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胍法辛缓释片:在注意缺陷多动障碍中的应用。

Guanfacine extended-release: in attention deficit hyperactivity disorder.

机构信息

Adis, a Wolters Kluwer Business, Auckland, New Zealand.

出版信息

Drugs. 2010 Sep 10;70(13):1693-702. doi: 10.2165/11205940-000000000-00000.

Abstract

Guanfacine, an alpha(2A)-adrenoceptor agonist, is available in the US as an extended-release (ER) tablet for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents (aged 6-17 years). In two large, randomized, double-blind, placebo-controlled trials of 8 and 9 weeks' duration, guanfacine ER (1-4 mg once daily) was effective in reducing the symptoms of ADHD (hyperactivity, impulsivity and inattention) in children and adolescents. There were significant reductions (denoting improvements) from baseline in ADHD rating scale IV (ADHD-RS-IV) total scores (the primary endpoint), compared with placebo. Oppositional symptoms were also significantly reduced from baseline in children with ADHD with oppositional symptoms who received guanfacine ER in a randomized, double-blind, placebo-controlled trial. Improvements in ADHD symptoms were sustained over 24 months in two noncomparative, open-label extension trials in children and adolescents who received guanfacine ER at an optimized dosage of 1-4 mg/day. Guanfacine ER was relatively well tolerated in clinical trials in children and adolescents. The most common treatment-emergent adverse events were somnolence-related, and tended to resolve over time.

摘要

胍法辛,一种α2A-肾上腺素能受体激动剂,在美国被批准为一种延长释放(ER)片剂,用于治疗儿童和青少年(6-17 岁)的注意力缺陷多动障碍(ADHD)。在两项为期 8 周和 9 周的大型、随机、双盲、安慰剂对照试验中,胍法辛 ER(每天 1-4 毫克,一次)在减少儿童和青少年 ADHD(多动、冲动和注意力不集中)的症状方面是有效的。与安慰剂相比,ADHD 评定量表 IV(ADHD-RS-IV)总分(主要终点)从基线显著降低(表示改善)。在接受胍法辛 ER 治疗的伴有对立症状的 ADHD 儿童中,对立症状也从基线显著减少。在两项非比较、开放性标签扩展试验中,接受优化剂量 1-4 毫克/天的胍法辛 ER 治疗的儿童和青少年,ADHD 症状改善可持续 24 个月。胍法辛 ER 在儿童和青少年的临床试验中相对耐受良好。最常见的治疗后出现的不良事件与嗜睡有关,且随着时间的推移趋于缓解。

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