Borrill Z L, Houghton C M, Woodcock A A, Vestbo J, Singh D
Medicines Evaluation Unit, North-west Lung Centre, Wythenshawe Hospital, Manchester, UK.
Br J Clin Pharmacol. 2005 Apr;59(4):379-84. doi: 10.1111/j.1365-2125.2004.02261.x.
The aim of this study was to compare the variability and sensitivity of impulse oscillometry (R5, X5 and RF), plethysmography (Raw and sGaw) and spirometry (FEV1, FVC and MMEF) in order to determine the most powerful technique for assessing bronchodilation in COPD clinical trials.
Twenty-four patients with COPD had impulse oscillometry, plethysmography and spirometry measured twice 30 mins apart, to determine variability. Then ascending doses of salbutamol (20, 50, 100, 200, 400 and 800 microg) were given and the same measurements made after each dose. Significant changes greater than variability were determined for each performed measurement (expressed as mean percentage improvement with 95% CI).
Significant effects (P < 0.05) were detected after 20 microg by X5 (18.5% CI 9.8-27.2) RF (11.1% CI 7.2-15.0) and sGaw (21.5% CI 10.1-32.9), and after 50 microg by R5 (16.7% CI 10.8-22.5) and Raw (19.7% CI 13.0-26.4). FEV1 was less sensitive, detecting significant bronchodilation at 100 microg (10.2% CI 7.4-12.9).
We conclude that impulse oscillometry and plethysmography should be considered the preferred techniques for measuring bronchodilation in COPD clinical trials.
本研究旨在比较脉冲振荡法(R5、X5和RF)、体积描记法(气道阻力和比气道传导率)和肺量计(第一秒用力呼气容积、用力肺活量和最大呼气中期流速)的变异性和敏感性,以确定在慢性阻塞性肺疾病(COPD)临床试验中评估支气管扩张最有效的技术。
24例COPD患者接受脉冲振荡法、体积描记法和肺量计测量,间隔30分钟测量两次,以确定变异性。然后给予递增剂量的沙丁胺醇(20、50、100、200、400和800微克),每次给药后进行相同的测量。确定每次测量中大于变异性的显著变化(以平均改善百分比及95%置信区间表示)。
X5(18.5%,置信区间9.8 - 27.2)、RF(11.1%,置信区间7.2 - 15.0)和比气道传导率(21.5%,置信区间10.1 - 32.9)在20微克后检测到显著效果(P < 0.05),R5(16.7%,置信区间10.8 - 22.5)和气道阻力(19.7%,置信区间13.0 - 26.4)在50微克后检测到显著效果。第一秒用力呼气容积敏感性较低,在100微克时检测到显著支气管扩张(10.2%,置信区间7.4 - 12.9)。
我们得出结论,在COPD临床试验中,脉冲振荡法和体积描记法应被视为测量支气管扩张的首选技术。