Abstract: Objective The aim of this study was to investigate the efficacy of entecavir and Fuzheng Jiedu Sanjie Decoction, a herbal compound, combination in the treatment of patients with hepatitis B-induced liver cirrhosis (LC). Methods A total of 112 patients with hepatitis B-induced LC were enrolled in our hospital between September 2020 and September 2022, and were divided randomly into control (n=56) and observation group (n=56), receiving entecavir or combination of entecavir and the herbal compound treatment for 24 weeks. Serum type-III procollagen (P-Ⅲ), laminin (LN), hyaluronic acid (HA) and type-IV collagen (Ⅳ-C) levels were detected by radioimmunoassay, the thickness of spleen, diameters of splenic vein and portal vein were detected by color Doppler ultrasonography and the liver stiffness measurement (LSM) was detected by FibroScan. Results At the end of 24 week treatment, the normalization rate of serum ALT level in the observation group was 92.9%, much higher than 75.0%(P<0.05) in the control; the traditional Chinese medicine (TCM) syndrome scores in the observation group decreased greatly, much superior to that in the control (P＜0.05); serum ALT level in the observation group was (41.6±9.0)U/L, significantly lower than in the control; serum PC-Ⅲ and HA levels were (106.4±17.9)μg/L and (122.3±15.6)μg/L, both significantly lower than in the control; the spleen thickness and LSM were (43.8±3.5)mm and (11.0±1.6)kPa, both much lower than in the control group. Conclusion The combination of a herbal medicine compound at base of entecavir antiviral therapy could improve liver function test normal and ameliorate liver fibrosis, and warrants further clinical investigation.

Key words: Liver cirrhosis, Hepatitis B, Entecavir, Fuzheng Jiedu Sanjie Decoction, Herbal medicine, Therapy