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[重度非甾体抗炎药加重的呼吸道疾病且曾有阿司匹林脱敏治疗患者的生物治疗:一项多中心研究结果]

[Biologic therapy in patients with severe NSAID-exacerbated respiratory disease and previous aspirin desensitization : Results of a multicentric study].

作者信息

Staufenberg Anna-Rebekka, Frankenberger Hanna K, Förster-Ruhrmann Ulrike, Spahn Franziska C, Klimek Ludger, Fruth Kai, Stihl Clemens, Matthias Christoph, Gröger Moritz, Hagemann Jan

机构信息

Hals‑, Nasen‑, Ohrenklinik und Poliklinik, Universitätsmedizin Mainz, Langenbeckstr. 1, 55131, Mainz, Deutschland.

Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, Klinikum der Ludwig-Maximilians-Universität München, Campus Großhadern, München, Deutschland.

出版信息

HNO. 2024 Jul;72(7):473-483. doi: 10.1007/s00106-024-01433-y. Epub 2024 Mar 11.

Abstract

BACKGROUND

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type‑2 inflammatory disease of the upper airways, with severe impairment of quality of life. Persons affected by NSAID-exacerbated respiratory disease (NERD) usually present with highly dynamic recurrence of polyps and disease despite prior treatment with sinus surgeries, oral corticosteroids, and aspirin desensitization (ATAD). Biologic therapy has fundamentally changed the choice of therapeutic concept; however, limited data exist on subgroups such as NERD patients. The aim of the current article is to report on a multicenter retrospective study on add-on therapy with dupilumab, omalizumab, and mepolizumab in patients with NERD.

METHODS

This is a retrospective cohort study of patients (NERD+, status after ATAD) in three reference centers in Germany (Munich, Mainz, Berlin). Subjective and objective parameters were collected at 4, 8, and 12 months after biologic therapy initiation in accordance with current EPOS/EUFOREA (European Position Paper on Rhinosinusitis and Nasal Polyps/European Forum for Research and Education in Allergy and Airway Diseases) guidelines. Biologic agents were chosen depending on availability and patient characteristics.

RESULTS

Treatment was commenced in 122 patients meeting the criteria for CRSwNP and NERD. The endoscopic polyp score, SNOT-22 questionnaire score, visual analogue scoring of total symptoms/severity of disease, and sense of smell (psychophysical testing with Sniffin'Sticks/Brief Smell Identification Test, B‑SIT; Sensonics, Inc., Haddon Heights, NJ, USA) improved significantly after 4 and 12 months of add-on therapy (p < 0.0001). All three biologic agents significantly improved one or more disease parameter. Adverse events were not life threatening but led to change of biologic agent in 4 cases. Patients rated biologic therapy significantly better than ATAD, with improved long-term disease control.

CONCLUSION

Add-on biologic therapy is effective, safe, and widely accepted among CRSwNP + NERD patients. Future studies might allow for personalized algorithms with sequential surgery, ATAD, and/or biologic therapy.

摘要

背景

伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种上呼吸道的2型炎症性疾病,严重损害生活质量。尽管之前接受了鼻窦手术、口服糖皮质激素和阿司匹林脱敏治疗(ATAD),但受非甾体抗炎药加重的呼吸道疾病(NERD)影响的患者通常表现出息肉和疾病的高度动态复发。生物治疗从根本上改变了治疗理念的选择;然而,关于NERD患者等亚组的数据有限。本文的目的是报告一项关于度普利尤单抗、奥马珠单抗和美泊利珠单抗对NERD患者进行附加治疗的多中心回顾性研究。

方法

这是一项对德国三个参考中心(慕尼黑、美因茨、柏林)的患者(NERD+,ATAD后的状态)进行的回顾性队列研究。根据当前的EPOS/EUFOREA(欧洲鼻-鼻窦炎和鼻息肉立场文件/欧洲变应性疾病和气道疾病研究与教育论坛)指南,在生物治疗开始后的4、8和12个月收集主观和客观参数。根据可用性和患者特征选择生物制剂。

结果

122例符合CRSwNP和NERD标准的患者开始治疗。附加治疗4个月和12个月后,内镜息肉评分、SNOT-22问卷评分、总症状/疾病严重程度的视觉模拟评分以及嗅觉(使用Sniffin'Sticks/简短嗅觉识别测试进行心理物理学测试,B-SIT;美国新泽西州哈登高地的Sensonics公司)均有显著改善(p<0.0001)。所有三种生物制剂均显著改善了一个或多个疾病参数。不良事件不危及生命,但有4例导致生物制剂更换。患者对生物治疗的评价明显优于ATAD,长期疾病控制得到改善。

结论

附加生物治疗在CRSwNP+NERD患者中有效、安全且被广泛接受。未来的研究可能会产生个性化的算法,包括序贯手术、ATAD和/或生物治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58c2/11192825/9750ad048850/106_2024_1433_Fig1_HTML.jpg

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