屋尘螨免疫疗法对不同致敏模式的中国变应性鼻炎患者的疗效：一项多中心研究（COVER研究）

Efficacy of House Dust Mite Immunotherapy in Chinese Allergic Rhinitis Patients With Diverse Sensitization Patterns: A Multicenter Study (COVER Study).

作者信息

Xu Qingxiu, Yuan Xuan, Liao Wang, Chen Hao, Jiang Qing, Yang Lin, Liu Jin, Li Le, Huang Nan, Li Wenjing, Yang Yaqi, Ma Dongxia, Bai Jun, Xie Zhihai, Zhu Rongfei

机构信息

Department of Allergy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, China.

出版信息

Allergy. 2025 Sep 25. doi: 10.1111/all.70072.

DOI:10.1111/all.70072

PMID:40995889

Abstract

BACKGROUND

Allergen immunotherapy (AIT) is the only etiological treatment for allergic rhinitis (AR) patients, yet the impact of allergen sensitization patterns on AIT efficacy remains unclear. This study aimed to assess the effectiveness of subcutaneous immunotherapy (SCIT) using a native house dust mite (HDM) allergen extract in Chinese AR patients with diverse HDM sensitization patterns.

METHODS

This prospective multicenter study across three allergy centers in China enrolled patients aged 5-65 diagnosed with HDM-induced AR. Serum-specific IgE testing for nine HDM components (Der p1, Der p2, Der p23, Der f1, Der f2, Der p5, Der p7, Der p10, Der p21) categorized patients into two groups: Group A with sensitization limited to major allergen components and Group B with sensitization to minor components with or without major components. Both groups underwent 1 year of HDM SCIT (Allergopharma, Germany), whose efficacy was assessed using the visual analogue scale (VAS) and combined symptom medication scores (CSMS). Serum IgE and IgG4 levels against the nine HDM components were measured pre- and post-treatment, and SCIT-related adverse reactions were recorded.

RESULTS

The study enrolled 168 patients, with 75 in Group A and 93 in Group B. Group B patients had higher asthma prevalence and elevated baseline HDM sIgE and total IgE levels. After 1 year, Group B showed significantly greater CSMS reduction (67.70% vs. 59.09%, p = 0.03) and VAS improvement (66.67% vs. 50.00%, p = 0.01) compared to Group A. Group A had increased new sensitization risk to minor allergens (Der p5, Der p7, Der p21). No significant difference in SCIT efficacy was observed between patients with and without new sensitization. Both groups exhibited increased sIgG4 levels against all nine HDM allergens, with a more pronounced elevation of sIgG4 levels to Der p21 observed in Group B compared to Group A (p = 0.02). SCIT-related adverse reactions were comparable (p > 0.05).

CONCLUSIONS

The native HDM allergen extract demonstrates efficacy in Chinese AR patients with varying sensitization patterns. It offers enhanced benefits for patients sensitized to minor allergens with or without major allergens of HDM, positioning it as the preferred option for individuals with AR.

TRIAL REGISTRATION

Chinese Clinical Trial Registry identifier: ChiCTR2300078642.

摘要

背景

变应原免疫疗法（AIT）是变应性鼻炎（AR）患者的唯一病因治疗方法，但变应原致敏模式对AIT疗效的影响仍不清楚。本研究旨在评估使用天然屋尘螨（HDM）变应原提取物进行皮下免疫疗法（SCIT）对具有不同HDM致敏模式的中国AR患者的有效性。

方法

这项在中国三个过敏中心开展的前瞻性多中心研究纳入了5至65岁诊断为HDM诱发的AR患者。对九种HDM成分（Der p1、Der p2、Der p23、Der f1、Der f2、Der p5、Der p7、Der p10、Der p21）进行血清特异性IgE检测，将患者分为两组：A组致敏限于主要变应原成分，B组致敏于次要成分，有或无主要成分。两组均接受为期1年的HDM SCIT（德国Allergopharma公司产品），使用视觉模拟量表（VAS）和综合症状药物评分（CSMS）评估其疗效。在治疗前后测量针对九种HDM成分的血清IgE和IgG4水平，并记录SCIT相关的不良反应。

结果

该研究共纳入168例患者，A组75例，B组93例。B组患者哮喘患病率更高，基线HDM sIgE和总IgE水平升高。1年后，与A组相比，B组的CSMS降低幅度显著更大（67.70%对59.09%，p = 0.03），VAS改善更明显（66.67%对50.00%，p = 0.01）。A组对次要变应原（Der p5、Der p7、Der p21）出现新致敏的风险增加。有新致敏和无新致敏的患者之间，SCIT疗效未观察到显著差异。两组针对所有九种HDM变应原的sIgG4水平均升高，与A组相比，B组针对Der p21的sIgG4水平升高更为明显（p = 0.02）。SCIT相关的不良反应相当（p > 0.05）。