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首页> 外文期刊>The journal of clinical psychiatry >A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Methylphenidate Transdermal System in Pediatric Patients With Attention-Deficit/Hyperactivity Disorder.
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Methylphenidate Transdermal System in Pediatric Patients With Attention-Deficit/Hyperactivity Disorder.

机译：注意力障碍/多动症患儿的哌醋甲酯透皮系统的随机，双盲，安慰剂对照，平行组研究。

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OBJECTIVE: To evaluate the efficacy and safety of methylphenidate transdermal system compared with placebo, using osmotic-release oral system (OROS) methylphenidate as a reference therapy. METHOD: We conducted a 7-week, randomized, double-blind, double-dummy, placebo-controlled trial in children diagnosed with attention-deficit/hyperactivity disorder by DSM-IV-TR criteria, within a community setting. The study was conducted from August 2004 to February 2005. Participants were randomly assigned to 1 of 3 treatments: methylphenidate transdermal system patch plus placebo capsule (N = 100), OROS methylphenidate capsule plus placebo patch (N = 94), or placebo capsule plus placebo patch (N = 88). Over 5 weeks, once-daily doses were optimized using 10-, 15-, 20-, and 30-mg methylphenidate transdermal system patches (9-hour wear time) or 18-, 27-, 36-, and 54-mg OROS methylphenidate capsules. Thereafter, optimal treatment doses were maintained for 2 weeks with blinded ratings of attention, behavior, and academic performance occurring at the end of each week. The primary efficacy measure was the clinicianrated ADHD Rating Scale-Version IV (ADHD-RS-IV). Additional measures included teacher, parent, and other clinician rating scales. Safety and tolerability were assessed throughout the study. RESULTS: The mean change from baseline in ADHD-RS-IV scores was greater for participants receiving methylphenidate transdermal system and OROS methylphenidate treatments compared with placebo (p < .0001). Similar results were observed for parent and teacher rating scales. More participants receiving active treatments compared with placebo were rated as improved by clinicians and parents (p < .0001). Adverse events were generally mild or moderate in intensity, and the most common included decreased appetite, nausea, vomiting, and insomnia. CONCLUSIONS: The results of this study suggest that the methylphenidate transdermal system is an efficacious treatment option for children with attention-deficit/hyperactivity disorder. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00444574.
机译：目的：以渗透释放口服系统（OROS）哌醋甲酯为参考疗法，评价哌醋甲酯透皮系统与安慰剂相比的疗效和安全性。方法：我们在一个社区环境中，对根据DSM-IV-TR标准诊断为注意力缺陷/多动障碍的儿童进行了为期7周的随机，双盲，双虚拟，安慰剂对照试验。该研究于2004年8月至2005年2月进行。参与者被随机分配为3种治疗方法之一：哌醋甲酯透皮系统贴剂+安慰剂胶囊（N = 100），OROS哌醋甲酯胶囊+安慰剂贴剂（N = 94）或安慰剂胶囊+安慰剂贴剂（N = 88）。在5周内，每天使用10毫克，15毫克，20毫克和30毫克哌醋甲酯透皮系统贴剂（9小时佩戴时间）或18毫克，27毫克，36毫克和54毫克OROS来优化每日一次剂量。哌醋甲酯胶囊。此后，维持最佳治疗剂量2周，并在每个星期结束时对注意力，行为和学习成绩进行盲目评分。主要疗效指标是临床治疗的ADHD评分量表-IV版（ADHD-RS-IV）。其他措施包括教师，家长和其他临床医生的等级量表。在整个研究过程中评估了安全性和耐受性。结果：与安慰剂相比，接受哌醋甲酯透皮系统和OROS哌醋甲酯治疗的参与者的ADHD-RS-IV评分与基线相比的平均变化更大（p <.0001）。家长和老师的评定量表也观察到类似的结果。与安慰剂相比，更多接受积极治疗的参与者被临床医生和父母认为有改善（p <.0001）。不良事件一般为轻度或中度，最常见的包括食欲下降，恶心，呕吐和失眠。结论：这项研究的结果表明哌醋甲酯透皮系统是治疗患有注意力缺陷/多动症的儿童的有效选择。试验注册：clinicaltrials.gov标识符：NCT00444574。

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