Abstract：Objective：To observe the clinical effect of modified Fuzi Lizhong tang for hyperplasia of mammary glands of binding of phlegm and blood stasis type. Methods： A total of 82 cases of patients with hyperplasia of mammary glands of binding of phlegm and blood stasis type were selected and divided into the observation group and the control group according to different treatment methods， 41 cases in each group. The control group was treated with Rupixiao tablets， and the observation group was treated with modified Fuzi Lizhong tang. Both groups were treated for eight weeks. Clinical effects in the two groups were compared；Chinese medicine syndrome scores， hormone levels and immune function before and after treatment were compared between the two groups. Results：The total effective rate was 95.12% in the observation group， higher than that of 78.05% in the control group(P＜0.05). After treatment， the scores of mammalgia， chest tightness and expectoration， upset and bitter mouth， weak waist and knees， and irregular menstruation in the two groups were decreased when compared with those before treatment， and the above five Chinese medicine syndrome scores in the observation group were lower than those in the control group(P＜0.05). After treatment， the levels of luteinizing hormone (LH)， progesterone(P)， CD3 + and CD4 + in the two groups were increased when compared with those before treatment， and the above four levels in the observation group were higher than those in the control group(P＜0.05)；the levels of estradiol (E2)， prolactin(PRL) and CD8 + in the two groups were decreased when compared with those before treatment， and the above three levels in the observation group were lower than those in the control group(P＜0.05). Conclusion：Modified Fuzi Lizhong tang for hyperplasia of mammary glands of binding of phlegm and blood stasis type can effectively relieve clinical symptoms， correct endocrine imbalance and improve immune function.