多中心随机双盲观察地塞米松对婴儿细支气管炎的作用
2008/02/05
支气管炎是婴儿期最常见的下呼吸道感染，是儿童入院治疗的主要原因，地塞米松经常用于婴儿支气管炎的治疗。本临床试验为多中心随机双盲试验，观察了单次口服地塞米松1 mg/Kg对婴儿支气管炎的作用。
20个急诊中心在11月至次年4月之间参与了本研究，共入选年龄在2～12个月之间初次就诊的中-重度支气管炎患儿600例。观察指标为4小时急诊观察后入院率及呼吸改善状况。
研究结果显示，单次口服地塞米松没有降低婴儿中-重度支气管炎的入院率，两组患儿入院后呼吸状态（呼吸频率、氧饱和度及呼吸评分改善值）及治疗结果没有差异。
（刘颖格 第四军医大学西京医院呼吸科 710032 摘译）
(N Engl J Med 2007;357:331-339)
A Multicenter, Randomized, Controlled Trial of Dexamethasone for Bronchiolitis
ABSTRACT
Background Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited.
Methods We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score 
6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events.
6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. Results Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, –1.3%; 95% confidence interval [CI], –9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was –5.3 for dexamethasone, as compared with –4.8 for placebo (absolute difference, –0.5; 95% CI, –1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes.
Conclusions In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov] .)
N Engl J Med 2007;357:331-9.
上一篇：
克拉霉素通过抑制中性粒细胞性炎症治疗难治性哮喘
下一篇：
根据气道高反应性指导儿童哮喘的长期治疗：一项随机对照研究
