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一项关于使用布地奈德/福莫特罗(信必可都保®)作为轻度至中度哮喘发作替代缓解药物的随机开放标签试验。

A randomized open-label trial on the use of budesonide/formoterol (Symbicort®) as an alternative reliever medication for mild to moderate asthmatic attacks.

作者信息

Chew Keng Sheng, Kamarudin Hamizah, Hashim Che Wan

机构信息

Emergency Medicine Department, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, 16150 Kota Bharu, Kelantan, Malaysia.

出版信息

Int J Emerg Med. 2012 Apr 13;5:16. doi: 10.1186/1865-1380-5-16.

DOI:10.1186/1865-1380-5-16
PMID:22503137
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3352303/
Abstract

BACKGROUND

Conventionally, a nebulized short-acting β-2 agonist like salbutamol is often used as the reliever in acute exacerbations of asthma. However, recent worldwide respiratory outbreaks discourage routine use of nebulization. Previous studies have shown that combined budesonide/formoterol (Symbicort®, AstraZeneca) is effective as both a maintenance and reliever anti-asthmatic medication.

METHODS

We performed a randomized, open-label study from March until August 2011 to compare the bronchodilatory effects of Symbicort® vs. nebulized salbutamol in acute exacerbation of mild to moderate asthmatic attack in an emergency department. Initial objective parameters measured include the oxygen saturation, peak expiratory flow rate (PEFR) and respiratory rate. During clinical reassessment, subjective parameters [i.e., Visual Analog Scale (VAS) and 5-point Likert scale of breathlessness] and the second reading of the objective parameters were measured. For the 5-point Likert scale, the patients were asked to describe their symptom relief as 1, much worse; 2, a little worse; 3, no change; 4, a little better; 5, much better.

RESULTS

Out of the total of 32 patients enrolled, 17 patients (53%) were randomized to receive nebulized salbutamol and 15 (47%) to receive Symbicort®. For both treatment arms, by using paired t- and Wilcoxon signed rank tests, it was shown that there were statistically significant improvements in oxygen saturation, PEFR and respiratory rate within the individual treatment groups (pre- vs. post-treatment). Comparing the effects of Symbicort® vs. nebulized salbutamol, the average improvement of oxygen saturation was 1% in both treatment arms (p = 0.464), PEFR 78.67 l/min vs. 89.41 l/min, respectively (p = 0.507), and respiratory rate 2/min vs. 2/min (p = 0.890). For subjective evaluation, all patients reported improvement in the VAS (average 2.45 cm vs. 2.20 cm), respectively (p = 0.765). All patients in both treatment arms reported either "a little better" or "much better" on the 5-point Likert scale, with none reporting "no change" or getting worse.

CONCLUSION

This study suggests that there is no statistical difference between using Symbicort® vs. nebulized salbutamol as the reliever for the first 15 min post-intervention.

摘要

背景

按照惯例,雾化吸入短效β-2激动剂如沙丁胺醇常用于哮喘急性加重期的缓解治疗。然而,近期全球范围的呼吸道疾病爆发使得雾化治疗的常规使用受到限制。既往研究表明,布地奈德/福莫特罗联合制剂(信必可都保,阿斯利康公司)作为维持和缓解哮喘的药物是有效的。

方法

我们于2011年3月至8月进行了一项随机、开放标签的研究,以比较信必可都保与雾化吸入沙丁胺醇在急诊科轻至中度哮喘急性发作时的支气管扩张效果。最初测量的客观参数包括血氧饱和度、呼气峰值流速(PEFR)和呼吸频率。在临床重新评估时,测量主观参数[即视觉模拟评分法(VAS)和5级呼吸困难李克特量表]以及客观参数的第二次读数。对于5级李克特量表,要求患者将症状缓解程度描述为1,更差;2,稍差;3,无变化;4,稍好;5,更好。

结果

在总共纳入的32例患者中,17例(53%)被随机分配接受雾化吸入沙丁胺醇,15例(47%)接受信必可都保。对于两个治疗组,通过配对t检验和威尔科克森符号秩检验表明,各治疗组内(治疗前与治疗后)血氧饱和度、PEFR和呼吸频率均有统计学意义的改善。比较信必可都保与雾化吸入沙丁胺醇的效果,两个治疗组血氧饱和度的平均改善均为1%(p = 0.464),PEFR分别为78.67升/分钟和89.41升/分钟(p = 0.507),呼吸频率均为每分钟2次(p = 0.890)。对于主观评估,所有患者的VAS评分均有改善(分别为平均2.45厘米和2.20厘米)(p = 0.765)。两个治疗组的所有患者在5级李克特量表上均报告“稍好”或“更好”,无患者报告“无变化”或“更差”。

结论

本研究表明,干预后最初15分钟内,使用信必可都保与雾化吸入沙丁胺醇作为缓解药物在统计学上无差异。

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本文引用的文献

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The role of budesonide/formoterol for maintenance and relief in the management of asthma.布地奈德/福莫特罗在哮喘管理中的维持和缓解作用。
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Scientific rationale for using a single inhaler for asthma control.使用单一吸入器控制哮喘的科学依据。
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Budesonide/formoterol and formoterol provide similar rapid relief in patients with acute asthma showing refractoriness to salbutamol.布地奈德/福莫特罗与福莫特罗在对沙丁胺醇治疗无效的急性哮喘患者中提供相似的快速缓解作用。
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