Schuh S, Johnson D, Canny G, Reisman J, Shields M, Kovesi T, Kerem E, Bentur L, Levison H, Jaffe D
Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.
Pediatrics. 1992 Dec;90(6):920-3.
Nebulized ipratropium bromide is though to be synergistic with albuterol in therapy for acute childhood asthma. Because the efficacy of ipratropium in bronchiolitis is uncertain and some infants with bronchiolitis do not respond to nebulized albuterol alone, the following study was undertaken. In this double-blind, placebo-controlled trial, 69 infants between 6 weeks and 24 months of age who exhibited the first episode of acute bronchiolitis were randomly assigned to receive either nebulized albuterol (0.15 mg/kg per dose) and ipratropium bromide (250 micrograms per dose) (group A, n = 36) or nebulized albuterol and normal saline (placebo) (group B, n = 33) for two doses, 1 hour apart. The two groups were comparable at baseline. Both therapies resulted in clinically significant improvement. However, the addition of ipratropium resulted in no additional benefit with respect to decrease in the respiratory rate (mean decreases 10.6/min vs decreases 8.6/min, P = .86), accessory muscle score (range 0 through 3) (decreases 0.92 vs decreases 0.82, z = -0.44), wheeze score (range 0 through 3) (decreases 0.94 vs 0.85, z = -0.20), oxygen saturation (increases 0.25% vs increases -0.33%, P = .86), or hospitalization rate (17 vs 10). The number of "nonresponders" and "clear responders" was also very similar in both groups. No toxicity was noted. The increase in heart rate was mild and similar in both groups (increases 6.7 vs increases 11.1). The power of the study to detect a difference between the two treatment groups in the respiratory rate change > or = 8/min is greater than 90%.(ABSTRACT TRUNCATED AT 250 WORDS)
雾化吸入异丙托溴铵被认为在治疗儿童急性哮喘时与沙丁胺醇具有协同作用。由于异丙托溴铵在细支气管炎中的疗效尚不确定,且一些细支气管炎婴儿单独使用雾化沙丁胺醇无反应,因此进行了以下研究。在这项双盲、安慰剂对照试验中,69名6周龄至24月龄首次发生急性细支气管炎的婴儿被随机分配接受雾化沙丁胺醇(每剂0.15mg/kg)和异丙托溴铵(每剂250微克)(A组,n = 36)或雾化沙丁胺醇和生理盐水(安慰剂)(B组,n = 33),分两剂给药,间隔1小时。两组在基线时具有可比性。两种治疗均导致临床上显著改善。然而,加用异丙托溴铵在降低呼吸频率(平均降低10.6次/分钟 vs 降低8.6次/分钟,P = 0.86)、辅助肌评分(范围0至3)(降低0.92 vs 降低0.82,z = -0.44)、喘息评分(范围0至3)(降低0.94 vs 0.85,z = -0.20)、血氧饱和度(升高0.25% vs 升高 -0.33%,P = 0.86)或住院率(17例 vs 10例)方面未带来额外益处。两组中“无反应者”和“明显反应者”的数量也非常相似。未观察到毒性。两组心率升高均较轻微且相似(升高6.7 vs 升高11.1)。该研究检测两个治疗组呼吸频率变化≥8次/分钟差异的效能大于90%。(摘要截断于250字)