Abstract: AIM: To determine the therapeutic efficacy of bacterial lysates (Broncho-Vaxom) plus montelukast treatment in children with bronchial asthma. METHODS: With parental approval, 173 children with intermittent asthma were randomized to receive montelukast plus bacterial lysates treatment as experimental group or receive montelukast treatment as a control group. The episodes of respiratory tract infection and asthma exacerbation, T lymphocyte subsets, immunoglobulin and the adverse events were recorded in the following 12 months. RESULTS: A total of 156 patients (76 in the experimental group, 80 in the control group) were completed in the study. Compared with control group, The frequencies of asthma exacerbation and respiratory tract infection,duration of fever, cough and antibiotics usage in experimental patients with bronchial asthma were significantly reduced (P＜0.05), and the levels of CD₃⁺%, CD₄⁺%, CD₄⁺/CD₈⁺, serum IgA and salivary slgA were obvious increased in the experimental group (P＜0.01).There were no significant differences in the level of CD₈⁺%, serum IgM and serum IgG between two groups(P＞0.05). No serious adverse events was reported in both groups (χ²=0.939, P＞0.05). CONCLUSION: The results of this study suggest that treatment with bacterial lysates and montelukast may be effective and safe in children withintermittent asthma.

Key words: Child, Asthma, Subsets of lymphocyte, Immunoglobulin, Bacterial lysates