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生物药物在慢性鼻-鼻窦炎伴鼻息肉患者中的临床疗效及反应时间:真实世界经验

Clinical Effects and Response Time of Biological Drugs in Chronic Rhinosinusitis with Nasal Polyps Patients: Real-life Experience.

作者信息

De Santis Sante, Galassi Stefania, Cambi Jacopo

机构信息

ENT Department, SS. Annunziata Hospital, Cosenza, Italy.

Interventional Radiology, SS. Annunziata Hospital, Cosenza, Italy.

出版信息

Laryngoscope. 2025 May;135(5):1628-1635. doi: 10.1002/lary.31948. Epub 2024 Dec 9.

Abstract

OBJECTIVE

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a challenging condition often managed with biologic therapies. This study compares the clinical effects and response times of dupilumab, omalizumab, and mepolizumab in Italian patients with severe uncontrolled CRSwNP.

METHODS

This bicentric, retrospective study included 33 patients treated at two Italian hospitals between April and December 2023. Inclusion criteria followed EPOS 2020 guidelines, focusing on adults with bilateral polyposis, history of endoscopic sinus surgery, and evidence of type 2 inflammation. Patients self-administered biologics according to AIFA protocols. Outcomes were assessed using SNOT-22 for quality of life, Nasal Polyp Score (NPS) for polyp size, and Sniffin' Sticks-12 for olfactory function at baseline, 4 weeks, 3, 6, and 9 months.

RESULTS

All three treatment groups (dupilumab, omalizumab, mepolizumab) showed significant improvements in SNOT-22 scores from baseline to 9 months, with no significant differences between groups. Dupilumab showed the most rapid and sustained improvement in NPS, with significant reductions observed from 4 weeks onward. Both omalizumab and mepolizumab showed significant NPS reductions by 6 months. Olfactory function improved significantly in the dupilumab group, with a notable decrease in anosmic patients from 64.3% to 28.6% at 9 months. Asthma control, measured by Asthma Control Test (ACT) scores, improved across all groups.

CONCLUSION

Dupilumab, omalizumab, and mepolizumab significantly improve quality of life and reduce nasal polyp size in CRSwNP patients, with dupilumab showing the fastest response. These findings support the effectiveness of biologics in real-world settings for managing severe CRSwNP.

LEVEL OF EVIDENCE

3 Laryngoscope, 135:1628-1635, 2025.

摘要

目的

伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种具有挑战性的疾病,通常采用生物疗法进行治疗。本研究比较了度普利尤单抗、奥马珠单抗和美泊利单抗在意大利重度未控制的CRSwNP患者中的临床疗效和反应时间。

方法

这项双中心回顾性研究纳入了2023年4月至12月期间在两家意大利医院接受治疗的33例患者。纳入标准遵循2020年欧洲鼻窦炎和鼻息肉意见书(EPOS)指南,重点关注患有双侧息肉病的成年人、有内镜鼻窦手术史以及2型炎症证据的患者。患者根据意大利药品管理局(AIFA)的方案自行使用生物制剂。在基线、4周、3个月、6个月和9个月时,使用鼻窦鼻症状测试22项问卷(SNOT-22)评估生活质量,使用鼻息肉评分(NPS)评估息肉大小,使用嗅觉棒12项测试评估嗅觉功能。

结果

从基线到9个月,所有三个治疗组(度普利尤单抗、奥马珠单抗、美泊利单抗)的SNOT-22评分均有显著改善,组间无显著差异。度普利尤单抗在NPS方面显示出最快速和持续的改善,从4周起就观察到显著降低。奥马珠单抗和美泊利单抗在6个月时NPS均显著降低。度普利尤单抗组的嗅觉功能显著改善,9个月时嗅觉丧失患者从64.3%显著降至28.6%。通过哮喘控制测试(ACT)评分衡量的哮喘控制在所有组中均有所改善。

结论

度普利尤单抗、奥马珠单抗和美泊利单抗可显著改善CRSwNP患者的生活质量并减小鼻息肉大小,度普利尤单抗反应最快。这些发现支持了生物制剂在现实环境中治疗重度CRSwNP的有效性。

证据级别

3《喉镜》,135:1628 - 1635,2025年。

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