Geelhoed G C, Macdonald W B
Emergency Department, Princess Margaret Hospital for Children, Perth, Western Australia.
Pediatr Pulmonol. 1995 Dec;20(6):355-61. doi: 10.1002/ppul.1950200604.
It was the objective of this study to compare the efficacy of oral dexamethasone and inhaled budesonide in children hospitalized with croup, using a three-way, double blind, randomized, placebo-controlled clinical trial design. The trial was carried out in the Emergency Department Observation Ward of a tertiary pediatric hospital. The subjects for the study were 80 children (age range 5 to 158 months) who were hospitalized with croup. Children received either 2 mg of nebulised budesonide, dexamethasone syrup (0.6 mg/kg) or a placebo. Median duration of hospitalization was shorter for children treated with dexamethasone (12 hr) and budesonide (13 hr) compared to placebo (20 hr) (P < 0.03). There was no significant difference in hospitalization time between children treated with dexamethasone and budesonide. Median time to a croup score of < or = 1 was shorter for children treated with dexamethasone (2 hr) or budesonide (3 hr) compared to those who received placebo (8 hr) (P < 0.01). Croup scores for both steroid groups were significantly lower than the placebo group by 1 hr and remained so subsequently. The croup scores did not differ significantly in the 2 steroid treated groups. Six of the 30 children (20%) in the placebo group required adrenaline after the first hour compared to none of the 50 children in the steroid treated groups (P < 0.02). We conclude that oral dexamethasone and inhaled budesonide are both effective in reducing symptoms and duration of hospitalization in children with croup.
本研究的目的是采用三向、双盲、随机、安慰剂对照的临床试验设计,比较口服地塞米松和吸入布地奈德对因哮吼住院儿童的疗效。该试验在一家三级儿科医院的急诊科观察病房进行。研究对象为80名因哮吼住院的儿童(年龄范围5至158个月)。儿童分别接受2毫克雾化布地奈德、地塞米松糖浆(0.6毫克/千克)或安慰剂。与接受安慰剂的儿童(20小时)相比,接受地塞米松(12小时)和布地奈德(13小时)治疗的儿童住院时间中位数较短(P<0.03)。接受地塞米松和布地奈德治疗的儿童住院时间无显著差异。与接受安慰剂的儿童(8小时)相比,接受地塞米松(2小时)或布地奈德(3小时)治疗的儿童哮吼评分≤1的中位时间较短(P<0.01)。两个类固醇治疗组的哮吼评分均比安慰剂组在1小时时显著降低,且随后一直保持较低水平。两个类固醇治疗组的哮吼评分无显著差异。安慰剂组30名儿童中有6名(20%)在第1小时后需要肾上腺素治疗,而类固醇治疗组的50名儿童中无人需要(P<0.02)。我们得出结论,口服地塞米松和吸入布地奈德在减轻哮吼儿童的症状和缩短住院时间方面均有效。