Greening A P, Baillie E, Gribbin H R, Pride N B
J Int Med Res. 1979;7 Suppl 1:47-51.
Twenty-two patients with reversible airflow obstruction were entered into a double-blind crossover trial of Phyllocontin Continus tablets and placebo to assess the additional benefit of the controlled-release aminophylline preparation when added to the patients' medication. Most patients were taking inhaled or oral steroids in addition to inhaled beta-sympathomimetics throughout the trial. The dosage of Phyllocontin tablets was adjusted in a pre-trial study to provide serum theophylline levels in the accepted therapeutic range of 10--20 mg/l. In the seventeen patients who completed the 8-week study a small, but significant, increase in both the patients' own recordings of PEFR and weekly clinic measurements of FEV1 was seen whilst on the active drug. Ten patients had improvement in FEV1 greater than 200 ml. Eleven patients recorded subjective improvement on the active drug and five out of ten patients who used inhaled beta-sympathomimetics p.r.n. showed a reduction in their usage of greater than 10%. Side-effects were reported by twelve patients.
22例可逆性气流受限患者进入一项关于菲洛待因持续片(Phyllocontin Continus tablets)和安慰剂的双盲交叉试验,以评估控释氨茶碱制剂添加到患者药物治疗中所带来的额外益处。在整个试验过程中,大多数患者除吸入β-拟交感神经药外,还服用吸入或口服类固醇。在一项预试验研究中对菲洛待因片的剂量进行了调整,以使血清茶碱水平维持在10 - 20mg/L的公认治疗范围内。在完成8周研究的17例患者中,在服用活性药物期间,患者自行记录的呼气峰流速(PEFR)以及每周门诊测量的第一秒用力呼气容积(FEV1)均出现了虽小但显著的增加。10例患者的FEV1改善超过200ml。11例患者记录了服用活性药物后的主观改善,10例按需使用吸入β-拟交感神经药的患者中有5例使用量减少超过10%。12例患者报告了副作用。