Abstract: OBJECTIVE   To observe the clinical efficacy of Rougan Huaxian granules on patients with liver and kidney-yin deficiency type of compensated hepatitis B cirrhosis and the effects on the expression levels of serum NLRP3 inflammasomes and related-products.METHODS   80 patients were randomly divided into the treatment group and the control group, 40 patients for each. The two groups were given Entacvir orally according to the guideline, while the treatment group was given Rougan Huaqian granules in addition to Entacvir. The course lasted 24 weeks. At the end of the treatment course, the liver function, four indicators of liver fibrosis procollagen type Ⅲ(PC-Ⅲ), collagen type Ⅳ (Ⅳ-C), laminin (LN), hyaluronic acid (HA), liver and spleen imaging indexes, HBV DNA, traditional Chinese medicine (TCM) syndrome scores, clinical efficacy, serum protein levels of interleukin-1β (IL-1β), interleukin-18 (IL-18), and tumor necrosis factor-α (TNF-α), serum levels of NLRP3 inflammasomes, cysteine aspartate protease 1 (Caspase-1), IL-1β, IL-18 mRNA were compared between the two groups.RESULTS   After treatment, the TCM syndrome scores of both groups were lower than those before treatment (P < 0.01), and the scores of the treatment group were better than those of the control group (P < 0.01). The liver function, four indicators of liver fibrosis, TCM syndrome scores, liver and spleen imaging indexes of both groups were better than those before treatment (P < 0.01). The indexes of the treatment group were better than those of the control group (P < 0.01). The serum protein levels of IL-1β, IL-18, TNF-α in both groups were lower than those before treatment. The levels of NLRP3, Caspase-1, IL-1β, and IL-18 mRNA were better than those before treatment (P < 0.01), and the treatment group was significantly better than the control group (P < 0.01). The total effective rate of the treatment group was 87.5%, higher than the control group (P < 0.05).CONCLUSION   The clinical efficacy of Rougan Huaxian granules combined with Entacvir is significantly improved in the treatment of patients with liver and kidney yin deficiency type of compensated hepatitis B cirrhosis. The mechanisms may involve inhibiting the expression levels of NLRP3 inflammasomes, Caspase-1, IL-1β, IL-18, and TNF-α, effectively controlling the inflammatory response of the body, thus improving the clinical symptoms of patients.