| The hyperplasia Of mammary glands occupies the first place of the disease morbidity of mammary gland. In modern medicine's opinion, the hyperplasia Of mammary glands has relation with the disorder of hormone metabolism, especially the estradiol-progestone ratio, and the disorder of hormone receptor in mammary substance in female. These disorders have mammary glands excess hyperplasia and incomplete restoration, so as to make every part of hyperplasia intensity of breast different. And the relevance of hyperplasia and breast cancer of mammary gland is verified. In modern medicine study, the mechanism theory of "development model of many stages", known as "normal-hyperplasia-atypical hyperplasia-first position cancer-infiltration cancer", has been advanced. So, it is a trend and necessary to find a safe, effective and reliable drug to block even reverse this course and it is significant for prevention and control of breast cancer. Traditional Chinese medicine has unique advantages in treating the hyperplasia Of mammary glands, such as obvious curative effect, no side effects and not disturbing endocrine system. Tongluosanjie pill was developed in 1960s by our hospital. This medicine has good effect on the hyperplasia of mammary gland used for many years. So, this article is based on evidence to study the curative effect of the blood stasis pattern of the hyperplasia of mammary gland.Objective: To confirm the clinical curative effect of Tongluosanjie pill treating the blood stasis pattern of the hyperplasia of mammary gland. To elucidate Tongluosanjie pill's impacts on the serum levels of estradiol, progestone and prolactin of patients. To discuss the pathogenesis of the blood stasis pattern of the hyperplasia of mammary gland and the mechanism of Tongluosanjie pill treating the blood stasis pattern of the hyperplasia of mammary gland. To further develop its applicability and spread.Method:①Patient are randomly divided into two groups including Tongluosanjie pill group(treatment group) and Rukuaixiao group(positive control group).②In treatment group, patients take Tongluosanjie pill 5 grams one time, two times a day. In control group, patients take Rukuaixiao 5 pills one time, two times a day. One course includes 8 weeks. Patients don't take medicines for 5 days among menstrual period.③To observe the changes of breast pain before and after treatment, regarding 4 weeks as one course. To observe the serum levels of estradiol, progestone and prolactin(limosis in the morning) before and after treatment.④We adopt normality test and test for homogeneity of variance (SPSS 12．0 software). It will take double t test for quantitative data and rank-sum test for grades data.to count the software, carry on the straight attitude test and neat test of variance to all groups of data, measuring the materials uses one pair of sides t to examine, the grade materials adopt the order and examine.Result:①In treatment group, there are 3 cure, 16 markedly improvement, 7 improvement and 4 failure and total effective rate is 86．7%. In control group, there are 2 cure, 14 markedly improvement, 8 improvement and 6 failure and total effective rate is 80．0%. There is no difference between two groups (P>0．05) by rank-sum test.②In both groups, pain and tumor of breast are both relieved after 8 weeks treatment(P<0．01) . Tongluosanjie pills ameliorate tumor better than Rukuaixiao after 4 weeks treatment (P<0．05) . But there is no difference between two groups after 8 weeks treatment (P>0．05) . These verify that Tongluosanjie pill is quicker than Rukuaixiao in tumor amelioration. There are no difference between two groups after 4 weeks and 8 weeks treatment(P>0．05) .③Tongluosanjie pill (P<0．05) and Rukuaixiao (P<0．05) can both obviously lower the serum level of estradiol by paired-samples t test. There is no difference between two groups both before and after treatment(P>0．05) .④There is no difference in both groups in the level of progestone. There is no difference between two groups both before and after treatment(P>0．05) .⑤Tongluosanjie pill (P<0．05) and Rukuaixiao (P<0．05) can both obviously lower E/P ratio between before and after treatment. There is no difference between two groups.⑥Tongluosanjie pill can obviously lower the level of prolactin (P<0．05) after treatment. But Rukuaixiao can't (P>0．05) . There is significant difference between two groups after treatment.⑦Through cost analysis in medicine, the price of one day taking Tongluosanjie pill is 2．31 Yuan and Rukuaixiao is 6．8～10．2 Yuan. The daily cost of Tongluosanjie pill is only third of that of Rukuaixiao.Conclusion: The pathogeny of the blood stasis pattern of the hypeplasia of mammary gland is related to endocrine disorder, especial estradiol and prolactin increases and E/P ratio disorder. Tongluosanjie pill can obviously ameliorate symptoms of pain and tumor, especially in detumescence, and also lower the levels of. estradiol and prolactin and E/P ratio. It has no effect on the level of progestone. Tongluosanjie pill has better price-performance ratio in 24 current medicines. So, it is worth application and spread in clinics. |
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