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哌醋甲酯对癫痫和注意缺陷多动障碍儿童生活质量的影响:使用渗透压控制释放口服递送系统的开放标签研究。

Effect of methylphenidate on the quality of life in children with epilepsy and attention deficit hyperactivity disorder: and open-label study using an osmotic-controlled release oral delivery system.

机构信息

Department of Psychiatry, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.

出版信息

Epileptic Disord. 2009 Dec;11(4):301-8. doi: 10.1684/epd.2009.0278. Epub 2009 Dec 15.

Abstract

This open study explored whether methylphenidate could be tolerated and effective in improving the quality of life (QOL) and attention deficit hyperactivity disorder (ADHD) symptoms of children with epilepsy and ADHD. Twenty-five subjects (aged 10.1 +/- 3.0 years) with ADHD and epilepsy were recruited at an outpatient clinic in Seoul, Korea. We used the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE), ADHD rating scale (ARS) and clinical global impression (CGI) in this study. Osmotic-controlled release oral delivery system (OROS) methylphenidate, 1.0 +/- 0.4 mg/kg/day, was administered for 55.2 +/- 7.5 days. The QOL subscales including physical restriction (p = 0.005), self-esteem (p = 0.002), memory (p < 0.001), language (p = 0.005), other cognition (p < 0.001), social interaction (p = 0.002), behaviour (p < 0.001), general health (p = 0.002) and QOL (p < 0.001) were significantly increased and the ARS (p < 0.001) and CGI-Severity of illness scores (p < 0.001) were significantly reduced after medication. Although 60% of subjects had experienced adverse effects, most were tolerable and only two subjects withdrew from the study owing to unbearable adverse effects (anorexia and insomnia). Two subjects had seizure attacks during the study period without having to discontinue the trial drug. Despite limitations related to the small sample size and the open design of the present pilot study, our results suggest that OROS methylphenidate may be well tolerated and effective in reducing ADHD symptoms and improving QOL in this patient population.

摘要

这项开放研究旨在探讨哌醋甲酯是否可耐受,并能有效改善患有癫痫和注意缺陷多动障碍(ADHD)的儿童的生活质量(QOL)和 ADHD 症状。在韩国首尔的一家门诊招募了 25 名患有 ADHD 和癫痫的患者(年龄 10.1 +/- 3.0 岁)。我们在这项研究中使用了儿童癫痫生活质量问卷(QOLCE)、ADHD 评定量表(ARS)和临床总体印象(CGI)。给予渗透压控制释放口服递药系统(OROS)哌醋甲酯 1.0 +/- 0.4 mg/kg/天,治疗 55.2 +/- 7.5 天。QOL 子量表包括身体限制(p = 0.005)、自尊(p = 0.002)、记忆(p < 0.001)、语言(p = 0.005)、其他认知(p < 0.001)、社会互动(p = 0.002)、行为(p < 0.001)、总体健康(p = 0.002)和 QOL(p < 0.001)显著增加,ARS(p < 0.001)和 CGI-疾病严重程度评分(p < 0.001)显著降低。尽管 60%的受试者出现不良反应,但大多数是可耐受的,只有两名受试者因无法忍受的不良反应(厌食和失眠)而退出研究。两名受试者在研究期间出现癫痫发作,但无需停用试验药物。尽管本初步研究存在样本量小和开放设计的局限性,但我们的结果表明,OROS 哌醋甲酯可能耐受良好,能有效降低该患者人群的 ADHD 症状并改善 QOL。

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