Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid-dependent, persistent asthma
Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid-dependent, persistent asthma
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DOI：
10.1016/s0091-6749(98)70019-3
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发表时间：
1998-11-01
影响因子：
14.2
通讯作者：
Smith, JA
中科院分区：
文献类型：
--
作者：
Shapiro, G;Mendelson, L;Smith, JA
背景资料：吸入性糖皮质激素可用于治疗持续性哮喘，但许多儿童不能有效地使用现有的吸入剂。目的：评价3种不同剂量的布地奈德混悬液的有效性和安全性（普米克令舒）在吸入性激素依赖性哮喘儿童中的应用，方法：这是一项为期12周、随机、双盲、安慰剂对照、平行组研究，在美国17个中心纳入了178名儿童（年龄范围为4至8岁）。通过喷射雾化器和空气压缩机系统给予布地奈德吸入混悬液0.25 mg、0.50 mg或1.0 mg，每日两次。通过在家中记录夜间和白天哮喘症状评分、急救药物使用、肺功能检查和因症状恶化而停止治疗来评估疗效。安全性进行了评估报告的不良事件和基线和促肾上腺皮质激素刺激的血浆皮质醇水平的变化在一个子集的patients.Results：基线人口统计学，症状评分，肺功能数据是相似的治疗组。所有剂量的布地奈德吸入混悬液在改善夜间和日间哮喘症状评分（P ≤ 0.026）、减少突破性药物的使用（P ≤ 0.032）和改善晨峰呼气流量（P ≤ 0.030）方面均上级安慰剂。布地奈德组因哮喘恶化而退出的人数也明显较少（P小于或等于0.015），布地奈德剂量之间没有差异，不良事件和基础和促肾上腺皮质激素刺激的皮质醇反应在布地奈德组和安慰剂组之间没有差异。布地奈德吸入混悬液，0.25毫克，0.50毫克，1.0毫克，每日两次，是一种有效和安全的治疗吸入类固醇依赖性，持续性哮喘的幼儿。
Background: Inhaled glucocorticosteroids are indicated for the treatment of persistent asthma: however, many young children are unable to effectively use currently available inhalers.Objective: We sought to evaluate the efficacy and safety of 3 different tn icr daily doses of budesonide inhalation suspension (Pulmicort Respules) in inhaled steroid-dependent asthmatic children,Methods: 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 nas assessed by recording at home nighttime and day time 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.Results: 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 less than or equal to .026), reducing use of breakthrough medication (P less than or equal to .032), and improving morning peak expiratory flow (P less than or equal to .030). The number of dropouts because of worsening asthma was also significantly fewer in the budesonide groups (P less than or equal to .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.Conclusion: 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.