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异丙托溴铵与频繁小剂量沙丁胺醇治疗轻度和中度小儿急性哮喘的随机对照试验

Randomized controlled trial of ipratropium bromide and frequent low doses of salbutamol in the management of mild and moderate acute pediatric asthma.

作者信息

Ducharme F M, Davis G M

机构信息

Department of Pediatrics, Montreal Children's Hospital, McGill University Faculty of Medicine, Quebec, Canada.

出版信息

J Pediatr. 1998 Oct;133(4):479-85. doi: 10.1016/s0022-3476(98)70054-x.

Abstract

OBJECTIVES

To compare the effectiveness and safety of alternative nebulized drug protocols in children with mild or moderate asthma exacerbations.

METHODS

We conducted a blinded, randomized, controlled trial with a 2 x 2 factorial design. Two interventions, nebulized salbutamol in frequent low doses (0.075 mg/kg every 30 minutes) and the addition of ipratropium bromide (250 micrograms), were compared with salbutamol in hourly high doses (0.15 mg/kg every 60 minutes) in children with mild or moderate acute asthma. The primary end point was the improvement in respiratory resistance. Secondary end points included oxygen saturation, corticosteroid use, patient disposition, and relapse status.

RESULTS

A total of 298 participants aged 3 to 17 years were studied, and 15% were admitted to the hospital; 14% of the children had relapses. No increased bronchodilation was associated with frequent low doses versus hourly high doses of salbutamol (RR = 0.9 [95% confidence interval 0.7, 1.3]) or the addition of ipratropium bromide versus placebo (RR = 1.0 [0.8, 1.3]). No group differences were observed in secondary end points. Salbutamol in frequent low doses was associated with increased vomiting (RR = 2.5 [1.1, 6.0]).

CONCLUSION

Our results do not support the use of frequent low doses of nebulized salbutamol or the addition of ipratropium bromide compared with hourly high doses of salbutamol in children with mild or moderate asthma.

摘要

目的

比较不同雾化药物方案治疗轻度或中度哮喘急性发作儿童的有效性和安全性。

方法

我们采用2×2析因设计进行了一项双盲、随机、对照试验。将两种干预措施,即频繁低剂量雾化沙丁胺醇(每30分钟0.075 mg/kg)和加用异丙托溴铵(250微克),与每小时高剂量雾化沙丁胺醇(每60分钟0.15 mg/kg)用于治疗轻度或中度急性哮喘儿童进行比较。主要终点是呼吸阻力的改善情况。次要终点包括血氧饱和度、皮质类固醇使用情况、患者处置情况和复发状态。

结果

共研究了298名3至17岁的参与者,其中15%住院治疗;14%的儿童复发。与每小时高剂量沙丁胺醇相比,频繁低剂量沙丁胺醇未增加支气管扩张作用(RR = 0.9 [95%置信区间0.7, 1.3]),加用异丙托溴铵与安慰剂相比也未增加支气管扩张作用(RR = 1.0 [0.8, 1.3])。次要终点未观察到组间差异。频繁低剂量沙丁胺醇与呕吐增加相关(RR = 2.5 [1.1, 6.0])。

结论

我们的结果不支持在轻度或中度哮喘儿童中使用频繁低剂量雾化沙丁胺醇或加用异丙托溴铵,与每小时高剂量沙丁胺醇相比。

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