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中国应用生物制剂治疗慢性鼻窦炎的专家共识(2022)

制定者:
中国鼻病研究协作组

2023年4月4日

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摘要:

中英对照

Background: Chronic rhinosinusitis (CRS) is a common inflammatory disease in otolaryngology, mainly manifested as nasal congestion, nasal discharge, facial pain/pressure, and smell disorder. CRS with nasal polyps (CRSwNP), an important phenotype of CRS, has a high recurrence rate even after receiving corticosteroids and/or functional endoscopic sinus surgery. In recent years, clinicians have focused on the application of biological agents in CRSwNP. However, it has not reached a consensus on the timing and selection of biologics for the treatment of CRS so far.

Summary: We reviewed the previous studies of biologics in CRS and summarized the indications, contraindications, efficacy assessment, prognosis, and adverse effects of biologics. Also, we evaluated the treatment response and adverse reactions of dupilumab, omalizumab, and mepolizumab in the management of CRS and made recommendations.

Key Messages: Dupilumab, omalizumab, and mepolizumab have been approved for the treatment of CRSwNP by the US Food and Drug Administration. Type 2 and eosinophilic inflammation, need for systemic steroids or contraindication to systemic steroids, significantly impaired quality of life,anosmia, and comorbid asthma are required for the use of biologics. Based on current evidence, dupilumab has the prominent advantage in improving quality of life and reducing the risk of comorbid asthma in CRSwNP among the approved monoclonal antibodies. Most patients tolerate biological agents well in general with few major or severe adverse effects. Biologics have provided more options for severe uncontrolled CRSwNP patients or patients who refuse to have surgery. In the future, more novel biologics will be assessed in high-quality clinical trials and applied clinically.

背景:慢性鼻-鼻窦炎 (Chronic rhinosinusitis,CRS) 是耳鼻喉科常见的炎症性疾病,主要表现为鼻塞、流涕、面部疼痛/压迫感、嗅觉障碍等。

CRS 伴鼻息肉 (CRSwNP) 是 CRS 的重要表型,即使接受皮质类固醇和(或)功能性鼻内镜手术后,复发率也较高。近年来,临床医生重点关注生物制剂在 CRSwNP 中的应用。但至今对于生物制剂治疗 CRS 的时机和选择尚未达成共识。

Summary:我们回顾了以往生物制剂在 CRS 中的研究,总结了生物制剂的适应证、禁忌证、疗效评估、预后和不良反应。

此外,我们还评估了dupilumab、奥马珠单抗和美泊利单抗在 CRS 管理中的治疗反应和不良反应,并提出了建议。

关键信息:美国食品药品监督管理局已批准dupilumab、奥马珠单抗和美泊利单抗用于治疗CRSwNP。

使用生物制剂需要2型和嗜酸性粒细胞性炎症、需要全身类固醇或全身类固醇禁忌症、生活质量显著受损、嗅觉丧失和共患哮喘。基于当前的证据,在获批的单克隆抗体中,dupilumab在改善 CRSwNP 患者的生活质量和降低哮喘共病风险方面具有显著优势。大多数患者通常对生物制剂耐受良好,几乎没有重大或严重不良反应。生物制剂为严重未控制的 CRSwNP 患者或拒绝手术的患者提供了更多的选择。未来,将在高质量的临床试验中评估更多新型生物制剂,并应用于临床。

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中国应用生物制剂治疗慢性鼻窦炎的专家共识(2022)
发布时间:  2023年4月4日
制定者:  
中国鼻病研究协作组

396人浏览

1收藏

4次下载

摘要

Background: Chronic rhinosinusitis (CRS) is a common inflammatory disease in otolaryngology, mainly manifested as nasal congestion, nasal discharge, facial pain/pressure, and smell disorder. CRS with nasal polyps (CRSwNP), an important phenotype of CRS, has a high recurrence rate even after receiving corticosteroids and/or functional endoscopic sinus surgery. In recent years, clinicians have focused on the application of biological agents in CRSwNP. However, it has not reached a consensus on the timing and selection of biologics for the treatment of CRS so far.

Summary: We reviewed the previous studies of biologics in CRS and summarized the indications, contraindications, efficacy assessment, prognosis, and adverse effects of biologics. Also, we evaluated the treatment response and adverse reactions of dupilumab, omalizumab, and mepolizumab in the management of CRS and made recommendations.

Key Messages: Dupilumab, omalizumab, and mepolizumab have been approved for the treatment of CRSwNP by the US Food and Drug Administration. Type 2 and eosinophilic inflammation, need for systemic steroids or contraindication to systemic steroids, significantly impaired quality of life,anosmia, and comorbid asthma are required for the use of biologics. Based on current evidence, dupilumab has the prominent advantage in improving quality of life and reducing the risk of comorbid asthma in CRSwNP among the approved monoclonal antibodies. Most patients tolerate biological agents well in general with few major or severe adverse effects. Biologics have provided more options for severe uncontrolled CRSwNP patients or patients who refuse to have surgery. In the future, more novel biologics will be assessed in high-quality clinical trials and applied clinically.

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