Zhi-fen Huang1, Jin-song Wei, Han-zhong Li. 1. Department of Traditional Chinese Medicine, Affiliated Tumor Hospital of Guangxi Medical University, Nanning. bib.an@126.com
Abstract
OBJECTIVE: To observe the clinical efficacy of Shenqi Fuzheng Injection (SFI) combined with chemotherapy in treating patients with advanced breast cancer. METHODS:Sixty patients were randomly assigned to two groups by digital table, the control group and the treatment group, 30 in each group. All patients were treated with the same CTF regimen of chemotherapy for 21 days as one therapeutic cycle, while those in the treatment group were given SFI additionally in the meanwhite. The therapeutic efficacy was evaluated after 2 cycles of treatment by observing the changes of short-term efficacy, TCM syndrome, quality of life and immune function, as well as the adverse reaction. RESULTS: The total short-term remission rate, the improvement rate of clinical syndrome and quality of life was 50.0%, 70.0% and 76.7% in the treatment group, and 43.3%, 46.7% and 50.0% in the control group, respectively, showing significant difference between the two groups (all P < 0.05). The occurrence of adverse reaction in the treatment group was lower than that in the control group (P < 0.05). The level of CD3+ CD4+ and CD4+/CD8+ ratio increased (P < 0.05) and CD8+ decreased in the treatment group (P < 0.01), while they showed insignificant change in the control group. CONCLUSION: For treatment of advanced breast cancer, SFI can alleviate the bone marrow inhibition caused by chemotherapy, improve clinical symptoms and quality of life and prolong the survival period by regulating cellular immune function of patients, so as to enhance the therapeutic effect of chemotherapy.
RCT Entities:
OBJECTIVE: To observe the clinical efficacy of Shenqi Fuzheng Injection (SFI) combined with chemotherapy in treating patients with advanced breast cancer. METHODS: Sixty patients were randomly assigned to two groups by digital table, the control group and the treatment group, 30 in each group. All patients were treated with the same CTF regimen of chemotherapy for 21 days as one therapeutic cycle, while those in the treatment group were given SFI additionally in the meanwhite. The therapeutic efficacy was evaluated after 2 cycles of treatment by observing the changes of short-term efficacy, TCM syndrome, quality of life and immune function, as well as the adverse reaction. RESULTS: The total short-term remission rate, the improvement rate of clinical syndrome and quality of life was 50.0%, 70.0% and 76.7% in the treatment group, and 43.3%, 46.7% and 50.0% in the control group, respectively, showing significant difference between the two groups (all P < 0.05). The occurrence of adverse reaction in the treatment group was lower than that in the control group (P < 0.05). The level of CD3+ CD4+ and CD4+/CD8+ ratio increased (P < 0.05) and CD8+ decreased in the treatment group (P < 0.01), while they showed insignificant change in the control group. CONCLUSION: For treatment of advanced breast cancer, SFI can alleviate the bone marrow inhibition caused by chemotherapy, improve clinical symptoms and quality of life and prolong the survival period by regulating cellular immune function of patients, so as to enhance the therapeutic effect of chemotherapy.