通过一种新型手掌大小的雾化器（Aerodose吸入器）、传统雾化器（Pari LC Plus）和定量气雾剂（万托林气雾剂）对中重度哮喘患者进行沙丁胺醇的剂量反应研究。
Dose-response to salbutamol via a novel palm sized nebuliser (Aerodose Inhaler), conventional nebuliser (Pari LC Plus) and metered dose inhaler (Ventolin Evohaler) in moderate to severe asthmatics.
作者信息
Lipworth Brian J, Sims Erika J, Taylor Karla, Cockburn Wendy, Fishman Robert
机构信息
Department of Medicine and Therapeutics, Asthma & Allergy Research Group, Ninewells Hospital & Medical School, University of Dundee, Dundee Scotland, DD1 9SY, UK.
出版信息
Br J Clin Pharmacol. 2005 Jan;59(1):5-13. doi: 10.1111/j.1365-2125.2005.02168.x.
AIMS
The Aerodose inhaler is a novel, palm-sized, breath actuated device which requires little patient coordination. This study compared the dose-response of salbutamol delivered by the Aerodose Inhaler (Aerogen Inc., Mountain View, USA) vs Pari LC Plus jet nebulizer (Pari LC Plus; Pari GmbH, Starnberg, Germany) and Ventolin Evohaler HFA pMDI (Evohaler; Allen & Hanburys [GlaxoSmithkline], Uxbridge, UK).
METHODS
Twenty-two moderate to severe asthmatic patients, mean (s.d.) age: 44.7 (9.4), FEV(1): 58.1 (12.0), received 4 cumulative doubling doses of salbutamol in a randomised, investigator blind, balanced crossover design. Spirometry and systemic safety variables (heart rate, blood pressure, T wave amplitude, QTc interval and potassium) were measured at baseline and after each dose.
RESULTS
Parallel regression analysis revealed that microgram relative potency ratios for the Aerodose Inhaler to be five times more efficient for FEV(1) than either the Pari LC Plus (0.202, 90% CI: 0.189-0.216) or the Evohaler (0.202, 90% CI: 0.189-0.216), while there was no difference between Pari LC Plus vs Evohaler. Similarly, Aerodose Inhaler vs. Pari LC Plus showed approximately five-fold greater potency for all systemic parameters, except blood pressure. As compared to the Evohaler, Aerodose Inhaler had equivalent potency for plasma potassium and T wave amplitude, but demonstrated greater potency for heart rate and QT(c) interval.
CONCLUSIONS
This study has indicated therefore, that Aerodose Inhaler is approximately five times as efficient as the Pari LC Plus and Evohaler in relative lung delivery of salbutamol in moderate to severe asthmatics.
目的
Aerodose吸入器是一种新颖的、手掌大小的、通过呼吸驱动的装置，几乎不需要患者配合。本研究比较了Aerodose吸入器（美国山景城的Aerogen公司）、Pari LC Plus喷射雾化器（Pari LC Plus；德国施塔恩贝格的Pari公司）和万托林易纳器HFA定量吸入气雾剂（易纳器；英国乌克斯布里奇的艾伦汉伯里公司[葛兰素史克]）递送沙丁胺醇的剂量反应。
方法
22名中度至重度哮喘患者，平均（标准差）年龄：44.7（9.4），第一秒用力呼气容积（FEV₁）：58.1（12.0），在随机、研究者盲法、平衡交叉设计中接受4次累积加倍剂量的沙丁胺醇。在基线和每次给药后测量肺功能和全身安全性变量（心率、血压、T波振幅、QTc间期和血钾）。
结果
平行回归分析显示，Aerodose吸入器每微克的相对效价比Pari LC Plus（0.202，90%可信区间：0.189 - 0.216）或易纳器（0.202，90%可信区间：0.189 - 0.216）在增加FEV₁方面效率高五倍，而Pari LC Plus和易纳器之间没有差异。同样，除血压外，Aerodose吸入器在所有全身参数方面的效价比Pari LC Plus高约五倍。与易纳器相比，Aerodose吸入器在血钾和T波振幅方面效价相当，但在心率和QTc间期方面效价更高。
结论
因此，本研究表明，在中度至重度哮喘患者中，Aerodose吸入器在沙丁胺醇相对肺部递送方面的效率约为Pari LC Plus和易纳器的五倍。
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