奥昔哌汀治疗癫痫合并注意缺陷多动障碍的 I 期适应性研究。
Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy.
机构信息
Department of Psychiatry, Children's Hospital Boston, Harvard Medical School, Boston, MA 02115, USA.
出版信息
Epilepsy Behav. 2010 Jul;18(3):229-37. doi: 10.1016/j.yebeh.2010.02.022. Epub 2010 May 21.
OBJECTIVE
The goal of this study was to pilot a randomized controlled trial of OROS methylphenidate (OROS-MPH) to treat attention deficit hyperactivity disorder (ADHD) plus epilepsy.
METHODS
Thirty-three patients, 6-18years of age, taking antiepileptic drugs and with a last seizure 1-60months prior were assigned to a maximum daily dose of 18, 36, or 54mg of OROS-MPH in a double-blind placebo-controlled crossover trial.
RESULTS
There were no serious adverse events and no carryover effects in the crossover trial. OROS-MPH reduced ADHD symptoms more than did placebo treatment. There were too few seizures during the active (5) and placebo arms (3) to confidently assess seizure risk; however, considering exposure time, we observed an increased daily risk of seizures with increasing dose of OROS-MPH, suggesting that potential safety concerns require further study.
CONCLUSION
A larger study to assess the effect of OROS-MPH on seizure risk is needed. A crossover design including subjects with frequent seizures could maximize power and address high patient heterogeneity and recruitment difficulties.
目的
本研究旨在对奥昔哌汀控释片（OROS-MPH）治疗注意缺陷多动障碍（ADHD）合并癫痫进行随机对照试验的初步探索。
方法
33 名年龄在 6-18 岁之间、正在服用抗癫痫药物且最后一次癫痫发作发生在 1-60 个月前的患者被随机分为三组，分别接受最高剂量为 18mg、36mg 或 54mg 的 OROS-MPH 或安慰剂治疗，采用双盲安慰剂对照交叉试验设计。
结果
在交叉试验中没有出现严重不良事件和交叉效应。与安慰剂治疗相比，奥昔哌汀控释片能更有效地改善 ADHD 症状。在活性药物（5 例）和安慰剂组（3 例）中发生的癫痫发作次数太少，无法自信地评估癫痫发作的风险；然而，考虑到暴露时间，我们观察到奥昔哌汀控释片剂量增加与每日癫痫发作风险增加相关，这表明潜在的安全性问题需要进一步研究。
结论
需要进行更大规模的研究来评估奥昔哌汀控释片对癫痫发作风险的影响。包括频繁发作的患者在内的交叉设计可以最大限度地提高研究的效力，并解决高患者异质性和招募困难的问题。
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