Paediatric Emergency Research Unit, Emergency Department, Our Lady's Children's Hospital, Crumlin, Dublin 12, Ireland.
Trials. 2012 Aug 21;13:141. doi: 10.1186/1745-6215-13-141.
Asthma is a major cause of pediatric morbidity and mortality. In acute exacerbations of asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for ß₂-agonist therapy. Prednisolone is relatively short-acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Prolonged treatment course, vomiting and a bitter taste may reduce patient compliance with prednisolone. Dexamethasone is a long-acting corticosteroid with a half-life of 36 to 72 hours. It is used frequently in children with croup and bacterial meningitis, and is well absorbed orally. The purpose of this trial is to examine whether a single dose of oral dexamethasone (0.3 mg/kg) is clinically non-inferior to prednisolone (1 mg/kg/day for three days) in the treatment of exacerbations of asthma in children who attend the Emergency Department.
METHODS/DESIGN: This is a randomized, non-inferiority, open-label clinical trial. After informed consent with or without assent, patients will be randomized to either oral dexamethasone 0.3 mg/kg stat or prednisolone 1 mg/kg/day for three days. The primary outcome measure is the comparison between the Pediatric Respiratory Assessment Measure (PRAM) across both groups on Day 4. The PRAM score, a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, will be performed by a clinician blinded to treatment allocation. Secondary outcomes include relapse, hospital admission and requirement for further steroid therapy. Data will be analyzed on an intention-to-treat and a per protocol basis. With a sample size of 232 subjects (105 in each group with an estimated 10% loss to follow-up), we will be able to reject the null hypothesis - that the population means of the experimental and control groups are equal with a probability (power) of 0.9. The Type I error probability associated with this test (of the null hypothesis) is 0.05.
This clinical trial may provide evidence that a shorter steroid course using dexamethasone can be used in the treatment of acute pediatric asthma, thus eliminating the issue of compliance to treatment.
ISRCTN26944158 and EudraCT Number 2010-022001-18.
哮喘是导致儿童发病率和死亡率的主要原因。在哮喘急性发作中，皮质类固醇可减少复发、随后的住院和β₂-激动剂治疗的需要。泼尼松龙的半衰期为 12 至 36 小时，相对较短，因此需要每日给药。长期治疗过程、呕吐和苦味可能会降低患者对泼尼松龙的依从性。地塞米松是一种半衰期为 36 至 72 小时的长效皮质类固醇。它常用于治疗喘鸣和细菌性脑膜炎的儿童，并且口服吸收良好。本试验的目的是检查单次口服地塞米松（0.3mg/kg）在治疗急诊科就诊的哮喘急性发作患儿中是否临床等效于泼尼松龙（1mg/kg/天，连用 3 天）。
方法/设计：这是一项随机、非劣效、开放性临床试验。在获得知情同意（或无同意）后，患者将随机分为口服地塞米松 0.3mg/kg 组或泼尼松龙 1mg/kg/天，连用 3 天。主要结局指标是两组第 4 天的小儿呼吸评估量表（PRAM）比较。PRAM 评分是一种经过验证、敏感和可靠的工具，用于评估 2 至 16 岁儿童的哮喘严重程度，由一名对治疗分配不知情的临床医生进行。次要结局包括复发、住院和进一步类固醇治疗的需要。数据将根据意向治疗和方案进行分析。样本量为 232 例（每组 105 例，估计随访丢失率为 10%），我们将能够拒绝零假设-实验组和对照组的总体平均值相等的可能性（功效）为 0.9。该检验（零假设）的Ⅰ型错误概率为 0.05。
这项临床试验可能提供证据表明，使用地塞米松进行更短的类固醇疗程可用于治疗急性儿科哮喘，从而消除治疗依从性问题。
ISRCTN81656320 和 EudraCT 编号 2010-022001-18。
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