[目的]观察具有活血通络、软坚散结之功效的活血软肝丸在早期乙肝肝硬化治疗上的临床疗效及作用机理。[方法]将60例早期乙肝肝硬化患者按照入组顺序随机分为治疗组和对照组各30例,治疗组在常规治疗的基础上加用活血软肝丸口服,对照组予以水飞蓟宾葡甲胺片口服,观察2组治疗前后临床疗效、肝功能、肝纤维化等指标的变化。[结果]治疗组总有效率明显高于对照组,差异有统计学意义(P<0.05),说明治疗组疗效优于对照组。各组治疗前后肝功能指标比较,差异有统计学意义(P<0.05);与对照组治疗后比较,差异有统计学意义(P<0.05),说明每组在治疗后肝功能的改善明显优于治疗前;2组治疗后比较,治疗组明显优于对照组(P<0.05),说明活血软肝丸在改善肝功能方面明显优于对照组。各组治疗前后肝纤维化指标比较,差异有统计学意义(P<0.05),治疗后肝纤维化指标明显较治疗前降低;2组治疗后比较,差异有统计学意义(P<0.05),说明治疗组抗肝纤维化作用明显优于对照组。[结论]活血软肝丸能改善肝脏的血液循环,减轻肝脏炎性反应,改善肝细胞代谢,稳定细胞膜,防止肝细胞损伤和促进肝细胞恢复,从而促进肝纤维化逆转,起到抗肝纤维化的作用。 [Objective] To observe the clinical effect and mechanism of Huoxue Ruanan Pill with the function of promoting blood circulation and clearing away the blood, [Methods] Sixty patients with early-stage hepatitis B cirrhosis were randomly divided into treatment group and control group according to the order of admission. The treatment group was treated with Huoxue Ruangan pills orally on the basis of routine treatment, while the control group was treated with silybin Meglumine tablets orally, observe the clinical efficacy of two groups before and after treatment, liver function, liver fibrosis and other indicators of change. [Results] The total effective rate of the treatment group was significantly higher than that of the control group, the difference was statistically significant (P <0.05), indicating that the treatment group than the control group. Compared with the control group, there was significant difference (P <0.05) in the indexes of liver function before and after treatment in each group, which showed that the improvement of liver function in each group was obvious Before treatment, after treatment, the treatment group was significantly better than the control group (P <0.05), indicating that Huoxue Ruangan pill was significantly better than the control group in improving liver function. The indexes of liver fibrosis before and after treatment in each group were significantly different (P <0.05), and the indexes of liver fibrosis after treatment were significantly lower than those before treatment. The differences between the two groups were statistically significant (P <0.05) The treatment group was significantly better than the control group anti-liver fibrosis. [Conclusion] Huoxue Ruangan Pill can improve the blood circulation of the liver, relieve the inflammatory reaction of the liver, improve the metabolism of hepatocytes, stabilize the cell membrane, prevent the damage of hepatocytes and promote the recovery of hepatocytes, thus promoting the reversal of liver fibrosis and playing a role in anti-liver fibrosis The role of the