Shapiro G, Mendelson L, Kraemer M J, Cruz-Rivera M, Walton-Bowen K, Smith J A
ASTHMA Inc, Seattle, WA 89105, USA.
J Allergy Clin Immunol. 1998 Nov;102(5):789-96. doi: 10.1016/s0091-6749(98)70019-3.
Inhaled glucocorticosteroids are indicated for the treatment of persistent asthma; however, many young children are unable to effectively use currently available inhalers.
We sought to evaluate the efficacy and safety of 3 different twice daily doses of budesonide inhalation suspension (Pulmicort Respules) in inhaled steroid-dependent asthmatic children.
This was a 12-week, randomized, double-blind, placebo-controlled, parallel-group study involving 178 children (age range, 4 to 8 years) at 17 centers in the United States. Budesonide inhalation suspension doses of 0.25 mg, 0.50 mg, or 1.0 mg twice daily were administered by means of a jet nebulizer and air compressor system. Efficacy was assessed by recording at home nighttime and daytime asthma symptom scores, use of rescue medication, pulmonary function tests, and treatment discontinuation because of worsening symptoms. Safety was assessed by reported adverse events and changes in baseline and adrenocorticotrophic hormone-stimulated plasma cortisol levels in a subset of patients.
Baseline demographics, symptom scores, and pulmonary function data were similar across treatment groups. All doses of budesonide inhalation suspension were superior to placebo in improving nighttime and daytime asthma symptom scores (P </=.026), reducing use of breakthrough medication (P </=.032), and improving morning peak expiratory flow (P </=.030). The number of dropouts because of worsening asthma was also significantly fewer in the budesonide groups (P </=.015). There were no differences between doses of budesonide. Adverse events and basal and adrenocorticotrophic hormone-stimulated cortisol responses were not different between budesonide and placebo groups.
Budesonide inhalation suspension, 0.25 mg, 0.50 mg, and 1.0 mg twice daily, is an effective and safe treatment for young children with inhaled steroid-dependent, persistent asthma.
吸入性糖皮质激素适用于治疗持续性哮喘；然而，许多幼儿无法有效使用现有的吸入器。
我们试图评估3种不同的每日两次布地奈德吸入混悬液（普米克令舒）剂量对吸入性糖皮质激素依赖型哮喘儿童的疗效和安全性。
这是一项为期12周的随机、双盲、安慰剂对照、平行组研究，涉及美国17个中心的178名儿童（年龄范围4至8岁）。通过喷射雾化器和空气压缩机系统给予每日两次0.25毫克、0.50毫克或1.0毫克的布地奈德吸入混悬液。通过记录家庭夜间和白天哮喘症状评分、急救药物使用情况、肺功能测试以及因症状恶化而停药的情况来评估疗效。通过报告的不良事件以及部分患者基线和促肾上腺皮质激素刺激的血浆皮质醇水平变化来评估安全性。
各治疗组的基线人口统计学、症状评分和肺功能数据相似。所有剂量的布地奈德吸入混悬液在改善夜间和白天哮喘症状评分（P≤0.026）、减少急救药物使用（P≤0.032）以及改善早晨呼气峰值流速方面均优于安慰剂（P≤0.030）。布地奈德组因哮喘恶化而退出研究的人数也显著较少（P≤0.015）。布地奈德各剂量之间无差异。布地奈德组和安慰剂组在不良事件以及基础和促肾上腺皮质激素刺激的皮质醇反应方面无差异。
每日两次0.25毫克、0.50毫克和1.0毫克的布地奈德吸入混悬液是治疗吸入性糖皮质激素依赖型持续性哮喘幼儿的有效且安全的疗法。
