Abstract: Objective This study was conducted to investigate the therapeutic efficacy of prednisone and azathioprine combination in the treatment of patients with autoimmune hepatitis (AIH). Methods There were 52 consecutive patients with AIH recruited in our hospital between January 2020 and January 2023, and they were randomly divided into observation (n=26) and control (n=26). All the patients in the two groups took prednisone and azathioprine combination therapy, the dose of prednisone in the control group was tapered relatively rapidly, while in the combination group was slowly week by week. Serum IgG, IgA and IgM levels were detected by ELISA, and peripheral blood lymphocyte subsets were determined by FCM. Results At the end of six-month treatment, serum ALT and AST levels in the observation group were (32.4±7.5)U/L and (31.9±5.2)U/L, both significantly lower than [(46.8±10.1)U/L and (43.6±7.7)U/L, respectively, P<0.05] in the control; serum IgA, IgM and IgG levels were (3.4±0.6)g/L, (3.5±0.8)g/L and (15.3±2.1)g/L, all much lower than [(4.1±0.5)g/L, (4.1±0.6)g/L and (19.8±6.7)g/L, P<0.05] in the control group; the percentages of peripheral blood T lymphocytes, B lymphocytes, inhibitory/cytotoxic T lymphocytes and the ratio of CD4⁺/CD8⁺ cells were(0.7±0.2)%, (12.1±3.5)%, (24.1±3.4)% and (1.2±0.2), all significantly lower thn [(0.9±0.2)%, (16.4±5.1)%, (28.4±3.1)% and (1.4±0.3), respectively, P<0.05] in the control; the incidence of untoward effects in the observation group was 50.0%, much higher than 7.7%(P<0.05) in the control group. Conclusion The regimen of prednisone and azathioprine combination in treatment of patients with AIH has definite clinical efficacy, while the way of dose tapering needs further investigation.

Key words: Autoimmune hepatitis, Prednisone, Azathioprine, Tapering, Lymphocyte subsets, Therapy