Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray

Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray
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DOI:
10.1186/1939-4551-6-5
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发表时间:
2013-01-01
影响因子:
5.1
通讯作者:
Teper, Ariel
Teper, Ariel
中科院分区:
医学3区
文献类型:
--
作者:
Meltzer, Eli O.;Baena-Cagnani, Carlos E.;Teper, Ariel

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背景资料:在对过敏性鼻炎(AR)儿童的调查中,鼻塞已被确定为最常见和最令人烦恼的症状。本分析旨在探讨糠酸莫米松鼻喷雾剂(MFNS)对AR儿童充血的影响。方法:两项多中心、双盲、安慰剂对照研究将儿童随机分配至MFNS 100 μ g或安慰剂组,1喷/次,QD,持续4周(研究1:6-11岁,季节性AR [SAR] >= 1年;研究2:3-11岁,常年AR [PAR] >= 1年)。最小二乘(LS)均值是从ANCOVA模型中获得的,该模型具有治疗和研究中心效应,基线评分作为协变量。我们对AM/PM PRIOR(反射性AM和PM评分的平均值)鼻充血(0=无到3=严重)从基线的变化进行事后评估。结果:研究1:MFNS(n=134)在第2天(P= 0.004)和第23/29天(P= 0.037)比安慰剂(n=135)显著减少充血。MFNS组和安慰剂组较基线的变化分别为-0.53和-0.28(P
Background: In surveys of children with allergic rhinitis (AR), nasal congestion has been identified as the most frequently experienced and bothersome symptom. This analysis was conducted to investigate the effect of mometasone furoate nasal spray (MFNS) on congestion in children with AR.Methods: Two multicenter, double-blind, placebo-controlled studies randomly assigned children to MFNS 100 mu g or placebo, 1 spray/nostril QD for 4 weeks (Study 1: ages 6-11 years with seasonal AR [SAR] >= 1 year; Study 2: ages 3-11 years with perennial AR [PAR] >= 1 year). Least square (LS) means were obtained from an ANCOVA model with treatment and study center effects, with baseline score as a covariate. We conducted post hoc evaluation of changes from baseline in AM/PM PRIOR (average of reflective AM and PM scores) nasal congestion (0=none to 3=severe).Results: Study 1: MFNS (n=134) reduced congestion significantly more than placebo (n=135) on day 2 (P=.004) and on 23/29 days (P=.037). Change from baseline was-0.53 and-0.28 for MFNS and placebo (P