嗜酸性中耳炎伴与不伴生物制剂治疗的皮质类固醇负担与听力结局：一项初步回顾性队列研究

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中文摘要

引言： 嗜酸性中耳炎（EOM）是一种难治性、2型炎症驱动型中耳炎，常需反复局部和/或全身皮质类固醇治疗。针对合并2型气道疾病而处方的生物制剂可能改善EOM结局；然而，比较性真实世界数据仍然有限。因此，我们旨在单中心回顾性队列中评估接受与未接受生物制剂治疗的EOM患者在EOM严重程度、气导纯音平均听阈（PTA）和皮质类固醇治疗负担方面的变化。
方法： 我们回顾性审查了在单一三级中心连续治疗的EOM患者。索引日期定义为生物制剂组开始生物制剂治疗（度普利尤单抗或美泊利单抗）的日期，以及非生物制剂组开始针对EOM的皮质类固醇治疗（全身和/或鼓室内）的日期。索引后结局在预先设定的10-14个月窗口内评估，选择最接近12个月的访视。主要分析在患者层面进行，适当时对双耳结局取平均值。主要结局为EOM严重程度评分（0-10）和气导PTA（0.5/1/2/4 kHz）。
结果： 共纳入14例患者（24耳）（平均年龄：57.3±9.3岁；3名男性/11名女性），每组7例患者。随访时间已标准化（中位数：12.5个月；四分位距[IQR]：12.0-13.0）。基线严重程度评分和气导PTA在两组间存在差异（分别为4.9±1.7 vs. 5.7±1.1；39.6±19.0 vs. 55.0±19.0 dB）。两组严重程度均改善；然而，组间变化差异未达到统计学显著性（p=0.077）。生物制剂组内气导PTA改善（p=0.031）；然而，组间PTA变化差异不显著（p=0.249）。生物制剂组停用全身皮质类固醇（0.00±0.00 mg/天），但非生物制剂组仍需使用（1.35±1.55 mg/天；p=0.011）。
结论： 在这项初步真实世界队列中，用于合并2型气道疾病的生物制剂治疗与皮质类固醇负担降低和索引后EOM严重程度较低相关。生物制剂组内气导PTA改善；然而，组间PTA变化差异无统计学显著性，因此听力发现应视为探索性。这些初步发现应谨慎解读，并可能有助于为未来样本量充分的研究提供信息。

英文摘要

INTRODUCTION: Eosinophilic otitis media (EOM) is a refractory, type 2-driven form of otitis media that often requires repeated local and/or systemic corticosteroid therapy. Biologic agents prescribed for comorbid type 2 airway disease may improve EOM outcomes; however, comparative real-world data remain limited. Therefore, we aimed to evaluate changes in EOM severity, air-conduction pure-tone average (PTA), and corticosteroid treatment burden in patients with EOM treated with and without biologic therapy in a single-center retrospective cohort.
METHODS: We retrospectively reviewed consecutive patients with EOM treated at a single tertiary center. The index date was defined as initiation of biologic therapy (dupilumab or mepolizumab) in the biologics group and initiation of EOM-directed corticosteroid therapy (systemic and/or intratympanic) in the non-biologics group. Post-index outcomes were assessed within a prespecified 10-14-month window, selecting the visit closest to 12 months. The primary analysis was conducted at the patient level, averaging bilateral ear outcomes when applicable. Primary outcomes were the EOM severity score (0-10) and air-conduction PTA (0.5/1/2/4 kHz).
RESULTS: Fourteen patients (24 ears) were included (mean age: 57.3±9.3 years; three men/11 women), with seven patients per group. Follow-up timing was standardized (median: 12.5 months; interquartile range [IQR]: 12.0-13.0). Baseline severity score and air-conduction PTA differed between groups (4.9±1.7 vs. 5.7±1.1; 39.6±19.0 vs. 55.0±19.0 dB, respectively). Severity improved in both groups; however, the between-group difference in change did not reach statistical significance (p=0.077). Air-conduction PTA improved within the biologics group (p=0.031); however, the between-group difference in PTA change was not significant (p=0.249). Systemic corticosteroids were discontinued in the biologics group (0.00±0.00 mg/day) but remained required in the non-biologics group (1.35±1.55 mg/day; p=0.011).
CONCLUSION: In this pilot real-world cohort, biologic therapy used for comorbid type 2 airway disease was associated with a reduced corticosteroid burden and lower post-index EOM severity. Air-conduction PTA improved within the biologics group; however, the between-group difference in PTA change was not statistically significant, and the hearing findings should therefore be considered exploratory. These preliminary findings should be interpreted cautiously and may help inform adequately powered future studies.