Objective:To explore the effi cacy and mechanism of Lirukang Granule(利乳康颗粒,LRKG) in treating hyperplasia of mammary gland(HMG).Methods:One hundred patients with HMG were randomly assigned to two groups,50 in each group.The patients in the treated group were orally administered with LRKG thrice a day,one package each time,and those in the control group were given orally Rukuaixiao Tablet(乳块消,RKX) thrice a day,4 tablets each time.The therapeutic course for both groups was 4 months.The clinical eff icacy,pain alleviating rate,as well as changes of local sign and symptom scores were observed before and after treatment.The changes of serum estradiol(E2),progesterone(P),testosterone(T),follicle stimulating hormone(FSH),luteinizing hormone(LH) and prolactin(PRL) in some randomly selected patients(24 patients in the treated group and 24 in the control group) before and after treatment were measured with radioimmunoassay.Results:The total clinical effi cacy in the treated group was superior to that in the control group,signifi cant difference was shown between the two groups(P<0.01).The cure-effective rate and total effective rate in the treated group were 70.0%and 88.0% respectively,signif icantly higher than those in the control group(38.0% and 64.0%) respectively(P<0.01),and the pain alleviating rate in the treated group was also significantly higher in the former than that in the latter(88.0% vs 64.0%,P<0.05).Moreover,the treated group showed obvious superiority in improving the patients’ symptom and sign scores(P<0.01),and abnormalities of gonadal hormone as compared with the respective items in the control group(P<0.01).Conclusion:LRKG has good effi cacy in the treatment of HMG,and its mechanism may be related to the regulation on endocrine and immune function. Objective:To explore the effi cacy and mechanism of Lirukang Granule(LRKG) in treating hyperplasia of mammary gland(HMG).Methods:One hundred patients with HMG were randomly assigned to two groups,50 in each group.The Patients in the treated group were orally administered with LRKG thrice a day,one package each time,and those in the control group were given orally Rukuaixiao Tablet(乳块消,RKX) thrice a day,4 tablets each time.The fuck course for Both groups was 4 months.The clinical eff icacy,pain alleviating rate,as well as changes of local sign and symptom scores were observed before and after treatment.The changes of serum estradiol(E2),progesterone(P),testosterone(T) ,Follicle stimulating hormone (FSH), luteinizing hormone(LH) and prolactin(PRL) in some randomly selected patients(24 patients in the treated group and 24 in the control group) before and after treatment were measured with radioimmunoassay.Results:The total Clinical effi cacy in the treated group Was superior to that in the control group, signifi cant difference was shown between the two groups (P<0.01). The cure-effective rate and total effective rate in the treated group were 70.0% and 88.0% respectively, signif icantly higher than those In the control group (38.0% and 64.0%) respectively (P<0.01), and the pain alleviating rate in the treated group was also significantly higher in the former than that in the latter(88.0% vs 64.0%, P<0.05). .Moreover, the treated group showed obvious superiority in improving the patients’ symptom and sign scores (P<0.01), and abnormalities of gonadal hormone as compared with the related items in the control group (P<0.01). Conclusion: LRKG has good Effi cacy in the treatment of HMG,and its mechanism may be related to the regulation on endocrine and immune function.