在患有鼻息肉的慢性鼻炎患者中使用生物制剂--4 年实际生活观察。

IF 1.9 3区 医学 Q2 OTORHINOLARYNGOLOGY European Archives of Oto-Rhino-Laryngology Pub Date : 2024-11-01 Epub Date: 2024-07-08 DOI:10.1007/s00405-024-08790-y
Hanna Frankenberger, Robert Wiebringhaus, Benedikt Paul, Patrick Huber, Frank Haubner, Moritz Gröger, Clemens Stihl
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引用次数: 0

摘要

目的:德国自 2019 年起开始对慢性鼻炎伴鼻息肉(CRSwNP)进行抗体治疗。由于 CRSwNP 生物疗法的长期数据有限,我们对 4 年的数据进行了全面评估。这项单中心研究旨在评估这种治疗方法在临床过程、生活质量、治疗依从性、生物制剂转换、双重治疗和合并症等方面的实际效果:我们回顾性分析了严重慢性鼻炎伴鼻息肉患者的生物治疗数据。我们对 191 名接受杜匹单抗、美博利珠单抗或奥马珠单抗治疗的 CRSwNP 患者进行了长达 4 年的实际观察:结果:我们观察到症状明显改善,副作用很少。结果:我们观察到症状得到明显改善,副作用较少,4 年间未发现疗效或耐受性下降。与之前的疗法相比,患者的满意度很高,总体生活质量有所改善。在生物治疗期间,很少出现翻修手术或口服类固醇的情况。一些患者延长了注射间隔或停用了类固醇鼻喷雾剂。由于副作用或疗效不佳而更换生物制剂的情况并不多见,患者一般都能很好地耐受。许多患者报告了额外的积极效果,如哮喘或过敏症状得到改善,药物摄入量减少:总之,这项研究证实了生物制剂治疗 CRSwNP 的有效性和耐受性,而且疗效可持续 4 年之久。如果反应不充分或出现无法忍受的副作用,生物制剂转换是一个可行的选择。治疗对Th2合并症、皮质类固醇需求和手术需求有积极影响,总体依从性仍然很高:项目编号:22-0802。临床试验注册:项目编号:22-0802.注册名称:慢性鼻窦炎患者的生物治疗(Biologika bei Patient*innen mit chronischer Sinusitis mit Nasenpolypen)。
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The use of biologics in patients suffering from chronic rhinosinusitis with nasal polyps - a 4-year real life observation.

Purpose: Antibody therapy for chronic rhinosinusitis with nasal polyps (CRSwNP) has been established in Germany since 2019. With limited long-term data on biologic treatment for CRSwNP, we conducted a comprehensive evaluation of our 4-year data. This monocentric study aims to assess the real-world effects of this treatment on clinical course, quality of life, treatment adherence, biologic switching, dual therapy, and comorbidities.

Methods: We retrospectively analysed biologic therapy data in patients with severe chronic rhinosinusitis with nasal polyps. 191 patients with CRSwNP treated with Dupilumab, Mepolizumab, or Omalizumab were observed for up to 4 years in a real-life setting.

Results: We observed clear symptom improvements with few side effects. No loss of efficacy or tolerability was noted during the 4-year period. Patients reported high satisfaction compared to previous therapies, with overall improved quality of life. Revision surgery or oral steroid use during biologic therapy was rare. Some patients prolonged injection intervals or discontinued steroid nasal spray. Biologic switching occurred infrequently due to side effects or inadequate response and was generally well tolerated. Many patients reported additional positive effects such as asthma or allergy symptom improvement and reduced medication intake.

Conclusion: In summary, this study confirms the potency and tolerability of biologics for CRSwNP treatment, with sustained efficacy over 4 years. Biologic switching is a viable option for inadequate response or intolerable side effects. Therapy positively impacts Th2 comorbidities, corticosteroid requirements, surgery need, and overall compliance remains high.

Clinical trial registration: Project No.: 22-0802. Registry name: Biologika bei Patient*innen mit chronischer Sinusitis mit Nasenpolypen.

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来源期刊
CiteScore
5.30
自引率
7.70%
发文量
537
审稿时长
2-4 weeks
期刊介绍: Official Journal of European Union of Medical Specialists – ORL Section and Board Official Journal of Confederation of European Oto-Rhino-Laryngology Head and Neck Surgery "European Archives of Oto-Rhino-Laryngology" publishes original clinical reports and clinically relevant experimental studies, as well as short communications presenting new results of special interest. With peer review by a respected international editorial board and prompt English-language publication, the journal provides rapid dissemination of information by authors from around the world. This particular feature makes it the journal of choice for readers who want to be informed about the continuing state of the art concerning basic sciences and the diagnosis and management of diseases of the head and neck on an international level. European Archives of Oto-Rhino-Laryngology was founded in 1864 as "Archiv für Ohrenheilkunde" by A. von Tröltsch, A. Politzer and H. Schwartze.
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