Abstract: Objective The aim of this study was to investigate entecavir (ETV) in combination with Ruangan Sanjie prescription, a herbal medicine formula, in the treatment of patient with chronic hepatitis B (CHB). Methods A total of 124 patients with CHB were enrolled in this study between July 2022 and July 2024, and the recruited patients belonged to CTM liver-depression/spleen deficiency syndrome, and were randomly assigned to receive ETV in 62 cases in group A, or receive ETV and the herbal medicine combination in another 62 cases in group B for 48 weeks. The scores of main TCM syndromes, such as lateral thorax lumps, abdominal distension, fatigue due to anorexia and pale complexion were evaluated. Serum hyaluronic acid (HA), laminin (LN), IV collagen (IV-C) and III procollagen (PCIII) levels were detected by ELISA, and peripheral blood T lymphocyte subsets were determined by FCM. Results By end of 48-week of treatment, TCM lateral thorax lumps, abdominal distension, fatigue due to anorexia and pale complexion scores in group B were(1.4±0.8)points, (2.4±0.9)points, (2.1±0.9)points and (1.8±0.6)points, all much lower than [(2.7±1.2)points,(3.1±1.6)points,(2.9±1.1)points and (2.6±1.3)points, respectively P＜0.05] in group A;serum ALT and AST levels were much lower than in group A(P＜0.05); serum HA, LN, Ⅳ-C and PCⅢ levels were (62.9±15.2)μg/mL, (94.1±18.8)ng/mL, (78.6±12.7)ng/mL and (99.7±18.1)ng/mL, all significantly lower than [(85.7±17.9)μg /mL, (132.9±21.7)ng/mL, (112.9±18.2)ng/mL and (159.8±26.9)ng/mL,respectively, P＜0.05] in group A;percentages of peripheral blood CD3⁺ and CD4⁺ cells, and CD4⁺/CD8⁺ cell ratio were (68.1±5.3)%, (37.6±4.1)% and (1.3±0.4), all much higher than [(61.9±4.9)%, (32.4±3.8)% and (1.0±0.3),respectively P＜0.05] in group A;serum HBV DNA negative rates in the two groups were 96.8% to 95.2%,not significantly different (P>0.05). Conclusion Combination of ETV and herbal medicine, Ruangan Sanjie Prescription , in the treatment of patients with CHB could improve TCM syndromes, and even ameliorate liver fibrosis, which might be related to modulation of body immune system.

Key words: Hepatitis B, Liver fibrosis, Entecavir, Ruangan Sanjie prescription, herbal medicine, T lymphocyte subsets, Therapy