OBJECTIVETo explore the efficacy and mechanism of Lirukang Granule in treating hyperplasia of mammary gland (HMG).

METHODSOne 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 thrice a day, 4 tablets each time. The therapeutic course for both groups was 4 months. The clinical efficacy, pain alleviating rate, as well as changes of local sign and symptom scores were observed before and after treatment. The changes of serum estradiol (E(2)), 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.

RESULTSThe total clinical efficacy in the treated group was superior to that in the control group, significant 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, significantly 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).

CONCLUSIONLRKG has good efficacy in the treatment of HMG, and its mechanism may be related to the regulation on endocrine and immune function.