Abstract: Background Omalizumab is effective in treating moderate to severe allergic asthma in children over 6 years old abroad, and there is a lack of clinical data of asthmatic children in China.Objective To evaluate the efficacy and safety of omalizumab in the treatment of children with allergic asthma and allergic rhinitis.DesignSelf-controlled trial.Methods We included those aged 6-18 years with moderate to severe allergic asthma and allergic rhinitis, who can afford 16 weeks of treatment and were in the non acute stage of asthma, whose serum IgE were 75-1,500 U·mL^-1 before using omalizumab, and whose vital signs were stable. Inhaled corticosteroids combined with omalizumab was performed to observe asthma control, rhinitis and cough symptoms, and quality of life of asthmatic children, quality of life of asthmatic children lung function, height and weight gain. Outcome measures were evaluated before and 16 weeks after treatment.The main outcome measures Children aged 4 to 11 years old were scored by C-ACT. Children aged ≥12 years old were scored by ACT. The C-ACT/ACT score increasing by more than 3 points before and after treatment was defined as effective treatment.Results Thirty-five cases of moderate and severe allergic asthma with allergic rhinitis were included into the analysis. The weight was (31±9.6) kg and height was (134.8±13.8) cm. A total of 32 cases could use level 3 and 4 treatment plan, and there were 3 cases for level 5 treatment plan . The average IgE level was 340 (168~583) IU·mL^-1. The C-ACT/ACT score, rhinitis and cough VAS score, PAQLQ/pedsQL^TM3.0 asthma module evaluation were improved after 4 weeks of treatment with omalizumab, and the differences were statistically significant (P<0.05). The C-ACT/ACT score were improved by more than 3 points after 16 weeks of treatment, and the rhinitis and cough VAS score, PAQLQ/pedsQL^TM3.0 asthma module evaluation were further improved after 4 weeks of treatment. After 16 weeks, the lung function and FeNO evaluation indexes were significantly improved compared with those before treatment (P<0.05). During the treatment, one patient developed pruritus at the injection site.Conclusion Inhaled corticosteroids combined with omalizumab in the treatment of children with moderate to severe allergic asthma and allergic rhinitis showed good effect and safety, and improved the clinical symptoms during medication.

Key words: Omalizumab, IgE, Chinese children, Allergic asthma, Allergic rhinitis