摘要
目的：评估苯丙胺盐混合物类扩展一缓释剂（MASXR；Adderall XR）的短期和长期心血管作用，这种药每日1次用于治疗6—12岁儿童注意缺陷多动障碍综合征（ADHD）。设计：在4周期间，双盲、随机、安慰剂对照、每日1次的10mg、20mg，和30mgMASXR（n=580）的效应-剂量-滴定研究。在2年中，通过对568名受试者MASXR（10—30mg／d）的开放性标签延伸研究来评估这种药物的长期心血管效应。基线水平、短期研究期间每周及长期研究期间每月测定安静坐位血压和脉搏。结果：在短期治疗中，接受MASXR治疗的儿童血压、脉搏及由Bazett公式校正的QT间期的变化与接受安慰剂治疗组之间无差异。经过2年的MASXR治疗之后血压和脉搏的平均增加值无临床意义，而且无明显的剂量一效应关系。结论：以≤30mg／d剂量治疗时MASXR的长期和短期的心血管效应很弱。
Objective： To assess the short- and long-term cardiovascular effects of once-daily treatment with a mixed amphetamine salts extended-release formulation （MAS XR; Adderall XR ） in children age 6 to 12 years with attention-deficit/hyperactivity disorder （ADHD） . Study design： Short-term cardiovascular effects were assessed during a g-week, double-blind, randomized, placebo-controlled, forced-dose-titration study of once-daily 10, 20, and 30 mg MAS XR （n = 580） . Long-term cardiovascular effects were assessed in 568 subjects during a 2- year, open-label extension study of MAS XR （ 10 to 30 mg/day） . Resting sitting blood pressure and pulse were measured at baseline and weekly during the short-term study, then monthly during long-term treatment. Results： Changes in blood pressure, pulse, and QT interval corrected by Bazett＇s formula （QTcB） in children receiving MAS XR were not statistically significantly different than those changes seen in children receiving placebo during short-term treatment. Mean increases in blood pressure after 2 years of MAS XR treatment （systolic, 3.5 mm Hg; diastolic, 2.6 mm Hg） and pulse （3.4 bpm） were clinically insignificant, and there was no apparent dose-response relationship. Conclusions： Cardiovascular effects of shortand long-term MAS XR were minimal during shortand long-term MAS XR treatment at doses of ≤ 30 mg/day in otherwise healthy children.
