Reisman J, Galdes-Sebalt M, Kazim F, Canny G, Levison H
Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.
J Allergy Clin Immunol. 1988 Jan;81(1):16-20. doi: 10.1016/0091-6749(88)90214-x.
A study was performed to compare the efficacy and safety of two therapeutic regimens for the treatment of children presenting to the emergency department with acute asthma. A regimen of inhaled salbutamol alone was compared to inhaled salbutamol combined with ipratropium bromide. Twenty-five children ranging in age from 5 to 15 years were enrolled in the study. Children with FEV1 less than or equal to 55% predicted were eligible to participate in the study. Subjects were randomized in a double-blind fashion into one of two treatment groups. Both groups received an initial dose of salbutamol by nebulizer of 150 micrograms/kg (0.03 cc/kg), followed by six consecutive doses of 50 micrograms/kg (0.01 cc/kg) at 20-minute intervals. In one group of subjects, 250 micrograms (1.0 ml) of ipratropium bromide respirator solution was added to the salbutamol administered at the time of the initial inhalation, and at 40 and 80 minutes, whereas the remaining subjects received a placebo with salbutamol at those times. Formal one-way statistical ANOVA with change in percent predicted FEV1 as a response variable confirmed there was a statistically significant difference at all time points caused by drug regimen during the 150-minute observation period. There was no significant difference in side effects reported in the two groups. Significant additional bronchodilation achieved with salbutamol and ipratropium bromide together indicates that there is likely a substantial cholinergic element to the bronchospasm observed in acute exacerbations of asthma in the pediatric age group.
一项研究旨在比较两种治疗方案治疗急性哮喘患儿的疗效和安全性。单独吸入沙丁胺醇的方案与吸入沙丁胺醇联合异丙托溴铵的方案进行了比较。25名年龄在5至15岁的儿童参与了该研究。预计第一秒用力呼气容积(FEV1)小于或等于55%的儿童有资格参与该研究。受试者以双盲方式随机分为两个治疗组之一。两组均通过雾化器给予初始剂量为150微克/千克(0.03毫升/千克)的沙丁胺醇,随后每隔20分钟连续给予六剂50微克/千克(0.01毫升/千克)。在一组受试者中,在初始吸入时以及40分钟和80分钟时,将250微克(1.0毫升)异丙托溴铵呼吸溶液加入沙丁胺醇中,而其余受试者在这些时间接受含沙丁胺醇的安慰剂。以预计FEV1百分比变化作为反应变量的正式单因素统计方差分析证实,在150分钟观察期内,药物治疗方案在所有时间点均导致了统计学上的显著差异。两组报告的副作用无显著差异。沙丁胺醇和异丙托溴铵联合使用实现的显著额外支气管扩张表明,在小儿哮喘急性加重期观察到的支气管痉挛可能有大量胆碱能因素。