2020 年第 12 期 第 15 卷

国产与进口注射用醋酸亮丙瑞林微球对绝经前激素受体阳性乳腺癌患者卵巢功能抑制的效果比较

Comparison of inhibitory effects of domestic and imported leuprorelin acetate microspheres on ovarian function in patients with premenopausal hormone receptor positive breast cancer

作者：邵彬严颖宛凤玲邸立军

英文作者：Shao Bin Yan Ying Wan Fengling Di Lijun

单位：北京大学临床肿瘤学院北京肿瘤医院暨北京市肿瘤防治研究所乳腺肿瘤内科恶性肿瘤发病机制及转化研究教育部重点实验室，100142

英文单位：Department of Breast Oncology Peking University School of Oncology Beijing Cancer Hospital Beijing Institute for Cancer Research Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education) Beijing 100142 China

关键词：乳腺癌；绝经前；激素受体阳性；注射用醋酸亮丙瑞林微球

英文关键词：Breastcancer;Premenopause;Hormonereceptor-positive;Leuprorelinacetatemicrospheresforinjection

• 摘要：

• 目的 比较国产与进口注射用醋酸亮丙瑞林微球对于绝经前激素受体阳性乳腺癌患者卵巢功能抑制（OFS）的效果。方法回顾性分析2018 年 6 月至2019 年6 月于北京肿瘤医院接受注射用醋酸亮丙瑞林微球治疗的绝经前激素受体阳性乳腺癌患者54例,使用国产注射用醋酸亮丙瑞林微球患者作为观察组（27例），使用进口注射用醋酸亮丙瑞林微球患者作为对照组（27例）。比较2组患者治疗前及治疗后1、3、6、12个月雌二醇和卵泡刺激素（FSH）水平。结果 2组患者在年龄、月经状态、体重指数、病理类型、治疗阶段及OFS合并药物方面差异均无统计学意义（均P>0.05）。治疗前，观察组雌二醇和FSH水平与对照组比较，差异均无统计学意义（均P>0.05）。所有患者均完成至少连续6个月的治疗，但部分患者未在全部时点进行性激素水平检测。治疗后1、3、6、12个月，观察组各时点激素检测患者为25、22、23、14例，雌二醇水平为（14±7）、（14±9）、（9±5）、（8±5）ng/L，FSH水平为（3.9±1.9）、（7.1±2.5）、（8.6±3.5）、（8.8±3.6）IU/L，对照组各时点激素检测患者为25、24、20、12例，雌二醇水平为（14±8）、（12±6）、（7±6）、（8±5）ng/L，FSH水平为（3.8±1.5）、（6.7±2.5）、（7.2±2.4）、（8.7±2.9）IU/L，2组治疗前及治疗后各时点雌二醇、FSH水平比较差异均无统计学意义（均P>0.05）。结论 国产注射用醋酸亮丙瑞林微球对绝经前激素受体阳性乳腺癌患者的卵巢功能抑制作用与进口药相当，能有效降低患者性激素水平。

• Objective To compare the inhibitory effects of domestic and imported leuprorelin acetate microspheres on ovarian function suppression (OFS) in patients with premenopausal hormone receptor positive breast cancer. Methods From June 2018 to June 2019, 54 premenopausal breast cancer patients with hormone receptor-positive admitted to Beijing Cancer Hospital were selected retrospectively. Twenty-seven patients treated with domestic leuprorelin acetate microspheres for injection were included in the observation group, and 27 patients who were treated with imported leuprorelin acetate microspheres for injection were included in the control group. Estradiol (E2) and follicle-stimulating hormone (FSH) levels were compared between the two groups before and 1, 3, 6 and 12 months after treatment. Results There were no significant differences in age, menstrual status, body mass index, pathological type, therapeutic stage and the drugs combined with OFS between the both groups (all P>0.05). There were no significant differences in E2 and FSH between the two groups before treatment (both P>0.05). All patients completed at least 6 months of treatment, but some patients were not detected the sex hormone levels at all time points. At 1, 3, 6 and 12 months after treatment, there were 25, 22, 23 and 14 cases in observation group detected hormone levels at each time point, the levels of E2 were（14±7）,（14±9）,（9±5）,（8±5）ng/L and levels of FSH were（3.9±1.9）,（7.1±2.5）,（8.6±3.5）,（8.8±3.6）IU/L; there were 25, 24, 20 and 12 cases in control group detected hormone levels at each time point, the levels of E2 were（14±8）,（12±6）,（7±6）,（8±5）ng/L and levels of FSH were（3.8±1.5）,（6.7±2.5）,（7.2±2.4）,（8.7±2.9）IU/L, there were no significant differences in E2 and FSH levels between the two groups at each time point (all P>0.05). Conclusion The OFS efficacy of domestic leuprorelin acetate microspheres for injection on premenopausal breast cancer patients with hormone receptor-positve is comparable to that of the imported. It can effectively reduce the level of sex hormone in patients.