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难治性过敏性哮喘是指使用高剂量吸入皮质类固醇(含或不含其他控制性药物)治疗，病情仍得不到控制的、较为顽固的过敏性哮喘。作为重组人源化IgE单克隆抗体的奥马珠单抗，是目前唯一被授权应用于6～18岁中、重度难治性过敏性哮喘患儿的生物制剂。其对血清游离IgE具有高度特异性，能有效阻断IgE与肥大细胞、嗜碱粒细胞等炎症细胞膜表面的高亲和力受体FcεRⅠ相结合，下调该受体在炎症细胞表面的表达，阻止炎症细胞脱颗粒而引发的过敏反应。与单纯使用常规控制性药物相比，联合奥马珠单抗作为附加治疗，能显著降低哮喘急性发作风险和恶化率，减少频繁就医状况及皮质类固醇的使用剂量，改善肺功能，提高患儿生活质量。“,”Refractory asthma refers to the use of high-dose of inhaled corticosterodis associated with or without other controllers for the treatment of asthma that inadequate control of symptoms.At present, the only biologic agent available in clinical practice for refractory asthma treatment in 6-18 years children in with moderate-to-severe refractory allergic asthma is omalizumab: a recombinant humanized monoclonal anti-IgE antibody.Omalizumab is a blocking antibody that neutralizes circulating free IgE in serum, preventing their bond to high-affinity IgE receptor (FcεRI) on mast cells and basophils and reducing the number of FcεRI on basophils and mast cells.By preventing this binding, the IgE can not trigger degranulation of the mast cells and basophils, therefore preventing the release of inflammatory cytokines that trigger airway inflammation.Compared with the use of conventional control drugs alone, the combination of omalizumab as additional treatment can significantly reduce the risk of acute asthma attack and the rate of exacerbation, reduce the frequent medical treatment status and the use of corticosteroid dose, improve the lung function and improve the quality of life of children.