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用二甲磺酸赖右苯丙胺治疗的成人注意力缺陷多动障碍亚型及症状反应

Attention deficit hyperactivity disorder subtypes and symptom response in adults treated with lisdexamfetamine dimesylate.

作者信息

Mattingly Greg, Weisler Richard, Dirks Bryan, Babcock Thomas, Adeyi Ben, Scheckner Brian, Lasser Robert

机构信息

Washington University School of Medicine,St. Charles, Missouri, USA.

出版信息

Innov Clin Neurosci. 2012 May;9(5-6):22-30.

Abstract

OBJECTIVE

To evaluate the efficacy of lisdexamfetamine dimesylate in adults with attention deficit hyperactivity disorder symptom subtypes who exhibit predominantly inattention, hyperactivity/ impulsivity, or combined symptom clusters.

DESIGN/SETTING/PARTICIPANTS: This is a post-hoc analysis from a multicenter, one-year, open-label lisdexamfetamine dimesylate study in adults with attention deficit hyperactivity disorder previously completing two weeks or more in a four-week, randomized, placebo-controlled lisdexamfetamine dimesylate study, using Attention Deficit Hyperactivity Disorder Rating Scale IV symptom ratings as an attention deficit hyperactivity disorder subtype proxy (N=349).

MEASUREMENTS

Attention Deficit Hyperactivity Disorder Rating Scale IV was measured at baseline of prior study and throughout the open-label study. Proxy subtypes were based on item scores of 2 (moderate) or 3 (severe), representing endorsement of at least six of nine symptoms on respective subscales; predominantly combined type endorsed at least six of nine symptoms on each subscale. Overall safety evaluations included treatment-emergent adverse events.

RESULTS

At baseline, 93 of 345 participants exhibited predominantly inattention, 13 predominantly hyperactivity/ impulsivity, 236 combined symptom clusters, and three were unassigned. For the three subgroups, respectively, mean (standard deviation) Attention Deficit Hyperactivity Disorder Rating Scale IV total scores at baseline were 34.5 (4.02), 33.8 (3.27), and 43.6 (5.24); change from baseline to endpoint scores were -19.3 (9.48), -24.0 (7.22), and -27.3 (11.78). Mean (standard deviation) end-of-study lisdexamfetamine dimesylate dose was 57.7 (14.75), 53.1 (16.01), and 56.9 (14.94)mg/day, respectively.Treatment-emergent adverse events (>5%) were upper respiratory tract infection (21.8%), insomnia (19.5%), headache (17.2%), dry mouth (16.6%), decreased appetite (14.3%), irritability (11.2%), anxiety (8.3%), nasopharyngitis (7.4%), sinusitis (6.6%), decreased weight (6.0%), back pain (5.4%), and muscle spasms (5.2%).

CONCLUSIONS

Lisdexamfetamine dimesylate was effective in participants with predominantly inattention, hyperactivity/ impulsivity, and combined attention deficit hyperactivity disorder symptom clusters. Groups exhibiting specific predominant subtype symptoms did not differ in clinical response to lisdexamfetamine dimesylate.

摘要

目的

评估二甲磺酸赖右苯丙胺对主要表现为注意力不集中、多动/冲动或混合症状群的成人注意力缺陷多动障碍症状亚型的疗效。

设计/地点/参与者:这是一项事后分析,来自一项多中心、为期一年的开放标签二甲磺酸赖右苯丙胺研究,研究对象为患有注意力缺陷多动障碍的成人,这些成人此前在一项为期四周的随机、安慰剂对照二甲磺酸赖右苯丙胺研究中完成了两周或更长时间的治疗,使用注意力缺陷多动障碍评定量表IV症状评分作为注意力缺陷多动障碍亚型的替代指标(N = 349)。

测量指标

在先前研究的基线以及整个开放标签研究期间测量注意力缺陷多动障碍评定量表IV。替代亚型基于2分(中度)或3分(重度)的项目得分,分别代表在各自子量表上九个症状中至少有六个得到认可;主要为混合型在每个子量表上九个症状中至少有六个得到认可。总体安全性评估包括治疗中出现的不良事件。

结果

在基线时,345名参与者中93名主要表现为注意力不集中,13名主要表现为多动/冲动,236名表现为混合症状群,3名未分类。对于这三个亚组,基线时注意力缺陷多动障碍评定量表IV总分的均值(标准差)分别为34.5(4.02)、33.8(3.27)和43.6(5.24);从基线到终点得分的变化分别为-19.3(9.48)、-24.0(7.22)和-27.3(11.78)。研究结束时二甲磺酸赖右苯丙胺剂量的均值(标准差)分别为57.7(14.75)、53.1(16.01)和56.9(14.94)mg/天。治疗中出现的不良事件(>5%)有上呼吸道感染(21.8%)、失眠(19.5%)、头痛(17.2%)、口干(16.6%)、食欲减退(14.3%)、易怒(11.2%)、焦虑(8.3%)、鼻咽炎(7.4%)、鼻窦炎(6.6%)、体重减轻(6.0%)、背痛(5.4%)和肌肉痉挛(5.2%)。

结论

二甲磺酸赖右苯丙胺对主要表现为注意力不集中、多动/冲动以及混合型注意力缺陷多动障碍症状群的参与者有效。表现出特定主要亚型症状的组在对二甲磺酸赖右苯丙胺的临床反应上没有差异。

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