Effects of nebulized high-dose budesonide on moderate-to-severe acute exacerbation of asthma in children: A randomized, double-blind, placebo-controlled study

Effects of nebulized high-dose budesonide on moderate-to-severe acute exacerbation of asthma in children: A randomized, double-blind, placebo-controlled study
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DOI:
10.1111/resp.12168
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发表时间:
2013-11-01
期刊:
影响因子:
6.9
通讯作者:
Zhong, Nanshan
Zhong, Nanshan
中科院分区:
医学2区
文献类型:
--
作者:
Chen, Ai-huan;Zeng, Guang-qiao;Zhong, Nanshan

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背景与目的吸入性皮质类固醇(ICS)治疗哮喘急性发作的疗效尚不明确。本研究的目的是调查雾化吸入ICS在儿童中度至重度哮喘急性发作在急诊室设置的有效性,以阐明潜在的使用ICS作为一线治疗的管理急性加重哮喘。MethodsThis是一项前瞻性,随机,双盲,安慰剂对照研究。急诊室中重度哮喘急性发作的患儿随机接受沙丁胺醇和异丙托溴铵雾化吸入治疗,并加用大剂量布地奈德雾化吸入BUD组(n=60)对照组58例,第1 h内3次给药。结果3次给药后0 h,两组1 s用力呼气量的改善相似,但BUD组在1和2h时(分别为0.095 ± 0.062L和0.100 ± 0.120L)与对照组(分别为0.059 ± 0.082L和0.021 ± 0.128L)相比有显著的进一步改善,P分别为0.013和0.001。完全缓解率明显高于(84.7% vs 46.3%,P=0.004),口服皮质类固醇的需求显著降低BUD组有效率为16.9%,对照组为46.3%,P=0.011。结论在雾化吸入短效支气管扩张剂的基础上,添加雾化高剂量布地奈德导致中重度哮喘急性加重儿童的临床改善,提示雾化吸入大剂量ICS可作为儿童哮喘非危及生命急性发作的一线治疗,本前瞻性、随机、双盲、安慰剂对照研究显示,在雾化吸入沙丁胺醇和异丙托溴铵的基础上,高剂量布地奈德雾化吸入作为中重度哮喘急性发作儿童患者的一线治疗,可有效改善症状,减少全身皮质类固醇和住院治疗的需要。
Background and objectiveThe efficacy of inhaled corticosteroids (ICS) in asthma exacerbation are yet to be clarified. The aim of this study was to investigate the efficacy of nebulized ICS in children with moderate-to-severe acute exacerbation of asthma in an emergency room setting in order to elucidate the potential use of ICS as the first-line therapy in the management of acute exacerbation of asthma.MethodsThis was a prospective, randomized, double-blind, placebo-controlled study. Paediatric patients with moderate-to-severe acute exacerbation of asthma in emergency room were randomized to receive nebulized salbutamol and ipratropium bromide, with the addition of nebulized high-dose budesonide (BUD group, n=60) or normal saline (control group, n=58), three doses in the first hour.ResultsThe improvement in forced expiratory volume in 1s was similar in both groups at 0h after three doses of nebulization, but there was significantly further improvement at 1 and 2h in the BUD group (0.0950.062L and 0.1000.120L, respectively) compared with the control group (0.059 +/- 0.082L and 0.021 +/- 0.128L, respectively), P=0.013 and 0.001, respectively. Complete remission rate was significantly higher (84.7% vs 46.3%, P=0.004) and need for oral corticosteroids was significantly lower (16.9% vs 46.3%, P=0.011) in BUD group than in control group.ConclusionOn the basis of nebulized short-acting bronchodilators, addition of nebulized high-dose budesonide resulted in clinical improvement in children with moderate-to-severe acute exacerbation of asthma, suggesting that nebulized high-dose ICS can be used as first-line therapy for non-life-threatening acute exacerbation of asthma in children.This prospective, randomized, double-blind, placebo-controlled study showed that on the basis of nebulized salbutamol and ipratropium bromide, nebulized high-dose budesonide as the first-line therapy for paediatric patients with moderate-to-severe acute exacerbation of asthma is effective in improving symptoms and reducing the need of systemic corticosteroid and hospitalization.