Abstract: Objective The aim of this study was to explore the rescued therapy of budesonide in patients with primary biliary cholangitis (PBC) for poor response to ursodeoxycholic acid (UDCA) treatment. Methods 76 patients with PBC who had not response to UDCA treatment were recruited in our hospital between February 2019 and February 2022, and were divided randomly into control group (n=38) and observation group (n=38). The patients in the control group maintained treatment with UDCA, and those in the observation group were treated with budesonide at base of UDCA treatment. The observation lasted for 24 weeks. Serum interleukin-2 (IL-2), IL-6, IL-10, malondialdehyde (MDA), superoxide dismutase (SOD), hemeoxygenase-1(HO-1) and nuclear factor-related factor 2(Nrf2) levels were detected by ELISA. Plasma immunoglobulin levels were detected by turbidimetric inhibition immnoassay. Results At the end of 24 week treatment, serum ALP, GGT and bilirubin levels in the observation group were (97.6±18.5) U/L, (82.4±10.2) U/L and (25.4±4.2)μmol/L, all significantly lower than [(234.8±40.6) U/L, (160.6±17.6) U/L and (34.5±6.1)μmol/L, respectively, P＜0.05] in the control; serum IL-2 and IL-10 levels were (62.9±15.7) pg/ml and 154.9±12.8)pg/ml, both significantly higher than [(37.4±18.3) pg/ml and (89.6±17.6) pg/ml, respectively, P＜0.05], while serum IL-6 levels was (5.3±1.3) pg/ml, much lower than [(7.9±1.7) pg/ml, P＜0.05] in the control; plasma IgM, IgG and IgA levels were (2.4±0.3) g/L, (11.2±1.9) g/L and (2.8±0.4) g/L, all significantly lower than [(4.1±0.5) g/L, (15.7±2.4)g/L and (4.4±0.6) g/L, respectively, P＜0.05]; serum MDA level was (5.2±0.7)μmol/L, much lower than [(7.9±1.1)μmol/L, P＜0.05], while serum SOD, HO-1 and Nrf2 levels were (86.2±9.6)U/L, (22.1±2.9) U/L and (669.8±87.6) U/L, all significantly higher than [(72.5±8.2) U/L, (16.8±2.5) U/L and (547.5±80.4) U/L, respectively, P＜0.05] in the control group. Conclusion The rescue treatment of budesonide in PBC patients without response to UDCA therapy could improve the recovery of liver function tests, which might be related to the regulation of immune system and inhibition of oxidative stress.

Key words: Primary biliary cholangitis, Budesonide, Ursodeoxycholic acid, Oxidative stress, Treatment