Pharmacy, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
Eur J Clin Pharmacol. 2010 Jun;66(6):605-10. doi: 10.1007/s00228-010-0787-4. Epub 2010 Feb 27.
The objective was to determine if the plasma concentrations of salbutamol, obtained during inhalation treatment of infantile acute asthma, are influenced by age range and by the aerosol system used.
A randomized clinical trial was conducted in 46 children (1-5 years of age) with a diagnosis of acute asthma crisis, established in an emergency room pediatric service. Twenty-five children received salbutamol using a pressurized metered-dose inhaler with spacer (50 microg/kg), and 21 children received salbutamol by nebulization (150 microg/kg),three times during a 1-h period. At the end of the treatment, one blood sample was drawn and the plasma was stored for later determination of salbutamol concentration (liquid chromatography). Salbutamol plasma concentrations were compared in two age groups (< or =2 years and >2 years of age). The type of device used (pressurized metered-dose inhaler or nebulizer) and the need of hospitalization were also tested. The Mann-Whitney U test was used with the level of significance set at 5% (P < 0.05).
No differences were detected regarding either the aerosol delivery system used or the need for hospitalization in relation to the plasma concentrations of salbutamol. However, higher plasma levels were found in patients >2 years vs patients < or =2 years [median (IQR): 9.40 (6.32-18.22) vs. 4.65 (2.77-10.10) ng/mL], demonstrating a significance difference (P = 0.05).
Salbutamol plasma concentrations were influenced by age group of the patients submitted to inhalation therapy, even with doses adjusted for body weight. After correcting for the differences in the biovailabilities of the delivery systems, the concentrations were independent of the aerosol delivery device used.
确定婴儿急性哮喘吸入治疗时沙丁胺醇的血浆浓度是否受年龄范围和所用气雾剂系统的影响。
在一家儿科急诊室进行了一项随机临床试验,纳入了 46 名被诊断为急性哮喘发作的儿童(1-5 岁)。25 名儿童使用带储雾器的压力定量气雾剂(50μg/kg)给予沙丁胺醇,21 名儿童通过雾化(150μg/kg),在 1 小时内分 3 次给予沙丁胺醇。治疗结束时,抽取一份血样并储存血浆,以备日后测定沙丁胺醇浓度(液相色谱法)。在两个年龄组(≤2 岁和>2 岁)中比较沙丁胺醇的血浆浓度。还测试了所用设备(压力定量气雾剂或雾化器)和住院的必要性。使用 Mann-Whitney U 检验,显著性水平为 5%(P<0.05)。
无论使用哪种气雾剂输送系统或与沙丁胺醇血浆浓度相关的住院需求,都没有差异。然而,与≤2 岁的患者相比,>2 岁的患者血浆水平更高[中位数(IQR):9.40(6.32-18.22)比 4.65(2.77-10.10)ng/ml],差异有统计学意义(P=0.05)。
即使根据体重调整了剂量,沙丁胺醇的血浆浓度仍受接受吸入治疗的患者年龄组的影响。在纠正了输送系统生物利用度差异后,浓度与所使用的气雾剂输送装置无关。