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布地奈德雾化吸入治疗小儿喉炎的双盲安慰剂对照试验

Double blind placebo controlled trial of nebulised budesonide for croup.

作者信息

Godden C W, Campbell M J, Hussey M, Cogswell J J

机构信息

Department of Paediatrics, Poole NHS Trust Hospital, Dorset.

出版信息

Arch Dis Child. 1997 Feb;76(2):155-8. doi: 10.1136/adc.76.2.155.

DOI:10.1136/adc.76.2.155
PMID:9068309
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1717068/
Abstract

AIMS

To determine whether nebulised budesonide improves the symptoms or shortens the duration of stay of children admitted to hospital with a clinical diagnosis of croup.

METHODS

A prospective, randomised, double blind placebo controlled trial. Patients received either nebulised budesonide or placebo every 12 hours. The main outcome measures were duration of inpatient stay and croup scores at 30 minutes, one, two, four, 12, and 24 hours.

RESULTS

87 patients (89 admissions) aged 7-116 months entered the trial. Nebulised budesonide was associated with a significant improvement in symptoms at 12 hours (95% confidence interval (CI) 1 to 3) and 24 hours (95% CI 0 to 3). Patients with an initial croup score above 3 demonstrated a significant improvement in symptoms at two hours (95% CI 1 to 3). Nebulised budesonide was also associated with a 33% reduction in the length of stay (95% CI 2% to 63%) when the confounding variables of age, initial croup score, and coryzal symptoms were taken into consideration.

CONCLUSIONS

Nebulised budesonide is an effective treatment for children admitted to hospital with a clinical diagnosis of croup.

摘要

目的

确定雾化吸入布地奈德是否能改善临床诊断为哮吼的住院儿童的症状或缩短其住院时间。

方法

一项前瞻性、随机、双盲、安慰剂对照试验。患者每12小时接受一次雾化吸入布地奈德或安慰剂。主要观察指标为住院时间以及在30分钟、1小时、2小时、4小时、12小时和24小时时的哮吼评分。

结果

87名年龄在7至116个月的患者(89例入院)进入试验。雾化吸入布地奈德在12小时(95%置信区间(CI)1至3)和24小时(95%CI 0至3)时与症状显著改善相关。初始哮吼评分高于3分的患者在2小时时症状有显著改善(95%CI 1至3)。在考虑年龄、初始哮吼评分和鼻卡他症状等混杂变量时,雾化吸入布地奈德还与住院时间缩短33%相关(95%CI 2%至63%)。

结论

雾化吸入布地奈德是临床诊断为哮吼的住院儿童的一种有效治疗方法。

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本文引用的文献

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Efficacy of a small single dose of oral dexamethasone for outpatient croup: a double blind placebo controlled clinical trial.小剂量单次口服地塞米松治疗门诊喉炎的疗效:一项双盲安慰剂对照临床试验。
BMJ. 1996 Jul 20;313(7050):140-2. doi: 10.1136/bmj.313.7050.140.
2
Oral dexamethasone in the treatment of croup: 0.15 mg/kg versus 0.3 mg/kg versus 0.6 mg/kg.口服地塞米松治疗哮吼:0.15毫克/千克对比0.3毫克/千克对比0.6毫克/千克。
Pediatr Pulmonol. 1995 Dec;20(6):362-8. doi: 10.1002/ppul.1950200605.
3
Oral and inhaled steroids in croup: a randomized, placebo-controlled trial.口服和吸入性类固醇治疗哮吼:一项随机、安慰剂对照试验。
Pediatr Pulmonol. 1995 Dec;20(6):355-61. doi: 10.1002/ppul.1950200604.
4
The efficacy of nebulized budesonide in dexamethasone-treated outpatients with croup.布地奈德雾化吸入对接受地塞米松治疗的门诊哮吼患儿的疗效。
Pediatrics. 1996 Apr;97(4):463-6.
5
Treatment of croup with nebulised steroid (budesonide): a double blind, placebo controlled study.雾化吸入类固醇(布地奈德)治疗哮吼:一项双盲、安慰剂对照研究。
Arch Dis Child. 1993 Mar;68(3):352-5. doi: 10.1136/adc.68.3.352.
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Nebulized budesonide for children with mild-to-moderate croup.雾化布地奈德治疗轻至中度喉炎患儿。
N Engl J Med. 1994 Aug 4;331(5):285-9. doi: 10.1056/NEJM199408043310501.
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Humidification in viral croup: a controlled trial.病毒性喉炎的湿化治疗:一项对照试验。
Aust Paediatr J. 1984 Nov;20(4):289-91. doi: 10.1111/j.1440-1754.1984.tb00096.x.
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Croup: an 11-year study in a pediatric practice.哮吼:在一家儿科诊所进行的为期11年的研究。
Pediatrics. 1983 Jun;71(6):871-6.
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Arch Dis Child. 1988 Nov;63(11):1305-8. doi: 10.1136/adc.63.11.1305.
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Treatment of croup. A critical review.哮吼的治疗。一项批判性综述。
Am J Dis Child. 1989 Sep;143(9):1045-9. doi: 10.1001/archpedi.1989.02150210079022.