慢性鼻窦炎伴鼻息肉的生物制剂:韩国的现状和临床考虑。

Journal of Rhinology Pub Date : 2025-03-01 Epub Date: 2025-03-21 DOI:10.18787/jr.2025.00002
Ki-Il Lee, Gwanghui Ryu, Shin Hyuk Yoo, Hyung-Ju Cho, Ji-Hun Mo, Chang-Hoon Kim
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引用次数: 0

摘要

慢性鼻窦炎伴鼻息肉(CRSwNP)是一种严重影响生活质量并给卫生保健系统带来负担的普遍疾病。针对2型免疫途径的生物制剂的出现为严重和/或不受控制的CRSwNP提供了新的治疗选择。最初,生物用途是由欧洲鼻窦炎和鼻息肉立场文件(EPOS) 2020和欧洲过敏和气道疾病研究与教育论坛(EUFOREA)指南指导的,尽管临床适应症、反应措施和治疗持续时间的数据有限。从那时起,大量的研究和EPOS/EUFOREA 2023的更新完善了这些指南。该更新定义了基于2型炎症标志物的生物制剂的临床适应症,将血液嗜酸性粒细胞阈值从250个细胞/μL降低到150个细胞/μL。对生物制剂的反应现在更简单地分为三个层次,分别是鼻息肉大小的缩小、生活质量的改善和嗅觉的增强。建议在6个月时进行治疗评估,并每年随访。较长的给药间隔,如每四周一次,也被证明对控制良好的患者有效。尽管仍缺乏关于停药或转换生物制剂的具体指南,但临床判断对于确定何时停止或调整治疗至关重要。此外,监管更新支持使用生物制剂治疗CRSwNP,新型药物如tezepelumab(一种抗胸腺基质淋巴生成素单克隆抗体)继续显示出希望。最后,在韩国,用于CRSwNP的生物制剂不包括在国民健康保险范围内,由于费用高昂,导致给药间隔延长。尽管存在这种局限性,但研究表明,调整剂量可以维持主观生活质量。韩国作者最近的研究也探讨了实际的考虑因素,如给药间隔和与手术的比较。需要进一步的研究来优化治疗策略,特别是针对韩国医疗保健系统的成本效益和前瞻性研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Biologics for Chronic Rhinosinusitis With Nasal Polyps: Current Status and Clinical Considerations in Korea.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a prevalent condition that significantly impacts quality of life and places a burden on healthcare systems. The advent of biologics targeting type 2 immune pathways offers new therapeutic options for severe and/or uncontrolled CRSwNP. Initially, biologic use was guided by the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) 2020 and the European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) guidelines, despite limited data on clinical indications, response measures, and treatment duration. Since then, numerous studies and the EPOS/EUFOREA 2023 update have refined these guidelines. The update defines clinical indications for biologics based on type 2 inflammation markers by lowering the blood eosinophil threshold from 250 to 150 cells/μL. The response to biologics is now more simply categorized into three levels based on reductions in nasal polyp size, improvements in quality of life, and enhancement of smell. Treatment evaluation is recommended at 6 months with annual follow-up. Longer administration intervals, such as every four weeks, have also proven effective in well-controlled patients. Although specific guidelines for discontinuation or switching biologics remain lacking, clinical judgment is essential in determining when treatment should be stopped or adjusted. Additionally, regulatory updates support the use of biologics for CRSwNP, and novel agents such as tezepelumab (an anti-thymic stromal lymphopoietin monoclonal antibody) continue to show promise. Finally, in Korea, biologics for CRSwNP are not covered by national health insurance, leading to extended dosing intervals due to high costs. Despite this limitation, studies have shown that adjusted dosing can maintain subjective quality of life. Recent studies by Korean authors have also explored practical considerations such as dosing intervals and comparisons to surgery. Further research is needed to optimize treatment strategies, particularly regarding cost-effectiveness and prospective studies tailored to the Korean healthcare system.

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