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奥马珠单抗联合变应原特异性免疫治疗中重度过敏性哮喘的疗效和安全性:一项中国人群的前瞻性队列研究

 

Authors Liu N, Jin P , Li X , Gao T, Sun Y, Zhang N, Zhang Y, Liu P, Zhang H , Zhi L 

Received 16 April 2025

Accepted for publication 30 August 2025

Published 23 September 2025 Volume 2025:18 Pages 1337—1346

DOI https://doi.org/10.2147/JAA.S530738

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 4

Editor who approved publication: Prof. Dr. Agnès Hamzaoui

Na Liu,1,* Peng Jin,2,* Xu Li,1 Tingting Gao,1 Yan Sun,1 Na Zhang,1 Yunqing Zhang,1 Peize Liu,1,3 Hailing Zhang,2 Lili Zhi1 

1Department of Allergy, Shandong Provincial Qianfoshan Hospital, Shandong Institute of Respiratory Diseases, The First Affiliated Hospital of Shandong First Medical University, Jinan, 250014, People’s Republic of China; 2Department of Otolaryngology, The Second Qilu Hospital of Shandong University, Jinan, 250033, People’s Republic of China; 3Shandong First Medical University, Shandong Academy of Medical Sciences, Jinan, 250117, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Lili Zhi Department of Allergy, Shandong Provincial Qianfoshan Hospital, Shandong Institute of Respiratory Diseases, The First Affiliated Hospital of Shandong First Medical University, No. 16766, Jingshi Road, Jinan, Shandong, 250014, People’s Republic of China, Email qfsyyallergy@163.com Hailing Zhang Department of Otolaryngology, The Second Qilu Hospital of Shandong University, 247 Beiyuan Avenue, Jinan, 250033, People’s Republic of China, Email 15853138360@163.com

Background: Moderate-to-severe allergic asthma caused by dust mite sensitization is challenging to treat. Allergen-specific immunotherapy (AIT) is the only disease-modifying option but is limited by delayed effects, allergic side reactions, and poor adherence. Omalizumab, an anti-IgE antibody, may improve AIT’s safety and effectiveness.
Objective: To assess whether combining omalizumab with AIT is more effective and safer than AIT alone in patients with dust mite-induced moderate-to-severe asthma.
Methods: This prospective study involved 37 patients divided into two groups: AIT alone (n=18) and omalizumab + AIT (n=19). Over 48 weeks, asthma control (ACT, ACQ), lung function (FEV₁%, PEF%, FEV₁/FVC), and airway inflammation (FeNO) were measured. Secondary outcomes included IgE levels, eosinophil counts, quality of life (AQLQ), and safety.
Results: Both groups improved, but the combination group showed significantly better asthma control, lung function, and quality of life at week 48. Only the combination group had significant reductions in FeNO and eosinophils, suggesting stronger anti-inflammatory effects. IgE levels followed expected trends with no major group differences. Fewer adverse reactions occurred in the combination group; severe systemic events were reported only in the AIT-alone group.
Conclusion: Adding omalizumab to AIT significantly enhances asthma control, lung function, and inflammation reduction while improving treatment safety. This supports its role as an effective adjunct in managing moderate-to-severe dust mite-allergic asthma in Chinese patients.

Keywords: asthma, allergen immunotherapy, omalizumab, allergy, efficacy, safety, treatment