| Purpose:This study is based on the PhaseⅡclinical trial work, validate FuFang Xianrong particles on the HMG (ChongRen imbalance type) in patients with breast pain and breast mass effectiveness and security; evaluation of FuFang Xianrong particles on the HMG (ChongRen imbalance type) Syndrome patients, clinical symptoms and signs and the improvement of the duration of the role of the breast.Method:All subjects were from age 18 to 50 years old, Chinese medicine of the evidence for the ChongRen disorder caused by HMG of female patients were recruited. According to the program of FuFang Xianrong particles phaseⅢclinicl trial:grouping a randomized, double-blind, P lacebo control. The pacients were divided into two groups. The treatment group (45 cases) used fuFang Xianrong particles. Take it orally twice a day. Course of disease is during menstrual cycle. Stop taking in menstrual days. The control group (15 cases) used placebo.Observation point:1. The targe of effectiveness evaluation:test before treatment (7 days before menstruation) and the study drug period (the study drug were three menstrual cycles) of the monthly menstrual cycle after the first 7 days, and after the end of trial medication Syndrome assessment, and 7 days before treatment, after treatment for breast test color Doppler examination.2. Safety Evaluation:before treatment (7 days before menstruati on), respectively, after the end of the inspection test drug a routine blood test, liver function (ALT, AST), renal function (BUN, Cr), urine routine, stool, ECG.Results:There is no statistically significant different in age, height, weight, duration, menstrual period, marital status, treatment of breast pain, breast lumps, breast lumps maximum diameter, total score and syndromes in the Statistical analysis. There is no significant difference(P＞0.05), be compared.1. There is no significant difference in effect of pain in breast between the two groups (P＞0.05). The total effective rates is 84.4%, and it is 57.1% in the controlled group.2. There is no significant difference in the effect of breast lump between the two groups (P＞0.05). The total effective rates is 48.9%, and it is 21.4% in the controlled group.3. There is very significant difference in effect of TCM syndromes between the two groups (P＜0.05). The total effective rates is 95.6%, and it is 71.4% in the controlled group. The effect of the experimental group is better than the control group.4. Comparing the score of breast pain before and after treatmen, there is very significant difference in two groups after 3 months treatment (P＜0.05), suggesting that the experimental group is better than the controlled group after 3 months treatment. 5. Comparing the score of breast lumps before and after treatment, there is no significant difference between the two groups after treatment(P＞0.05), suggesting that two groups is similar in improving breast lumps.6. Comparing the score of TCM syndromes 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), suggesting that two groups can improve the clinical symptoms.7. Security observation:the test group appear in 5 cases of adverse reactions; the control group of 2 cases of adverse reactions. Were not clearly drug related.Conclusion:The clinical trial results further show that:FuFang Xianrong particles has better therapeutic effect on hyperplasia of mammary glands (ChongRen imbalance type). It can lessen the lump of breast and lighten the pain in breasteffectively. Moreover, it can improve the accompanying symptom of patients,and it has not toxicity. |
