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度普利尤单抗治疗伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)的疗效:一项多中心真实世界研究。

Efficacy of Dupilumab in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP): a multicentric real-life study.

作者信息

Marco Govoni, Arianna Soncini, Domenico Cuda, Gabriele Oretti, Silvia Lazio Maria, Giulia Zambonini, Sara Ugolini, Irene Herman, Celeste Carpentiero Colarusso, Enrico Liaci, Enrico Pasanisi, Daria Salsi

机构信息

Department of Otorhinolaryngology and Otoneurosurgery, University Hospital of Parma, Viale Antonio Gramsci, 14, Parma (PR), 43126, Italy.

Department of Medicine and Surgery, University of Parma, Viale Antonio Gramsci, 14, Parma (PR), 43126, Italy.

出版信息

Eur Arch Otorhinolaryngol. 2025 Jul 12. doi: 10.1007/s00405-025-09540-4.

Abstract

PURPOSE

Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with morbidity and impairment in quality of life. Lately, new biological drugs have been developed and approved for its treatment. Dupilumab was the first to be approved but long-term real-world results are still limited.

METHODS

This is a real-life, multicenter observational study assessing the effectiveness of dupilumab in patients with CRSwNP with a follow-up from 3 to 24 months. We focused on nasal polyps score (NPS), quality of life (SNOT-22), olfactory function and blood eosinophils trend. Moreover, results were stratified by previous surgery, comorbidities, and blood eosinophils and IgE levels at baseline.

RESULTS

We observed a significant decrease in NPS and SNOT-22 from baseline to all the follow-up sessions. Olfaction improved over time and a significant difference was observed between baseline and 12 and 18 months. At 12 months follow-up, NPS of patients who had undergone surgery was lower than NPS of naïve patients (p =.012). Surgery did not influence SNOT-22 or improvement of smell. Comorbidities did not affect the outcomes. Blood eosinophils increased from baseline, reaching a peak at 3 months and gradually decreasing to a value similar to baseline at 18 months. The level of blood eosinophils and total IgE at baseline did not influence the effect of the drug on NPS at 12 months. No major adverse events were observed.

CONCLUSION

Dupilumab was proven to be effective in terms of reduction of dimension of nasal polyps, improvement of quality of life and olfaction and no major adverse events were observed.

摘要

目的

伴有鼻息肉的慢性鼻-鼻窦炎(CRSwNP)与发病率及生活质量受损相关。最近,已研发出并批准了用于治疗该病的新型生物药物。度普利尤单抗是首个获批的药物,但长期的真实世界研究结果仍然有限。

方法

这是一项真实生活中的多中心观察性研究,评估度普利尤单抗对CRSwNP患者的有效性,随访时间为3至24个月。我们重点关注鼻息肉评分(NPS)、生活质量(SNOT-22)、嗅觉功能及血液嗜酸性粒细胞变化趋势。此外,根据既往手术史、合并症以及基线时血液嗜酸性粒细胞和IgE水平对结果进行分层。

结果

我们观察到从基线到所有随访阶段,NPS和SNOT-22均显著降低。嗅觉随时间改善,在基线与12个月及18个月时观察到显著差异。在12个月随访时,接受过手术的患者的NPS低于未接受过手术的患者(p = 0.012)。手术未影响SNOT-22或嗅觉改善。合并症未影响结果。血液嗜酸性粒细胞从基线水平升高,在3个月时达到峰值,然后逐渐下降,至18个月时降至与基线相似的值。基线时血液嗜酸性粒细胞水平和总IgE水平不影响该药物在12个月时对NPS的疗效。未观察到重大不良事件。

结论

度普利尤单抗在缩小鼻息肉尺寸、改善生活质量和嗅觉方面被证明是有效的,且未观察到重大不良事件。

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