疏肝益肾方治疗肝郁脾虚型绝经后雌激素受体阳性乳腺癌术后患者的临床疗效

Clinical Effects of Shugan Yishen Recipe on Postmenopausal Estrogen Receptor-positive Breast Cancer Patients with Hepatic Stagnation and Spleen Deficiency Type

目的观察疏肝益肾方治疗绝经后雌激素受体阳性乳腺癌术后患者内分泌治疗期的临床疗效。方法选取2021年7月~2023年9月上海市中医医院收治的行芳香化酶抑制剂内分泌治疗的110例绝经后乳腺癌术后患者,采用随机数字表法将其分为观察组和对照组,每组各55例。两组患者均给予基础治疗,观察组加用疏肝益肾方,对照组加用疏肝益肾方安慰剂,疗程均为12周。观察两组患者的临床疗效及中医证候积分、骨代谢、肿瘤标志物、T细胞亚群(CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+))变化情况,并进行安全性评价。结果共106例患者完成试验,其中观察组与对照组各53例。治疗后,观察组临床总有效率为75.5%,对照组为58.5%,观察组的临床疗效优于对照组(P<0.01)。与治疗前比较,两组中医证候积分均有所降低(P<0.01)。治疗后,观察组患者的β-胶原特殊序列(β-c-terminal telopeptide of type-Ⅰcollagen,β-CTX)、糖类抗原125(carbohydrate antigen 125,CA125)、糖类抗原153(carbohydrate antigen 153,CA153)、CD8^(+)均较治疗前降低(P<0.05),骨钙素N端中分子片段(N-mid osteocalcin,N-MID)、CD4^(+)、CD4^(+)/CD8^(+)均较治疗前升高(P<0.01)。治疗后,观察组β-CTX、N-MID、CA153、CD8^(+)、CD4^(+)/CD8^(+)明显优于对照组(P<0.01)。结论疏肝益肾方可改善绝经后雌激素受体阳性乳腺癌术后患者内分泌治疗引起的骨代谢异常,降低血清肿瘤标志物水平,提高患者免疫功能,且安全有效。

Objective To observe the clinical efficacy of shugan yishen recipe in the treatment of postmenopausal estrogen receptor-positive breast cancer patients during endocrine therapy.Methods A total of 110 postmenopausal breast cancer patients undergoing aromatase inhibitor endocrine therapy at Shanghai Municipal Hospital of Traditional Chinese Medicine from July 2021 to September 2023 were divided into observation group and control group by random number table method,with 55 patients in each group..Both groups received standard treatment;the observation group also took shugan yishen recipe,while the control group also took shugan yishen recipe placebo,treatment for 12 weeks.The clinical efficacy,traditional Chinese medicine syndrome scores,bone metabolism,tumor markers,T-cell subsets(CD4^(+),CD8^(+),CD4^(+)/CD8^(+))of the two groups were observed,and the safety was evaluated.Results A total of 106 patients completed the experiment,with 53 patients in each group.After treatment,the total clinical effective rate was 75.5%in the observation group,and 58.5%in the control group,the clinical effect of the observation group was better than that of the control group(P<0.01).Compared with before treatment,TCM syndrome scores in both groups were decreased(P<0.01).After treatment,β-c-terminal telopeptide of type-Ⅰcollagen(β-CTX),carbohydrate antigen 125(CA125),carbohydrate antigen 153(CA153)and CD8^(+)were all decreased compared with those before treatment(P<0.05);N-mid osteocalcin(N-MID),CD4^(+),CD4^(+)/CD8^(+)were higher than those before treatment(P<0.01).After treatment,β-CTX,N-MID,CA153,CD8^(+)and CD4^(+)/CD8^(+)in the observation group were significantly better than those in the control group(P<0.01).Conclusion Shugan yishen recipe can improve bone metabolism abnormalities caused by endocrine treatment in postmenopausal patients with estrogen receptor-positive breast cancer,reduce serum tumor marker levels,enhance immune function of patients,and is safe and effective.