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一项针对儿童急性哮喘中地塞米松耐受性的随机对照研究:玛丽·波平斯在临床试验!

A Randomized Controlled Study Addressing Dexamethasone Tolerability in the Treatment of Acute Asthma in Children: Mary Poppins on Trial!

机构信息

University of Alberta, Glenrose Rehabilitation Hospital, Edmonton, AB, Canada.

Department of Emergency Medicine, IWK Health Centre and Dalhousie University, Halifax, NS, Canada.

出版信息

J Pharm Pract. 2023 Aug;36(4):803-809. doi: 10.1177/08971900221076447. Epub 2022 Mar 26.

Abstract

AimEmesis of oral medications continues to be a problem in the management of acute pediatric asthma exacerbations; therefore, we set out to assess whether smaller volumes of oral dexamethasone resulted in better tolerability. Children aged 2-14 years, presenting to the emergency department with acute asthma exacerbation, were enrolled in this open, prospective randomized controlled trial. Participants received 0.3 mg/kg of dexamethasone in either its concentrated volume (10 mg/mL) or mixed with Ora Sweet (1 mg/mL). Tolerability was measured by vomiting within 45 minutes of receiving dexamethasone, with stratification, a priori, for prior vomiting. 430 participants were enrolled. 23/213 (11%) in the 10 mg/mL group vomited dexamethasone compared to 16/217 (7%) in the 1 mg/mL group (P = .29). 11/179 (6%) in the 10 mg/mL group vomited compared to 8/183 (3%) in the 1 mg/mL group (.61). For those 68 stratified with prior vomiting, 12/34 (35%) in the 10 mg/mL group vomited compared to 8/34 (24%) in the 1 mg/mL group (P = .43). None of these results were statistically different. Prior vomiting increased the risk of vomiting, regardless of the formulation given (P < .001). Volume does not play a significant role in the tolerability of dexamethasone. Therefore, palatability should not be sacrificed for a smaller volume of dexamethasone to improve tolerability.

摘要

目的

口服药物呕吐仍然是急性儿科哮喘发作管理中的一个问题;因此,我们评估了较小剂量的口服地塞米松是否能提高耐受性。

方法

本开放前瞻性随机对照试验纳入了 2-14 岁因急性哮喘加重就诊急诊科的儿童。参与者接受 0.3mg/kg 的地塞米松,分为浓缩体积(10mg/mL)或与 Ora Sweet(1mg/mL)混合。通过在接受地塞米松后 45 分钟内呕吐来衡量耐受性,并对先前呕吐进行分层预先分组。

结果

共纳入 430 名参与者。在 10mg/mL 组中,23/213(11%)呕吐地塞米松,而在 1mg/mL 组中,16/217(7%)呕吐(P=.29)。在 10mg/mL 组中,11/179(6%)呕吐,而在 1mg/mL 组中,8/183(3%)呕吐(.61)。在 68 名预先呕吐的患者中,在 10mg/mL 组中,12/34(35%)呕吐,而在 1mg/mL 组中,8/34(24%)呕吐(P=.43)。这些结果均无统计学差异。无论给予何种制剂,先前呕吐均增加呕吐的风险(P<.001)。

结论

体积对地塞米松的耐受性没有显著影响。因此,为了提高耐受性而牺牲地塞米松的适口性是不可取的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8610/10350716/5d7aeaab2827/10.1177_08971900221076447-fig1.jpg

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