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慢性鼻-鼻窦炎伴鼻息肉中单抗药物和阿司匹林脱敏治疗的疗效和安全性比较:系统评价和网络荟萃分析。

Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: A systematic review and network meta-analysis.

机构信息

Department of Medicine, Division of Clinical Immunology and Allergy, McMaster University, Hamilton, Ontario, Canada.

Charité Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Department of Dermatology and Allergy, Berlin Institute of Health, Comprehensive Allergy Center, Berlin, Germany; CHU and MACVIA-France, Montpellier, France.

出版信息

J Allergy Clin Immunol. 2022 Apr;149(4):1286-1295. doi: 10.1016/j.jaci.2021.09.009. Epub 2021 Sep 17.

Abstract

BACKGROUND

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is an inflammatory condition of the upper airways. Optimal management is unclear.

OBJECTIVE

We compared the effects of mAbs and aspirin desensitization (ASA-D) for treatment of CRSwNP.

METHODS

We searched the Medline, Embase, Cochrane Central Register of Controlled Trials, International Clinical Trials Registry Platform, US Food and Drug Administration, and the European Medicines Agency databases from inception to August 4, 2021, for randomized controlled trials comparing the effects of mAbs and ASA-D for CRSwNP. We conducted network meta-analysis of sinusitis symptoms, heath-related quality of life, rescue oral corticosteroids and surgery, endoscopic and radiologic scores, and adverse events. We used the Grades of Recommendation Assessment, Development and Evaluation (GRADE) approach to assess certainty of evidence. PROSPERO CRD42020177334.

RESULTS

Twenty-nine randomized controlled trials evaluating 8 treatments (n = 3461) were included in the network meta-analysis. Compared to placebo, moderate to high certainty evidence showed that health-related quality of life (SNOT-22) improved with dupilumab (mean difference [MD] -19.91 [95% confidence interval (CI) -22.50, -17.32]), omalizumab (MD -16.09 [95% CI -19.88, -12.30]), mepolizumab (MD -12.89 [95% CI -16.58, -9.19], ASA-D (MD -10.61 [95% CI -14.51, -6.71]), and benralizumab (MD -7.68 [95% CI -12.09, -3.27]). The risk of rescue nasal polyp surgery likely decreased with dupilumab (risk difference [RD] -16.35% [95% CI -18.13, -13.48]), omalizumab (RD -7.40% [95% CI -11.04, -2.43]), mepolizumab (RD -12.33% [95% CI -15.56, -7.22]), and ASA-D (RD -16.00% [95% CI -19.79, 0.21]; all moderate certainty). Comparisons among agents show with moderate to high certainty that dupilumab ranks among the most beneficial for 7 of 7 outcomes, omalizumab for 2 of 7, mepolizumab for 1 of 7, and ASA-D for 1 of 7.

CONCLUSIONS

Multiple biologics and ASA-D credibly improve patient-important outcomes, with clinically important differences in effects among agents; dupilumab uniquely ranks among the most beneficial for all outcomes studied.

摘要

背景

伴有鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种上呼吸道的炎症性疾病。其最佳治疗方法尚不清楚。

目的

我们比较了单克隆抗体和阿司匹林脱敏(ASA-D)治疗 CRSwNP 的效果。

方法

我们检索了 Medline、Embase、Cochrane 对照试验中心注册库、国际临床试验注册平台、美国食品和药物管理局以及欧洲药品管理局数据库,检索时间从建库至 2021 年 8 月 4 日,以比较单克隆抗体和 ASA-D 治疗 CRSwNP 的效果的随机对照试验。我们对鼻窦炎症状、健康相关生活质量、挽救性口服皮质类固醇和手术、内镜和影像学评分以及不良事件进行了网络荟萃分析。我们使用推荐评估、制定与评估(GRADE)方法评估证据的确定性。PROSPERO CRD42020177334。

结果

共纳入 29 项随机对照试验,评估了 8 种治疗方法(n=3461),进行了网络荟萃分析。与安慰剂相比,中高度确定性证据表明,健康相关生活质量(SNOT-22)得到改善:度普利尤单抗(平均差值 [MD] -19.91 [95%置信区间(CI)-22.50,-17.32])、奥马珠单抗(MD -16.09 [95% CI -19.88,-12.30])、美泊利珠单抗(MD -12.89 [95% CI -16.58,-9.19])、ASA-D(MD -10.61 [95% CI -14.51,-6.71])和贝那鲁单抗(MD -7.68 [95% CI -12.09,-3.27])。接受度普利尤单抗、奥马珠单抗、美泊利珠单抗和 ASA-D 治疗的患者,挽救性鼻息肉手术的风险可能降低:度普利尤单抗(风险差异 [RD] -16.35% [95% CI -18.13,-13.48])、奥马珠单抗(RD -7.40% [95% CI -11.04,-2.43])、美泊利珠单抗(RD -12.33% [95% CI -15.56,-7.22])和 ASA-D(RD -16.00% [95% CI -19.79,0.21]),均为中度确定性。药物间比较显示,度普利尤单抗在 7 项结局中有 7 项、奥马珠单抗在 7 项中有 2 项、美泊利珠单抗在 7 项中有 1 项、ASA-D 在 7 项中有 1 项具有高度可信的有益作用。

结论

多种生物制剂和 ASA-D 可改善患者重要的结局,且药物间的作用具有显著的临床差异;度普利尤单抗在所有研究结局中均为最有益的药物。

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