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Objective: Ruheshanjie piece as a control, treatment of mammary glands (liver stagnation and blood stasis) multi-center Phase Ⅱ clinical efficacy and safety of clinical trials through Phase Ⅱ clinical trial research, milk-core tablets to make a preliminary evaluation and Ⅲ clinical dose and treatment and to determine. METHODS: A randomized, double-blind, double-dummy, positive controlled, multi-center trial design. Choose to comply with Western medicine diagnosis of breast hyperplasia and TCM syndrome of qi stagnation and blood stasis standard 18-50 female patients with 240 cases, the ratio of 1:1 (milk-core tablets) were randomly assigned to the experimental group and the control group (Ruheshanjie tablets). The course of treatment was 3 months. Acquisition and associated symptoms / signs integral to evaluate efficacy; simultaneously collecting adverse events and safety laboratory tests (blood, urine, stool routine; liver and kidney function; ECG) results to evaluate security. According to the main and associated symptoms / signs integral efficacy index to determine the overall efficacy. The total efficiency (including clinical recovery, effective, effective), the chi-square test of efficacy index rank sum test, various symptoms / signs of improvement and the disappearance rate CMH chi-square test and the chi-square test to compare test group and the control group, the difference in terms of efficacy. Results: This study enrolled 240 subjects, excluding 11 cases, withdrawn from nine cases. All can be incorporated into the security set, 229 cases included in the full analysis set (test group of 113 patients in the control group 116 cases), 220 cases of to incorporate consistent with the program set (test group of 109 cases, 111 cases of the control group). The two sets of demographic and baseline condition equalization comparable. The total clinical efficacy: PPS analysis: efficacy index of the total clinical efficacy between the two groups, the experimental group than the control group is 0.52 ± 0.16, 0.47 ± 0.22, the difference was statistically significant (P = 0.04); total efficiency of the test group 93.58%, 80.18% better than the control group, the difference was statistically significant (P = 0.003). The FAS analysis results analysis consistent with the PPS, the efficacy index and total efficiency, the experimental group than the control group. Clinical symptoms and signs of efficacy: breast after treatment of breast pain, breast tenderness, and the breast lumps distribution range of hardness, breast lumps, breast lumps the size of the main clinical symptoms were improved to varying degrees, but the difference between the groups was not statistically significant (P gt; 0.05). About half of the subjects were breast pain disappeared (test group 57.41% vs control group, 42.34%), breast tenderness disappeared (test group 53.70% vs 42.34%) of the control group, but only less than 10% of the subjects breast lumps disappear ( test group 8.26% vs 9.91% of the control group). Between the two groups breast the pain disappears rate test group was higher, the difference was statistically significant (P = 0.03); breast tenderness disappears rate, the disappearance rate of breast lumps group difference was not statistically significant sex (P gt; 0.05 ). After treatment, nipple discharge, nipple itching, chest swelling, nausea, irritability, insomnia, dreams, mouth waiting associated symptoms / signs multi disappear (60.71% -100%), the difference between groups was not statistically significant ( P gt; 0.05). Safety laboratory tests: After treatment, all part of patient blood, urine, stool routine, liver and kidney function, ECG test results appear abnormal causality judgments no clinical significance, and has nothing to do with the test drug. Which test group 1 cases the ALT treatment before 8 IU / L after treatment, 82 IU / L, and researchers believe that patients without any discomfort, consider the Month patients due to work stress, fatigue affect clinical significance. Reexamination resume normal , ALT: 21 IU / L \Control group with ALT before treatment 14 IU / L after treatment, 89 IU / L, and the researchers explain postprandial testing. Adverse events / adverse reactions: the experimental group of five cases of adverse reactions, the incidence rate was 4.17% (5/120). 3 cases of menstrual disorders (1 case of menstruation has no regular, two cases through reduced); 1 cases epigastric discomfort; 1 cases of stomach pain, belching associated with dysmenorrhea. Causality judgment for the two cases of \The control group had three cases of adverse reactions, the incidence rate was 2.50% (3/120). Two cases of epigastric discomfort; cases of stomach pain. The judgment of the causal relationship between one cases of \Conclusion: preliminary evaluation through Phase II clinical trial therapeutic effect and safety of the milk-core tablets treatment of mammary glands clinical liver stagnation and blood stasis syndrome effective than Ruheshanjie piece has a better analgesic effect, breast pain the disappearance rate Ruheshanjie piece. The incidence of adverse events were low, and no serious adverse events, the subjects of the milk-core tablets was well tolerated. The application of this phase Ⅱ study dose, the recommended Phase III clinical study to further verify the efficacy and safety of the milk-core tablets.
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