Weisler Richard H, Biederman Joseph, Spencer Thomas J, Wilens Timothy E, Faraone Stephen V, Chrisman Allan K, Read Stephanie C, Tulloch Simon J
University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
CNS Spectr. 2006 Aug;11(8):625-39. doi: 10.1017/s1092852900013687.
Attention-deficit/hyperactivity disorder (ADHD) is a serious neurobehavioral disorder of childhood onset that often persists into adolescence and adulthood. Functional impairments, underachievement, and difficult interpersonal relationships illustrate the need for effective treatment of ADHD through adulthood.
This prospective, multisite, randomized, double-blind, placebo-controlled, parallel-group, dose-escalation study was conducted to assess the efficacy, safety, and duration of action of mixed amphetamine salts extended-release (MAS XR) in adults with ADHD, combined type. Adults > or =18 years of age were given placebo or MAS XR 20, 40, or 60 mg/day for 4 weeks. The main outcome measures were the ADHD Rating Scale and Conners' Adult ADHD Rating Scale Short Version Self-Report (CAARS-S-S).
Two hundred fifty-five subjects were randomly assigned to treatment with MAS XR or placebo. MAS XR treatment was associated with statistically and clinically significant ADHD symptom reduction at endpoint; mean ADHD Rating Scale scores were 18.5 for the 20-mg group (P=.001), 18.4 for the 40-mg group (P<.001), and 18.5 for the 60-mg group (P<.001). Adults with severe symptoms (ADHD Rating Scale score >32 at baseline) had significantly greater symptom reduction with the highest MAS XR dose (60 mg/day), however, this dose-response relationship was determined by post-hoc analysis. The mean MAS XR effect size was 0.8. Statistically significant (P<.05) improvements in CAARS-S-S ADHD index scores occurred at 4- and 12-hours postdose for all MAS XR groups, indicating a 12-hour duration of effect. Symptoms improved within the first treatment week. Most adverse events reported were mild or moderate in intensity, and the most commonly reported adverse events were consistent with the known profile of stimulant medications. Vital signs and electrocardiograms showed no clinically significant cardiovascular changes.
These results suggest that MAS XR is safe and effective in adults with ADHD and controlled ADHD symptoms for up to 12 hours.
注意力缺陷多动障碍（ADHD）是一种始于儿童期的严重神经行为障碍，常持续至青少年期及成年期。功能损害、学业成绩不佳以及人际关系困难表明，需要在成年期对ADHD进行有效治疗。
本前瞻性、多中心、随机、双盲、安慰剂对照、平行组、剂量递增研究旨在评估混合安非他明盐缓释剂（MAS XR）对成年混合型ADHD患者的疗效、安全性及作用持续时间。年龄≥18岁的成年人接受安慰剂或每日20、40或60毫克的MAS XR治疗，为期4周。主要结局指标为ADHD评定量表和康纳斯成人ADHD评定量表简版自我报告（CAARS-S-S）。
255名受试者被随机分配接受MAS XR或安慰剂治疗。在研究终点，MAS XR治疗与ADHD症状在统计学和临床上的显著减轻相关；20毫克组的平均ADHD评定量表得分为18.5（P = 0.001），40毫克组为18.4（P < 0.001），60毫克组为18.5（P < 0.001）。基线时ADHD评定量表得分>32的重度症状成年人，使用最高剂量的MAS XR（60毫克/天）时症状减轻更为显著，然而，这种剂量反应关系是通过事后分析确定的。MAS XR的平均效应大小为0.8。所有MAS XR组在给药后4小时和12小时，CAARS-S-S ADHD指数得分均有统计学意义（P < 0.05）的改善，表明作用持续时间为12小时。症状在治疗的第一周内有所改善。报告的大多数不良事件强度为轻度或中度，最常报告的不良事件与已知的刺激性药物特征相符。生命体征和心电图显示无临床显著的心血管变化。
这些结果表明，MAS XR对成年ADHD患者安全有效，且能控制ADHD症状长达12小时。
