Randomized Controlled Clinical Observation on Bushen Ruyan Formulation （补肾乳岩方） in Treating 44 Cases of Premenopausal Breast Cancer Patients of Disharmony of the Chong （冲） and Ren （任） Meridian Type under Endocrine Intensive Therapy
10.13288/j.11-2166/r.2025.08.011
- VernacularTitle:补肾乳岩方治疗冲任失调型绝经前乳腺癌内分泌强化治疗患者44例随机对照临床观察
- Author:
Zepeng WANG
1
;
Xufeng CHENG
1
;
Jiangshan YUAN
1
;
Ruidong LIU
1
;
Qi LIU
2
Author Information
1. The First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou，450000
2. Henan University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
breast cancer;
premenopausal;
endocrine intensive therapy;
disharmony of chong （冲） and ren （任） meridian;
Bushen Ruyan Formulation （补肾乳岩方）
- From:
Journal of Traditional Chinese Medicine
2025;66(8):817-825
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical efficacy and safety of Bushen Ruyan Formulation （补肾乳岩方， BRF） in treating premenopausal breast cancer patients of disharmony of the chong （冲） and ren （任） meridian type under endocrine intensive therapy. MethodsA total of 88 premenopausal breast cancer patients who received endocrine intensive therapy and were diagnosed with disharmony of the chong and ren meridian by traditional Chinese medicine （TCM） were included and randomly divided into a control group and a treatment group， with 44 cases in each group. The control group received ovarian function suppression （OFS） combined with endocrine therapy， while the treatment group was given oral BRF additionally. Both groups were treated for three months. The clinical efficacy was evaluated by comparing the pre- and post-treatment results of the Functional Assessment of Cancer Therapy-Breast （FACT-B）， modified Kupperman score， T cell subsets （CD3+， CD4+， CD8+， CD4+/CD8+）， sex hormone levels， including estradiol （E2）， luteinizing hormone （LH）， follicle-stimulating hormone （FSH）， progesterone （P）， testosterone （T）， and prolactin （PRL）， tumor markers， such as carcinoembryonic antigen （CEA）， carbohydrate antigen 125 （CA125）， and carbohydrate antigen 153 （CA153）， TCM syndrome score， and TCM syndrome efficacy. Blood routine tests， liver function and kidney function were monitored to assess safety. ResultsThe FACT-B scores of each domains and the total scores of the treatment group increased， while the social/family status score of the control group decreased. The treatment group had significantly higher scores in all domains and total score compared to the control group （P＜0.05 or P＜0.01）. The modified Kupperman score and TCM syndrome score of the treatment group decreased， and were lower than those of the control group （P＜0.01）. The levels of CD3+ and CD4+ in the treatment group increased， and were higher than those of the control group （P＜0.05）. Serum testosterone levels in the treatment group were lower than those in the control group （P＜0.05）. The total effective rate of TCM syndrome efficacy in the treatment group was 67.44%， significantly higher than the 23.26% in the control group （P＜0.05）. No significant abnormalities were observed in the blood routine tests or liver/kidney function indicators in either group before or after treatment. ConclusionBRF can effectively improve quality of life， alleviate symptoms， increase serum CD3+ and CD4+ levels， and enhance clinical efficacy in premenopausal breast cancer patients undergoing endocrine intensive endocrine therapy. It is also safe with no significant adverse effects.
