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一项比较单剂量口服地塞米松与多次剂量泼尼松龙治疗急诊科就诊的哮喘急性发作患儿的随机临床研究

2015/12/03

   摘要
   研究目的:
对于哮喘急性发作的哮喘患儿来说,皮质类固醇可以减少复发,降低后续的住院率以及减少对支气管扩张剂β2-激动剂的需要。泼尼松龙是常用的皮质类固醇,但是过长的使用疗程,相关的呕吐以及口感苦味可能会降低患者对药物的依从性。地塞米松有更长的半衰期并且已经被安全地用于其它急性儿科疾病。我们在第四天通过小儿呼吸评估法(PRAM)来进行评估从而检测单剂量的口服地塞米松对哮喘发作的患儿的急诊治疗是否不劣于泼尼松龙。
   方法:我们进行了一项随机、开放标签的非劣效研究,比较口服地塞米松(单剂量0.3mg/kg)与泼尼松龙(每日1mg/kg 治疗3天)治疗年龄2-16岁,且哮喘诊断明确或既往至少有一次β2-激动剂暴露下的喘息而至儿科急诊就诊。主要研究终点为第四天进行的平均PRAM评分(从0到12分)。次要终点包括需要进一步的激素治疗,给药呕吐,入院治疗以及在14天内未经预约拜访保健医师。
   结果:此项研究共纳入226例患者的245项登记。第四天的PRAM评分在地塞米松组和泼尼松龙组之间并无差异(0.91:0.91; 绝对差异 0.005; 95% CI -0.35-0.34)。有14例患者服用至少1个剂量泼尼松龙后出现呕吐,而地塞米松组无患者呕吐。在地塞米松组有16例患儿(13.1%)在入组研究后的14天内接受了进一步的全身激素治疗,而泼尼松龙组仅有5例(4.2%)使用全身激素治疗(绝对差异8.9%; 95% CI 1.9% -16.0%)。两组之间在入院治疗率或者计划外访视次数上无显著差异。
   结论:在哮喘急性发作的患儿中,通过在第四天进行平均PRAM评分衡量发现单剂量口服地塞米松(0.3 mg/kg)疗效不劣于3天疗程的口服泼尼松龙治疗(每日1 mg/kg)。

 

(杨冬 审校)
AnnEmergMed. 2015Oct10.pii:S0196-0644(15)01154-3.doi:10.1016/j.annemergmed.2015.08.001. [Epub ahead of print]

 

 

A Randomized Trial of Single-Dose Oral Dexamethasone Versus Multidose Prednisolone for Acute Exacerbations of Asthma in Children Who Attend the Emergency Department.
 

Cronin JJ1, McCoy S2, Kennedy U3, An Fhailí SN4, Wakai A5, Hayden J4, Crispino G6, Barrett MJ7, Walsh S2, O'Sullivan R8.
 

Abstract
STUDY OBJECTIVE:
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.
METHODS: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.
RESULTS: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.
CONCLUSION: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.

 

AnnEmergMed. 2015Oct10.pii:S0196-0644(15)01154-3.doi:10.1016/j.annemergmed.2015.08.001. [Epub ahead of print]


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