Cronin John J, McCoy Siobhan, Kennedy Una, An Fhailí Sinéad Nic, Wakai Abel, Hayden John, Crispino Gloria, Barrett Michael J, Walsh Sean, O'Sullivan Ronan
Paediatric Emergency Research Unit, National Children's Research Centre, Dublin 12, Ireland; Department of Emergency Medicine, Our Lady's Children's Hospital, Crumlin, Dublin 12, Ireland.
Department of Emergency Medicine, St James's Hospital, Dublin 8, Ireland.
Ann Emerg Med. 2016 May;67(5):593-601.e3. doi: 10.1016/j.annemergmed.2015.08.001. Epub 2015 Oct 14.
In acute exacerbations of asthma in children, corticosteroids reduce relapses, subsequent hospital admission, and the need for ß2-agonist bronchodilators. Prednisolone is the most commonly used corticosteroid, but prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance. Dexamethasone has a longer half-life and has been used safely in other acute pediatric conditions. We examine whether a single dose of oral dexamethasone is noninferior to prednisolone in the emergency department (ED) treatment of asthma exacerbations in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM) at day 4.
We conducted a randomized, open-label, noninferiority trial comparing oral dexamethasone (single dose of 0.3 mg/kg) with prednisolone (1 mg/kg per day for 3 days) in patients aged 2 to 16 years and with a known diagnosis of asthma or at least 1 previous episode of ß2-agonist-responsive wheeze who presented to a tertiary pediatric ED. The primary outcome measure was the mean PRAM score (range of 0 to 12 points) performed on day 4. Secondary outcome measures included requirement for further steroids, vomiting of study medication, hospital admission, and unscheduled return visits to a health care practitioner within 14 days.
There were 245 enrollments involving 226 patients. There was no difference in mean PRAM scores at day 4 between the dexamethasone and prednisolone groups (0.91 versus 0.91; absolute difference 0.005; 95% CI -0.35 to 0.34). Fourteen patients vomited at least 1 dose of prednisolone compared with no patients in the dexamethasone group. Sixteen children (13.1%) in the dexamethasone group received further systemic steroids within 14 days after trial enrollment compared with 5 (4.2%) in the prednisolone group (absolute difference 8.9%; 95% CI 1.9% to 16.0%). There was no significant difference between the groups in hospital admission rates or the number of unscheduled return visits to a health care practitioner.
In children with acute exacerbations of asthma, a single dose of oral dexamethasone (0.3 mg/kg) is noninferior to a 3-day course of oral prednisolone (1 mg/kg per day) as measured by the mean PRAM score on day 4.
在儿童哮喘急性加重期，皮质类固醇可减少复发、后续住院需求以及对β2受体激动剂支气管扩张剂的需求。泼尼松龙是最常用的皮质类固醇，但治疗疗程延长、呕吐和苦味可能会降低患者的依从性。地塞米松半衰期更长，已在其他儿科急症中安全使用。我们研究在儿童哮喘急性加重期的急诊科治疗中，单剂量口服地塞米松在第4天时通过儿科呼吸评估量表（PRAM）测量，是否不劣于泼尼松龙。
我们进行了一项随机、开放标签、非劣效性试验，比较2至16岁已知诊断为哮喘或至少有1次β2受体激动剂反应性喘息发作史的患者口服地塞米松（单剂量0.3mg/kg）与泼尼松龙（每天1mg/kg，共3天），这些患者就诊于三级儿科急诊科。主要结局指标是第4天进行的PRAM平均评分（范围为0至12分）。次要结局指标包括是否需要进一步使用类固醇、研究药物呕吐情况、住院情况以及14天内计划外返回医疗机构就诊的次数。
共纳入245例患者，涉及226名受试者。地塞米松组和泼尼松龙组在第4天的PRAM平均评分无差异（0.91对0.91；绝对差异0.005；95%CI -0.35至0.34）。14例患者呕吐了至少1剂泼尼松龙，而地塞米松组无患者出现这种情况。地塞米松组有16名儿童（13.1%）在试验入组后第14天内接受了进一步的全身类固醇治疗，而泼尼松龙组有5名（4.2%）（绝对差异8.9%；95%CI 1.9%至16.0%）。两组在住院率或计划外返回医疗机构就诊次数方面无显著差异。
在儿童哮喘急性加重期，以第4天的PRAM平均评分衡量，单剂量口服地塞米松（0.3mg/kg）不劣于口服泼尼松龙3天疗程（每天1mg/kg）。
