Abstract: Objective To investgate the effect of Xuebijing Injection on immune regulation in patients with systemic inflammatory response syndrome (SIRS). Methods 56 SIRS patients admitted to the ICU of Guizhou Provincial Hospital from January 2013 to December 2013 were included in this study. The patients were randomly divided into a control (C) and a treatment (T) group. Patients in C group received routine treatment; while patients in T group received additional Xuebijing Injection 50 mL Bid. The following indicators were recorded and compared between the two groups before and 4 and 7 days after treatments: CD4+, CD8+, CD4+/CD8+, monocytes CD14+/human leukocyte antigen-DR （HLA-DR）, score of acute physiology and chronic health evaluation Ⅱ（APACHEⅡ）, heart rate, white blood cells, body temperature, respiration rate, and MODS (7 d after treatment only). Results No differences were found between the two groups before treatments (P>0.05). T Group had higher levels of CD4+,CD8+,CD4+ / CD8+ and monocytes CD14+/HLA-DR than C group at 4 and 7 d after treatments (P<0.05). T group also had higher levels of improvement in vital indicators compared with C group (P<0.05). No significant difference in incidence of multiple organ dysfunction syndrome (MODS) was found between the two groups (P>0.05). Conclusion Xuebijing Injection can regulate immune function of patients with SIRS.