Shapiro G, Bronsky E, Murray A, Barnhart F, VanderMeer A, Reisner C
A.S.T.H.M.A., Inc, 4500 Sand Point Way NE, Suite 222, Seattle, WA 98105, USA.
Arch Pediatr Adolesc Med. 2000 Dec;154(12):1219-25. doi: 10.1001/archpedi.154.12.1219.
Aerosolized asthma medications with chlorofluorocarbon (CFC) propellants are being phased out because of environmental concerns about the ozone layer. Medications are being reformulated with non-ozone-depleting propellants.
To evaluate the clinical comparability of albuterol sulfate formulated in a new hydrofluoroalkane-134a (HFA) propellant (Ventolin HFA Inhalation Aerosol), and conventional CFC-containing albuterol (Ventolin Inhalation Aerosol) in children with asthma.
Randomized, double-blind, placebo-controlled 2-week clinical trial with a 1- to 2-week run-in period. During the run-in, patients took Ventolin CFC as needed. Patients (n = 135) aged 4 to 11 years with asthma then were assigned randomly to treatment with Ventolin HFA, Ventolin CFC, or placebo administered 4 times daily via metered-dose inhaler for 2 weeks. All patients were allowed rescue albuterol use in matching propellant as needed for relief of breakthrough symptoms. The main outcome measure was the mean percentage of predicted peak expiratory flow (PEF) after the morning dose of study drug on day 1 and after 2 weeks as assessed by results of 6-hour serial tests.
At day 1, the mean (+/- SE) percentage of predicted PEF increased postdose by 14% (+/- 1%) in the Ventolin HFA group and 13% (+/- 1%) in the Ventolin CFC group compared with 6% (+/- 2%) in the placebo group (P</=.006). At week 2, mean postdose increases were 11% (+/- 1%) in the Ventolin HFA and CFC groups compared with 5% (+/- 1%) in the placebo group (P<.001). There were no significant differences between the Ventolin HFA and CFC groups in postdose increases in pulmonary function, time to onset of response, duration of response, or peak effects. Safety profiles were similar among the 3 groups.
Ventolin HFA is clinically comparable to Ventolin formulated with the conventional CFC-containing propellant when administered to children with asthma. Arch Pediatr Adolesc Med. 2000;154:1219-1225.
由于对臭氧层的环境问题担忧，含氯氟烃（CFC）推进剂的雾化哮喘药物正逐步淘汰。药物正改用无臭氧消耗的推进剂重新配方。
评估新的氢氟烷烃-134a（HFA）推进剂配方的硫酸沙丁胺醇（万托林HFA吸入气雾剂）与传统含CFC的沙丁胺醇（万托林吸入气雾剂）在哮喘儿童中的临床可比性。
一项为期2周的随机、双盲、安慰剂对照临床试验，有1至2周的导入期。在导入期，患者根据需要使用万托林CFC。4至11岁的哮喘患者（n = 135）随后被随机分配接受万托林HFA、万托林CFC或安慰剂治疗，通过定量吸入器每日给药4次，持续2周。所有患者在需要缓解突破性症状时可根据需要使用匹配推进剂的沙丁胺醇进行急救。主要结局指标是第1天早晨服用研究药物后以及2周后通过6小时连续测试结果评估的预测呼气峰值流速（PEF）的平均百分比。
第1天，万托林HFA组服用药物后预测PEF的平均（±SE）百分比增加了14%（±1%），万托林CFC组增加了13%（±1%），而安慰剂组为6%（±2%）（P≤.006）。第2周时，万托林HFA和CFC组服用药物后的平均增加量为11%（±1%），安慰剂组为5%（±1%）（P<.001）。万托林HFA组和CFC组在服用药物后肺功能增加量、起效时间、反应持续时间或峰值效应方面无显著差异。三组的安全性概况相似。
给哮喘儿童使用时，万托林HFA在临床上与用传统含CFC推进剂配方的万托林具有可比性。《儿科与青少年医学档案》。2000年；154:1219 - 1225。
