Objective：To observe the clinical effect of modified Huangqi Guizhi Wuwu tang for oral leukoplakia and its effect on immune response.M e th o d s：Selected 78 cases of patients with oral leukoplakia admitted in our department of stomatology，and divided them randomly into two groups，39 cases in each group.The control group received transfer factor capsules orally and vitamin AD preparations locally for treatment，while the treatment group received modified Huangqi Guizhi Wuwu tang orally and vitamin AD preparations locally.The treatment of the two groups lasted for 30 days.After treatment，respectively observed the clinical effect and changes of leukoplakia and immunoglobulin before and after treatment in the two groups.Results：The total effective rate was 94.87%in the treatment group，higher than that of 74.36%in the control group，the difference being significant(P ＜ 0.05).After treatment，the maximum diameter and the number of leukoplakia in the two groups were improved，and the comparisons of immunoglobulin A(IgA)，immunoglobulin M(IgM)and immunoglobulin G(IgG)before and after treatment showed significance in differences(P＜0.05).The comparisons of the maximum diameter and the number of leukoplakia and changes of IgA，IgM and IgG after treatment between the two groups showed significance in differences(P＜0.05).No significant difference was found in the comparison of the incidence of adverse reactions between the two groups(P＞0.05).Conclusion：The therapy of modified Guizhi Wuwu tang has significant curative effect in treating oral leukoplakia，which can effectively improve clinical symptoms and improve immune response of patients.