Abstract: Objective The aim of this study was to investigate efficacy of tenofovir alafenamide fumarate (TAF) and Ganshuang granules, a herbal medicine compound, combination in the treatment of patients with chronic hepatitis B (CHB). Methods 76 patients with CHB were enrolled in our hospital between January 2020 and December 2023, and were randomly divided into control (n=38) and observation group (n=38). They were treated with TAF or TAF and herbal medicine combination for 48 weeks. Serum HBV DNA load was assayed by real-time fluorescence quantitative PCR, and serum HBeAg level was detected by chemiluminescence immunoassay. TCM syndromes scores were evaluated according to the Guidelines for the Traditional Chinese Medicine Diagnosis and Treatment of Chronic Hepatitis B (2018 Edition). Fibrosis index based on four factors (FIB-4) was obtained and liver stiffness measurement (LSM) was detected by transient elastography. Serum transforming growth factor-β1 (TGF-β), matrix metalloproteinase-1 (MMP-1) and tissue inhibitor of metalloproteinase-1 (TIMP-1) levels were determined by ELISA. Results By end of 48 week treatment, ALT normalization rate in the observation group was 94.7%, much higher than 78.9%(P<0.05) in the control; scores of distending pain at hypochondrium, yellow and greasy tongue coating, poor appetite and nausea and yellow urine in the observation group were(0.9±0.1), (1.0±0.2), (0.9±0.1) and (0.7±0.1), all much lower than [(1.3±0.2), (1.3±0.2), (1.2±0.2) and (0.9±0.2), all P<0.05] in the control; FIB-4 score, LSM, serum TGF-β1 and TIMP-1 levels were (1.8±0.3), (7.0±0.6)kPa, (21.4±5.4)ng/mL and (119.3±19.5)ng/mL, all significantly lower than [(2.2±0.4), (9.7±1.1)kPa, (39.1±6.1)ng/mL and (168.9±22.3)ng/mL, respectively, P<0.05], while serum MMP-1 level was (9.8±1.2)ng/mL, significantly higher than [(7.1±1.0)ng/mL, P<0.05] in the control group. Conclusion Combination of TAF and Ganshuang granules in the treatment of patients with CHB could significantly reduce TCM syndrome scores, improve liver function and relieve liver fibrosis.

Key words: Hepatitis B, Ganshuang granules, herbal medicine, Tenofovir alafenamide fumarate, Liver fibrosis, Transforming growth factor β1, Therapy