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改变患者体验:美泊利单抗对伴鼻息肉的慢性鼻-鼻窦炎症状负担的真实世界影响——多中心视角

Transforming Patient Experience: Real-World Impact of Mepolizumab on Symptom Burden in Chronic Rhinosinusitis with Nasal Polyps-A Multicenter Perspective.

作者信息

García-Piñero Alfonso, Pérez-Carbonell Tomás, Gómez-Gómez María-José, Domenech-Campos Encarna, Martinez-Expósito Fernando, Muñoz-Fernández Noelia, Calvo-Gómez Jordi, García-Navalón Carmen, Fito-Martorell Lucas, Ferrer-Baixauli Felip, García-Lliberós Ainhoa, Mosquera-Lloreda Nezly, Taleb Chakib, Zac-Romero Carlos, López-Valdivia Cecilia, Pardo-Albiach Juan, Armengot-Carceller Miguel

机构信息

Rhinology Unit, Hospital Universitari i Politècnic La Fe, 46026 Valencia, Spain.

Rhinology Unit, Hospital Clínico Universitario, 46010 Valencia, Spain.

出版信息

J Clin Med. 2025 Jul 24;14(15):5248. doi: 10.3390/jcm14155248.

DOI:10.3390/jcm14155248
PMID:40806871
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12347621/
Abstract

: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic upper airway disease that may involve different inflammatory endotypes, although in Western populations it is most commonly associated with type 2 inflammation. CRSwNP has a significant impact on the patient's quality of life. The recommended appropriate medical therapy is effective in controlling CRSwNP symptoms in many patients; however, a subset continues to exhibit persistent type 2 inflammation, evidenced by recurrent nasal polyps, elevated eosinophil counts, or the need for systemic corticosteroids or surgery. Monoclonal antibodies have recently become a novel and personalized treatment that can help refractory patients restore disease control. : The present study aims to evaluate the effectiveness of mepolizumab in real-world settings in a diverse patient population, focusing on assessing the impact of this therapy on patient-reported outcomes after six months of treatment. This is a multicenter, observational study of CRSwNP patients treated with mepolizumab carried out in five hospitals located in Spain. Adult patients with a diagnosis of uncontrolled CRSwNP were included in the study. The change in the nasal polyp score (NPS) was the main clinical endpoint. Changes in the Sinonasal Outcome Test (SNOT-22), nasal congestion and smell impairment visual analogue scale scores, and blood and nasal polyp tissue eosinophil counts were among other endpoints included. : In total, 47 patients were included, and 91% were asthmatic. The nasal polyp score (0-8) was reduced significantly in the cohort (mean change: -2.56, < 0.0001). The mean SNOT-22 score improved 25.29 points. Nasal congestion (-3.57, < 0.0001) and smell impairment (-4.0, < 0.0001) visual analog scale scores (0-10) showed a significant improvement. Blood and tissue eosinophil median counts showed significant reductions versus baseline of 86% and 26%, respectively. Among those patients with asthma, the asthma control test score achieved a median value of 24 points. : This study provides real-world evidence supporting the effectiveness of mepolizumab in managing CRSwNP in patients with features suggestive of type 2 inflammation. The observed improvements in patient-reported outcomes, nasal polyp burden, and asthma control suggest that mepolizumab may be a valuable therapeutic option for this patient population.

摘要

伴有鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种慢性上呼吸道疾病,可能涉及不同的炎症亚型,尽管在西方人群中它最常与2型炎症相关。CRSwNP对患者的生活质量有重大影响。推荐的适当药物治疗在许多患者中能有效控制CRSwNP症状;然而,一部分患者仍表现出持续性2型炎症,表现为鼻息肉复发、嗜酸性粒细胞计数升高,或需要全身使用糖皮质激素或手术治疗。单克隆抗体最近已成为一种新型的个性化治疗方法,可帮助难治性患者恢复疾病控制。本研究旨在评估美泊利珠单抗在不同患者群体的真实世界环境中的有效性,重点评估该治疗在治疗六个月后对患者报告结局的影响。这是一项在西班牙五家医院对接受美泊利珠单抗治疗的CRSwNP患者进行的多中心观察性研究。研究纳入了诊断为未控制的CRSwNP的成年患者。鼻息肉评分(NPS)的变化是主要临床终点。鼻窦结局测试(SNOT-22)、鼻充血和嗅觉障碍视觉模拟量表评分的变化,以及血液和鼻息肉组织嗜酸性粒细胞计数也是纳入的其他终点。总共纳入了47例患者,其中91%患有哮喘。该队列中的鼻息肉评分(0 - 8)显著降低(平均变化:-2.56,< 0.0001)。SNOT-22平均评分提高了25.29分。鼻充血(-3.57,< 0.0001)和嗅觉障碍(-4.0,< 0.0001)视觉模拟量表评分(0 - 10)显示有显著改善。血液和组织嗜酸性粒细胞中位数计数与基线相比分别显著降低了86%和26%。在那些患有哮喘的患者中,哮喘控制测试评分的中位数达到了24分。本研究提供了真实世界的证据,支持美泊利珠单抗在管理具有2型炎症特征的患者的CRSwNP方面的有效性。观察到的患者报告结局、鼻息肉负担和哮喘控制的改善表明,美泊利珠单抗可能是该患者群体的一种有价值的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4644/12347621/379d3bc383bc/jcm-14-05248-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4644/12347621/1755c62762ee/jcm-14-05248-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4644/12347621/379d3bc383bc/jcm-14-05248-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4644/12347621/1755c62762ee/jcm-14-05248-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4644/12347621/379d3bc383bc/jcm-14-05248-g002.jpg

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本文引用的文献

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Mepolizumab in chronic rhinosinusitis with nasal polyps: Real life data in a multicentric Sicilian experience.美泊利珠单抗治疗慢性鼻-鼻窦炎伴鼻息肉:西西里岛多中心真实世界数据
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美泊利单抗治疗2型慢性鼻-鼻窦炎伴鼻息肉的效果:一项真实世界临床研究
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EUFOREA/EPOS2020 statement on the clinical considerations for chronic rhinosinusitis with nasal polyps care.EUFOREA/EPOS2020 关于慢性鼻-鼻窦炎伴鼻息肉患者护理的临床考量声明。
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