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一项随机临床试验,比较持续雾化吸入沙丁胺醇(15毫克)与持续雾化吸入沙丁胺醇(15毫克)加异丙托溴铵(2毫克)治疗急性哮喘的疗效。

A randomized, clinical trial comparing the efficacy of continuous nebulized albuterol (15 mg) versus continuous nebulized albuterol (15 mg) plus ipratropium bromide (2 mg) for the treatment of acute asthma.

作者信息

Salo David, Tuel Mark, Lavery Robert F, Reischel Ulrich, Lebowitz Jeff, Moore Terry

机构信息

Department of Emergency Medicine, Morristown Memorial Hospital, 100 Madison Avenue, Morristown, NJ 07962, USA.

出版信息

J Emerg Med. 2006 Nov;31(4):371-6. doi: 10.1016/j.jemermed.2006.05.025.

Abstract

Multiple studies have examined adding nebulized ipratropium bromide to intermittent albuterol for the treatment of acute asthma. Although continuous nebulized treatments in themselves offer benefits; few data exist regarding the efficacy of adding ipratropium bromide to a continuous nebulized system. To compare continuous nebulized albuterol alone (A) vs. albuterol and ipratropium bromide (AI) in adult Emergency Department (ED) patients with acute asthma, a prospective, randomized, double-blind, controlled clinical trial was conducted on a convenience sample of patients (IRB approved). The setting was an urban ED. Consenting patients > 18 years of age with peak expiratory flow rates (PEFR) < 70% predicted, between October 15 and December 28, 1999, were randomized to albuterol (7.5 mg/h) + ipratropium bromide (1.0 mg/h), or albuterol alone via continuous nebulization using the Hope Nebulizer (B&B Technologies Inc., Orangevale, CA) for 2 h. Main outcome measures were changed in mean improvement at 60 and 120 min PEFR compared to baseline (time 0). Secondary measures were admission rates. Data were analyzed using appropriate parametric and non-parametric tests (p < 0.05 statistically significant). Sixty-two patients (30 women) completed enrollment: 32 in (AI) and (30) in (A). Four (A) and 2 (AI) patients are without 120 min data: 3 (A) and 1 (AI) were discharged after 60 min, whereas one each (A) and (AI) worsened and were admitted before 120 min. There were no statistically significant differences between treatment groups in age, sex, predicted or initial PEFR. Thirteen (19.4%) patients were admitted. There was no statistically significant difference in improvement of mean PEFR at 60 min or 120 min compared to baseline, between groups, using repeated measures analysis of variance. Mean improvement in PEFR at 60 min compared to baseline (time 0): (A) = 93.2 L/min (95% confidence interval [CI] 64.5-121.8), (AI) = 86.6 L/min (95% CI 58.9-114.3); mean improvement in PEFR at 120 min compared to baseline (time 0) (A) = 116.5 L/min (95% CI 84.5-148.5), (AI) = 126.4 L/min (95% CI 95.4-157.4). There was no statistically significant difference in admission rates between groups: 5/30 (A) and 8/32 (AI) (p = 0.62). There were no significant differences in mean improvement of PEFR at either 60 or 120 min between ED patients with acute asthma receiving continuous albuterol alone vs. those receiving albuterol in combination with ipratropium bromide.

摘要

多项研究探讨了在间歇性使用沙丁胺醇治疗急性哮喘时加用雾化异丙托溴铵的效果。虽然持续雾化治疗本身有一定益处,但关于在持续雾化系统中加用异丙托溴铵的疗效,相关数据较少。为比较单纯持续雾化沙丁胺醇(A)与沙丁胺醇和异丙托溴铵联合使用(AI)对成年急诊科(ED)急性哮喘患者的疗效,我们对一组方便选取的患者进行了一项前瞻性、随机、双盲、对照临床试验(经机构审查委员会批准)。研究地点为一家城市急诊科。1999年10月15日至12月28日期间,年龄大于18岁、呼气峰值流速(PEFR)低于预测值70%的同意参与研究的患者,被随机分为两组,一组通过Hope雾化器(B&B Technologies Inc., Orangevale, CA)持续雾化吸入沙丁胺醇(7.5毫克/小时)+异丙托溴铵(1.0毫克/小时),另一组仅持续雾化吸入沙丁胺醇,治疗2小时。主要观察指标为与基线(0时)相比,60分钟和120分钟时PEFR的平均改善情况。次要指标为入院率。使用适当的参数和非参数检验对数据进行分析(p<0.05为具有统计学显著性)。62名患者(30名女性)完成入组:32名进入(AI)组,30名进入(A)组。4名(A)组和2名(AI)组患者没有120分钟的数据:3名(A)组和1名(AI)组患者在60分钟后出院,而各有1名(A)组和(AI)组患者病情恶化并在120分钟前入院。治疗组在年龄、性别、预测或初始PEFR方面无统计学显著差异。13名(19.4%)患者入院。使用重复测量方差分析,两组在60分钟或120分钟时与基线相比,PEFR平均改善情况无统计学显著差异。与基线(0时)相比,60分钟时PEFR的平均改善情况:(A)组=93.2升/分钟(95%置信区间[CI]64.5 - 121.8),(AI)组=86.6升/分钟(95%CI 58.9 - 114.3);与基线(0时)相比,120分钟时PEFR的平均改善情况:(A)组=116.5升/分钟(95%CI 84.5 - 148.5),(AI)组=126.4升/分钟(95%CI 95.4 - 157.4)。两组入院率无统计学显著差异:(A)组5/30,(AI)组8/32(p = .62)。在接受单纯持续沙丁胺醇雾化治疗的急性哮喘ED患者与接受沙丁胺醇联合异丙托溴铵治疗的患者之间,60分钟或120分钟时PEFR的平均改善情况无显著差异。

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