Department of Respiratory Medicine, Affiliated Hospital of Xuzhou Medical College, Xuzhou, Jiangsu, People's Republic of China.
Int J Chron Obstruct Pulmon Dis. 2020 Feb 26;15:409-415. doi: 10.2147/COPD.S235125. eCollection 2020.
Clinical studies have suggested nebulized budesonide (NB) as an alternative to systemic corticosteroids for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, the optimal budesonide dose for AECOPD remains unclear.
To compare the efficacy and safety of different doses of NB in the management of AECOPD.
A total of 321 AECOPD patients with moderate-to-severe exacerbation were randomly divided into three groups and treated with NB. The low dose group (L) was given 4 mg/day (n=95, 1 mg Q6h), while high-dose group 1 (H1, n=111, 2 mg Q6h) and high-dose group 2 (H2, n=115, 4 mg Q12h) were given 8 mg/day. Patients also received routine treatment including oxygen therapy, expectorant, nebulization bronchodilators, antibiotics, and fluid rehydration. The COPD assessment test (CAT), lung function, and artery blood gas were evaluated before and after 3 hrs and 5 days of treatment. In addition, hospital stay, frequency of acute exacerbations within 3 months of discharge, and adverse events during treatment were compared.
H1 and H2 showed improved spirograms and CAT score faster than L. In H2, forced expiratory volume in 1 s (FEV%) at 3 hrs and FEV%, forced expiratory flow after 50% of the forced vital capacity has been exhaled (FEF), mean forced expiratory flow between 25% and 75% of forced vital capacity (FEF) and CAT score at 5 days were significantly improved compared to L. FEV% improved most in H2, moderately in H1, and least in L, with significant differences between groups at 5 days. No differences between groups were observed in adverse effects, hospital stay, and frequency of exacerbations within 3 months of discharge.
Compared to the conventional dose (4 mg/day), a high dose (8 mg/day) of NB improved pulmonary function and symptoms more effectively in the early treatment of AECOPD, especially when given as 4 mg twice daily.
临床研究表明，雾化布地奈德（NB）可作为慢性阻塞性肺疾病（COPD）急性加重（AECOPD）患者全身皮质类固醇激素的替代疗法。然而，AECOPD 患者的最佳布地奈德剂量仍不清楚。
比较不同剂量 NB 在 AECOPD 治疗中的疗效和安全性。
将 321 例中重度 AECOPD 患者随机分为三组，给予 NB 治疗。低剂量组（L）给予 4 mg/天（n=95，1 mg Q6h），高剂量组 1（H1，n=111，2 mg Q6h）和高剂量组 2（H2，n=115，4 mg Q12h）给予 8 mg/天。患者还接受常规治疗，包括氧疗、祛痰剂、雾化支气管扩张剂、抗生素和补液。在治疗前和治疗后 3 小时和 5 天评估慢性阻塞性肺疾病评估测试（CAT）、肺功能和动脉血气。此外，比较住院时间、出院后 3 个月内急性加重的频率以及治疗期间的不良事件。
H1 和 H2 组比 L 组更快改善肺活量和 CAT 评分。在 H2 组中，治疗后 3 小时的 1 秒用力呼气容积（FEV%）和 FEV%、用力呼气量 50%（FEF）、用力肺活量 25%至 75%（FEF）的平均用力呼气流量和 CAT 评分在第 5 天均显著改善与 L 相比。FEV%在 H2 组中改善最大，在 H1 组中改善适度，在 L 组中改善最小，各组之间在第 5 天有显著差异。各组之间的不良反应、住院时间和出院后 3 个月内的急性加重频率无差异。
与常规剂量（4 mg/天）相比，NB 高剂量（8 mg/天）在 AECOPD 的早期治疗中更有效地改善肺功能和症状，特别是每天两次给予 4 mg 时。
