Longo G, Poli F, Strinati R, Longo F
Pediatr Med Chir. 1984 Sep-Oct;6(5):645-9.
Data from 34 patients were included in the analysis of this open group comparative study comparing a controlled release theophylline given twice daily with immediate release aminophylline given four times daily. The treatment period was of eight weeks duration. There was no significant difference between treatments in clinical assessments of asthma severity or pulmonary function tests. Similarly there were no significant differences between treatments in diary card assessments of asthma symptoms or PERF. Serum theophylline levels were measured prior to the morning dose of test treatment and 2 or 5 hours later, respectively for patients taking immediate release (IR) or controlled release (CR) preparations, at each clinic visit. There was no significant difference between treatments in serum theophylline levels fluctuations, although the dosing interval (12 hours) was twice as long for CR formulation. Six patients reported unusual symptoms, two in the CR group (headache, gastric discomfort) four in the aminophylline group (three headache, one headache and vomiting).
在这项开放组对比研究的分析中纳入了34例患者的数据,该研究比较了每日两次给药的控释茶碱与每日四次给药的速释氨茶碱。治疗期为8周。在哮喘严重程度的临床评估或肺功能测试中,各治疗组之间无显著差异。同样,在哮喘症状的日记卡评估或呼气峰流速(PERF)方面,各治疗组之间也无显著差异。在每次门诊就诊时,分别于服用速释(IR)或控释(CR)制剂的患者早晨服用试验治疗药物前以及2或5小时后测量血清茶碱水平。尽管CR制剂的给药间隔(12小时)是速释制剂的两倍,但各治疗组之间血清茶碱水平波动无显著差异。6例患者报告了异常症状,CR组2例(头痛、胃部不适),氨茶碱组4例(3例头痛、1例头痛伴呕吐)。