Abstract: Objective The purpose of this clinical trial was to investigate the auxiliary treatment of a herbal compound, Ganshuang granule, with entecavir for patients with chronic hepatitis B (CHB). Methods 60 patients with CHB were enrolled in our hospital between January 2019 and January 2021, and were randomly divided into control and observation groups, with 30 cases in each. The patients in the control group received entecavir, and those in the observation were treated with entecavir and a herbal compound, Ganshuang granule, for 48 weeks. The AST to platelet ratio index (APRI), fibrosis 4 score (FIB-4) were obtained, and the liver stiffness measurement (LSM) was determined by FibroTouch scan. Serum interleukin-6(IL-6), transforming growth factor-beta (TGF-β), platelet-derived growth factor (PDGF) and C-reactive protein (CRP) levels were assayed by ELISA. Results At the end of 48 week treatment, serum ALT and AST levels in the observation group were significantly lower than in the control group (P<0.05); serum HBV DNA loss in the two groups were both 100.0%, and serum HBeAg negative rates were both 0.0% (P>0.05); the APRI, FIB-4 and LSM in the observation group were (1.02±0.23), (4.38±0.77) and (7.73±1.53), all significantly lower than [(1.30±0.33), (5.26±0.85) and (9.68±2.02), respectively, P<0.05] in the control; serum IL-6, TGF-β, PDGF and CRP levels in the observation were much lower than in the control (P<0.05). Conclusion The auxiliary treatment of Ganshuang granule at base of entecavir antiviral therapy could significantly improve biochemical response in patients with CHB, which might be related to the anti-fibrotic effect and inhibition of body inflammatory reaction of the herbal compound.

Key words: Hepatitis B, Entecavir, Herbal medicine, Ganshuang granule, Interleukin-6, Therapy