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400微克吸入性布地奈德与200微克吸入性布地奈德及口服孟鲁司特治疗中度持续性哮喘儿童的随机对照试验。

Treatment with 400 microg of inhaled budesonide vs 200 microg of inhaled budesonide and oral montelukast in children with moderate persistent asthma: randomized controlled trial.

作者信息

Jat Gokul Chand, Mathew Joseph L, Singh Meenu

机构信息

Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Ann Allergy Asthma Immunol. 2006 Sep;97(3):397-401. doi: 10.1016/s1081-1206(10)60807-1.

DOI:10.1016/s1081-1206(10)60807-1
PMID:17042148
Abstract

BACKGROUND

Montelukast is reported to be beneficial in asthma as add-on therapy to inhaled corticosteroids and may reduce the need for the latter.

OBJECTIVE

To evaluate whether a combination of oral montelukast and 200 microg of inhaled budesonide has comparable efficacy to 400 microg of inhaled budesonide alone in children with moderate persistent asthma.

METHODS

In this prospective, blinded, hospital-based randomized controlled trial, 71 children with moderate persistent asthma were randomized to receive either montelukast, 5-mg chewable tablet, with 200 microg of inhaled budesonide or only 400 microg of inhaled budesonide daily for 12 weeks. Baseline and serial measurements of forced expiratory volume in 1 second, peak expiratory flow rate, and Asthma Symptom Score were performed; the frequency and severity of exacerbations were also recorded.

RESULTS

Measurements of forced expiratory volume in 1 second, peak expiratory flow rate, and Asthma Symptom Score showed no significant differences between the 2 groups at baseline, during the serial follow-up visits, and at the end of the study. However, children who received montelukast had a greater frequency of exacerbations vs those who did not (33.3% vs 9.1%; P < .01).

CONCLUSION

The overall control of asthma with 5 mg of oral montelukast and 200 microg of inhaled budesonide is inferior to that with 400 microg of inhaled budesonide in children with moderate persistent asthma.

摘要

背景

据报道,孟鲁司特作为吸入性糖皮质激素的附加疗法对哮喘有益,可能会减少对后者的需求。

目的

评估口服孟鲁司特与200微克吸入性布地奈德联合使用在中度持续性哮喘儿童中是否与单独使用400微克吸入性布地奈德具有相当的疗效。

方法

在这项前瞻性、盲法、基于医院的随机对照试验中,71名中度持续性哮喘儿童被随机分为两组,一组接受5毫克咀嚼片孟鲁司特与200微克吸入性布地奈德,另一组每天仅接受400微克吸入性布地奈德,为期12周。进行了1秒用力呼气量、呼气峰值流速和哮喘症状评分的基线和系列测量;还记录了病情加重的频率和严重程度。

结果

1秒用力呼气量、呼气峰值流速和哮喘症状评分的测量结果显示,两组在基线、系列随访期间和研究结束时均无显著差异。然而,接受孟鲁司特治疗的儿童与未接受孟鲁司特治疗的儿童相比,病情加重的频率更高(33.3%对9.1%;P <.01)。

结论

在中度持续性哮喘儿童中,5毫克口服孟鲁司特与200微克吸入性布地奈德联合使用对哮喘的总体控制效果不如400微克吸入性布地奈德。

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