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OBJECTIVE:To investigate the effect of entecavir plus Ganshuang granule (肝爽颗粒,GSG) on ad-vanced fibrosis and cirrhosis in patients with chron-ic hepatitis B virus infection.METHODS:One hundred thirty-five patients were randomly assigned to one of two cohorts:GSG co-hort (n =69) or placebo cohort (n =66).The GSG co-hort received entecavir plus GSG and the placebo cohort received entecavir plus placebo for 48 weeks.Liver biopsy was performed at baseline and between weeks 44 and 48 during this placebo-con-trolled trial.We assessed histological improvement(greater than a two-point decrease using the Knodell inflammatory score and no worsening of the Ishak fibrosis score) and fibrosis regression (a decrease of at least one point in the Ishak fibrosis score).RESULTS:There were 95.7％ of patients (66/69) in the GSG cohort and 66.7％ (44/66) of patients in the placebo cohort who showed necroin fl ammation improvement.The mean reduction in the Knodell necroinflammatory score was 5.1 and 2.6,respec-tively.There were 89.9％ (62/69) of patients in the GSG cohort and 31.8％ (21/66) of patients in the pla-cebo cohort who showed at least a one-point im-provement in the Ishak fibrosis score.The mean re-duction in the Ishak fibrosis score was 1.7 and 0.4,respectively.CONCLUSION:Patients with advanced fibrosis and cirrhosis caused by chronic hepatitis B showed more improvement in liver histology in a shorter time after treatment with entecavir plus GSG com-pared with entecavir plus placebo.