Abstract: Objective To investigate and analysis the efficacy and safety of oral Breast No.1 combined with external application in the treatment of hyperplasia of mammary glands with liver depression and qi stagnation. Methods From May 2021 to May 2022, 70 cases of patients with mammary gland hyperplasia of liver depression and qi stagnation type diagnosed and treated in Beijing Miyun District Hospital of Traditional Chinese Medicine were selected as the research objects. The patients were randomly divided into the combined group and the control group with 35 cases each accorded to the numerical table. The control group were treated with oral Chinese medicine, and the combined group were treated with oral Breast No.1 combined with external application. Both groups were treated and observed for 4 weeks, and recorded the effectiveness and safety of treatment, determined the changes of breast lump and breast pain score, measure the changes of breast diameter, and detected the changes of serum prolactin and estradiol. Results All patients were completed the treatment, and there were no serious adverse reactions occurred during the treatment. The total response rates in the post-treatment combination group was higher than the control group, and it was not significant between the groups (P>0.05). The scores of breast lump and breast pain, diameter of breast masses in the two groups after treatment were significantly lower than those before treatment (P<0.05), and the scores of breast lump hardness and breast pain, diameter of breast masses in the combined group after treatment were significantly lower than those in the control group (P<0.05). The levels of serum prolactin and estradiol in the two groups after treatment were significantly lower than those before treatment (P<0.05), and the combined group after treatment were also significantly lower than those in the control group (P<0.05). Conclusion Oral Breast No.1 combined with external application can inhibit the release of prolactin and estradiol, promote the reduction of breast mass diameter, alleviate the symptoms of breast mass hardness and breast pain, and improve the overall therapeutic effect in the treatment of liver qi stagnation type of hyperplasia of mammary glands.

Key words: oral breast No.1, external application of traditional chinese medicine, liver qi stagnation type, hyperplasia of mammary glands, Prolactin, diameter of breast lump, breast pain