阿司咪唑和氯苯那敏对儿童中枢神经系统不良反应的比较:一项随机、双盲研究。

A Shanon, W Feldman, L Leikin, A H Pong, R Peterson, V Williams
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引用次数: 7

摘要

目的:评价氯非那敏与阿司咪唑对儿童中枢神经系统的不良反应。设计:前瞻性、随机、双盲交叉研究。环境:从过敏门诊和当地报纸广告的应答者中招募儿童。这项研究是在东安大略儿童医院的门诊门诊进行的。患者,参与者:8-16岁的儿童,患有孤立的过敏性鼻炎或花粉热,符合研究条件。我们排除了患有以下疾病的儿童:(1)慢性疾病(特别是哮喘、特应性皮炎、学习障碍或目前正在接受口服皮质类固醇药物治疗);(2)已知对研究药物过敏;(3)近期使用任何抗组胺药物。103名儿童参加了研究,92名完成了研究。干预措施:儿童按年龄分层,随机分配到两种药物序列中的一种治疗。在13周的时间里,两组都有1周的基线研究,3周的一种研究药物,氯苯那敏或阿司咪唑,6周的洗脱期,然后3周的另一种研究药物进行第二个治疗期。主要结果测量:注意力持续时间(连续表现测试)、短期听觉和视觉记忆(视觉听觉数字广度测试)、几何形状视觉记忆(本顿视觉保持测试)、运动协调和视觉运动整合(凹槽钉板测试)、敲击速度和精细运动协调(手指敲击测试)、身体副作用(如嗜睡和头晕)和依从性。结果:103例患者入组,92例(89%)完成研究。药物对视力保持试验和连续性能试验均无显著影响。在视觉听觉手指广度测试中,阿司咪唑治疗的患者得分高于基线。两种药物之间或每种药物与基线之间的不良反应没有临床或统计学差异。结论:所研究的两种抗组胺药对儿童的表现无不良影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of CNS adverse effects between astemizole and chlorpheniramine in children: a randomized, double-blind study.

Objective: To assess the central nervous system side effects of chlorpheniramine and astemizole in children.

Design: Prospective, randomized, double-blind cross-over study.

Setting: Children were recruited from the out-patient allergy clinic and from respondents to an advertisement in a local newspaper. The study was conducted in the outpatient clinics of the ambulatory care services of the Children's Hospital of Eastern Ontario.

Patients, participants: Children 8-16 years of age, with isolated allergic rhinitis or hay fever, were eligible for the study. We excluded children with: (1) chronic conditions (specifically asthma, atopic dermatitis, learning disabilities, or current treatment with oral corticosteroid medication); (2) known allergy to the study medications; (3) recent use of any antihistamine medication. One hundred and three children entered the study and 92 completed it.

Interventions: Children were stratified by age and randomly allocated to treatment with one of the two medication sequences. Over a period of 13 weeks both groups had 1 week of baseline studies, 3 weeks of one study medication, either chlorpheniramine or astemizole, a 6-week wash-out period and then 3 weeks of the other study medication for a second treatment period.

Main outcome measures: Attention span (continuous performance test), short-term auditory and visual memory (visual aural digit span test), visual memory for geometric shapes (Benton visual retention test), motor coordination and visual-motor integration (grooved pegboard test), tapping speed and fine motor coordination (finger tapping test), physical side effects (such as sleepiness and dizziness), and compliance.

Results: One hundred and three patients were enrolled in the study, 92 (89%) completed the study. There were no significant drug effects on the visual retention test and the continuous performance test. On the visual aural digit span test, patients treated with astemizole scored higher than at baseline. There were no clinical or statistical differences in adverse effects between the two medications or between each medication and baseline.

Conclusions: The two antihistamines studied had no adverse effects on the performance of children.

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