二维和三维成像显示环来奈德具有高肺沉积和周围分布:一项健康志愿者的非随机研究。

Chet L Leach, Thomas D Bethke, Robert J Boudreau, Bruce E Hasselquist, Anton Drollmann, Patricia Davidson, Wilhelm Wurst
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引用次数: 81

摘要

药物沉积是影响吸入类固醇治疗安全性和有效性的重要因素。环来奈德是一种非卤化的吸入性皮质类固醇,目前正在研究用于治疗哮喘。因此,本研究旨在评估环来奈德的肺沉积。通过二维(2-D)和三维(3-D)成像分析健康志愿者吸入的锝-99m (99mTc)标记的环来奈德(99mTc标签物理溶解在环来奈德-氢氟烷烃[HFA]溶液气溶胶中),以确定肺部沉积。六名健康志愿者吸入一口40微克(呼气,相当于50微克呼气)的环赛奈德进行二维成像,两名健康志愿者吸入10口40微克的环赛奈德进行二维和三维成像。环奈德气溶胶通过含有HFA-134a作为推进剂的计量吸入器(MDI)给药。环来奈德在肺中的平均(+/-标准差)沉积(52% +/- 11%)高于在口腔/咽部(38% +/- 14%)。二维和三维成像显示环索内德到达肺的所有区域。3-D和2-D成像分别显示,外周区域的平均沉积百分比(47%和34%)高于中下区域(17%和30%)。吸入高达400微克的环奈德不会产生与药物相关的副作用。总之,使用HFA-134a作为推进剂通过计量吸入器给药的环来奈德提供了高肺沉积(>50%),更大的分布在肺周围区域,相对较低的口咽沉积。
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Two-dimensional and three-dimensional imaging show ciclesonide has high lung deposition and peripheral distribution: a nonrandomized study in healthy volunteers.

Drug deposition is an important factor that contributes to safety and efficacy outcomes of inhaled steroid therapy. Ciclesonide is a nonhalogenated, inhaled corticosteroid under investigation for the treatment of asthma. Therefore, this study was performed to assess lung deposition of ciclesonide. Technetium-99m (99mTc)-labeled ciclesonide (where the 99mTc-label is physically dissolved in the ciclesonide-hydrofluoroalkane [HFA] solution aerosol) inhaled by healthy volunteers was analyzed by two-dimensional (2-D) and three-dimensional (3-D) imaging to determine lung deposition. Six healthy volunteers inhaled one puff of 40 microg (exactuator, equivalent to 50 microg ex-valve) ciclesonide for 2-D imaging, and two healthy volunteers inhaled 10 puffs of 40 microg ciclesonide for 2-D and 3-D imaging. The ciclesonide aerosol was administered via metered-dose inhaler (MDI) containing HFA-134a as propellant. The ex-actuator mean (+/- standard deviation) deposition of ciclesonide in the lungs was higher (52% +/- 11%) than in the mouth/pharynx (38% +/- 14%). Two-dimensional and 3-D imaging showed that ciclesonide reached all regions of the lung. Mean percent deposition in peripheral regions (47% and 34%) was higher than in lower central regions (17% and 30%), as revealed by 3-D and 2-D imaging, respectively. Inhalation of up to 400 microg of ciclesonide produced no drug-related side effects. In conclusion, ciclesonide administered via metered-dose inhaler using HFA-134a as a propellant provided high lung deposition (>50%), greater distribution throughout peripheral regions of the lungs, and relatively low oropharyngeal deposition.

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