Ming Xue, Mulvey Martha, Mohanty Sharanya, Patel Viraj
Department of Neurosciences, University of Medicine and Dentistry New Jersey, New Jersey Medical School, Newark, USA.
The College of New Jersey, Ewing, NJ, USA.
Adolesc Health Med Ther. 2011 Sep 30;2:105-12. doi: 10.2147/AHMT.S15672. eCollection 2011.
Clonidine has been used off-label in children and adolescents with attention deficit and hyperactivity disorders (ADHD) with or without comorbidities. Clonidine extended-release was recently approved by the US Food and Drug Administration for ADHD in children. This review evaluates the efficacy and safety of clonidine extended-release and clonidine in children and adolescents with ADHD. A search of the Medline database and clinical trials register from 1996-2011 yielded ten clinical trials for critical evaluation of efficacy and safety. Eight of the ten trials reviewed were double-blinded and placebo-controlled. Nine of the ten trials utilized multiple outcome measures. Both clonidine extended-release and clonidine, as monotherapy or adjunctive therapy, were reported to be efficacious in treating ADHD symptoms in children and adolescents with or without comorbid disorders in nine of the ten clinical trials. One study showed clonidine to be ineffective in improving performance of a single task, at a specific point in time, in a small number of subjects. All of the studies that evaluated safety reported clonidine and clonidine extended-release to be well tolerated. The side effects of clonidine included somnolence, fatigue, headache, bradycardia, hypotension, and clinically insignificant electrocardiographic changes. However, there are historical anecdotal reports of serious cardiac side effects, including death in cases with other risk factors. None of the studies compared clonidine extended-release with clonidine in subjects with ADHD. Therefore, it is not clear whether clonidine extended-release is advantageous over clonidine, with regard to either efficacy or safety. It is equally unclear whether clonidine or clonidine extended-release is more efficacious in treating ADHD in subjects with comorbid disorders than in those without comorbidities. All the studies reviewed had limitations in their designs and methods. Clonidine and clonidine extended-release could be efficacious and safe for the treatment of ADHD both as monotherapy and as adjunctive therapy with stimulant medications in selected patients. There is a need for clinical trials to determine the long-term efficacy and safety of treatment with clonidine and clonidine extended-release in patients with ADHD.
可乐定已被用于治疗患有或未患有共病的儿童和青少年注意力缺陷多动障碍（ADHD），但属于非适应证用药。可乐定缓释片最近被美国食品药品监督管理局批准用于治疗儿童ADHD。本综述评估了可乐定缓释片和可乐定治疗儿童及青少年ADHD的疗效和安全性。检索1996年至2011年的Medline数据库和临床试验注册库，获得了10项用于疗效和安全性关键评估的临床试验。10项综述试验中有8项为双盲安慰剂对照试验。10项试验中有9项采用了多种结局指标。在10项临床试验中的9项中，无论是可乐定缓释片还是可乐定，作为单一疗法或辅助疗法，均被报道对治疗患有或未患有共病的儿童及青少年ADHD症状有效。一项研究表明，在特定时间点，可乐定对少数受试者改善单一任务的表现无效。所有评估安全性的研究均报告可乐定和可乐定缓释片耐受性良好。可乐定的副作用包括嗜睡、疲劳、头痛、心动过缓、低血压以及临床上无显著意义的心电图改变。然而，有历史轶事报道了严重的心脏副作用，包括在有其他危险因素的病例中出现死亡。没有一项研究在ADHD受试者中比较可乐定缓释片和可乐定。因此，关于疗效或安全性，尚不清楚可乐定缓释片是否优于可乐定。同样不清楚可乐定或可乐定缓释片在治疗患有共病的ADHD受试者时是否比未患有共病的受试者更有效。所有综述的研究在设计和方法上都有局限性。可乐定和可乐定缓释片作为单一疗法以及与刺激性药物联合作为辅助疗法，在选定患者中治疗ADHD可能是有效且安全的。需要进行临床试验以确定可乐定和可乐定缓释片治疗ADHD患者的长期疗效和安全性。
