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
机构：[1]Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China[2]Department of Pediatric Neurology, The First Hospital, Jilin University, Changchun, Jilin 130021, China[3]Department of Psychology, Children’s Hospital of Fudan University, Shanghai 201102, China[4]Department of Pediatric Psychology, Shenzhen Kangning Hospital, Shenzhen, Guangdong 518003, China[5]Guangdong Mental Health Center, Guangdong General Hospital, Guangzhou, Guangdong 510120, China研究所广东省精神卫生中心（广东省精神卫生研究所）精神科广东省人民医院[6]Department of Neurology, Beijing Children’s Hospital, Capital Medical University, Beijing 100053, China临床科室泌尿外科小儿神经科首都医科大学附属北京儿童医院[7]Department of Pediatric Psychology, Children’s Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, China[8]Janssen Research and Development Department, 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 function of Chinese school-aged children with ADHD. The treatment was found to be safe and generally well-tolerated over 12 weeks.
第一作者机构：[1]Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China[*1]Beijing Anding Hospital, Capital Medical University, Beijing 100088, China
通讯作者：
通讯机构：[1]Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China[*1]Beijing Anding Hospital, Capital Medical University, Beijing 100088, China
推荐引用方式(GB/T 7714)：
Zheng Yi,Liang Jian-Min,Gao Hong-Yun,et al.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[J].CHINESE MEDICAL JOURNAL.2015,128(22):2988-2997.doi:10.4103/0366-6999.168948.
APA：
Zheng, Yi,Liang, Jian-Min,Gao, Hong-Yun,Yang, Zhi-Wei,Jia, Fu-Jun...&Zhuo, Jian-Min.(2015).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.CHINESE MEDICAL JOURNAL,128,(22)
MLA：
Zheng, Yi,et al."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".CHINESE MEDICAL JOURNAL 128..22(2015):2988-2997
