and Immunoglobulin M (IgM) levels in both groups. Besides, the scores of AST and PLT Ratio Index (Aspartate-aminotransferase-to-Platelet Ratio Index (APRI) were calculated in the two groups, and adverse reactions were also recorded.

  RESULTS  After treatment, liver function, APRI score, LSM value, CD4⁺, CD8⁺ and IgM levels improved in both groups (P < 0.01). However, ALP, GGT, TB, APRI score, LSM value, CD4⁺, CD8⁺ and IgM levels improved more significantly in the observation group than in the control group (P < 0.05, P < 0.01). In addition, the TCM symptom scores in both groups were decreased (P < 0.01), but the results in the observation group were better than those in the control group (P < 0.05, P < 0.01).

  CONCLUSION  Jianpi Lidan Tongluo formula can effectively relieve clinical symptoms, improve liver function, regulate immunity and protect intrahepatic bile duct cells in patients with PBC without significant adverse reactions.