Amirav Israel, Mansour Yasser, Mandelberg Avigdor, Bar-Ilan Igal, Newhouse Michael T
Pediatric Department, Sieff Hospital, Safed, Israel.
Pediatr Pulmonol. 2004 Feb;37(2):172-7. doi: 10.1002/ppul.10418.
The currently available facemask interface for the Nebuchamber (N) valved-holding chamber (VHC) provides a very poor seal to the face, which, on average, decreases the aerosol dose and was previously shown to increase the variability of aerosol delivery. The efficiency of a redesigned mask (RD) for the Nebuchamber with a potentially better seal was compared to the standard mask (SM) supplied with the N in a randomized real-life crossover clinical trial. Twenty children (mean age, 26 +/- 10 months) were randomized to use the Nebuchamber for 1 week with the old mask and then for another week with the newer mask, and vice versa. Filters, changed daily, inserted between the mask and the VHC, trapped the delivered drug (budesonide). The dose of budesonide was quantified by high-performance liquid chromatography (HPLC). Use of the redesigned mask improved aerosol delivery to the filter by 30%, compared to the SM (mean 28.1 +/- 7.7% of nominal dose with RD vs. 21.6 +/- 9.6% with SM, P = 0.017). The relatively high within-subject variability in aerosol delivery (36-38%) did not change, however. Facemasks are arguably the most important determinants of aerosol delivery. The newly developed RD for the Nebuchamber proved to be considerably more efficient than the SM for aerosol delivery to young children. Patient-related factors may be more important with respect to the variability observed.
目前用于雾化吸入器（N）带阀储物罐（VHC）的面罩与面部的密封效果很差，平均而言会降低气雾剂剂量，并且先前已证明会增加气雾剂输送的变异性。在一项随机现实交叉临床试验中，将一种重新设计的、可能具有更好密封效果的雾化吸入器面罩（RD）与雾化吸入器随附的标准面罩（SM）的效率进行了比较。20名儿童（平均年龄26±10个月）被随机分配，先用旧面罩使用雾化吸入器1周，然后再用新面罩使用1周，反之亦然。每天更换的过滤器插在面罩和带阀储物罐之间，截留递送的药物（布地奈德）。布地奈德的剂量通过高效液相色谱法（HPLC）进行定量。与标准面罩相比，使用重新设计的面罩可使过滤器的气雾剂递送提高30%（使用重新设计的面罩时，平均为标称剂量的28.1±7.7%，而使用标准面罩时为21.6±9.6%，P = 0.017）。然而，气雾剂递送中相对较高的受试者内变异性（36 - 38%）并未改变。面罩可以说是气雾剂递送的最重要决定因素。新开发的雾化吸入器重新设计面罩在向幼儿递送气雾剂方面被证明比标准面罩效率高得多。就观察到的变异性而言，与患者相关的因素可能更为重要。
