Abstract: Objective To evaluate the clinical efficacy of infliximab combined with azathioprine in treatment of Crohn's disease and its effect on immune function and cytokines level. Methods One hundred and seventy patients with Crohn's disease were randomly divided into 2 groups with 85 cases in each group.The patients in the control group were given azathioprine,while the patients in the observation group were given additional infliximab based on the treatment in the control group.The biological indicators counting[white blood cell (WBC),erythrocyte sedimentation rate (ESR),C-reactive protein (CRP) and serum total protein (STP)],immune function indexes[peripheral blood T lymphocyte subsets (CD4 percentage,CD4/CD8 and CD8 percentage),and immunoglobulin (IgA,IgG,IgM)],inflammatory cytokines[tumor necrosis factor alpha (TNF-α) and interleukin-10(IL-10),interleukin-12(IL-12),transforming growth factor beta (TGF-β)],clinical effect and adverse reactions of the two groups were compared. Results After the treatment,WBC,ESR,CRP,STP,CD4,CD4/CD8,CD8,IgA,IgG,IgM,TNF-α,IL-12,TGF-β and IL-10 levels of the two groups were significantly improved when compared with those before the treatment (P<0.05),and those indicators levels of the observation group were significantly better than those of the control group (P<0.05).The total effective rate in the observation group was 92.9%,which was significantly higher than 80.0% in the control group,P<0.05.There was no significant difference in the adverse reactions between the two groups (P>0.05). Conclusion Infliximab combined with azathioprine can effectively improve the immune function and inflammatory cytokines of patients with Crohn's disease,the curative effect is satisfactory.