Pedersen S, Nathan E
Eur J Respir Dis. 1983 Nov;64(8):564-70.
After one year of sustained-release theophylline (SRT) treatment, 19 children with severe perennial asthma participated in a 6-week, placebo-controlled, randomized, double-blind cross-over study. The severity of their asthma was evaluated before SRT-treatment (pre-period) and one year later, both during the theophylline period and the placebo period of the double-blind study. Compared with the pre-period, all observed parameters, except the number of extra bronchodilators required, were statistically significantly improved in the placebo period of the double-blind trial performed after one year. In addition, except for peak expiratory flow measured at home and the number of acute attacks, all parameters were significantly improved during the theophylline period when compared with placebo treatment. During this study, mean serum theophylline level was 13.3 mg/l (range 7.8-19.4 mg/l). The results show that theophylline remains efficient after one year's administration. The much better control of the children's asthma following one year of treatment emphasizes the need for regular re-evaluation of children receiving continuous prophylactic treatment.
在接受缓释茶碱(SRT)治疗一年后,19名重度常年性哮喘患儿参加了一项为期6周的安慰剂对照、随机、双盲交叉研究。在SRT治疗前(治疗前期)以及一年后,即在双盲研究的茶碱期和安慰剂期,对他们的哮喘严重程度进行了评估。与治疗前期相比,在一年后进行的双盲试验的安慰剂期,除所需额外支气管扩张剂的数量外,所有观察参数均有统计学意义上的显著改善。此外,与安慰剂治疗相比,在茶碱期,除在家中测量的呼气峰值流速和急性发作次数外,所有参数均有显著改善。在本研究期间,血清茶碱平均水平为13.3mg/l(范围7.8 - 19.4mg/l)。结果表明,茶碱在给药一年后仍有效。经过一年治疗后对儿童哮喘的更好控制强调了对接受持续预防性治疗的儿童进行定期重新评估的必要性。