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Attention Deficit Hyperactivity Disorder Subtypes and Symptom Response in Adults Treated with Lisdexamfetamine Dimesylate

机译:葡糖胺二甲磺酸酯治疗成人的注意缺陷多动障碍亚型和症状反应

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摘要

>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.
机译:>目的:评估赖氨苯丙胺二甲磺酸盐对患有注意力不足多动障碍症状亚型的成年人,主要表现为注意力不集中,多动/冲动或综合症状群的功效。>设计/设置/参与者 >:这是一项多中心,为期一年的,开放标签的赖斯地非胺二甲磺酸盐研究的事后分析,该研究先前有四周,安慰剂对照的赖斯地非乙胺二甲磺酸盐研究在两周或更长时间内完成,将注意力缺陷多动障碍评分量表IV症状分级作为注意力缺陷多动障碍亚型代用者(N = 349)。>测量结果:注意力缺陷多动障碍量表IV在先前研究的基线和整个研究过程中进行了测量开放标签研究。代用亚型是基于2分(中等)或3分(严重)的项目得分,表示在相应的子量表上认可9种症状中的至少6种。在每个子量表上,主要为合并型的患者至少认可了九种症状中的六种。 >结果:基线时,345名参与者中有93名主要表现为注意力不集中,13名主要表现为过度活跃/冲动,236名综合症状群,其中3名未分配。对于这三个亚组,基线时的平均(标准差)注意力缺陷多动障碍评分量表IV总分分别为34.5(4.02),33.8(3.27)和43.6(5.24);从基线到终点的变化分别为-19.3(9.48),-24.0(7.22)和-27.3(11.78)。研究结束时赖氨苯丙胺二甲磺酸酯的平均剂量(标准差)分别为57.7(14.75),53.1(16.01)和56.9(14.94)mg /天,治疗紧急不良事件(> 5%)为上呼吸道感染。 (21.8%),失眠(19.5%),头痛(17.2%),口干(16.6%),食欲下降(14.3%),烦躁(11.2%),焦虑(8.3%),鼻咽炎(7.4%),鼻窦炎(6.6%),体重减轻(6.0%),背部疼痛(5.4%)和肌肉痉挛(5.2%)。>结论:右旋安非他明二甲磺酸酯对患有注意力不集中,活动过度/冲动,和注意缺陷多动障碍综合症症状群。表现出特定优势亚型症状的组在对赖氨苯丙胺二甲磺酸酯的临床反应中没有差异。

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