中医杂志

目的 观察补肾乳岩方对冲任失调型绝经前乳腺癌内分泌强化治疗患者的临床疗效及安全性。方法纳入88例接受内分泌强化治疗且中医辨证为冲任失调型的绝经前乳腺癌患者，随机分为对照组和治疗组各44例。对照组予卵巢功能抑制(OFS)+内分泌治疗，治疗组在对照组的基础上给予口服补肾乳岩方治疗。两组均连续治疗3个月，观察并比较两组患者治疗前后乳腺癌患者生命质量测定量表(FACT-B)、改良版Kupperman评分、T细胞亚群(CD3⁺、CD4⁺、CD8⁺、CD4⁺/CD8⁺值)水平、性激素六项[雌激素(E₂)、黄体生成素(LH)、卵泡刺激素(FSH)、孕酮(P)、睾酮(T)、催乳素(PRL)]水平、肿瘤标志物[癌胚抗原(CEA)、糖类抗原125 (CA125)、糖类抗原153 (CA153)]水平及中医证候积分、中医证候疗效；监测血常规、肝肾功能评价其安全性。结果 与本组治疗前比较，治疗后治疗组FACT-B各模块评分和总分均提高、对照组治疗后的社会/家庭状况评分降低，且治疗后治疗组的各领域评分和总分均较对照组提高(P<0.05或P<0.01)。治疗后治疗组改良版Kupperman评分、中医证候积分均较治疗前降低，且均低于对照组(P<0.01)。治疗后治疗组的CD3⁺、CD4⁺水平较治疗前升高，且高于对照组(P<0.05)。治疗后治疗组血清T低于对照组(P<0.05)。治疗组中医证候疗效总有效率为67.44%，高于对照组的23.26%(P<0.05)。两组患者治疗前后血常规、肝肾功能指标均未见明显异常。结论 补肾乳岩方可提高绝经前乳腺癌内分泌强化治疗患者的生活质量、减轻症状，提高患者血清CD3⁺、CD4⁺水平及临床疗效，且安全性较好。

Objective To 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. Methods A 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. Results The 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. Conclusion BRF 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.