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生物制剂用于伴鼻息肉的慢性鼻-鼻窦炎的疗效与安全性

Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps.

作者信息

Koski Renee R, Hill Luke, Taavola Kylee

机构信息

Pharmacy Practice, College of Pharmacy, Ferris State University, Big Rapids, MI, USA.

UP Health System Marquette, Marquette, MI, USA.

出版信息

J Pharm Technol. 2022 Oct;38(5):289-296. doi: 10.1177/87551225221105749. Epub 2022 Jul 11.

Abstract

To review published literature for biologic treatment of nasal polyps. PubMed search performed on February 16, 2022, using search terms: biologics, benralizumab, dupilumab, mepolizumab, omalizumab, or reslizumab AND nasal polyps, nasal polyposis, or chronic rhinosinusitis with nasal polyposis (CRSwNP). Inclusion criteria were English language, published randomized controlled trials, post hoc analyses, and meta-analyses evaluating biologics for nasal polyposis, with or without comorbid asthma, and no date limits. Additional studies were found through references of primary and tertiary literature. Nineteen studies, including 8 randomized controlled trials, 2 meta-analyses, and 9 post hoc analyses, examined the efficacy and safety of biologics for nasal polyposis. Agents studied included benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab. Studies had similar inclusion (refractory and recurrent CRSwNP) and exclusion criteria. All studies included the use of an intranasal corticosteroid (mometasone or fluticasone) in addition to the biologic or placebo. The most commonly studied primary endpoint was change in endoscopic nasal polyp score. All studies, post hoc analyses, and meta-analyses found improvement in endoscopic, clinical, and/or radiographic endpoints with benralizumab, dupilumab, mepolizumab, omalizumab, or reslizumab in patients with CRSwNP with or without comorbid asthma. Dupilumab has the most published data. Dupilumab, mepolizumab, and omalizumab are the only biologics currently Food and Drug Administration-approved for CRSwNP. Biologics are beneficial for treating nasal polyps with or without comorbid asthma. The choice depends on patient and provider preference and insurance coverage.

摘要

回顾已发表的关于鼻息肉生物治疗的文献。2022年2月16日在PubMed上进行检索,使用的检索词为:生物制剂、贝那利珠单抗、度普利尤单抗、美泊利单抗、奥马珠单抗或瑞利珠单抗以及鼻息肉、鼻息肉病或伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)。纳入标准为英文文献、已发表的随机对照试验、事后分析以及评估生物制剂治疗鼻息肉病(无论有无合并哮喘)的荟萃分析,且无日期限制。通过一级和三级文献的参考文献找到其他研究。19项研究,包括8项随机对照试验、2项荟萃分析和9项事后分析,检验了生物制剂治疗鼻息肉病的疗效和安全性。研究的药物包括贝那利珠单抗、度普利尤单抗、美泊利单抗、奥马珠单抗和瑞利珠单抗。这些研究有相似的纳入(难治性和复发性CRSwNP)和排除标准。所有研究除生物制剂或安慰剂外均使用了鼻内皮质类固醇(莫米松或氟替卡松)。最常研究的主要终点是鼻内镜下鼻息肉评分的变化。所有研究、事后分析和荟萃分析均发现,对于合并或不合并哮喘的CRSwNP患者,使用贝那利珠单抗、度普利尤单抗、美泊利单抗、奥马珠单抗或瑞利珠单抗可改善鼻内镜、临床和/或影像学终点。度普利尤单抗有最多的已发表数据。度普利尤单抗、美泊利单抗和奥马珠单抗是目前美国食品药品监督管理局批准用于CRSwNP的仅有的生物制剂。生物制剂对治疗合并或不合并哮喘的鼻息肉有益。选择取决于患者和医疗服务提供者的偏好以及保险覆盖范围。

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