Objective: To observe the effect and immunologic regulation of sofren injection in breast cancer patients

and investigate its action mechanism. Method: The 141 patients with breast cancer between June 2013 to June 2015 were divided into observation group and control group by random number table. There were 69 cases in observetion group

including 9 drop-out cases

so only 60 cases completed this study. There were 72 cases in control group

including 10 drop-out cases

so only 62 cases completed this study. Both groups used paclitaxel and cisplatin chemotherapy program for 6 cycles

and patients in observation group also received sofren injection for 10 days based on the chemotherapy. Cellular immunity indicators were observed in both groups

blood was collected on the mornings of 1 day before chemotherapy and 10th day after chemotherapy to detect T cell subsets CD4+

CD8+

CD4+/CD8+ values of two groups by flow cytometry before and after chemotherapy. Humoral immunity indicators:blood was collected on the mornings of 1 day early before chemotherapy and 10th day after chemotherapy

the levels of immunoglobulin (Ig) G

IgA

IgM

and complement C3 were quantitatively determined by immunoturbidimetric assay. Drug toxicity reactions were observed in both groups:patients were observed for blood routine

liver and kidney functions during chemotherapy

and at the same time the drug toxicity reactions during chemotherapy were recorded by referring to WHO NCI-CTC3.0 Criteria for Determination of Acute and Subacute Toxicity of Anticancer Drugs. After chemotherapy

the changes of T cell subsets

humoral immunity indicators and drug toxicities were compared between the two groups. Result: After one cycle of chemotherapy

the levels of CD4+

CD4+/CD8+ in T cell subsets were decreased obviously in control group (P<0.05)

and the level of CD4+ in observation group was higher than that in control group after chemotherapy (P<0.05). Conclusion: Sofren injection combined with paclitaxel and cisplatin chemotherapy can improve the cellular immunity of breast cancer patients.