Greenhill Laurence L, Muniz Rafael, Ball Roberta R, Levine Alan, Pestreich Linda, Jiang Hai
Research Unit of Pediatric Psychopharmacology at the New York State Psychiatric Institute, New York, NY 10032, USA.
J Am Acad Child Adolesc Psychiatry. 2006 Jul;45(7):817-23. doi: 10.1097/01.chi.0000220847.41027.5d.
The efficacy and safety of dexmethylphenidate extended release (d-MPH-ER) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD).
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-phase study included 97 patients (ages 6-17 years) with DSM-IV-defined ADHD. The study was carried out between 2001 and 2003. After a 2-week evaluation phase, patients were randomized to d-MPH-ER or placebo for 7 weeks. Flexible d-MPH-ER dosing (30 mg/day) was permitted for 5 weeks, then patients remained on their optimal dose during the last 2 study weeks. The primary efficacy measure was change from baseline to final rating in Conners ADHD/DSM-IV Scale-Teacher version (CADS-T) total subscale score. Secondary efficacy variables included changes from baseline to final visit in CADS-T Inattentive and Hyperactive-Impulsive subscale scores, CADS-P DSM-IV total subscale score and Inattentive and Hyperactive-Impulsive subscale scores, Clinical Global Impressions-Improvement (CGI-I) and CGI-Severity (CGI-S) scale scores, and Child Health Questionnaire Parent Form 50 scores.
d-MPH-ER improved CADS-T total scores significantly compared with placebo (p <.001), and 67.3% of d-MPH-ER patients were rated much improved or very much improved on CGI-I at final visit versus 13.3% of placebo patients (p <.001). More patients taking d-MPH-ER (49.1%) than placebo (25.5%) spontaneously reported adverse events suspected as drug related.
Once-daily d-MPH-ER was more effective than placebo in the treatment of ADHD in children and adolescents.
比较右旋哌甲酯缓释片（d-MPH-ER）与安慰剂治疗儿童注意力缺陷多动障碍（ADHD）的疗效和安全性。
这项多中心、随机、双盲、安慰剂对照、平行组、两阶段研究纳入了97例符合DSM-IV定义的ADHD患者（年龄6-17岁）。研究于2001年至2003年进行。在为期2周的评估阶段后，患者被随机分为d-MPH-ER组或安慰剂组，为期7周。允许灵活调整d-MPH-ER剂量（30毫克/天），持续5周，然后患者在研究的最后2周维持最佳剂量。主要疗效指标是康纳斯ADHD/DSM-IV量表教师版（CADS-T）总分从基线到最终评分的变化。次要疗效变量包括CADS-T注意力不集中和多动冲动分量表评分、CADS-P DSM-IV总分及注意力不集中和多动冲动分量表评分、临床总体印象改善（CGI-I）和临床总体印象严重程度（CGI-S）量表评分以及儿童健康问卷家长版50项评分从基线到最终访视的变化。
与安慰剂相比，d-MPH-ER显著改善了CADS-T总分（p<.001），在最终访视时，67.3%服用d-MPH-ER的患者在CGI-I上被评为改善很多或非常显著改善，而安慰剂组患者为13.3%（p<.001）。自发报告疑似与药物相关不良事件的服用d-MPH-ER的患者（49.1%）多于安慰剂组患者（25.5%）。
每日一次的d-MPH-ER在治疗儿童和青少年ADHD方面比安慰剂更有效。
