Abstract: Objective The aim of this study was to investigate the clinical efficacy of tenofovir disoproxil fumarate (TDF) and Dangfei Liganning capsule, a herbal medicine compound, in the treatment of patients with chronic hepatitis B (CHB). Methods 97 consecutive patients with CHB were enrolled in our hospital between January 2021 and February 2024, and were randomly assigned to receive TDF in 48 cases in control, or to receive combination of TDF with the herbal medicine in 49 cases for 48 weeks. Serum HBeAg and HBsAg levels were detected by electrochemiluminescence and serum HBV DNA loads were quantitatively measured by real-time PCR. Serum hyaluronic acid (HA), laminin (LN), type III procollagen (PCIII) and type IV collagen (IV-C) levels were detected by chemiluminescence, serum interleukin(IL)-6, IL-8, tumor necrosis factor-α and transforming growth factor-β1 (TGF-β1) levels were assayed by ELISA, and serum superoxide dismutase (SOD), malondialdehyde (MDA), and nitric oxide (NO) levels were determined by xanthine oxidase, thiobarbituric acid and nitric acid reduction, respectively. Results By end of 48-week treatment, serum ALT and AST levels in combination group were (31.7±6.1)U/L and (39.5±7.3)U/L, both significantly lower than [(39.4±6.3)U/L and (45.3±6.1)U/L, respectively, P<0.05] in the control; serum HBV DNA in both groups transferred to negative, and there were no significant differences as respect to serum virologic and serologic markers in the two groups (P<0.05); serum HA, LN and PCⅢ levels in the combination group were (186.3±8.2)ng/mL, (171.2±10.4)ng/mL and (158.5±14.7)ng/mL, all much lower than [(292.4±16.7)ng/mL, (230.5±12.7)ng/mL and (181.2±18.6)ng/mL, respectively, P<0.05] in the control; serum IL-6, IL-8, TNF-α and TGF-β1 levels were (12.9±4.2)μg/L, (5.4±1.0)μg/L, (31.7±9.3)μg/L and (12.6±4.2)ng/L, all significantly lower than [(19.2±4.6)μg/L, (7.1±1.3)μg/L, (49.2±8.6)μg/L and (26.1±4.9)ng/L, respectively, P<0.05] in the control groups; serum SOD and NO levels were (116.3±17.2)U/mL and (44.2±6.5)μmol/L, both much higher than [(97.4±18.5)U/mL and (37.1±5.9)μmol/L, respectively, P<0.05], while serum MDA level was (7.1±1.8)nmol/L, much lower than [(9.3±1.5)nmol/L, P<0.05] in the control group. Conclusion Combination of TDF and Dangfei Liganning capsule has a better efficacy than TDF alone in the treatment of patients with CHB, which might be related to inhibition of liver fibrosis, body' s inflammatory reaction and oxidative stress.

Key words: Hepatitis B, Tenofovir disoproxil fumarate, Dangfei Liganning capsule,a herbal medicine compound, Therapy