A Preliminary Study On The General Treatment Of Breast Hyperplasia And The Clinical Curative Effect Evaluation Of Rukangshu Capsule

Objective:Observation and analysis of Rukangshu Capsule on the clinical validity and safety of the treatment of hyperplastic disease of breast (stagnation of liver and deficiency of kidney, Chong Ren dysfunction syndrome). In order to explore on the basis of the liver qi, resolving phlegm and removing effect of difference product method and promoting blood circulation by removing blood stasis in the treatment of breast hyperplasia.Method:In the Third Affiliated Hospital of Beijing University of Chinese Medicine,44 cases were taken as the research object. Give Rukangshu capsule 3 capsules each time,3 times a day, after meals, menstrual disabled.2 menstrual cycles after the observation of the treatment effect of patients. Efficacy measures included:(1) Breast pain (the number of days of pain in a menstrual cycle, the degree of the most pain). (2) The size, hardness and distribution range of breast lump. (3) Breast pain and tenderness index. (4) The curative effect of traditional Chinese medicine. (5) Bilateral breast color Doppler sonography. The main outcome measures were the number of days of breast pain and the degree of pain in a menstrual cycle. Safety indicators included (1) adverse events/adverse effects of symptoms, signs, disease/ syndrome. (2) Blood, urine routine, women of childbearing age in the urine pregnancy test. (3) Liver function (ALT, AST, TBIL, ALP, GGT), renal function (BUN and Cr). (4) ECG. (5) Vital signs and physical examination. The incidence rate of adverse reaction was the main safety evaluation index. To observe the therapeutic effect of the patients and to carry out statistical analysis. Analysis using SPSS20.0 IBM software. To carry out exploration and research, count data expressed by the x±s, measurement data using general linear model repeated measures test, P>0.05 that meet the test of sphericity, if does not meet the test of sphericity using greenhouse geisser proofread. Count data using chi square test, Fisher exact test, etc.Result:According to the breast pain, breast nodule size and traditional Chinese medicine grading score to determine the efficacy. The total effective rate of Rukangshu capsule is 75.60%, which can be considered to have obvious curative effect. Curative effect index analysis of breast pain, breast lump size, single syndrome (including the main symptoms, the second disease) and so on have better improvement. Safety evaluation:possible symptoms such as dizziness, toothache. Body temperature, respiration, blood pressure, resting heart rate, blood routine, urine routine showed no abnormal change. The adverse events may be related to the drug in the medicine containing nourishing Chinese medicine.Conclusion:Rukangshu Capsule on hyperplasia of mammary glands (stagnation of liver and deficiency of kidney, Chong Ren dysfunction syndrome) has better clinical efficacy, and think it is worthy of popularization and application.