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用于治疗注意力缺陷多动障碍的混合安非他明盐缓释胶囊的安全性、有效性及作用持续时间延长

Safety, efficacy and extended duration of action of mixed amphetamine salts extended-release capsules for the treatment of ADHD.

作者信息

Weisler Richard H

机构信息

Department of Psychiatry, Duke University Medical Center, 700 Spring Forest Rd. Suite 125, Raleigh, NC 27609, USA.

出版信息

Expert Opin Pharmacother. 2005 Jun;6(6):1003-18. doi: 10.1517/14656566.6.6.1003.

Abstract

Stimulant medications have proven to be effective in reducing the core symptoms of hyperactivity, impulsivity and inattention and are considered the first line of therapy for patients with attention-deficit/hyperactivity disorder (ADHD). Mixed amphetamine salts extended-release capsules (MAS XR; Adderall XR, Shire Pharmaceuticals Group) include immediate-release pellets of mixed amphetamine salts that release the first half of the dose upon ingestion and delayed-release pellets that begin to release active drug approximately 4 h later. The MAS XR capsule contains the same 3:1 ratio of dextroamphetamine to levoamphetamine as do mixed amphetamine salts immediate-release tablets (MAS IR; Adderall), Shire Pharmaceuticals Group), and the bioavailability and pharmacokinetic profiles of MAS XR 20 mg are comparable to those with MAS IR 10 mg b.i.d. MAS XR has a rapid onset of action--within 1.5 h--and provides 12 h coverage. The efficacy, safety and extended duration of action of MAS XR have been established through clinical studies in school-age children, adolescents and adults.

摘要

兴奋剂药物已被证明在减轻多动、冲动和注意力不集中等核心症状方面有效,被视为治疗注意力缺陷多动障碍(ADHD)患者的一线疗法。混合安非他命盐缓释胶囊(MAS XR;阿得拉 XR,夏尔制药集团)包含混合安非他命盐速释微丸,摄入后释放一半剂量,以及延迟释放微丸,约4小时后开始释放活性药物。MAS XR胶囊中右旋安非他命与左旋安非他命的比例与混合安非他命盐速释片(MAS IR;阿得拉,夏尔制药集团)相同,为3:1,且MAS XR 20 mg的生物利用度和药代动力学特征与MAS IR 10 mg每日两次相当。MAS XR起效迅速——在1.5小时内——并提供12小时的药效覆盖。通过对学龄儿童、青少年和成人的临床研究,已证实了MAS XR的疗效、安全性和延长的作用持续时间。

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