在注意力缺陷多动障碍儿童的损伤发生率和发生时间方面，渗透型控释口服给药系统-哌甲酯治疗并不优于短效/中效哌甲酯制剂。
No Superiority of Treatment With Osmotic Controlled-Release Oral Delivery System-Methylphenidate Over Short/Medium-Acting Methylphenidate Preparations in the Rate and Timing of Injuries in Children With Attention-Deficit/Hyperactivity Disorder.
作者信息
Golubchik Pavel, Kodesh Arad, Weizman Abraham
机构信息
*Child and Adolescent Division, Geha Mental Health Center, Petah Tikva; †Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv; ‡Maccabi Healthcare Services, Jerusalem and Plain Region, Jerusalem; §Department of Community Mental Health, Haifa University, Haifa; ‖Research Unit, Geha Mental Health Center; and ¶Felsenstein Medical Research Center, Tel Aviv University, Petah Tikva, Israel.
出版信息
Clin Neuropharmacol. 2017 Jan/Feb;40(1):11-15. doi: 10.1097/WNF.0000000000000189.
OBJECTIVES
Methylphenidate (MPH) treatment in patients with attention-deficit/hyperactivity disorder (ADHD) is reported to reduce the risk for injuries. In the present study, the rate and timing of injuries were compared among the various MPH preparations (4 and 6-8 vs 12 hour-acting) in children with ADHD.
METHODS
This real-world retrospective study covered the years 2011 to 2013. Participants included 2042 youngsters (aged 4-18 years, 13.01 ± 3.2 years; 71.8% males and 28.2% females) diagnosed with ADHD according to the International Statistical Classification of Diseases, 10th Revision criteria and treated with various MPH preparations. They were divided into 2 groups by their treatment preparation as follows: MPH-immediate release (MPH-IR)-4 hour-acting pooled with MPH-slow release/long-acting (MPH-SR/LA)- 6 to 8 hour-acting versus osmotic controlled-release oral delivery system-MPH (OROS-MPH; Concerta)-12 hour-acting that consisted of pooling of OROS-MPH only and OROS-MPH combined with the other MPH preparations. The monthly rates of injury, specifically, late injury (occurrence between 4:00 p.m. to midnight) and for multiple injuries, the time interval between injuries, were assessed.
RESULTS
No significant differences in monthly rate of nonfatal injuries were found between OROS-MPH with or without 4/6 to 8 hour-acting MPH-formulations versus only 4/6 to 8 hour-acting MPH-preparations (P = 0.53). Neither were differences found in the between-injury time interval (P = 0.83) or in late-injury-rates (P = 0.37) between those groups.
CONCLUSIONS
This real-world-naturalistic study in the community demonstrates that, in ADHD pediatric populations, OROS-MPH preparation is not superior to short/medium-acting (4/6-8 hours) MPH preparations regarding the rate and timing of injuries.
目的
据报道，哌甲酯（MPH）治疗注意力缺陷多动障碍（ADHD）患者可降低受伤风险。在本研究中，对ADHD儿童使用的各种MPH制剂（4小时及6 - 8小时作用时间与12小时作用时间）的受伤率和受伤时间进行了比较。
方法
这项真实世界的回顾性研究涵盖2011年至2013年。参与者包括2042名青少年（年龄4 - 18岁，平均13.01±3.2岁；男性占71.8%，女性占28.2%），他们根据国际疾病分类第10版标准被诊断为ADHD，并接受了各种MPH制剂治疗。根据治疗制剂将他们分为两组：4小时作用时间的速释MPH（MPH - IR）与6至8小时作用时间的缓释/长效MPH（MPH - SR/LA）合并为一组，与仅由渗透控释口服给药系统MPH（OROS - MPH；专注达）组成的12小时作用时间组以及OROS - MPH与其他MPH制剂联合使用的组进行比较。评估了每月的受伤率，特别是迟发性损伤（下午4点至午夜之间发生），对于多处损伤，还评估了损伤之间的时间间隔。
结果
含或不含4/6至8小时作用时间MPH制剂的OROS - MPH组与仅4/6至8小时作用时间MPH制剂组之间，非致命性损伤的每月发生率无显著差异（P = 0.53）。这些组之间在损伤间隔时间（P = 0.83）或迟发性损伤率（P = 0.37）方面也未发现差异。
结论
这项在社区开展的真实世界自然主义研究表明，在ADHD儿童群体中，就受伤率和受伤时间而言，OROS - MPH制剂并不优于短效/中效（4/6 - 8小时）MPH制剂。
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