Sir Peter Mansfield Magnetic Resonance Centre, School of Physics and Astronomy, The University of Nottingham, Nottingham, UK.
Division of Therapeutics and Molecular Medicine, University of Nottingham, UK.
Pulm Pharmacol Ther. 2014 Feb;27(1):121-6. doi: 10.1016/j.pupt.2013.08.002. Epub 2013 Aug 27.
This study aimed to assess the qualitative and quantitative utility of MRI imaging to illustrate the magnitude and duration of the effect of a standard 100 μg dose of oxymetazoline in a commercially available formulation that also contains aromatic oils.
This was a randomized, open label, single dose, parallel group study in 21 adult male and female subjects who reported moderate to severe nasal congestion due to acute upper respiratory tract infection or hay fever. MRI scans were acquired using a 3T Philips Achieva scanner with a 16 channel head receive coil. High resolution MRI scans of the nasal turbinates were obtained immediately prior to dosing (baseline) and at approximately 1, 8, 10, 11, and 12 h after dosing. The efficacy variables of primary interest were inferior turbinate total volume at 8 and 12 h post-dosing. The secondary efficacy variables analysed were inferior turbinate total volume at 1, 10, and 11 h post-dosing, middle turbinate total volume at 1, 8, 10, 11, and 12 h post-dosing.
Changes from baseline volumes measured for the inferior and middle turbinates of subjects receiving the oxymetazoline formulation showed significant (P < 0.05) decreases at all times up to and including 12 h post-administration. No significant decreases from baseline were detected in subjects receiving a sham 'spray' (untreated control - spray bottles with no spray solution). Statistical ANCOVA results of inferior and middle turbinate volume indicated significant differences (P < 0.05) at all measurement points up to and including 12 h post-administration between the oxymetazoline treatment group and the untreated control with the only exception the middle turbinate volume at 10 h (P = 0.0896). The significant changes were likely to be clinically relevant though this was not measured in the study. No AEs were reported during this study and no other safety evaluations were made.
This study showed that MRI assessment of nasal congestion in human volunteers is a robust, repeatable and viable measurement technique. The application of a 100 μg Vicks Sinex Micromist(®) nasal decongestant (0.05% oxymetazoline solution) delivered a highly significant reduction in inferior and middle turbinate volumes compared with the application of a control, measurable by the MRI method up to and including a 12 h post-dose scan.
本研究旨在评估 MRI 成像的定性和定量效用，以说明标准 100 μg 剂量的 oxymetazoline 在一种市售制剂中的作用大小和持续时间，该制剂还含有芳香油。
这是一项在 21 名因急性上呼吸道感染或花粉热而报告中度至重度鼻塞的成年男性和女性受试者中进行的随机、开放标签、单剂量、平行组研究。使用 3T Philips Achieva 扫描仪和 16 通道头部接收线圈进行 MRI 扫描。在给药前（基线）和给药后约 1、8、10、11 和 12 小时，获得鼻甲的高分辨率 MRI 扫描。主要关注的疗效变量是给药后 8 和 12 小时下鼻甲的总容积。分析的次要疗效变量包括给药后 1、10 和 11 小时下鼻甲总容积、给药后 1、8、10、11 和 12 小时中鼻甲总容积。
接受 oxymetazoline 制剂的受试者下鼻甲和中鼻甲的基线体积变化显示，给药后所有时间点（包括 12 小时）均有显著（P < 0.05）下降。接受假“喷雾”（未治疗对照-无喷雾溶液的喷雾瓶）的受试者未检测到与基线相比有显著下降。下鼻甲和中鼻甲体积的统计学 ANCOVA 结果表明，给药后所有测量点（包括 12 小时）oxymetazoline 治疗组与未治疗对照组之间存在显著差异（P < 0.05），唯一的例外是 10 小时时的中鼻甲体积（P = 0.0896）。虽然在研究中未进行测量，但这些显著变化可能具有临床相关性。在这项研究中没有报告任何不良事件，也没有进行其他安全性评估。
这项研究表明，MRI 评估人类志愿者的鼻塞是一种强大、可重复和可行的测量技术。与应用对照（可通过 MRI 方法测量）相比，应用 100 μg Vicks Sinex Micromist®（0.05% oxymetazoline 溶液）鼻减充血剂可显著降低下鼻甲和中鼻甲的体积，给药后高达 12 小时的扫描。
