OBJECTIVE： To investigate clinical efficacy and safety of Miao medicine Jinyin huashi granules combined with western medicine in the treatment of chronic calculous cholecystitis （CCC）. METHODS： A total of 120 CCC patients in our hospital during Jan. 2014-Jan. 2016 were randomly divided into control group and observation group， with 60 cases in each group. Control group was given 50％ Magnesium sulfate solution 10 mL orally before meal， tid； amoxicillin 0.5 g orally， tid+Racanisodamine tablets 10 mg， tid+Compound dantong tablets 1 slice， tid， after meal. Observation group was additionally treated with Miao medicine Jinyin huashi granules 15 g， tid， on the basis of control group. Both groups were treated for consecutive 4 weeks. Clinical efficacies， the improvement of upper abdominal pain， nausea and greasy， calculus were observed in 2 groups. The thickness of gallbladder， serum levels of IL-2 and IL-5， mRNA and protein expression of CYP7A1 and B-UCT were compared between 2 groups before and after treatment. The occurrence of ADR was recorded in 2 groups. RESULTS： Total response rate of observation group was 96.67％， which was significantly higher than 88.33％ of control group， with statistical significance （P＜0.05）. One d and one week after treatment， the improvement rates of upper abdominal pain were 63.33％ and 81.67％ in observation group， which were significantly than 36.67％ and 50.00％ of control group， with statistical significance （P＜0.05）. There was no statistical significance in the improvement rate of nausea or greasy after treatment between 2 groups （P＞0.05）. The stone-free rate of observation group was 33.33％ and significantly higher than 11.67％ of control group， with statistical significance （P＜0.05）. Before treatment， there was no statistical significance in the thickness of gallbladder wall， serum levels of IL-2 or IL-15， mRNA and protein expression of CYP7A1 or B-UCT between 2 groups （P＞0.05）. After treatment， the thickness of gallbladder wall， serum levels of IL-2 and IL-15 were all decreased significantly in 2 groups， while mRNA and protein expression of CYP7A1 and B-UCT were increased significantly； observation group was significantly better than control group， with statistical significance （P＜0.05）. There was no statistical significance in the incidence of ADR between 2 groups （P＞0.05）. CONCLUSIONS： Miao medicine Jinyin huashi granules combined with western medicine show significant therapeutic efficacy for CCC， can effectively improve right upper quadrant pain， nausea and greasy， decrease serum levels of IL-2 and IL-5 and up-regulate mRNA and protein expression of CYP7A1 and B-UCT with good safety.