RESUMO
OBJECTIVE:To observe clinical efficacy and safety of pidotimod combined with montelukast sodium in the treat-ment of children with bronchial asthma. METHODS:120 children with bronchial asthma were randomly divided into control group and observation group,with 60 cases in each group. Both group were given routine treatment as aerosol inhalation of glucocorticoid and anti-infective treatment. Control group was additionally given Montelukast sodium chewable tablet 5 mg orally,qd,at bed-time;observation group was additionally given Pidotimod capsule 0.4 g,qd,on the basis of control group. Both group received treatment for consecutive 3 months. Clinical efficacies of 2 groups were observed as well as IL-4,IFN-γ,IgE,T lymphocyte sub-set and lung function indexes of 2 groups before and after treatment. The occurrence of ADR were compared between 2 groups. RE-SULTS:The effective rate of observation group was 88.3%,which was significantly higher than that of control group (61.7%). There was no statistical significance in IL-4,IFN-γ,IgE,T lymphocyte subset and lung function indexes between 2 groups before treatment(P>0.05). After treatment,IL-4,IFN-γ,IgE,CD4+,CD4+/CD8+ and lung function of 2 groups were improved signifi-cantly,and the observation group was significantly better than the control group,with statistical significance(P0.05). CONCLUSIONS:Pidotimod combined with monte-lukast sodium is effective for children with bronchial asthma,and can significantly relieve airway inflammation,enhance immunity and improve lung function with good safety.