雾化布地奈德、肌肉注射地塞米松和安慰剂治疗中度重症喉炎的比较。

A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup.

作者信息

Johnson D W, Jacobson S, Edney P C, Hadfield P, Mundy M E, Schuh S

机构信息

Department of Paediatrics, University of Calgary, Alberta Children's Hospital, Canada.

出版信息

N Engl J Med. 1998 Aug 20;339(8):498-503. doi: 10.1056/NEJM199808203390802.

DOI:10.1056/NEJM199808203390802

PMID:9709042

Abstract

BACKGROUND

In children with croup, treatment with nebulized budesonide decreases symptoms, but it is uncertain how budesonide compares with dexamethasone, the conventional therapy for croup, and whether either reduces the rate of hospitalization.

METHODS

We performed a double-blind, randomized trial involving 144 children with moderately severe croup. The children were treated with racepinephrine and a single dose of 4 mg of nebulized budesonide (48 children), 0.6 mg of intramuscular dexamethasone per kilogram of body weight (47 children), or placebo (49 children). The children were assessed before treatment and then hourly for five hours after treatment. Physicians who were unaware of the treatment assignments determined the children's need for further treatment and hospitalization.

RESULTS

The characteristics of the groups were similar at base line, including the types of viruses identified, the types of croup, and the clinical severity of the illness. The overall rates of hospitalization were 71 percent in the placebo group (35 of 49 children), 38 percent in the budesonide group (18 of 48 children), and 23 percent in the dexamethasone group (11 of 47 children) (unadjusted P=0.001 for the comparison of budesonide with placebo, P<0.001 for the comparison of dexamethasone with placebo, and P=0.18 for the comparison of budesonide with dexamethasone). Children treated with budesonide or dexamethasone had a greater improvement in croup scores than those given placebo (P=0.03 and P<0.001, respectively), and those treated with dexamethasone had a greater improvement than those treated with budesonide (P=0.003).

CONCLUSIONS

In children with moderately severe croup, treatment with intramuscular dexamethasone or nebulized budesonide resulted in more rapid clinical improvement than did the administration of placebo, with dexamethasone offering the greatest improvement. Treatment with either glucocorticoid resulted in fewer hospitalizations.

摘要

背景

在患有哮吼的儿童中，雾化布地奈德治疗可减轻症状，但布地奈德与哮吼的传统治疗药物地塞米松相比效果如何，以及这两种药物是否能降低住院率尚不确定。

方法

我们进行了一项双盲随机试验，纳入144名中度重症哮吼患儿。这些患儿接受了消旋肾上腺素治疗，并分别给予单剂量4毫克雾化布地奈德（48名患儿）、每千克体重0.6毫克肌肉注射地塞米松（47名患儿）或安慰剂（49名患儿）。在治疗前对患儿进行评估，治疗后每小时评估一次，共持续5小时。不知道治疗分配情况的医生确定患儿是否需要进一步治疗和住院。

结果

各组在基线时的特征相似，包括所鉴定的病毒类型、哮吼类型和疾病的临床严重程度。安慰剂组的总体住院率为71%（49名患儿中的35名），布地奈德组为38%（48名患儿中的18名），地塞米松组为23%（47名患儿中的11名）（布地奈德与安慰剂比较，未调整P=0.001；地塞米松与安慰剂比较，P<0.001；布地奈德与地塞米松比较，P=0.18）。接受布地奈德或地塞米松治疗的患儿哮吼评分改善程度大于接受安慰剂治疗的患儿（分别为P=0.03和P<0.001），接受地塞米松治疗的患儿改善程度大于接受布地奈德治疗的患儿（P=0.003）。