Zheng Yi, Liang Jian-Min, Gao Hong-Yun, Yang Zhi-Wei, Jia Fu-Jun, Liang Yue-Zhu, Fang Fang, Li Rong, Xie Sheng-Nan, Zhuo Jian-Min
Department of Pediatrics, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China.
Chin Med J (Engl). 2015 Nov 20;128(22):2988-97. doi: 10.4103/0366-6999.168948.
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.
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.
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.
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.
ClinicalTrials.gov, NCT01933880; http://clinicaltrials.gov/ct2/show/NCT01933880?term=CONCERTAATT4099&rank=1.
注意力缺陷多动障碍（ADHD）是学龄儿童中最常见的精神和行为障碍。本研究评估了渗透泵控释口服系统（OROS）哌甲酯（MPH）对中国学龄期ADHD儿童认知功能和学业成绩的影响。
这项为期12周的前瞻性、多中心、开放标签、自身对照研究纳入了153名中国学龄期ADHD儿童和41名非ADHD儿童。ADHD儿童接受每日一次的OROS-MPH治疗（18毫克、36毫克或54毫克）。主要终点是与基线相比，第12周时使用康纳斯行为评定量表（爱荷华版）注意力不集中/多动（I/O）分量表和数字广度测试。次要终点包括爱荷华版I/O分量表中的对立违抗（O/D）分量表、临床总体印象（CGI）、编码测试、斯特鲁普色词测试、威斯康星卡片分类测试（WCST）、教师评定的学校考试中的学业成绩，以及与基线相比第12周时的安全性。非ADHD儿童和ADHD儿童接受相同频率的认知操作测试，以避免训练可能造成的偏差。
共有128名患者接受了认知评估。与基线相比（10.0±2.4），第12周时OROS-MPH治疗显著改善了康纳斯行为评定量表（爱荷华版）I/O分量表得分（3.8±2.3；P<0.0001）。数字广度测试得分显著提高（P<0.0001），第12周时与基线相比缓解率较高（81.1%）。与基线相比，第12周时爱荷华版I/O分量表中的O/D分量表、CGI、编码测试、斯特鲁普色词测试、WCST和学业成绩均有显著改善（P<0.0001）。与基线相比，第12周时非ADHD组很少有与练习相关改进。研究期间未报告严重不良事件和死亡。
OROS-MPH治疗有效控制了ADHD症状，并显著改善了中国学龄期ADHD儿童的学业成绩和认知功能。发现该治疗在12周内安全且总体耐受性良好。
ClinicalTrials.gov，NCT01933880；http://clinicaltrials.gov/ct/show/NCT01933880?term=CONCERTAATT4099&rank=1 。
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