Aziziye Arastirma Hastanesi, Gogus Hastaliklari, Atatürk Universitesi, Yenisehir Girisi, 25070, Erzurum, Turkey.
Clin Drug Investig. 2003;23(1):55-62. doi: 10.2165/00044011-200323010-00007.
To compare the efficacy and safety of nebulised budesonide and systemic corticosteroid in the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD).
Randomised, double-blind, placebo-controlled, parallel-group trial.
A total of 40 patients who had moderate to severe acute exacerbations of COPD and required hospitalisation were enrolled in the study. The patients were randomised to receive either nebulised budesonide 8mg daily (n = 21) or systemic (intravenous) prednisolone 40mg daily (n = 19). Airway obstruction (peak expiratory flow rate [PEFR]) and gas exchange (arterial partial pressure of oxygen [PaO(2)] and carbon dioxide [PaCO(2)], pH and oxygen saturation [SaO(2)]) were evaluated at 30 min, at 6, 24 and 48 hours, and at day 10.
There were no significant differences between groups at baseline. In both groups, differences were significant for PEFR, SaO(2) and PaO(2) (p < 0.001), but not for PaCO(2) and pH, in comparison with their baseline values. There were no significant differences between groups for all parameters (PEFR, PaO(2), PaCO(2), pH and SaO(2)) at all time periods. No adverse events were recorded in either group.
Our study suggests that nebulised budesonide may be an alternative to parenteral corticosteroids in the treatment of acute exacerbations of COPD.
比较雾化布地奈德和全身皮质类固醇治疗慢性阻塞性肺疾病（COPD）急性加重的疗效和安全性。
随机、双盲、安慰剂对照、平行组试验。
共纳入 40 例中重度 COPD 急性加重并需要住院的患者。将患者随机分为每日雾化布地奈德 8mg 组（n = 21）或每日全身（静脉内）泼尼松龙 40mg 组（n = 19）。在 30 分钟、6、24 和 48 小时以及第 10 天评估气道阻塞（呼气峰流速[PEFR]）和气体交换（动脉血氧分压[PaO（2）]和二氧化碳分压[PaCO（2）]、pH 值和血氧饱和度[SaO（2）]）。
两组在基线时无显著差异。两组患者的 PEFR、SaO（2）和 PaO（2）（p < 0.001）均有显著差异，但 PaCO（2）和 pH 值无显著差异，与基线值相比。在所有时间点，两组之间所有参数（PEFR、PaO（2）、PaCO（2）、pH 值和 SaO（2））均无显著差异。两组均未发生不良反应。
我们的研究表明，雾化布地奈德可能是治疗 COPD 急性加重的替代全身皮质类固醇的选择。
