Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy.
Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy.
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DOI：
10.1016/j.yebeh.2010.02.022
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发表时间：
2010-07
期刊：
影响因子：
--
通讯作者：
Biederman J
中科院分区：
文献类型：
--
作者：
Gonzalez-Heydrich J;Whitney J;Waber D;Forbes P;Hsin O;Faraone SV;Dodds A;Rao S;Mrakotsky C;Macmillan C;Demaso DR;de Moor C;Torres A;Bourgeois B;Biederman J
开展一项OROS-哌甲酯（MPH）治疗ADHD合并癫痫的随机对照试验。在一项双盲安慰剂对照交叉试验中，33名6-18岁服用抗癫痫药物且末次癫痫发作前1-60个月的患者被分配至最大日剂量为18、36或54 mg的OROS-MPH。在交叉试验中没有严重的不良事件，也没有遗留效应。OROS-MPH比安慰剂治疗更能减少ADHD症状。活性组（5）和安慰剂组（3）的癫痫发作次数太少，无法自信地评估癫痫发作风险;然而，考虑到暴露时间，我们观察到癫痫发作的每日风险随着OROS-MPH剂量的增加而增加，这表明潜在的安全性问题需要进一步研究。需要进行更大规模的研究来评估OROS-MPH对癫痫发作风险的影响。包括频繁发作受试者的交叉设计可以最大限度地提高把握度，并解决患者高度异质性和招募困难。
To pilot a randomized controlled trial of OROS-Methylphenidate (MPH) to treat ADHD plus epilepsy. Thirty-three patients, 6–18 years, taking antiepileptic drugs and with a last seizure 1–60 months prior were assigned to a maximum daily dose of 18, 36, or 54mg of OROS-MPH in a double-blind placebo-controlled crossover trial. There were no serious adverse events and no carry over effects in the crossover trial. OROS-MPH reduced ADHD symptoms more than 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 need further study. 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.
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影响因子：
3.8
作者：
Dunn, DW;Austin, JK;Ambrosius, WT
通讯作者：
Ambrosius, WT
影响因子：
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作者：
Jensen, PS;Arnold, LE;Kraemer, HC
通讯作者：
Kraemer, HC
影响因子：
9.9
作者：
OTTMAN, R;LEE, JH;SCHEUER, ML
通讯作者：
SCHEUER, ML
DOI：
10.1001/archpedi.1989.02150210117030
发表时间：
1989-09-01
影响因子：
--
作者：
FELDMAN, H;CRUMRINE, P;TEODORI, J
通讯作者：
TEODORI, J
DOI：
10.1089/cap.2006.16.351
发表时间：
2006-06-01
影响因子：
1.9
作者：
McGough, James J.;McBurnett, Keith;Stein, Mark
通讯作者：
Stein, Mark