Daviss W Burleson, Patel Nick C, Robb Adelaide S, McDERMOTT Michael P, Bukstein Oscar G, Pelham William E, Palumbo Donna, Harris Peter, Sallee Floyd R
Dr. Daviss is affiliated with University of Texas Health Science Center at San Antonio; Dr. Bukstein is with the University of Pittsburgh; Drs. Patel and Sallee are with the University of Cincinnati; Drs. McDermott, Palumbo, and Harris are with the University of Rochester; Dr. Pelham is with State University of New York at Buffalo; and Dr. Robb is with George Washington University School of Medicine and Children's National Medical Center.
Dr. Daviss is affiliated with University of Texas Health Science Center at San Antonio; Dr. Bukstein is with the University of Pittsburgh; Drs. Patel and Sallee are with the University of Cincinnati; Drs. McDermott, Palumbo, and Harris are with the University of Rochester; Dr. Pelham is with State University of New York at Buffalo; and Dr. Robb is with George Washington University School of Medicine and Children's National Medical Center..
J Am Acad Child Adolesc Psychiatry. 2008 Feb;47(2):189-198. doi: 10.1097/chi.0b013e31815d9ae4.
To examine the safety and tolerability of clonidine used alone or with methylphenidate in children with attention-deficit/hyperactivity disorder (ADHD).
In a 16-week multicenter, double-blind trial, 122 children with ADHD were randomly assigned to clonidine (n = 31), methylphenidate (n = 29), clonidine and methylphenidate (n = 32), or placebo (n = 30). Doses were flexibly titrated up to 0.6 mg/day for clonidine and 60 mg/day for methylphenidate (both with divided dosing). Groups were compared regarding adverse events and changes from baseline to week 16 in electrocardiograms and vital signs.
There were more incidents of bradycardia in subjects treated with clonidine compared with those not treated with clonidine (17.5% versus 3.4%; p =.02), but no other significant group differences regarding electrocardiogram and other cardiovascular outcomes. There were no suggestions of interactions between clonidine and methylphenidate regarding cardiovascular outcomes. Moderate or severe adverse events were more common in subjects on clonidine (79.4% versus 49.2%; p =.0006) but not associated with higher rates of early study withdrawal. Drowsiness was common on clonidine, but generally resolved by 6 to 8 weeks.
Clonidine, used alone or with methylphenidate, appears safe and well tolerated in childhood ADHD. Physicians prescribing clonidine should monitor for bradycardia and advise patients about the high likelihood of initial drowsiness.
研究可乐定单独使用或与哌甲酯联合用于治疗注意力缺陷多动障碍（ADHD）儿童的安全性和耐受性。
在一项为期16周的多中心双盲试验中，122名ADHD儿童被随机分配至可乐定组（n = 31）、哌甲酯组（n = 29）、可乐定与哌甲酯联合组（n = 32）或安慰剂组（n = 30）。可乐定剂量灵活滴定至最大0.6 mg/天，哌甲酯剂量灵活滴定至最大60 mg/天（均为分次给药）。比较各组不良事件以及从基线至第16周心电图和生命体征的变化。
与未使用可乐定治疗的受试者相比，使用可乐定治疗的受试者心动过缓事件更多（17.5% 对3.4%；p = 0.02），但在心电图和其他心血管结局方面无其他显著组间差异。在心血管结局方面，未发现可乐定与哌甲酯之间存在相互作用。可乐定治疗的受试者中中度或重度不良事件更为常见（79.4% 对49.2%；p = 0.0006），但与早期研究退出率较高无关。可乐定治疗时嗜睡常见，但一般在6至8周内缓解。
可乐定单独使用或与哌甲酯联合用于儿童ADHD似乎安全且耐受性良好。开具可乐定处方的医生应监测心动过缓情况，并告知患者初始时嗜睡的可能性很大。
