Abstract: Objective To investigate the efficacy and safety of Yangzheng Xiaoji capsule combined with chemotherapy in the treatment of metastatic breast cancer and its influence on T lymphocyte cell subsets. Methods A total of 79 metastatic breast cancer patients were randomly divided into the treatment group(n=40)and control group(n=39)according to digital table method. The control group was treated with GT chemotherapy, which was a total of 6 courses of treatment with q3w. The treatment group received the same amount of chemotherapy, and Yangzheng Xiaoji capsules, 4 capsules/time, 3 times/day, 21 days/course, for 6 courses of treatment. The clinical efficacy and adverse reactions were compared between the two groups. The survival quality of all patients was analyzed by QLQ-BR23. T sublymphocyte level was detected in both groups. Results The total efficacy rate of the treatment group was 55%, which was superior to that of the control group, 28.21%(P<0.05). Incidence of liver and kidney function deficiency in the treatment group was 10%, which was lower than that of the control group, 33.33%(P<0.05). Six months after treatment, scores of QLQ-BR23 in the treatment group were superior to those of the control group(P<0.01). Three months after treatment, levels of CD3⁺, CD4⁺ and CD4⁺/CD8⁺ of the treatment group were higher than those of the control group, while CD8⁺ was lower, with statistically significant difference(P<0.01). Conclusion Yangzheng 山 东 大 学 学 报 (医 学 版)54卷5期 -徐志宏,等.养正消积胶囊联合化疗治疗转移性乳腺癌的临床疗效及安全性 \=-Xiaoji capsule combined with chemotherapy in treating metastatic breast cancer can increase efficacy, decrease adverse reactions, and improve quality of life and cellular immune function.

Key words: Yangzheng Xiaoji capsule, Metastatic breast cancer, Combined chemotherapy, T lymphocyte cell subsets