奥马珠单抗联合孟鲁司特钠治疗儿童中重度难治性哮喘的临床研究OA

Objective To investigate the clinical efficacy and safety of omalizumab combined with montelukast sodium in children with moderate-to-severe refractory asthma.Methods A total of 87 children with moderate to severe refractory asthma were included.They were divided into the treatment group(52 cases)and the control group(35 cases)according to the treatment plan.The treatment group received subcutaneous injection of omalizumab(dose determined by body weight and baseline serum total IgE level,once every 2-4 weeks)combined with montelukast sodium chewable tablets(5 mg·d-1)for 6-14 years old,4 mg·d-1 for children under 6 years old,orally every night).The control group was treated with montelukast sodium chewable tablets alone at the same dose and usage.The treatment course in both groups was 6 months.Symptom control,airway function and incidence of adverse events were observed.Results After 6 months of treatment,ACT/C-ACT scores and FE V1％ pred in both groups were significantly improved compared with baseline(all P＜0.05).The ACT/C-ACT score(23.41±2.18)and FEV1％pred(84.63±8.74)％in the treatment group were significantly higher than those in the control group[(21.08±2.53)％,(79.27±9.35)％,both P＜0.05].The levels of FeNO and EOS in the combination group(28.15±9.63 ppb,0.31±0.13 × 10·L-1)were lower than those in the control group[(36.74±11.28)ppb,0.42±0.16 × 10·L-1],and the reduction in acute exacerbation times was more significant(all P＜0.05).The success rate of ICS step-down in the combination group(63.46％)was higher than that in the control group(42.86％,P＜0.05).There was no significant difference in the incidence of adverse events between the two groups(P＞0.05).Conclusion On the basis of montelukast sodium,combined with omalizumab can further improve pulmonary function,reduce airway inflammation,improve asthma control and reduce acute exacerbations,without increasing the risk of adverse events.