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重组人脱氧核糖核酸酶用于治疗儿童急性哮喘。

Recombinant human deoxyribonuclease for the treatment of acute asthma in children.

作者信息

Boogaard R, Smit F, Schornagel R, Vaessen-Verberne A A P H, Kouwenberg J M, Hekkelaan M, Hendriks T, Feith S W W, Hop W C J, de Jongste J C, Merkus P J F M

机构信息

Department of Pediatric Pulmonology, Erasmus MC-Sophia Children's Hospital, Rotterdam, P O Box 2060, 3000 CB Rotterdam, The Netherlands.

出版信息

Thorax. 2008 Feb;63(2):141-6. doi: 10.1136/thx.2007.081703. Epub 2007 Aug 3.

Abstract

BACKGROUND

Airway obstruction in acute asthma is the result of airway smooth muscle contraction, inflammation and mucus plugging. Case reports suggest that mucolytic therapy might be beneficial in acute asthma. The aim of this study was to determine the efficacy of the mucolytic drug recombinant human deoxyribonuclease (rhDNase) in addition to standard treatment at the emergency department in children with an asthma exacerbation.

METHODS

In a multicentre randomised double-blind controlled clinical trial, 121 children brought to the emergency room for a moderate to severe asthma exacerbation were randomly assigned to receive either a single dose of 5 mg nebulised rhDNase or placebo following the second dose of bronchodilators. An asthma score (scale 5-15) was assessed at baseline and at 1, 2, 6, 12 and 24 h. The primary outcome variable was the asthma score 1 h after the study medication.

RESULTS

One hour after the study medication the asthma score in the rhDNase group showed an adjusted mean decrease from baseline of 1.0 (95% CI 0.5 to 1.6) points compared with 0.7 (95% CI 0.3 to 1.2) points in the placebo group (mean difference 0.4 (95% CI -0.2 to 1.0) points; p = 0.23). The asthma score over the study period of 24 h also did not differ significantly between the rhDNase and placebo group (mean difference 0.2 (95% CI -0.3 to 0.7) points, p = 0.40). The duration of oxygen supplementation and number of bronchodilator treatments in the first 24 h were similar in both groups.

CONCLUSION

Adding a single dose of nebulised rhDNase to standard treatment in the emergency room has no beneficial effects in children with moderate to severe acute asthma.

摘要

背景

急性哮喘中的气道阻塞是气道平滑肌收缩、炎症和黏液阻塞的结果。病例报告表明黏液溶解疗法可能对急性哮喘有益。本研究的目的是确定在急诊科对哮喘急性发作儿童进行标准治疗的基础上,黏液溶解药物重组人脱氧核糖核酸酶(rhDNase)的疗效。

方法

在一项多中心随机双盲对照临床试验中,121名因中度至重度哮喘急性发作被送往急诊室的儿童在接受第二剂支气管扩张剂后,被随机分配接受单剂量5毫克雾化rhDNase或安慰剂治疗。在基线以及1、2、6、12和24小时评估哮喘评分(5 - 15分制)。主要结局变量是研究用药后1小时的哮喘评分。

结果

研究用药后1小时,rhDNase组的哮喘评分较基线调整后平均下降1.0(95%置信区间0.5至1.6)分,而安慰剂组为0.7(95%置信区间0.3至1.2)分(平均差异0.4(95%置信区间 - 0.2至1.0)分;p = 0.23)。在24小时的研究期间,rhDNase组和安慰剂组的哮喘评分也无显著差异(平均差异0.2(95%置信区间 - 0.3至0.7)分,p = 0.40)。两组在前24小时的吸氧时间和支气管扩张剂治疗次数相似。

结论

在急诊科对中度至重度急性哮喘儿童进行标准治疗的基础上加用单剂量雾化rhDNase并无益处。

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