Park Kee Jeong, Ahn Hyunji, Yum Mi-Sun, Ko Tae-Sung, Kim Hyo-Won
Department of Psychiatry, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Department of Pediatric Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Psychiatry Investig. 2020 May;17(5):412-416. doi: 10.30773/pi.2019.0287. Epub 2020 Apr 17.
The objective of this study was to assess the effectiveness and safety of atomoxetine in Korean children and adolescents with epilepsy.
We retrospectively reviewed the electronic medical records of 105 children and adolescents with epilepsy treated with atomoxetine. Effectiveness was measured with the Clinical Global Impressions-Severity (CGI-S) and/or Clinical Global Impressions-Improvement (CGI-I) scales at baseline, and after 4 and 12 weeks. We defined response to atomoxetine as a CGI-I score less than three at week 12. Safety was evaluated at each visit, based on clinical assessment by a child and adolescent psychiatrist and reports from participants or their caregivers.
In total participants (n=105), 33 (31.4%) showed a response to treatment: a significant decrease in CGI-S scale score was observed over 12 weeks of atomoxetine treatment. The most common adverse event (AE) was decreased appetite (n=16, 15.2%), and life-threatening AEs were not observed. Seizure aggravation due to atomoxetine was observed in 7.6% (n=8) of total participants, and one of them discontinued atomoxetine.
Our results provide preliminary evidence of the effectiveness and safety of atomoxetine in children and adolescents with epilepsy.
本研究的目的是评估托莫西汀在韩国癫痫儿童和青少年中的有效性和安全性。
我们回顾性分析了105例接受托莫西汀治疗的癫痫儿童和青少年的电子病历。在基线、4周和12周后,使用临床总体印象-严重程度(CGI-S)和/或临床总体印象-改善(CGI-I)量表来衡量有效性。我们将对托莫西汀的反应定义为第12周时CGI-I评分小于3分。每次就诊时,根据儿童和青少年精神科医生的临床评估以及参与者或其照顾者的报告来评估安全性。
在总共105名参与者中,33名(31.4%)显示出对治疗有反应:在托莫西汀治疗的12周内,观察到CGI-S量表评分显著下降。最常见的不良事件(AE)是食欲下降(n = 16,15.2%),未观察到危及生命的不良事件。在总共7.6%(n = 8)的参与者中观察到托莫西汀导致癫痫发作加重,其中一人停用了托莫西汀。
我们的结果为托莫西汀在癫痫儿童和青少年中的有效性和安全性提供了初步证据。