Division of Pediatric Emergency Medicine, Department of Emergency Medicine, University of New Mexico, Albuquerque, USA.
Acad Emerg Med. 2011 Jul;18(7):665-73. doi: 10.1111/j.1553-2712.2011.01114.x.
The goal was to determine if adding inhaled budesonide to standard asthma therapy improves outcomes of pediatric patients presenting to the emergency department (ED) with acute asthma.
The authors conducted a randomized, double-blind, placebo-controlled trial in a tertiary care, urban pediatric ED. Patients 2 to 18 years of age with moderate to severe acute asthma were randomized to receive either a single 2-mg dose of budesonide inhalation suspension (BUD) or normal sterile saline (NSS) placebo, added to albuterol, ipratropium bromide (IB), and systemic corticosteroids (SCS). The primary outcome was the difference in median asthma scores between treatment groups at 2 hours. Secondary outcomes included differences in vital signs and hospitalization rates.
A total of 180 patients were enrolled. Treatment groups had similar baseline demographics, asthma scores, and vital signs. A total of 169 patients (88 BUD, 81 NSS) were assessed for the primary outcome. No significant difference was found between groups in the change in median asthma score at 2 hours (BUD -3, NSS -3, p = 0.64). Vital signs at 2 hours were also similar between groups. Fifty-six children (62%) were admitted to the hospital in the BUD group and 55 (62%) in the NSS group (difference 0%, 95% confidence interval [CI] = -14% to 14%). Neither multivariate adjustment nor planned subgroup analysis by inhaled corticosteroids (ICS) use prior to the ED significantly altered the results.
For children 2 to 18 years of age treated in the ED for acute asthma, a single 2-mg dose of budesonide added to standard therapy did not improve asthma severity scores or other short-term ED-based outcomes.
本研究旨在评估在标准哮喘治疗基础上加用布地奈德吸入剂是否能改善儿科急诊就诊的中重度急性哮喘患儿的结局。
本研究为一项在三级城市儿科急诊开展的随机、双盲、安慰剂对照试验。研究纳入 2 至 18 岁的中重度急性哮喘患儿，随机分为布地奈德混悬液（BUD）组（2mg 单剂量）和生理盐水（NSS）组（安慰剂），两组均联合沙丁胺醇、异丙托溴铵和全身用糖皮质激素治疗。主要结局为两组患儿在 2 小时时哮喘评分的差异。次要结局包括生命体征和住院率的差异。
共纳入 180 例患儿。两组患儿的基线特征、哮喘评分和生命体征相似。169 例（88 例 BUD，81 例 NSS）患儿纳入主要结局分析。2 小时时两组患儿的哮喘评分均有显著改善（BUD：-3，NSS：-3，p=0.64），两组间差异无统计学意义。2 小时时两组患儿的生命体征也无显著差异。BUD 组 56 例（62%）患儿和 NSS 组 55 例（62%）患儿需住院治疗（差异 0%，95%置信区间为-14%至 14%）。多变量调整和亚组分析（包括急诊前是否使用吸入性糖皮质激素）均未显著改变研究结果。
对于在儿科急诊就诊的急性哮喘患儿，在标准治疗基础上加用 2mg 布地奈德并不能改善哮喘严重程度评分或其他短期的急诊结局。
