目的 探讨艾愈胶囊联合阿那曲唑治疗绝经后激素受体(HR)阳性乳腺癌的临床疗效。方法 选取2019年1月-2022年1月海南医学院第一附属医院收治的136例绝经后HR阳性乳腺癌患者,按随机数字表法分为对照组和治疗组,每组各68例。对照组口服阿那曲唑片,1片/次,1次/d。治疗组在对照组基础上口服艾愈胶囊,3粒/次,3次/d。两组均连续治疗3个月。观察两组临床疗效,比较治疗前后两组癌灶最大径、中医症状评分、癌症治疗性功能评价量表-乳腺癌(FACT-B)评分以及血清肿瘤标志物[糖类抗原15-3(CA15-3)、癌胚抗原(CEA)、组织多肽特异性抗原(TPS)]和肿瘤坏死因子(TNF)-α、白细胞介素(IL)-8、血管内皮生长因子(VEGF)、可溶性E-选择素(sE-selectin)水平。结果 治疗后,治疗组客观缓解率是38.2%,高于对照组的29.4%,两组比较差异无统计学意义;治疗组临床获益率是76.5%,显著高于对照组的60.3%(P<0.05)。治疗后,两组癌灶最大径均显著缩小,中医症状评分均显著降低,FACT-B评分则均显著增加(P<0.05);且均以治疗组改善更显著(P<0.05)。治疗后,两组血清CA15-3、CEA、TPS水平均较治疗前显著下降(P<0.05);且均以治疗组降低更显著(P<0.05)。治疗后,两组血清TNF-α、IL-8、VEGF、sE-selectin水平均较治疗前显著下降(P<0.05);且均以治疗组降低均更显著(P<0.05)。结论 艾愈胶囊联合阿那曲唑治疗绝经后HR阳性乳腺癌的抗肿瘤疗效确切,能有效降低患者肿瘤负荷,减轻症状,提高生活质量,并可进一步改善肿瘤微环境,且安全性好。

Objective To investigate the clinical efficacy of Aiyu Capsules combined with anastrozole in treatment of postmenopausal hormone receptor (HR) positive breast cancer. Methods A total of 136 postmenopausal HR positive breast cancer patients admitted to the First Affiliated Hospital of Hainan Medical University from January 2019 to January 2022 were selected and divided into control group and treatment group according to random number table method, with 68 cases in each group. Patients in the control group were po administered with Anastrozole Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Aiyu Capsules on the basis of the control group, 3 grain/time, three times daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacy was evaluated, the maximum tumor diameter, TCM symptom score, Cancer Therapeutic Function Evaluation Scale-Breast Cancer (FACT-B) score, serum tumor markers [carbohydrate antigen 15-3 (CA15-3), carcinoembryonic antigen (CEA), tissue polypeptide specific antigen (TPS)], tumor necrosis factor (TNF-α), interleukin (IL)-8, vascular endothelial growth factor (VEGF), soluble E-selectin (sE-selectin) in the two groups before and after treatment were compared. Results After treatment, the objective remission rate of the treatment group was 38.2%, which was higher than that of the control group (29.4%), and there was no significant difference between the two groups. The clinical benefit rate of the treatment group was 76.5%, which was significantly higher than that of the control group (60.3%) (P＜0.05). After treatment, the maximum diameter of cancer foci was significantly reduced, and the TCM symptom score was significantly decreased, and the FACT-B score was significantly increased in both groups (P＜0.05). The improvement was more significant in treatment group (P＜0.05). After treatment, the serum levels of CA15-3, CEA, and TPS in two groups were significantly decreased compared with before treatment (P＜0.05). The decrease was more significant in treatment group (P＜0.05). After treatment, serum levels of TNF-α, IL-8, VEGF, and sE-selectin in two groups were significantly decreased compared with before treatment (P＜0.05). In addition, the reduction was more significant in treatment group (P＜0.05). Conclusion Aiyu Capsules combined with anastrozole has definite anti-tumor efficacy in treatment of postmenopausal hormone receptor positive breast cancer, and can effectively reduce the tumor burden, relieve symptoms, improve the life quality, which can further improve the tumor microenvironment with good safety.

R914

海南省自然科学基金资助项目(819QN369)