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奥马珠单抗治疗难治性鼻息肉和轻度哮喘患者的效果:一项多中心回顾性研究。

Effects of Omalizumab Treatment in Patients With Recalcitrant Nasal Polyposis and Mild Asthma: A Multicenter Retrospective Study.

机构信息

Otolaryngology Department, University and Polytechnic La Fe Hospital, Valencia, Spain.

Department of Surgery, Valencia University, Valencia, Spain.

出版信息

Am J Rhinol Allergy. 2021 Jul;35(4):516-524. doi: 10.1177/1945892420972326. Epub 2020 Nov 5.

Abstract

BACKGROUND

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a clinical entity with specific features that impacts significantly on patient quality of life (QoL). CRSwNP is often associated with asthma and is difficult to control and manage despite pharmacological and/or surgical treatment. Omalizumab, a monoclonal anti-IgE antibody, has emerged as a putative therapeutic option.

OBJECTIVE

To evaluate the effects of omalizumab on nasal polyp (NP) size and QoL assessed by Sino-Nasal Outcome Test-22 (SNOT-22) in patients with recalcitrant CRSwNP and mild asthma.

METHODS

A multicenter retrospective analysis of patient data from the Community of Valencia (Spain) was performed. Adult patients with recalcitrant CRSwNP and comorbid mild asthma receiving compassionate use of omalizumab were included. NP size measured by total nasal endoscopic polyp score (TPS) and QoL evaluated through the SNOT-22 questionnaire were assessed at baseline and monthly over 12 months. An ordinal regression model was built to analyze the results.

RESULTS

A total of 23 CRSwNP patients with a mean age (± SD) of 54.78 ± 9.46 years were included. Nineteen suffered from aspirin-exacerbated respiratory disease (AERD). In all patients, a significant and sustained reduction in TPS was observed over time, accompanied by improvements in QoL reflected in lower SNOT-22 scores. In the ordinal regression model, time but not total IgE, age or tissue eosinophilia impacted on NP size and SNOT-22 outcomes. Additionally, improvements in QoL were not explained by reductions in the size of polyps.

CONCLUSION

Omalizumab was effective for the treatment of patients with recalcitrant CRSwNP and mild asthma, even when AERD was present, by reducing NP size and improving QoL; treatment time was a key factor. SNOT-22 improvements were not explained by decreases in TPS, indicating that omalizumab may be effective in all patients, regardless of polyp size.

摘要

背景

伴有鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种具有特定特征的临床实体,对患者的生活质量(QoL)有显著影响。CRSwNP 常与哮喘相关,尽管进行了药物和/或手术治疗,仍难以控制和管理。奥马珠单抗是一种单克隆抗 IgE 抗体,已成为一种潜在的治疗选择。

目的

评估奥马珠单抗对伴有轻度哮喘的难治性 CRSwNP 患者的鼻息肉(NP)大小和 Sino-Nasal Outcome Test-22(SNOT-22)评估的生活质量的影响。

方法

对西班牙巴伦西亚社区的多中心回顾性患者数据分析。纳入接受奥马珠单抗同情使用的难治性 CRSwNP 合并伴发轻度哮喘的成年患者。NP 大小通过总鼻内镜息肉评分(TPS)测量,生活质量通过 SNOT-22 问卷评估,在基线和 12 个月内每月评估一次。建立有序回归模型分析结果。

结果

共纳入 23 例 CRSwNP 患者,平均年龄(±标准差)为 54.78±9.46 岁。19 例患有阿司匹林加重的呼吸道疾病(AERD)。所有患者的 TPS 随时间显著且持续减少,同时 QoL 改善,SNOT-22 评分降低。在有序回归模型中,时间而非总 IgE、年龄或组织嗜酸性粒细胞计数对 NP 大小和 SNOT-22 结果有影响。此外,生活质量的改善不能用息肉大小的减少来解释。

结论

奥马珠单抗对伴有轻度哮喘的难治性 CRSwNP 患者有效,即使存在 AERD,也能通过缩小 NP 大小和改善 QoL 来治疗;治疗时间是一个关键因素。SNOT-22 的改善不能用 TPS 的减少来解释,这表明奥马珠单抗可能对所有患者有效,而与息肉大小无关。

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