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一项关于雾化肾上腺素治疗急性细支气管炎婴儿的多中心、随机、双盲、对照试验。

A multicenter, randomized, double-blind, controlled trial of nebulized epinephrine in infants with acute bronchiolitis.

作者信息

Wainwright Claire, Altamirano Luis, Cheney Marise, Cheney Joyce, Barber Scott, Price Darrell, Moloney Sue, Kimberley Ann, Woolfield Nick, Cadzow Susan, Fiumara Frank, Wilson Peter, Mego Steve, VandeVelde Dianne, Sanders Sharon, O'Rourke Peter, Francis Paul

机构信息

Department of Respiratory Medicine, Royal Children's Hospital, Brisbane, Queensland, Australia.

出版信息

N Engl J Med. 2003 Jul 3;349(1):27-35. doi: 10.1056/NEJMoa022226.

DOI:10.1056/NEJMoa022226
PMID:12840089
Abstract

BACKGROUND

The treatment of infants with bronchiolitis is largely supportive. The role of bronchodilators is controversial. Most studies of the use of bronchodilators have enrolled small numbers of subjects and have examined only short-term outcomes, such as clinical scores.

METHODS

We conducted a randomized, double-blind, controlled trial comparing nebulized single-isomer epinephrine with placebo in 194 infants admitted to four hospitals in Queens-land, Australia, with a clinical diagnosis of bronchiolitis. Three 4-ml doses of 1 percent nebulized epinephrine or three 4-ml doses of normal saline were administered at four-hour intervals after hospital admission. Observations were made at admission and just before, 30 minutes after, and 60 minutes after each dose. The primary outcome measures were the length of the hospital stay and the time until the infant was ready for discharge. The secondary outcome measures were the degree of change in the respiratory rate, the heart rate, and the respiratory-effort score and the time that supplemental oxygen was required.

RESULTS

There were no significant overall differences between the groups in the length of the hospital stay (P=0.16) or the time until the infant was ready for discharge (P=0.86). Among infants who required supplemental oxygen and intravenous fluids, the time until the infant was ready for discharge was significantly longer in the epinephrine group than in the placebo group (P=0.02). The need for supplemental oxygen at admission had the greatest influence on the score for severity of illness and strongly predicted the length of the hospital stay and the time until the infant was ready for discharge (P<0.001). There were no significant changes in the respiratory rate, blood pressure, or respiratory-effort scores from before each treatment to after each treatment. The heart rate was significantly increased after each treatment with epinephrine (P=0.02 to P<0.001).

CONCLUSIONS

The use of nebulized epinephrine did not significantly reduce the length of the hospital stay or the time until the infant was ready for discharge among infants admitted to the hospital with bronchiolitis.

摘要

背景

小儿细支气管炎的治疗主要是支持性治疗。支气管扩张剂的作用存在争议。大多数关于支气管扩张剂使用的研究纳入的受试者数量较少,且仅考察了短期结局,如临床评分。

方法

我们在澳大利亚昆士兰州的四家医院对194例临床诊断为细支气管炎的婴儿进行了一项随机、双盲、对照试验,比较雾化吸入单异构体肾上腺素与安慰剂的效果。入院后每隔4小时给予3剂4毫升1%的雾化肾上腺素或3剂4毫升生理盐水。在入院时以及每次给药前、给药后30分钟和60分钟进行观察。主要结局指标为住院时间和婴儿准备出院所需时间。次要结局指标为呼吸频率、心率和呼吸用力评分的变化程度以及需要补充氧气的时间。

结果

两组在住院时间(P = 0.16)或婴儿准备出院所需时间(P = 0.86)方面无显著总体差异。在需要补充氧气和静脉输液的婴儿中,肾上腺素组婴儿准备出院所需时间显著长于安慰剂组(P = 0.02)。入院时需要补充氧气对疾病严重程度评分影响最大,并强烈预测住院时间和婴儿准备出院所需时间(P < 0.001)。每次治疗前后呼吸频率、血压或呼吸用力评分均无显著变化。每次使用肾上腺素治疗后心率显著增加(P = 0.02至P < 0.001)。

结论

对于因细支气管炎入院的婴儿,雾化吸入肾上腺素并未显著缩短住院时间或婴儿准备出院所需时间。

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