Low-dose inhaled budesonide once or twice daily for 27 months in children with mild asthma
Low-dose inhaled budesonide once or twice daily for 27 months in children with mild asthma
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DOI：
10.1034/j.1398-9995.2000.00661.x
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发表时间：
2000-08-01
期刊：
影响因子：
12.4
通讯作者：
Mowinckel, P
中科院分区：
文献类型：
--
作者：
Jónasson, G;Carlsen, KH;Mowinckel, P
这项研究是对为期12周的试验的24个月的延长随访，以研究每天一次或两次的小剂量吸入布地奈德(BUD)对轻度哮喘儿童的长期临床疗效。纳入了一项双盲、随机、平行分组研究，对象为轻度哮喘儿童(平均年龄9.7岁，男/女；42/80)，其中FEV1为预计值的103.7%，FEV1可逆性为3.5%，运动后FEV1下降为12.2%。这些儿童接受通过Turbuhaler(R)吸入的Bud 100或200 mg，每天早上一次，每天两次，或安慰剂治疗27个月。运动和乙酰甲胆碱挑战在第一年每隔3个月进行一次，第二年每隔B个月进行一次，总共进行了七次访问。当比较FEV1、FEF25%和FEV50%的变化、运动试验后FEV1的下降以及对血嗜酸性粒细胞的影响时，发现每天服用BUD 200mgVS 100mUg有显著的剂量-反应效应。与安慰剂相比，每天服用BUD 200毫克的患者在三次治疗中对乙酰甲胆碱的高反应性显著降低。治疗12个月后，除基线上7-11岁的儿童外，生长速度没有明显影响。总之，每天吸入100或200微克的Bud，持续27个月，在预防运动性哮喘和接近正常的肺功能方面是安全有效的。在这组患有轻度哮喘的儿童中，基线肺功能没有受到明显影响。
This study is an extended follow-up for 24 months of a 12-week trial to study the long-term clinical efficacy of low-dose inhaled budesonide (BUD) once or twice daily in children with mild asthma. A total of 122 children (mean age 9.7 years, girls/boys; 42/80) with mild asthma (FEV1 103.7% of predicted, reversibility in FEV1 3.5%, and fall in FEV1 after exercise 12.2%), not previously treated with inhaled steroids, were included in a double-blind, randomized, parallel-group study. The children were treated with inhaled BUD 100 or 200 mu g administered via Turbuhaler(R) once daily in the morning, 100 mu g twice daily, or placebo for 27 months. Exercise and methacholine challenges were performed at 3-month intervals the first year and at B-month intervals the second year, in a total of seven visits. A significant dose-response effect favoring BUD 200 mu g daily (vs 100 mu g daily) was found when comparing changes in FEV1, FEF25%, and FEV50%; the fall in FEV1 after an exercise test; and the effect on blood eosinophils. Bronchial hyperreactivity to methacholine decreased significantly on three visits in patients treated with BUD 200 mu g daily compared to placebo. Growth rate was not significantly affected except in children aged 7-11 years at baseline after 12 months of treatment. In conclusion, 100 or 200 mu g daily of inhaled BUD for 27 months is safe and effective in protecting against exercise-induced asthma and achieving nearly normal lung function. Baseline lung function was not significantly affected in this group of children with mild asthma.