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盐酸胍法辛作为成人注意缺陷多动障碍的治疗:一项双盲、安慰剂对照研究。

Supplementary guanfacine hydrochloride as a treatment of attention deficit hyperactivity disorder in adults: A double blind, placebo-controlled study.

机构信息

Point Loma Nazarene University, 3900 Lomaland Drive, San Diego 92016, CA, USA.

Rochester Center for Behavioral Medicine, 441 S Livernois Rd #205, Rochester Hills 48307, MI, USA.

出版信息

Psychiatry Res. 2016 Feb 28;236:136-141. doi: 10.1016/j.psychres.2015.12.017. Epub 2015 Dec 17.

Abstract

The purpose of this study was to examine the efficacy of an extended release guanfacine hydrochloride supplement relative to a placebo supplement in adults (19-62) with ADHD and a sub-optimal response to a stimulant-only treatment program. The study's primary outcome measures were the Attention Deficit Hyperactivity Disorder Rating Scale and the Clinical Global Impression - Severity. Twenty-six adults who met criteria for attention deficit hyperactivity disorder and sub-optimal functioning were randomly assigned to supplement their existing psychostimulant treatment regimen with either a titrated dose (1-6mg) of extended release guanfacine hydrochloride or a matching placebo for a 10-week trial. The data were analyzed with standard mixed model analysis of variance procedures, and participants in both the investigational agent group and the placebo group showed statistically significant improvement in their symptoms and functioning over the course of the trial. The treatments did not differ in terms of their efficacy, safety, or tolerability. Although these results do suggest that both treatments were associated with clinical improvement, the possible impacts of socially desirable responding and regression to the mean on these results are discussed.

摘要

本研究旨在考察盐酸胍法辛缓释补充剂相对于安慰剂补充剂在 ADHD 成人(19-62 岁)中的疗效,这些患者对单一兴奋剂治疗方案反应不佳。研究的主要结局指标是注意缺陷多动障碍评定量表和临床总体印象-严重程度。26 名符合注意缺陷多动障碍标准且功能不佳的成年人被随机分配,在现有的精神兴奋剂治疗方案中补充滴定剂量(1-6mg)的盐酸胍法辛缓释剂或匹配的安慰剂,进行为期 10 周的试验。数据采用标准混合模型方差分析程序进行分析,研究药物组和安慰剂组的参与者在试验过程中症状和功能均有统计学意义的改善。两种治疗方法在疗效、安全性或耐受性方面没有差异。尽管这些结果表明两种治疗方法均与临床改善相关,但对这些结果可能存在的社会期望反应和向平均值回归的影响进行了讨论。

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