Abstract: Objective　To investigate the effect of Shenbai Fuzheng Granules combined with Apatinib in the treatment of metastatic breast cancer with multi-line therapy failure and its effect on vascular endothelial growth factor receptor 2（VEGFR2） and immune function.Methods　A total of 96 patients with metastatic breast cancer who failed multi-line treatment were randomly divided into the control group（n=48） and the experimental group（n=48）.The control group was treated with oral Apatinib and the experimental group was given oral Shenbai Fuzheng Granules combined with Apatinit.The clinical efficacy，traditional Chinese medicine（TCM） syndrome scores，levels of serum insulin-like growth factors-1（IGF-I），CA153，interleukin8（IL-8），VEGFR2，CD4+，CD8+，CD4+/CD8+，natural killer cell（NK），IgG，IgA，adverse reactions，progression-free survival（PFS） and overall survival（OS） were compared between two groups.Results　The treatment efficiency and tumor control rate in the experimental group were significantly higher than those in the control group（P<0.05）.The TCM syndrome scores of the experimental group after the treatment were significantly lower than those before the treatment and those of the control group after the treatment（P<0.05）.After treatment，the levels of serum IGF-I，CA153，IL-8 and VEGFR2 in two groups were significantly lower than those before the treatment（all P<0.05），and these indexes in the experimental group were significantly lower than those in the control group（all P<0.05）.After treatment，the experimental group demonstrated higher levels of serum CD4+，CD4+/CD8+，NK，IgG，IgA and lower level of serum CD8+ compared with the control group（P<0.05）.The total incidence of adverse reactions in the experimental group was not significantly different from that in the control group（P>0.05）.The PFS and OS of the experimental group were significantly longer than those of the control group（P<0.05）.Conclusion　The effect of Shenbai Fuzheng Granules combined with Apatinib in the treatment of metastatic breast cancer with multi-line treatment failure is effective，which can effectively reduce the level of VEGFR2 and improve the immune function with higher safety.

Key words: Breast neoplasm, Metastatic breast cancer, Shenbai Fuzheng Granules, Apatinib

摘要： 目的　探讨参白扶正颗粒联合阿帕替尼治疗多线治疗失败的转移性乳腺癌的疗效及其对血管内皮细胞生长因子受体2（VEGFR2）和免疫功能的影响。方法　将96例多线治疗失败的转移性乳腺癌患者采用随机数字表法随机分为对照组（n=48）与试验组（n=48），对照组给予口服阿帕替尼治疗，试验组给予口服参白扶正颗粒联合阿帕替尼治疗。比较两组临床疗效、中医证候积分、血清胰岛素样生长因子-I（IGF-I）、糖类抗原153（CA153）、白介素8（IL-8）、VEGFR2、CD4+、CD8+、CD4+/CD8+、自然杀伤细胞（NK）、IgG、IgA、不良反应发生情况及无进展生存期（PFS）、总生存期（OS）。结果　试验组治疗有效率与肿瘤控制率高于对照组，差异有统计学意义（P<0.05）。治疗后，试验组中医证候积分低于治疗前与对照组，差异有统计学意义（P<0.05）。治疗后，两组血清IGF-I、CA153、IL-8及VEGFR2水平均低于治疗前，且试验组血清IGF-I、CA153、IL-8及VEGFR2水平低于对照组，差异有统计学意义（P<0.05）。治疗后，试验组患者血清CD4+、CD4+/CD8+、NK、IgG及IgA水平高于对照组，CD8+水平低于对照组，差异均有统计学意义（P<0.05）。试验组不良反应总发生率与对照组相比，差异无统计学意义（P>0.05）。试验组PFS、OS均长于对照组，差异有统计学意义（P<0.05）。结论　参白扶正颗粒联合阿帕替尼治疗多线治疗失败的转移性乳腺癌疗效确切，可有效降低VEGFR2水平，提高免疫功能，同时具有较高的安全性。

关键词: 乳腺肿瘤, 转移性乳腺癌, 参白扶正颗粒, 阿帕替尼