目的 探讨博尔宁胶囊联合吉西他滨和顺铂（GP方案）治疗晚期乳腺癌的临床疗效。方法 选取2016年5月—2020年1月在天津市第五中心医院和天津医科大学肿瘤医院治疗的134例晚期乳腺癌患者，患者根据抛硬币分组法分为对照组和治疗组，每组各67例。对照组给予GP化疗方案。第1、8天静脉滴注0.5 h注射用盐酸吉西他滨，1 000～1 200 mg/m²溶入0.9%氯化钠溶液100 mL。第1、3天静脉滴注1 h顺铂注射液，25 mg/m²溶入0.9%氯化钠溶液500 mL。治疗组在对照组治疗的基础上口服博尔宁胶囊，0.6 g/次，3次/d。两组以21 d为1个周期，持续治疗6个周期。观察两组的客观缓解率、疾病控制率，比较两组的免疫功能、肿瘤标志物、生活质量。结果 治疗后，治疗组的客观缓解率40.30%高于对照组的28.36%，治疗组的疾病控制率59.70%高于对照组的41.79%，组间比较差异显著（P<0.05）。治疗后，治疗组的KPS评分改善率高于对照组（P<0.05）。治疗后，两组癌胚抗原（CEA）、糖类抗原153（CA153）、血管内皮生长因子（VEGF）水平均较治疗前下降（P<0.05），治疗组CEA、CA153、VEGF水平较对照组低（P<0.05）。治疗后，两组CD3⁺、CD4⁺、CD4⁺/CD8⁺均较治疗前下降，CD8⁺均较治疗前升高（P<0.05），治疗组CD3⁺、CD4⁺、CD4⁺/CD8⁺较对照组高，但CD8⁺较对照组低（P<0.05）。结论 博尔宁胶囊联合GP方案治疗晚期乳腺癌的效果较好，可提高患者生存质量，减轻免疫抑制，阻止疾病进展，且未见额外不良反应增加。

Objective To investigate the effect of Boerning Capsules combined with GP chemotherapy regimen in treatment of advanced breast cancer. Methods Patients (134 cases) with advanced breast cancer in Tianjin Fifth Central Hospital and Tianjin Medical University Cancer Institute & Hospital from May 2016 to January 2020 were randomly divided into control and treatment groups, and each group had 67 cases. Patients of the control group were given GP chemotherapy regimen. Patients in the control group were given Gemcitabine Hydrochloride for injection for 0.5 h on the first and eighth day, 1 000 — 1 200 mg/m² dissolved in 100 mL 0.9% sodium chloride solution. And patients in the control group were intravenously infused with Cisplatin Injection for 1 h on the first and third day, 25 mg/m² dissolved in 500 mL 0.9% sodium chloride solution. Patients in the treatment group were po administered with Boerning Capsules on the basis of the control group, 0.6 g/time, three times daily. A course had 21 d, and patients in two groups were treated for 6 courses. After treatment, the objective remission rate and disease control rate were evaluated, and the immune function, tumor markers, and quality of life of the two groups were compared. Results After treatment, the objective remission rate of 40.30% in the treatment group was higher than 28.36% in the control group, and the disease control rate of 59.70% in the treatment group was higher than 41.79% in the control group, with significant difference between the two groups (P<0.05). After treatment, the improvement rate of KPS score in the treatment group was higher than that in the control group (P<0.05). After treatment, the levels of CEA, CA153, and VEGF in two groups were lower than those before treatment (P<0.05), and the levels of CEA, CA153, and VEGF in the treatment group were lower than those in the control group (P<0.05). After treatment, the CD3⁺, CD4⁺, and CD4⁺/CD8⁺ of two groups were decreased, but the CD8⁺ of two groups was increased (P<0.05). The CD3⁺, CD4⁺, and CD4⁺/CD8⁺ of the treatment group were higher than those of the control group, but the CD8⁺ of the treatment group was lower than that of the control group (P<0.05). Conclusion Boerning Capsules combined with GP chemotherapy regimen has a good effect in the treatment of advanced breast cancer, can improve the quality of life, reduce immunosuppression, prevent disease progression, and has no additional adverse reactions.

R979.1

天津市科技发展指导性计划（医疗卫生）项目（TJSW2016026）