To observe the effect of Kanglaite Injection on immune function in the patients with recurrent high-grade brain glioma.Methods:Ninety cases with recurrent high-grade brain glioma treated in the Guilin Municipal Hospital of Traditional Chinese Medicine from April 2018 to April 2022 were randomized into a control group(n=45，temozolomide) and an observation group(n=45，temozolomide+Kanglaite Injection).Blood routine，immune function，quality of life(QOL)，efficacy，and adverse reactions were compared between the two groups.Results:Since two cases in the control group and one in the observation group dropped out，43 cases in the control group and 44 cases in the observation group were included for analysis.After treatment，the white blood cell count(WBC)，neutrophil count(NE)，platelet count(PLT)，and hemoglobin(Hb) in the two groups decreased，and the WBC，NE，PLT，and Hb in the observation group were higher than those in the control group(P<0.05).After treatment，the control group showed decreased CD3+，CD4+，and CD4+/CD8+ and increased CD8+(P<0.05)，while the observation group showed no significant changes in the indicators above.Moreover，CD3+，CD4+，and CD4+/CD8+ in the observation group were higher than those in the control group after treatment(P<0.05).After treatment，the Kanofsky performance scale(KPS) and QOL scores increased in both groups，and KPS and QOL scores in the observation group were higher than those in the control group(P<0.05).The response rate in the observation group was 90.91%(40/44)，which was higher than that(74.42%，32/43) in the control group(P<0.05).Neither group showed serious adverse reactions.Conclusion:In the course of chemotherapy for recurrent high-grade brain glioma，Kanglaite Injection can improve the therapeutic effect，blood routine，immune function，and quality of life.