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Abstract

摘要

Background: Asthma-chronic obstructive pulmonary disease (COPD) overlap (ACO) represents a heterogeneous phenotype with diagnostic challenges and variable responses to biologic therapies. Omalizumab, an anti-IgE monoclonal antibody, is effective in allergic asthma but shows limited efficacy in ACO, necessitating mechanistic insights into treatment heterogeneity.

背景：哮喘-慢性阻塞性肺疾病（COPD）重叠（ACO）代表了一种具有诊断挑战和对生物疗法反应各异的异质表型。奥马珠单抗，一种抗IgE单克隆抗体，在过敏性哮喘中有效，但在ACO中疗效有限，因此需要对治疗异质性的机制进行深入研究。

This study aims to compare the 20-week omalizumab efficacy between ACO and non-ACO asthma patients and to assess how differing ACO diagnostic criteria affect Th2-inflammatory biomarker dynamics and clinical outcomes..

本研究旨在比较ACO和非ACO哮喘患者使用奥马珠单抗20周的疗效，并评估不同的ACO诊断标准如何影响Th2炎症生物标志物动态变化及临床结果。

Methods: We retrospectively analyzed the clinical data of asthma patients who received omalizumab therapy at our hospital between March 2024 and January 2025. All enrolled patients had a documented asthma diagnosis according to the Global Initiative for Asthma (GINA) guidelines. Participants were categorized into ACO and non-ACO asthma groups based on two distinct criteria.

方法：我们回顾性分析了2024年3月至2025年1月期间在本院接受奥马珠单抗治疗的哮喘患者的临床数据。所有纳入的患者均根据《全球哮喘防治倡议》（GINA）指南有明确的哮喘诊断记录。参与者根据两个不同的标准被分为ACO哮喘组和非ACO哮喘组。

The ACO-A group was defined by a prior diagnosis or self-reported history of COPD superimposed on asthma. The ACO-B group required a post-bronchodilator (BD) forced expiratory volume in one second to forced vital capacity ratio (post BD FEV1/FVC) <0.7 and a smoking history of ≥10 pack-years in addition to the asthma diagnosis.

ACO-A组定义为在哮喘基础上叠加了既往诊断或自报的COPD病史。ACO-B组除了哮喘诊断外，还需要满足支气管扩张剂（BD）后一秒用力呼气量与用力肺活量比值（post BD FEV1/FVC）<0.7以及吸烟史≥10包年的条件。

Serological, airway inflammatory, and pulmonary function biomarkers related to asthma were measured and comparatively analyzed..

测量并比较分析了与哮喘相关的血清学、气道炎症和肺功能生物标志物。

Results: A total of 74 patients were enrolled, of whom 25 were ACO-A, 49 were non-ACO-A, 11 were ACO-B, and 63 were non-ACO-B. Patients with ACO exhibited poorer baseline lung function and higher smoking exposure than those with asthma alone. While both groups showed increased asthma control test (ACT) scores, the non-ACO-A group displayed decreased fractional exhaled nitric oxide (FeNO) and eosinophil (EOS) (all P<0.001) and increased serum total IgE, pre-BD FEV1 %predicted, post-BD FEV1 %predicted, and post-BD FEV1/FVC (all P<0.001).

结果：共纳入74例患者，其中25例为ACO-A，49例为非ACO-A，11例为ACO-B，63例为非ACO-B。ACO患者的基线肺功能较单纯哮喘患者差，吸烟暴露更高。两组哮喘控制测试（ACT）评分均有所提高，但非ACO-A组的呼出气一氧化氮分数（FeNO）和嗜酸性粒细胞（EOS）减少（均P<0.001），血清总IgE、前支气管扩张剂FEV1%预计值、后支气管扩张剂FEV1%预计值及后支气管扩张剂FEV1/FVC增加（均P<0.001）。

Changes in serum total IgE, FeNO, and pre-BD FEV1 %predicted (all P<0.05) were more significant in the non-ACO-A group than in the ACO-A group..

血清总IgE、FeNO和预支气管扩张剂FEV1%预测值的变化（均P<0.05）在非ACO-A组比ACO-A组更为显著。

Conclusions: Our findings demonstrate that the Th2-high inflammatory endotype, rather than the ACO diagnostic label, is the primary predictor of omalizumab response. Prioritizing direct assessment of Th2 inflammation over the ACO definition can better guide biologic therapy.

结论：我们的研究结果表明，Th2高炎症内型而非ACO诊断标签是奥马珠单抗反应的主要预测因子。优先直接评估Th2炎症而非ACO定义可以更好地指导生物治疗。