Nikander K, Bisgaard H
AstraZeneca R&D, Lund, Sweden.
Pediatr Pulmonol. 1999 Sep;28(3):187-93. doi: 10.1002/(sici)1099-0496(199909)28:3<187::aid-ppul5>3.0.co;2-j.
The aim of the present study was to compare the output of a breath-synchronized jet nebulizer to a conventional constant output nebulizer over a fixed period of time in terms of inhaled mass of budesonide, i.e., the amount of budesonide deposited on a filter interposed between the nebulizer and the face mask. One hundred and sixty-five asthmatic children (103 boys) were enrolled in this open, randomized, crossover trial. Their age ranged from 6 months to 7.9 years, height from 69 to 132 cm, and weight from 8.2 to 31.3 kg. Their duration of asthma ranged from less than 1 to 7 years. Budesonide suspension, 0.5 mg mL-1, 2 mL, was used. With 5 min of constant output nebulization, the mean inhaled mass of budesonide in percent of the nominal dose was 11.4% in the youngest children and 14.9% in the 7-year-old children. Expressed in percent of the total output of budesonide, i.e., the amount that left the nebulizer as an aerosol, the inhaled mass ranged from 34.6-48.6%. Thus, 51.4-65.4% of the total output was deposited on the expiratory filter. With 5 min of breath-synchronized nebulization, the mean inhaled mass ranged from 10.5-14.9% of the nominal dose. For the youngest patients less than 3-4 years of age, it was approximately 80-90% of the total output. For the older patients the inhaled mass was approximately 95% of the total output, i.e., only small amounts of budesonide were deposited on the expiratory filter. For both modes of nebulization the between-subject variation in inhaled mass was large: up to 6-fold in the young children and 3-4-fold in the older ones. The results of the present study showed that the inhaled mass of budesonide was significantly age-dependent with both modes of nebulization, i.e., the inhaled mass was less in younger children. Breath-synchronized nebulization resulted in reduced waste of drug during expiration.
本研究的目的是在固定时间段内，比较呼吸同步喷射雾化器与传统恒量输出雾化器在布地奈德吸入量方面的差异，即布地奈德沉积在置于雾化器和面罩之间过滤器上的量。165名哮喘儿童（103名男孩）参与了这项开放性、随机、交叉试验。他们的年龄在6个月至7.9岁之间，身高在69至132厘米之间，体重在8.2至31.3千克之间。他们的哮喘病程在不到1年至7年之间。使用的是0.5毫克/毫升、2毫升的布地奈德混悬液。在进行5分钟的恒量输出雾化时，最年幼儿童布地奈德的平均吸入量占标称剂量的11.4%，7岁儿童为14.9%。以布地奈德总输出量的百分比表示，即作为气雾剂离开雾化器的量，吸入量在34.6%至48.6%之间。因此，总输出量的51.4%至65.4%沉积在呼气过滤器上。在进行5分钟的呼吸同步雾化时，平均吸入量占标称剂量的10.5%至14.9%。对于年龄小于3至4岁的最年幼患者，其约占总输出量的80%至90%。对于年龄较大的患者，吸入量约占总输出量的95%，即只有少量布地奈德沉积在呼气过滤器上。对于两种雾化方式，受试者之间吸入量的差异都很大：年幼儿童高达6倍，年龄较大儿童为3至4倍。本研究结果表明，两种雾化方式下布地奈德的吸入量均显著依赖于年龄，即年幼儿童的吸入量较少。呼吸同步雾化可减少呼气时药物的浪费。
