Department of Respiratory Medicine, the First Affiliated Hospital of Fujian Medical University, Fuzhou 350005, P. R. China;
J Thorac Dis. 2012 Dec;4(6):583-7. doi: 10.3978/j.issn.2072-1439.2012.11.02.
This study investigated the rapid onset of bronchodilation effect and compared lung function changes following budesonide/formoterol (Symbicort Turbuhaler®) inhalation in Chinese patients with moderate-severe chronic obstructive pulmonary disease (COPD) and bronchial asthma.
In this open-label, parallel-group clinical study, patients eligible for study were divided into COPD group (n=62, mean age 68.16±8.75 years) and asthma group (n=30, mean age 45.80±12.35 years). Lung function tests (include FEV1, FVC, FEV1/FVC, and IC) were performed at baseline (t=0 min time point, value before inhalation of budesonide/formoterol), and then eligible patients received two inhalations of budesonide/formoterol (160/4.5 μg). Lung function tests were reassessed at t=3, 10 and 30 min time point. The primary end-point was lung function change 3 min after drug inhalation, and the secondary end-points were comparison of the gas flow rate (ΔFEV1) and volume responses (ΔFVC, ΔIC) between COPD and asthma patients after inhalation of budesonide/formoterol.
Compared with the baseline, all patients significantly improved their lung function (included FEV1, FVC, FEV1/FVC, and IC) at 3 min (P<0.05). Greater bronchodilation efficacy was found in the asthma group compared with the COPD group (P<0.05). In the asthmatic patients, the curves of FEV1, FVC, FEV1/FVC, IC, showed improvement with an ascending trend at all time points from 3 to 30 min. Whereas in the COPD patients, only the curves of FEV1, FVC, IC showed similar pattern. We found that ΔFVC was significantly higher than ΔFEV1 in both groups (P<0.05), but no significant difference between ΔIC and ΔFEV1 (P>0.05). Compared with COPD group, asthma group had higher level of ΔFEV1 and ΔIC (P<0.05), but no significant difference for ΔFVC can be found.
Budesonide/formoterol has a fast onset of bronchodilation effect in patients with moderate-severe COPD and asthma. Greater efficacy was found in the asthma group compared with the COPD group. The gas flow rate and volume responses in patients with COPD differ from those with asthma after inhalation of Budesonide/formoterol.
本研究旨在探讨布地奈德/福莫特罗（信必可都保®）吸入治疗对中重度慢性阻塞性肺疾病（COPD）和支气管哮喘患者支气管扩张作用的快速起效，并比较其对肺功能的影响。
这是一项开放标签、平行组临床研究，符合条件的患者被分为 COPD 组（n=62，平均年龄 68.16±8.75 岁）和哮喘组（n=30，平均年龄 45.80±12.35 岁）。肺功能测试（包括 FEV1、FVC、FEV1/FVC 和 IC）在基线时（t=0 分钟时间点，吸入布地奈德/福莫特罗前的值）进行，然后合格的患者接受两吸布地奈德/福莫特罗（160/4.5μg）。在 t=3、10 和 30 分钟时间点重新评估肺功能测试。主要终点是药物吸入后 3 分钟时的肺功能变化，次要终点是比较 COPD 和哮喘患者吸入布地奈德/福莫特罗后气流速度（ΔFEV1）和体积反应（ΔFVC、ΔIC）的差异。
与基线相比，所有患者在 3 分钟时均显著改善了肺功能（包括 FEV1、FVC、FEV1/FVC 和 IC）（P<0.05）。哮喘组的支气管扩张效果明显优于 COPD 组（P<0.05）。在哮喘患者中，FEV1、FVC、FEV1/FVC、IC 的曲线在 3 至 30 分钟的所有时间点均呈上升趋势，表明改善。而在 COPD 患者中，只有 FEV1、FVC、IC 的曲线呈类似模式。我们发现，两组的ΔFVC 均显著高于ΔFEV1（P<0.05），但ΔIC 与ΔFEV1 之间无显著差异（P>0.05）。与 COPD 组相比，哮喘组的ΔFEV1 和ΔIC 水平更高（P<0.05），但ΔFVC 无显著差异。
布地奈德/福莫特罗对中重度 COPD 和哮喘患者具有快速起效的支气管扩张作用。哮喘组的疗效明显优于 COPD 组。COPD 患者吸入布地奈德/福莫特罗后的气流速度和体积反应与哮喘患者不同。
