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在降低儿童拔管后气道阻塞风险方面,24 小时预处理使用低剂量(0.25mg/kg/剂量)与高剂量(0.5mg/kg/剂量)地塞米松:一项随机、开放标签、非劣效性试验。

Twenty-four-hour pretreatment with low dose (0.25 mg/kg/dose) versus high dose (0.5 mg/kg/dose) dexamethasone in reducing the risk of postextubation airway obstruction in children: A randomized open-label noninferiority trial.

机构信息

Department of Pediatrics, Chitwan Medical College, Bharatpur, Nepal.

Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Pediatr Pulmonol. 2021 Jul;56(7):2292-2301. doi: 10.1002/ppul.25388. Epub 2021 Apr 5.

Abstract

OBJECTIVE

Multidose dexamethasone pretreatment reduces risk of postextubation airway obstruction (PEAO). However, its optimal dose is not known. We planned to compare 24 h pretreatment with low-dose dexamethasone (LDD) (0.25 mg/kg/dose) versus high-dose dexamethasone (HDD) (0.5 mg/kg/dose) in reducing risk of PEAO.

DESIGN

Stratified (for age and intubation duration) randomized open-label noninferiority trial.

SETTING

Fifteen-bed pediatric intensive care unit in a lower-middle-income country.

PATIENTS

Children (3 months-12 years) intubated for more than or equal to 48 h and planned for first extubation (February 17-March 19). Upper airway conditions, chronic respiratory diseases, chronic NSAID therapy, steroid, or intravenous immunoglobulin in the last 7 days, presence of gastrointestinal bleeding, hypertension, and hyperglycemia were exclusions.

INTERVENTIONS

LDD (n = 144) or HDD (n = 143) (q6h) for a total of six doses. Extubation was planned immediately after fifth dose. Noninferiority margin was kept at 12% from baseline.

摘要

目的

多次预用地塞米松可降低拔管后气道阻塞(PEAO)的风险。但最佳剂量尚不明确。我们计划比较低剂量地塞米松(LDD)(0.25mg/kg/剂量)与高剂量地塞米松(HDD)(0.5mg/kg/剂量)在降低 PEAO 风险方面的作用,LDD 和 HDD 均在 24 小时内预处理。

设计

分层(根据年龄和插管时间)随机开放标签非劣效性试验。

设置

中低收入国家的 15 床儿科重症监护病房。

患者

插管时间超过或等于 48 小时且计划首次拔管的儿童(2023 年 2 月 17 日至 3 月 19 日)。排除上气道疾病、慢性呼吸系统疾病、慢性非甾体抗炎药治疗、皮质类固醇或静脉注射免疫球蛋白在过去 7 天内、有胃肠道出血、高血压和高血糖。

干预措施

LDD(n=144)或 HDD(n=143)(q6h)共六剂。第五剂后立即计划拔管。非劣效性边界保持在 12%。

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