Boner A L, De Stefano G, Vallone G, Plebani M, Ventura P
Paediatric Clinic, University of Verona, Italy.
J Int Med Res. 1987 Sep-Oct;15(5):282-92. doi: 10.1177/030006058701500504.
This study was carried out on 14 asthmatic children aged 7-13 years. They all received three preparations (aminophylline by intravenous infusion, lysine theophyllinate orally in solution and slow release theophylline orally as capsules) in a single dose of 100 mg active ingredient in a crossover design. Plasma theophylline concentrations, determined by a fluorescent polarization immunoassay, were evaluated both by compartmental and non-compartmental analysis. After administration of slow release theophylline, its maximum plasma concentration and the time needed to reach this were (+/- SD) 3.19 +/- 0.63 microgram/ml and 8.71 +/- 2.30 h, respectively, compared to 4.51 +/- 0.94 microgram/ml and 1.96 +/- 0.85 h, respectively, for the oral normal release solution. Mean absolute and relative percentage bioavailabilities for slow release theophylline in asthmatic children were (+/- SD) 92.7 +/- 23.2% and 83.14 +/- 14.69%, respectively. These are similar to the values found with other slow release formulations in paediatric patients.
本研究对14名7至13岁的哮喘儿童进行。他们均按照交叉设计,接受了三种制剂(静脉输注氨茶碱、口服溶液赖氨酸茶碱以及口服缓释茶碱胶囊),单剂量活性成分均为100毫克。通过荧光偏振免疫分析法测定血浆茶碱浓度,并采用房室分析和非房室分析进行评估。服用缓释茶碱后,其最大血浆浓度及其达到该浓度所需时间分别为(±标准差)3.19±0.63微克/毫升和8.71±2.30小时,相比之下,口服普通释放溶液分别为4.51±0.94微克/毫升和1.96±0.85小时。哮喘儿童中缓释茶碱的平均绝对生物利用度和相对生物利用度百分比分别为(±标准差)92.7±23.2%和83.14±14.69%。这些值与儿科患者中其他缓释制剂的值相似。