Objective：To observe the effect of Shenfu injection on immune indexes，inflammatory indexes and clinical outcomes in patients with sepsis.M e th o d s：Divided 42 cases of patients with sepsis into the treatment group and the control group randomly，21 cases in each group.The control group received the routine western medicine treatment， while the treatment group was additionally given Shenfu injection.The treatment for both groups lasted for 7 days.Compared inflammatory indexes[white blood cell count(WBC)，procalcitonin(PCT)，C-reactive protein(CRP)]，and immune indexes[T lymphocyte subsets：helper T lymphocyte(CD4+)， suppressor T lymphocyte(CD8+)， CD4+/CD8+， CD14+monocytes/human leucocyte antigen-DR expression rate(CD14+/HLA-DR)，scores of acute physiology and chronic health evaluation(APACHE II scores)]of the two groups before treatment，on the 3rdday and the 7thday.Compared the differences of the incidence of MODS and mortality and hospitalization days within 7 days，and statistically analyzed the mortality rate on the 28thday of follow-up.R e s u lts：On the 3rdday of treatment，the levels of CRP and PCT in the control group and the levels of WBC，CRP，PCT and APACHE II scores in the treatment group were all lower than those before treatment，CD14+/HLA-DR in the treatment group was higher than that before treatment and in the control group，and APACHE II scores were lower than those in the control group，differences being significant(P ＜ 0.05).On the 7thday of treatment，the levels of WBC，CRP and PCT in the control group and the levels of WBC，CRP，PCT and APACHE II scores in the treatment group were all lower than those before treatment， CD14+/HLA-DR in the treatment group was higher than that before trentment.CD4+/CD8+，CD14+/HLA-DR in the treatment group were higher than those in the control group，and APACHE II scores were lower than those in the control group，differences being significant(P＜0.05).There were no significant differences in the incidence of MODS，mortality rate within 7 days，mortality rate within 28 days and length of hospitalization between the two groups(P＜0.05)；but comparing with those in the control group，each index in the treatment group showed a downtrend relatively.Conclusion：The application of Shenfu injection based on the routine western medicine treatment can improve the immune and inflammatory indexes in patients with sepsis，effectively regulate the proinflammatory or anti-inflammatory balance of body with sepsis，but it has no effect on prognosis，and its clinical application timing and indications are worth further discussing.