Gartner S, Cobos N, Pérez-Yarza E G, Moreno A, De Frutos C, Liñan S, Mintegui J
Unidad de Neumología y Fibrosis Quística, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
An Pediatr (Barc). 2004 Sep;61(3):207-12. doi: 10.1016/s1695-4033(04)78798-6.
To assess the efficacy and tolerability of oral deflazacort versus oral prednisolone in acute moderate asthma in children.
We performed a prospective, randomized, parallel group trial of children aged 6 to 14 years old with a diagnosis of asthma who presented to the pediatric emergency department for moderate asthma exacerbation. All patients were administered short-acting beta2-adrenergic agonists. The intervention groups received either oral deflazacort (1.5 mg/kg) or prednisolone (1 mg/kg) for 7 days. The primary outcome measure was forced expiratory volume in 1 second (FEV1) and secondary outcome measures were pulmonary symptom score index, peak expiratory flow rate (PEFR), hospitalization rate and the use of rescue beta2-agonists. Patients were evaluated at the start of treatment (visit 1), on day 2 (visit 2) and on day 7 (visit 3).
Of the 54 children enrolled, two were hospitalized on visit 2 (one from each group). Baseline clinical data were similar in both groups: FEV1: 53 and 51 %; bronchodilator test: 119 and 121 %; PEFR: 169 and 165 L/min; symptom score: 6 and 6.5 for the deflazacort and prednisolone groups, respectively. On visit 2, all measures improved: FEV1: 122.2 and 126.5 % (p < 0.05); PEFR: 164 and 149 L/min (p < 0.05); symptom score: -4.4 and -3.8 (p < 0.05), without significant differences between groups. On visit 3 all variables continued to show improvement: FEV1: 133.2 and 132.5 % (p < 0.05); PEFR: 1115.7 and 187.6 L/min (p < 0.05); symptom score: -5.4 and -5.9 (p < 0.05), without significant differences between groups. No adverse effects were reported.
Deflazacort and prednisolone show similar efficacy in improving pulmonary function and in producing clinical improvement in the management of acute moderate asthma in children.
评估口服地夫可特与口服泼尼松龙治疗儿童急性中度哮喘的疗效和耐受性。
我们对6至14岁诊断为哮喘且因中度哮喘加重而到儿科急诊科就诊的儿童进行了一项前瞻性、随机、平行组试验。所有患者均给予短效β2肾上腺素能激动剂。干预组接受口服地夫可特(1.5毫克/千克)或泼尼松龙(1毫克/千克)治疗7天。主要结局指标为第1秒用力呼气量(FEV1),次要结局指标为肺部症状评分指数、呼气峰值流速(PEFR)、住院率及急救β2激动剂的使用情况。在治疗开始时(第1次就诊)、第2天(第2次就诊)和第7天(第3次就诊)对患者进行评估。
在纳入的54名儿童中,有2名在第2次就诊时住院(每组各1名)。两组的基线临床数据相似:FEV1分别为53%和51%;支气管扩张试验分别为119%和121%;PEFR分别为169升/分钟和165升/分钟;症状评分,地夫可特组和泼尼松龙组分别为6分和6.5分。在第2次就诊时,所有指标均有所改善:FEV1分别为122.2%和126.5%(p<0.05);PEFR分别为164升/分钟和149升/分钟(p<0.05);症状评分分别为-4.4分和-3.8分(p<0.05),组间无显著差异。在第3次就诊时,所有变量继续显示改善:FEV1分别为133.2%和132.5%(p<0.05);PEFR分别为1115.7升/分钟和187.6升/分钟(p<0.05);症状评分分别为-5.4分和-5.9分(p<0.05),组间无显著差异。未报告不良反应。
地夫可特和泼尼松龙在改善儿童急性中度哮喘的肺功能及实现临床改善方面显示出相似的疗效。