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雾化布地奈德在面部和眼部的沉积:面罩设计的影响

Facial and ocular deposition of nebulized budesonide: effects of face mask design.

作者信息

Harris Keith W, Smaldone Gerald C

机构信息

Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, State University of New York, Stony Brook, NY 11794-8172, USA.

出版信息

Chest. 2008 Feb;133(2):482-8. doi: 10.1378/chest.07-1827. Epub 2007 Dec 10.

DOI:10.1378/chest.07-1827
PMID:18071018
Abstract

BACKGROUND

In vivo case reports and in vitro studies have indicated that aerosol therapy using face masks can result in drug deposition on the face and in the eyes, and that face mask design may affect drug delivery.

OBJECTIVE

To test different mask/nebulizer combinations for budesonide, a nebulized steroid used to treat pediatric patients with asthma.

METHODS

Using high-performance liquid chromatography, drug delivery (inhaled mass), facial, and ocular deposition of budesonide aerosols were studied in vitro using a ventilated face facsimile (tidal volume, 50 mL; rate, 25 breaths/min, duty cycle 0.4), a tight-fitting test mask, a standard commercial mask, and a prototype mask designed to optimize delivery by reducing particle inertia. Nebulizer insertion into the mask (front loaded vs bottom loaded) was also tested. Particle size was measured by cascade impaction. Pari LC Plus (PARI Respiratory Equipment; Midlothian, VA) and MistyNeb (Allegiance; McGaw Park, IL) nebulizers were tested.

RESULTS

Inhaled mass for tight-fitting and prototype masks was similar (13.2 +/- 1.85% vs 14.4 +/- 0.67% [percentage of nebulizer charge], p = 0.58) and significantly greater than for the commercial mask (3.03 +/- 0.26%, p = 0.005). Mask insertion of nebulizer was a key factor (inhaled mass: front loaded vs bottom loaded, 8.23 +/- 0.18% vs 3.03 +/- 0.26%; p = 0.005). Ocular deposition varied by an order of magnitude and was a strong function of mask design (4.77 +/- 0.24% vs 0.35 +/- 0.05%, p = 0.002, tight fitting vs prototype). Particle sizes (7.3 to 9 microm) were larger than previously reported for budesonide.

CONCLUSIONS

For pediatric breathing patterns, mask design is a key factor defining budesonide delivery to the lungs, face, and eyes. Front-loaded nebulizer mask combinations are more efficient than bottom-loaded systems.

摘要

背景

体内病例报告和体外研究表明,使用面罩进行雾化治疗可能会导致药物沉积在面部和眼睛,并且面罩设计可能会影响药物递送。

目的

测试不同的面罩/雾化器组合用于布地奈德,一种用于治疗小儿哮喘患者的雾化类固醇。

方法

使用高效液相色谱法,在体外使用通气面部模型(潮气量50 mL;频率25次/分钟,占空比0.4)、贴合性测试面罩、标准商用面罩和设计用于通过降低颗粒惯性来优化递送的原型面罩,研究布地奈德气雾剂的药物递送(吸入量)、面部和眼部沉积。还测试了雾化器插入面罩的方式(前装式与底装式)。通过串联冲击法测量颗粒大小。测试了Pari LC Plus(PARI呼吸设备公司;弗吉尼亚州米德洛锡安)和MistyNeb(阿利根斯公司;伊利诺伊州麦高公园)雾化器。

结果

贴合性面罩和原型面罩的吸入量相似(分别为13.2±1.85%和14.4±0.67%[雾化器装药的百分比],p = 0.58),且显著高于商用面罩(3.03±0.26%,p = 0.005)。雾化器插入面罩的方式是一个关键因素(吸入量:前装式与底装式,分别为8.23±0.18%和3.03±0.26%;p = 0.005)。眼部沉积相差一个数量级,并且是面罩设计的强函数(贴合性面罩与原型面罩分别为4.77±0.24%和0.35±0.05%,p = 0.002)。颗粒大小(7.3至9微米)比先前报道的布地奈德颗粒大小更大。

结论

对于小儿呼吸模式,面罩设计是决定布地奈德递送至肺部、面部和眼睛的关键因素。前装式雾化器面罩组合比底装式系统更有效。

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