Bender B G, Iklé D N, DuHamel T, Tinkelman D
Department of Pediatrics, National Jewish Medical and Research Center, Denver, Colorado 80206, USA.
Pediatrics. 1998 Mar;101(3 Pt 1):355-60. doi: 10.1542/peds.101.3.355.
Results from previous investigations that examined the psychological side effects of theophylline have been inconsistent, and none have reported about inhaled corticosteroids. The objective of this study was to assess the relative psychological side effects of theophylline and beclomethasone in asthmatic children.
This was a multicenter, randomized, double-blind, parallel-groups study in which 102 asthmatic patients were assigned to one of two treatments: beclomethasone three times daily or theophylline twice daily. At baseline, 1 month, and 1 year, parents completed standardized behavioral questionnaires while the children received psychometric testing of attention and concentration, memory and learning, and problem-solving.
Although power was sufficient to detect meaningful mean score changes, no consistent differential treatment effects were observed. Two significant treatment-by-period interactions were discordant, with one suggesting slightly better attention in the theophylline group, whereas the other indicated a small advantage in attention scores in the beclomethasone group. Numerous significant period effects revealed that behavior and cognitive test performance improved over the 1-year period, regardless of treatment, and confirmed a well established practice effect resulting from repeated administrations of such tests.
Neither theophylline nor beclomethasone should be avoided out of concern for significant psychological side effects. The possibility remains that a subset of asthmatic children may be susceptible to such medication-induced changes; investigators have suggested that preschool children may be at particular risk, although no controlled studies with this age group have been conducted. Parental perceptions of medication side effects can be influenced by temporary effects present at initiation of treatment or by erroneous attribution of the psychological effects of the chronic illness. Reports of psychological changes in response to asthma medications must be addressed respectfully but objectively, with due consideration of available evidence and an awareness of other potential explanations.
以往关于氨茶碱心理副作用的研究结果并不一致，且尚无关于吸入性糖皮质激素的相关报道。本研究的目的是评估氨茶碱和倍氯米松对哮喘儿童相对的心理副作用。
这是一项多中心、随机、双盲、平行组研究，102例哮喘患者被分配至两种治疗方案之一：倍氯米松每日三次或氨茶碱每日两次。在基线、1个月和1年时，家长完成标准化行为问卷，同时对儿童进行注意力和专注力、记忆与学习以及解决问题能力的心理测量测试。
尽管有足够的检验效能来检测有意义的平均得分变化，但未观察到一致的差异治疗效果。两个显著的治疗-时间交互作用不一致，一个表明氨茶碱组注意力稍好，而另一个表明倍氯米松组在注意力得分上有小优势。众多显著的时间效应表明，无论治疗如何，行为和认知测试表现在1年期间均有所改善，并证实了重复进行此类测试所产生的既定练习效应。
不应因担心显著的心理副作用而避免使用氨茶碱或倍氯米松。仍有可能一部分哮喘儿童易受此类药物引起的变化影响；研究人员认为学龄前儿童可能特别危险，尽管尚未对该年龄组进行对照研究。家长对药物副作用的认知可能会受到治疗开始时的暂时效应或对慢性病心理效应的错误归因影响。对于哮喘药物引起心理变化的报告，必须在充分考虑现有证据并认识到其他潜在解释的情况下，以尊重但客观的态度加以处理。
