Fanta C H, McFadden E R
Am J Med. 1985 Dec 20;79(6A):54-7. doi: 10.1016/0002-9343(85)90089-0.
Nine adult subjects with perennial bronchial asthma participated in a single-blind, cross-over, placebo-controlled study to evaluate and compare the effectiveness of a 24-hour sustained-release theophylline formulation, Uniphyl, with that of a twice-daily compound, Theo-Dur. The subjects took each drug for two weeks and monitored peak expiratory flow and recorded their symptoms in a diary three times daily. At the end of each experimental period, they were hospitalized for 24 hours for determination of the pharmacokinetics of the compound they were taking and the relationship between fluctuations in theophylline blood levels and changes in pulmonary mechanics. Both drugs were highly effective, and no significant differences between formulations were found in any aspects of the study. The results demonstrate that a single daily dose of Uniphyl is an efficacious form of therapy for controlling perennial asthma in adults.
九名患有常年性支气管哮喘的成年受试者参与了一项单盲、交叉、安慰剂对照研究，以评估和比较一种24小时缓释茶碱制剂优喘平（Uniphyl）与一种每日两次的复方制剂茶喘平（Theo-Dur）的有效性。受试者每种药物服用两周，监测呼气峰值流速，并每天三次在日记中记录症状。在每个实验期结束时，他们住院24小时，以测定所服用化合物的药代动力学以及茶碱血药浓度波动与肺力学变化之间的关系。两种药物都非常有效，并且在研究的任何方面均未发现制剂之间存在显著差异。结果表明，优喘平每日单剂量是控制成人常年性哮喘的一种有效治疗形式。
