Breast Block Away Piece Treatment (qi And Blood Stasis Type) Clinical Curative Effect Observation

Objective:Through clinical observation, Ru-kuai-xiao tablets treatment of hyperplasia of mammary gland (qi stagnancy and blood stasis syndrome) in patients with clinical efficacy make an objective evaluation.Methods:Before and after the efficacy of control.There were120cases which were in line with the western diagnosis of mammary gland hyperplasia and qi stagnation and blood stasis type of traditional Chinese medicine enrolled in this study. They were given to Ru-kuai-xiao tablets,0.5g per tablet, four tablets for one time, and three times a day, orally. The trial treatment lasted for eight weeks. The healed patients were followed-up for4weeks.Observations:①breast lumps efficacy;②breast pain efficacy;③the traditional Chinese medicine syndromes;④other symptoms and signs of efficacy. And we monitored their laboratory tests and the presence of serious adverse events.Statistical methods:All statistical tests used the T test or Wilcoxon rank sum test, P values less than0.05will be considered to be statistically significant difference test. Quantitative description of the indicators will calculate the number of cases, mean, standard deviation, median, minimum, maximum. A description of the classification index will use the number and percentage of various types of cases.Results:Efficacy assessment:(1) The efficacy of breast lumps:the difference before and after the treatment in the size and the texture of breast lumps was statistically significant (P<0.05). It prompts that Ru-kuai-xiao tablets can significantly improve the size and the texture of breast lumps in patients.(2) The efficacy of breast pain:the difference in the efficacy of breast pain before and after the treatment was statistically significant (P<0.05). It prompts that Ru-kuai-xiao tablets can significantly improve the efficacy of breast pain in patients.(3) The efficacy of the TCM Syndrome:The statistics found that113patients after treatment,7cases were clinically cured,27cases were markedly effective, and70cases were effective.Total effective rate was92%.(4)The efficacy of other signs and symptoms:the difference before and after the treatment in the efficacy of relieving pain and swelling, relieving irritability, menstruation in dark color, blood clots,the line of abdominal pain, petechiae, ecchymosis, wiry pulse,and astringent pulse was statistically significant (P<0.05). It prompts that Ru-kuai-xiao tablets can significantly improve the Xiong Xie fullness, irritability, menstruation in dark color, blood clots, line of abdominal pain, petechiae, ecchymosis, wiry pulse, pulse astringent similar effect. The difference before and after the treatment in the dark Tongue was not statistically significant (P=0.855>0.05). Safety assessment:After treatment, the changes in the blood and urine routine examinations were not drug-related abnormalities of clinical significance. Some indicators of the exception have a reasonable explanation. There were no abnormal results in the stool examination and biochemical tests after treatment. The changes in the ECG were not clinically and significantly abnormal. There was no serious adverse reaction.Conelusion:Ru-kuai-xiao tablets in the treatment of mammary gland hyperplasia (qi stagnation and blood stasis type of Traditional Chinese Medicine) are safe and effective.