OBJECTIVE： To observe clinical efficacy and safety of Esberitox combined with montelukast sodium in the treatment of children allergic rhinitis. METHODS： 178 children with allergic rhinitis were selected and divided into control group， and observation group according to random number table， with 89 cases in each group. Both groups were given Budesonide spray， once for left and right onstrils， 64 μg each spont， bid. Control group was given Montelukast sodium chewable tablet 10 mg， po， qd， on the basis of routine treatment； Esberitox group was given esberitox tablet 0.9 g， po， tid. Clinical efficacies of 2 groups were observed as well as the levels of humoral immune （IgG， IgA， IgM， IgE） and cellular immune （CD3+， CD4+， CD8+ and CD4+/CD8+） before and after treatment. The occurrence of ADR was compared. RESULTS： The total effective rate of observation group was 91.01％， which was significantly higher than 70.79％ of control group and with statistical significance （P＜0.05）. Before treatment， there was no statistical significance in the levels of IgG， IgA， IgM， IgE， CD3+， CD4+， CD8+ and CD4+/CD8+ between 2 groups （P＞0.05）. After treatment， the levels of IgG， IgA， IgE and CD8+ decreased significantly in 2 groups （P＜0.05）， while the levels of IgM， CD3+， CD4+ and CD4+/CD8+ increased significantly； the observation group was significantly better than the control group， with statistical significance （P＜0.05）. There was no statistical significance in the incidence of ADR between 2 groups （P＞0.05）. CONCLUSIONS： Esberitox combined with montelukast sodium is effective in the treatment of allergic rhinitis， and can regulate immune function with good safety.