ERS标准柠檬酸咳嗽激发试验在健康成人志愿者中的有效性
2011/01/27
摘要
使用不同的雾化器、止咳药物及剂量反应，使得检测咳嗽严重程度的方案也不同。因此，有必要建立一个能准确检测咳嗽严重程度的方法。ERS指南推荐采用KoKo DigiDoser（KD）给药系统。本试验旨在比较柠檬酸（CA）咳嗽激发试验以及前期建立的Mefar剂量检测仪（MD）方案的可重复性。39名平均年龄为40.4岁的志愿者（26名女性）随机分为KD组和MD组。比较同一天内和不同天间检测的可重复性。我们计算了激发2次咳嗽的柠檬酸的浓度（C2）。C2的几何平均值（95％CI）在KD和MD相似（分别为263[200,339] mM and 209[151,288] mM）。基线状态与试验1 h、2 h及4 h后，平均KD C2无显著差异（F=0.807, p=0.93），而MD存在显著的变化（F=7.85, P<0.001）。在基线状态和2周后检测平均log C2，与MD相比（ICC= 0.41），KD检测的基线状态的log C2与2周后的log C2存在较强的组内相关性（ICC=0.70）。在健康志愿者中采用KD进行CA咳嗽激发试验具有较好的可重复性。结果与MD激发试验具有一定相关性，但是每天内及各天检测间具有更好的可重复性。
（林江涛 审校）
Cough. 2010 Aug 10;6(1):8. [Epub ahead of print]
Validation of the ERS standard citric acid cough challenge in healthy adult volunteers.
Wright CE, Jackson J, Thompson RL, Morice AH.
Abstract
Protocols measuring cough sensitivity can vary in terms of nebuliser, tussive agent, single and dose response. A definitive method for measuring cough sensitivity needs to be established. The ERS guidelines recommend the KoKo DigiDoser (KD) delivery system. Study aim, was to compare the reproducibility of this citric acid (CA) cough challenge and previously established Mefar dosimeter (MD) protocol. 39 (female 26) volunteers mean age (40.4 yrs) were randomised to either KD or MD. Intra-day and inter-day reproducibility was compared. We calculated the concentration of citric acid evoking 2 coughs (C2). The geometric mean C2 (95%CI) was similar for both KD and MD, of 263 (200,339) mM and 209 (151,288) mM respectively. The mean KD C2 was not significantly different. (F=0.807, p=0.93) from baseline over 1, 2, and 4hrs however, the MD demonstrated significant variability (F=7.85, P<0.001) Measuring mean log C2 at baseline and at 2 weeks, the KD demonstrated a stronger intraclass correlation of log C2 at baseline with 2 week log C2, ICC=0.70 than was shown with the Mefar, ICC= 0.41 Administering CA from KD offers a reproducible cough challenge in healthy volunteers. The results correlate well with the MD challenge but offer greater intra-day and inter-day reproducibility. Trial Registration: Current controlled trials ISRCTN98385033.
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