鼻内用糠酸氟替卡松治疗儿童变应性鼻炎：随机对照研究。

Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study.

机构信息

Department of Otolaryngology, Head and Neck Surgery, Beijing Children's Hospital, Capital Medical University, Beijing, China.

Department of Otolaryngology, The Children's Hospital of Chongqing Medical University, Chongqing, China.

出版信息

Pediatr Res. 2021 May;89(7):1832-1839. doi: 10.1038/s41390-020-01180-0. Epub 2020 Oct 2.

DOI:10.1038/s41390-020-01180-0

PMID:33007780

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8249237/

Abstract

BACKGROUND

Intranasal corticosteroids are the most efficacious anti-inflammatory medications for allergic rhinitis (AR). However, the efficacy and safety of intranasal corticosteroids in children have not yet been subject to specific research in China. The aim of this study was to investigate the efficacy and safety of fluticasone furoate nasal spray (FFNS) in a Chinese pediatric population.

METHODS

In this phase 4 randomized, double-blind, placebo-controlled, multicenter study, pediatric AR patients aged 2-12 years were randomized 1:1:1, receiving either FFNS 55 µg or 110 µg or placebo. Electronic diary cards were completed to record symptoms, rescue medication use, and treatment compliance. Anterior rhinoscopy and overall response to therapy were evaluated and recorded.

RESULTS

Patients treated with FFNS at either dose experienced a significantly greater reduction in daily reflective total nasal symptom score compared with placebo. This was maintained in a younger subset of patients (2-6 years). Drug-related adverse events occurred in <20% of patients in all groups. FFNS was well tolerated at both doses.

CONCLUSIONS

This study demonstrates favorable efficacy and safety profiles for FFNS 55 µg or 110 µg in Chinese pediatric populations (2-12 years), supporting its use in clinical treatment for AR children, including younger children aged 2-6 years.

IMPACT

The aim of this study was to investigate the efficacy and safety of intranasal fluticasone furoate in Chinese pediatric allergic rhinitis. This research not only addresses the deficiency in efficacy and safety data for intranasal corticosteroids in very young patients (aged 2-6 years) worldwide but also demonstrates that fluticasone furoate nasal spray shows a favorable benefit/risk profile at different dose levels. Our data will be of interest to the broad readership of Pediatric Research and will positively contribute to the dialog regarding the treatment of allergic rhinitis in children aged 2-6 years.

摘要

背景

鼻内用皮质类固醇是治疗过敏性鼻炎（AR）最有效的抗炎药物。然而，鼻内用皮质类固醇在中国儿童中的疗效和安全性尚未进行专门研究。本研究旨在研究糠酸氟替卡松鼻喷雾剂（FFNS）在中国儿科人群中的疗效和安全性。

方法

在这项 4 期随机、双盲、安慰剂对照、多中心研究中，2-12 岁的儿童变应性鼻炎患者按 1:1:1 的比例随机分为 FFNS55μg、FFNS110μg 或安慰剂组。使用电子日记卡记录症状、急救药物使用和治疗依从性。评估并记录前鼻镜检查和整体治疗反应。

结果

FFNS 各剂量组患者的每日反射性总鼻部症状评分较安慰剂组显著降低，在年龄较小的患者（2-6 岁）中也有此结果。所有组中，药物相关不良事件发生率均<20%。FFNS 两个剂量均具有良好的耐受性。

结论

本研究表明 FFNS55μg 或 110μg 对中国儿科人群（2-12 岁）具有良好的疗效和安全性，支持其用于 AR 儿童的临床治疗，包括年龄较小的 2-6 岁儿童。

影响

本研究旨在研究糠酸氟替卡松鼻喷雾剂在中国儿科变应性鼻炎患者中的疗效和安全性。本研究不仅解决了全球范围内年幼患者（2-6 岁）使用鼻内皮质类固醇疗效和安全性数据不足的问题，还表明不同剂量水平的糠酸氟替卡松鼻喷雾剂具有良好的获益/风险比。我们的数据将引起儿科研究的广泛关注，并为治疗 2-6 岁儿童变应性鼻炎的对话做出积极贡献。