| Objective:1.To appraise the security of RuKangShu capsule preliminarily.2. To appraise the clinical effect of RuKangShu capsule on hyperplasia of mammary glands (Kidney deficiency Liver stagnation, ChongRen imbalance Zheng) preliminarily, and definite the clinical dosage of RuKangShu capsule and the course of treatment ultimately on the base of the clinical dosage of RuKangShu capsule and the course of treatment drawn up in the plan.Methods:To select the patients of hyperplasia of mammary glands whose age is from 18 to 50, and were diagnosed TCM BianZheng as Kidney deficiency Liver stagnation, ChongRen imbalance Zheng. According to the experimental plan, the patients were divided randly into two groups. The therapeutic group using RuKangShu capsule was 30 cases, the controlled group using RuZengNing capsule was 30 cases. The course of treatment was 2 menses periods. Take medicines 21 days in each menses period and don' t take them in menses.Observe target:1.The target of appraising the clinical effect : Appraise TCM ZhengHou before treatment , after taking 3 weeks medicines and 6 weeks , after treatment 1 menses period (patients recovered) . Observe color ultrasonic in breast before treatment , after taking 6 weeks medicines and after treatment 1 menses period (patients recovered) .2. The target of appraising the security of RuKangShu capsule : Observe Blood-routine , Urine-routine , Stool-routine , ALT , Bun , Cr and EKG before and after treatment .Results:There is no significant difference in age , illness course , breast symptoms and TCM ZhengHou before treatment between the two groups (P>0. 05) . Also , there is no significant difference between the two groups in menses, marriage, birth, breast-feed, history of illness and treatment ect(P>0. 05). Sothe two groups can be compared.1. There is no significant difference in effect between the two groups (P>0. 05). The total effective rates of the two groups are 96.43%.2. There is no significant difference in TCM ZhengHou between the two groups (P>0. 05). In the therapeutic group, the total effect rates is 96.43%, and it is 82. 14% in the controlled group.3. Comparing the total sign of TCM ZhengHou before and after treatment, there is very significant difference in each group (P<0. 01) . There is no significant difference between the two groups after treatment (P>0. 05).4. Comparing the pain in breast before and after treatment, there is very significant difference in each group (P<0. 01). There is no significant difference between the two groups after treatment (P>0.05).5. Comparing the lump of breast before and after treatment, there is very significant difference in each group (P<0. 01). There is no significant difference between the two groups after treatment (P>0. 05).6. There is no significant difference in Blood-routine , Urine-routine ,Stool-routine, ALT , Bun , Cr and EKG before and after treatment (P>0.05) . In the course of taking medicines, there was a patient had pain in stomach, without dealing with it, the symptom disappeared. It didn' t affect the treatment.Conclusion:RuKangShu capsule has better therapeutic effect on hyperplasia of mammary glands (Kidney deficiency Liver stagnation, ChongRen imbalance Zheng). It can lessen the lump of breast and lighten the pain in breast effectively. Moreover, it can improve the accompanying symptom of patients, and it hasn' t toxicity. |