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An Open-label, Self-control, Prospective Study on Cognitive Function, Academic Performance, and Tolerability of osmotic-release oral system methylphenidate in Children with Attention-deficit Hyperactivity Disorder

引用

Chinese Medical Journal 2015年第22期128卷 2988-2997页

作者： Yi Zheng Jian-Min Liang Hong-Yun Gao Zhi-Wei Yang Fu-Jun Jia Yue-Zhu Liang Fang Fang Rong Li Sheng-Nan Xie Jian-Min Zhuo Department of Pediatrics Beijing Anding Hospital Capital Medical University Beijing 100088 China Department of Pediatric Neurology The First Hospital Jilin University Changchun Jilin 130021 China Department of Psychology Children's Hospital of Fudan University Shanghai 201102 China Department of Pediatric Psychology Shenzhen Kangning Hospital shenzhen Guangdong 518003 China Guangdong Mental Health Center Guangdong General Hospital Guangzhou Guangdong 510120 China Department of Neurology Beijing Children's Hospital Capital Medical University Beijing 100053 China Department of Pediatric Psychology Children's Hospital Zhejiang University School of Medicine Hangzhou Zhejiang 310003 China Janssen Research and Development Departmeni Xi'an Janssen Pharmaceutical Ltd Beijing 100025 China

Background： Attention-deficit hyperactivity disorder （ADHD） is the most common mental and behavioral disorder in school-aged children. This study evaluated the effect of osmotic-release oral system （OROS） methylphenidate （MPH） on cognitive function and academic performance of Chinese school-aged children with ADHD. Methods： This 12-week, prospective, multicenter, open-label, self-controlled study enrolled 153 Chinese school-aged children with ADHD and 41 non-ADHD children. Children with ADHD were treated with once-daily OROS-MPH （18 mg, 36 mg, or 54 mg）. The primary endpoints were Inattention/Overactivity （I/O） with Aggression Conners Behavior Rating Scale （IOWA） and Digit Span Test at week 12 compared with baseline. Secondary endpoints included opposition/defiant （O/D） subscale of IOWA, Clinical Global Impression （CGI）, Coding Test, Stroop Color-word Test, Wisconsin Card Sorting Test （WCST）, academic performance on teacher-rated school examinations, and safety at week 12 compared with baseline. Both non-ADHD and ADHD children received the same frequency of cognitive operational test to avoid the possible bias caused by training. Results： A total of 128 patients were evaluated with cognitive assessments. The OROS-MPH treatment significantly improved IOWA Conners I/O subscale scores at week 12 （3.8 ± 2.3） versus baseline （10.0 ± 2.4; P 〈 0.0001）. Digit Span Test scores improved significantly （P 〈 0.0001 ） with a high remission rate （81.1%） at week 12 versus baseline. A significant （P 〈 0.0001 ） improvement was observed in O/D subscale of IOWA, CGI, Coding Test, Stroop Color-word Test, WCST, and academic performance at week 12 versus baseline. Very few practice-related improvements were noticed in the non-ADHD group at week 12 compared with baseline. No serious adverse events and deaths were reported during the study. Conclusions： The OROS-MPH treatment effectively controlled symptoms of ADHD and significantly improved academic performance and cognitive fimction of Ch

关键词： Academic Performance Attention-deficit Hyperactivity Disorder: Cognitive Function osmotic-release oral system-methylphenidate

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