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使用布地奈德鼻喷雾剂治疗的常年性变应性鼻炎患儿的生长速度。

Growth velocity in children with perennial allergic rhinitis treated with budesonide aqueous nasal spray.

作者信息

Murphy Kevin, Uryniak Tom, Simpson Brandon, O'Dowd Liza

机构信息

Midwest Allergy & Asthma Clinic, Midwest Children's Chest Physicians, Omaha, Nebraska 68114, USA.

出版信息

Ann Allergy Asthma Immunol. 2006 May;96(5):723-30. doi: 10.1016/S1081-1206(10)61072-1.

DOI:10.1016/S1081-1206(10)61072-1
PMID:16729787
Abstract

BACKGROUND

Recent guidelines recommend intranasal corticosteroids as first-line treatment for managing persistent symptoms of moderate to severe allergic rhinitis (AR). However, in children, long-term continual treatment with corticosteroids has raised concerns about potential growth suppression.

OBJECTIVE

To evaluate the effects of the recommended once-daily dose of budesonide aqueous nasal spray on growth velocity, as measured with stadiometry, in children with perennial AR.

METHODS

In this double-blind, placebo-controlled, multicenter study, 229 prepubertal children (mean age, 5.9 years; age range, 4-8 years) with perennial AR were randomized (2:1) to receive budesonide aqueous nasal spray, 64 microg (32 microg per nostril) once daily, or placebo for 1 year. The change from baseline in growth velocity, height after treatment, and the percentage of patients whose percentile for height decreased from baseline to the end of treatment were evaluated.

RESULTS

Growth velocity was not significantly different between the 2 groups. The least-squares mean +/- SE growth velocity during treatment was 5.91 +/- 0.11 cm per year for children receiving budesonide and 6.19 +/- 0.16 cm per year for those receiving placebo. The mean difference in growth velocity between the 2 groups was 0.27 +/- 0.18 cm per year (95% confidence interval, -0.07 to 0.62 cm per year). After treatment, the mean +/- SD height was 128.8 +/- 8.7 cm for children receiving budesonide and 128.2 +/- 8.8 for those receiving placebo. The percentage of children whose percentile for height decreased during treatment was not significantly different between the 2 groups (budesonide, 59%, placebo, 54%; P = .64). The incidence and types of adverse events and the mean 24-hour urinary cortisol-creatinine ratio were similar for the 2 groups.

CONCLUSIONS

Treatment with budesonide aqueous nasal spray, 64 microg once daily, for 1 year did not suppress growth velocity compared with placebo and was well tolerated in prepubertal children with perennial AR.

摘要

背景

近期指南推荐鼻用糖皮质激素作为治疗中度至重度变应性鼻炎(AR)持续症状的一线用药。然而,在儿童中,长期持续使用糖皮质激素引发了对潜在生长抑制的担忧。

目的

评估推荐的每日一次布地奈德水鼻喷雾剂剂量对常年性AR儿童身高增长速度(通过身高测量法测定)的影响。

方法

在这项双盲、安慰剂对照、多中心研究中,229名青春期前常年性AR儿童(平均年龄5.9岁;年龄范围4 - 8岁)被随机分组(2:1),分别接受每日一次64μg(每侧鼻孔32μg)布地奈德水鼻喷雾剂或安慰剂治疗1年。评估身高增长速度相对于基线的变化、治疗后的身高以及身高百分位数从基线降至治疗结束时下降的患者百分比。

结果

两组之间的身高增长速度无显著差异。接受布地奈德治疗的儿童在治疗期间的最小二乘均值±标准误身高增长速度为每年5.91±0.11cm,接受安慰剂治疗的儿童为每年6.19±0.16cm。两组之间身高增长速度的平均差异为每年0.27±0.18cm(95%置信区间为每年 - 0.07至0.62cm)。治疗后,接受布地奈德治疗的儿童平均±标准差身高为128.8±8.7cm,接受安慰剂治疗的儿童为128.2±8.8cm。两组之间治疗期间身高百分位数下降的儿童百分比无显著差异(布地奈德组为59%,安慰剂组为54%;P = 0.64)。两组不良事件的发生率和类型以及平均24小时尿皮质醇 - 肌酐比值相似。

结论

与安慰剂相比,每日一次64μg布地奈德水鼻喷雾剂治疗1年并未抑制常年性AR青春期前儿童的身高增长速度,且耐受性良好。

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