Abstract: Objective The aim of this study was to investigate the efficacy and serum cytokine level changes of ursodeoxycholic acid (UDCA) and fenofibrate combination in the treatment of patients with primary biliary cholangitis (PBC). Methods Fourty-eight patients with PBC were recruited in this study between December 2016 and December 2018, and were randomly divided into observation (n=24) and control group (n=24). The patients in control group were treated with UDCA at dose of 15 mg.kg^-1·d^-1, and those in the observation were treated with UDCA at the same dose and fenofibrate combination. The regimen lasted for six months. Serum transforming growth factor-β (TGF-β), interferon-γ(IFN-γ) and interleukin-10 (IL-10) levels were detected by ELISA. Liver stiffness measurement (LSM) was detected by FibroTouch. Results At the end of six-month observation, serum ALT level in combination was (51.4±23.7)U/L, significantly lower than 【(74.9±21.2)U/L, P<0.05】, serum AST level was (59.5±32.3)U/L, much lower than 【(81.3±35.8)U/L, P<0.05】, serum GGT level was (95.7±31.8)U/L, significantly lower than 【(127.3±50.7)U/L, P<0.05】 in the control; serum IFN-γ level was (57.4±21.3) pg/mL, significantly higher than 【(39.7±23.7)pg/mL, P<0.05】, while serum TGF-β level was (14.3±4.8)pg/mL, much lower than 【(23.6±3.5)pg/mL, P<0.05】 in the control; serum immunoglobulin M(IgM) was (2.3±0.4)g/L, significantly lower than 【(3.1±0.9)g/L, P<0.05】, serum IgG level was (11.3±1.8)g/L, significantly lower than 【(15.5±1.3)g/L, P<0.05】 and serum IgA level was (2.7±0.6)g/L, significantly lower than 【(3.5±0.2)g/L, P<0.05】 in the control; the LSM was (10.8±6.5)kPa, not significantly different compared to (9.7±7.7)kPa (P>0.05) in the control. Conclusion The combination of ursodeoxycholic acid and fenofibrate in treatment of patients with PBC significantly improves blood biochemical parameters, which might be related to the increased IFN-γ secretion. The long-term prognosis should be observed in the future.

Key words: Primary biliary cholangitis, Ursodeoxycholic acid, Fenofibrate, Transforming growth factor-β, Interferon-γ, Interleukin-10, Therapy