Navarro M, Durán J A, Delgado J A, Serrano J S, González Hachero J
An Esp Pediatr. 1987 Mar;26(3):171-7.
Twenty-seven asthmatic children have been studied in the phase between crises. According to treatment they have been grouped in treated with soluble theophylline and treated with retard theophylline. Initial oral dose was for both groups of 16 mg/kg/day. Three stages have been considered in every patient: control, at 7 days and at 21 days, performing at each time a clinical (symptoms), functional (spirometry) and analytical evaluation (theophylline blood levels). Following results were obtained: Both frequency and intensity of clinical symptoms are progressively reduced along the study. This reduction is more apparent with retard theophylline, that shows a positive significant correlation (p less than 0.05) between blood level-forced vital capacity after 7 days and blood-level-peak flow after 21 days. Incidence of undesired drug effects is comparable in both groups. The number of children showing no adverse drug effects was greater in group of retard theophylline, however, number of adverse drug effects child was greater in this group. Theophylline mean doses required to attain clinical efficacy are similar in both groups. Neither soluble nor retard theophylline provide a mean blood level in therapeutic range after 7 days, however retard theophylline does so after 21 days.
对27名处于哮喘发作间歇期的儿童进行了研究。根据治疗方法,他们被分为接受水溶性茶碱治疗组和接受缓释茶碱治疗组。两组的初始口服剂量均为16毫克/千克/天。对每位患者都考虑了三个阶段:对照阶段、7天和21天阶段,每次都进行临床(症状)、功能(肺功能测定)和分析评估(茶碱血药浓度)。获得了以下结果:在整个研究过程中,临床症状的频率和强度都逐渐降低。缓释茶碱的这种降低更为明显,其在7天后的血药浓度与用力肺活量之间以及21天后的血药浓度与峰值流速之间显示出显著的正相关(p小于0.05)。两组中不良药物反应的发生率相当。在缓释茶碱组中,未出现不良药物反应的儿童数量较多,然而,该组中出现不良药物反应的儿童数量也较多。两组达到临床疗效所需的茶碱平均剂量相似。7天后,水溶性茶碱和缓释茶碱均未达到治疗范围内的平均血药浓度,然而,21天后缓释茶碱达到了。