Abstract: Objective This study aimed to investigate clinical efficacy of tenofovir and Anluo Huaxian capsule, a herbal medicine compound, combination in the treatment of patients with hepatitis B-induced liver cirrhosis (LC). Methods A prospective study was carried out at Xuzhou Central Hospital, enrolled 145 patients with hepatitis B-induced LC between March 2019 and March 2023, and all were randomly assigned to receive tenofovir disoproxil fumarate (TDF) in 73 cases (control) or TDF with combination of the herbal medicine in another 72 cases (observation) for 12 months. Serum tumor necrosis factor-α(TNF-α), interleukin -6(IL-6) and IL-8 levels were detected by ELISA, and serum laminin(LN), collagen type Ⅳ(Ⅳ-C), precollagen-Ⅲ (PC-Ⅲ) and hyaluronic acid(HA) levels were assayed by ELISA. Traditional Chinese Medicine (TCM) symptom scores were evaluated routinely. Results By end of 12 month treatment, serum bilirubin and alanine aminotransferase levels in the combination group were (23.2±5.3)μmol/L and (31.1±2.4)u/L, both significantly lower than [(36.6±5.1)μmol/L and (41.1±6.4)u/L, respectively, P＜0.05], while serum albumin level was (39.1±7.0)g/L, significantly higher than [(35.6±5.9)g/L, P＜0.05] in the control; serum IV-C, PCⅢ and HA levels were (62.5±11.7)ng/mL, (59.3±11.8)ng/mL and (67.0±17.7)ng/mL, all significantly lower than [(74.7±12.5)ng/mL, (77.5±11.5)ng/mL and (80.6±17.0)ng/mL, respectively, P＜0.05] in the control group; serum TNF-α, IL-6 and IL-8 levels were (6.5±2.2)ng/L, (4.1±1.0)ng/L and (3.1±0.6)ng/L, all significantly lower than [(10.0±2.4)ng/L, (6.2±1.2)ng/L and (4.4±0.8)ng/L, respectively, P＜0.05] in the control; TCM symptom scores, such as abdominal distension, jaundice, right hypochondrial pain and dry mouth were(0.8±0.1)points, (1.0±0.4)points, (0.9±0.4) points and (0.8±0.1)points, all much lower than [(1.7±0.2)points, (2.0±0.2)points, (1.7±0.5)points and (1.4±0.3)points, respectively, P＜0.05] in the control group. Conclusion The combination therapy of tenofovir and herbal medicine, Anluohuaxian capsule in treatment of patients with hepatitis B-related LC is found to be efficacious, with improvement of liver function tests and reduction of serum liver fibrosis markers, especially ameliorates TCM syndromes, and warrants further clinical long-term investigation.

Key words: Liver cirrhosis, Hepatitis B, Tenofovir, Anluo Huaxian capsule, a herbal medicine, Therapy