ObjectiveTo investigate the effects of Huaier granule combined with systemic chemotherapy on immunologic function and prognosis for advanced breast cancer patients. MethodsNinety-eight cases ofⅣstage breast cancer from March 2006 to March 2009 in this hospital were divided into control group and research group. Only systemic chemotherapy was performed in the control group, while Huaier granule combined with systemic chemotherapy was applied in the research group, and Huaier granule was given on day 1 systemic chemotherapy start. The changes of T lymphocyte subsets and IL-2 level were detected on day 1 before systemic chemotherapy and on month 6 after Huaier granule combined with systemic chemotherapy. The fatality rate and median survival time were also observed between two groups. ResultsCompared with the control group, the changes of T lymphocyte subsets and IL-2 level had no signi-ficant differences on day 1 before systemic chemotherapy between these two groups(P > 0.05). On month 6 after Huaier granule combined with systemic chemotherapy, the CD4+, CD4+/CD8+ T lymphocyte, and IL-2 level were significantly increased, the CD8+ T lymphocyte was significantly decreased in the research group as compared with the control group〔CD4+:(47.35±6.23)% versus(41.33±5.61)%, P < 0.05; CD4+/CD8+: 1.84±0.42 versus 1.47±0.33, P < 0.05; IL-2 level:(1.78±0.45)μg/L versus(1.58±0.30)μg/L, P < 0.05; CD8+:(23.26±3.25)% versus(29.77±4.12)%, P < 0.05〕. The rate of chemotherapy complications and fatality rate within 3 years were significantly decreased in the research group as compared with the control group〔rate of chemotherapy complications: 58.3%(28/48) versus 86.0%(43/50), P < 0.01; fatality rate within 3 years: 62.5%(30/48)versus 82.0%(41/50), P < 0.05〕. The median survival time in the research group was significantly longer than that in the control group(33.5 months versus 24.5 months, P < 0.01). ConclusionsThe preliminary results from this study show that Huaier granule combined with systemic chemotherapy could greatly enhance immune function, reduce side-toxicity of chemotherapy and improve prognosis in advanced breast cancer patients. It provides a beneficial exploration for cancer treatment by integration of traditional and western medicine.