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单克隆抗体治疗难治性鼻息肉慢性鼻窦炎治疗成功的真实生活观察性研究

Real Life Observational Study of Treatment Success of Monoclonal Antibodies for Refractory Chronic Rhinosinusitis with Nasal Polyps.

作者信息

Gerstacker Kathrin, Ketterer Manuel Christoph, Jakob Till Fabian, Hildenbrand Tanja

机构信息

Department of Oto-Rhino-Laryngology, Medical Center-University of Freiburg, Killianstr. 5, 79106 Freiburg, Germany.

出版信息

J Clin Med. 2023 Jun 29;12(13):4374. doi: 10.3390/jcm12134374.

Abstract

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a mainly type-2-driven inflammatory disease that is often refractory to medical and surgical treatment and characterized by a high rate of recurrence. Monoclonal antibodies have been approved for severe refractory CRSwNP. Randomized controlled trials (RCT) have shown significant improvement in objective and subjective parameters. The results of these RCTs cannot necessarily be transferred to daily routine. The purpose of this retrospective study is to evaluate the treatment effects of biologics in patients with CRSwNP in a real-life setting. Patients treated with one of the approved biologics since July 2020 with at least 6 months follow-up were included in the study. Changes in SNOT-22 and nasal polyp score (NPS), as well as subjective change in sense of smell, number of sinus surgeries prior to and during treatment, comorbidities, discontinuation or change of monoclonal antibody and adverse events were evaluated. Thirty-three patients were included in this study. The mean SNOT-22 score and NPS improved significantly. The subjective assessment of sense of smell showed an improvement in 81.8% of patients. The monoclonal antibody had to be changed in seven patients. No severe adverse events occurred during the initiation of the treatment and follow-up. Biologics can be a treatment option in patients with severe refractory CRSwNP, showing significant improvements in quality of life, symptoms and polyp scores in randomized controlled trials and clinical routine with rare complications. Further research is needed to evaluate possible biomarkers, interdose interval prolongation and long-term safety.

摘要

伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种主要由2型炎症驱动的疾病,通常对药物和手术治疗具有难治性,且复发率高。单克隆抗体已被批准用于治疗重度难治性CRSwNP。随机对照试验(RCT)显示在客观和主观参数方面有显著改善。这些RCT的结果不一定能应用于日常临床。这项回顾性研究的目的是评估生物制剂在真实临床环境中对CRSwNP患者的治疗效果。自2020年7月起接受一种已获批生物制剂治疗且随访至少6个月的患者被纳入研究。评估了SNOT-22和鼻息肉评分(NPS)的变化,以及嗅觉的主观变化、治疗前和治疗期间的鼻窦手术次数、合并症、单克隆抗体的停用或更换情况以及不良事件。本研究共纳入33例患者。SNOT-22评分和NPS平均显著改善。81.8%的患者嗅觉主观评估有所改善。7例患者需要更换单克隆抗体。治疗开始及随访期间未发生严重不良事件。生物制剂可作为重度难治性CRSwNP患者的一种治疗选择,在随机对照试验和临床实践中显示出生活质量、症状和息肉评分有显著改善,且并发症罕见。需要进一步研究以评估可能的生物标志物、延长给药间隔时间以及长期安全性。

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