Weiss Margaret, Childress Ann, Mattingly Greg, Nordbrock Earl, Kupper Robert J, Adjei Akwete L
1 University of Arkansas for Medical Sciences, Child and Adolescent Psychiatry, Child Study Center , Little Rock, Arkansas.
2 Center for Psychiatry and Behavioral Medicine, Inc. , Las Vegas, Nevada.
J Child Adolesc Psychopharmacol. 2018 Oct;28(8):521-529. doi: 10.1089/cap.2017.0166. Epub 2018 Jul 23.
To evaluate the relationship between symptom and functional improvement and remission in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) enrolled in an 11-week open-label dose-optimization phase of an methylphenidate extended release (MPH-MLR) pivotal study.
Assessments included the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P) and ADHD Rating Scale, Fourth Edition (ADHD-RS-IV). Definitions included the following: symptom improvement (≥30% decrease in ADHD-RS-IV total score); symptom remission (ADHD-RS-IV total score ≤18); functional improvement (decrease in WFIRS-P total score ≥0.25 [minimally important difference]); and functional remission (WFIRS-P total score ≤0.65).
Two hundred children completed the open-label phase. At initial assessment, functional impairment was evident across all WFIRS-P domains and similar between children and adolescents. Those who were treatment naive had more functional impairment (WFIRS-P total: 0.82 vs. 0.70, p = 0.02). Significant improvements in all WFIRS-P domains were noted at open-label end (p < 0.001), with the largest improvement in Learning. At open-label end, 94% of children and adolescents demonstrated symptom improvement, of which 57% also showed functional improvement, and 75% of children and adolescents showed symptom remission, of which 81% also showed functional remission.
Children and adolescents treated with MPH-MLR showed moderate-to-large improvement in functioning during 3 months of treatment, both overall and in specific domains. However, a significant number of those who would be considered symptomatic responders failed to show improvement in functioning or continue to have significant functional impairment. Treatment with MPH-MLR showed that both symptomatic and functional remission are achievable goals. Identification of children and adolescents who have been successfully treated for their symptoms, but continue to suffer functional impairment, will allow us to offer additional targeted treatment interventions over and above medication to address residual difficulties.
评估参加一项为期11周的哌甲酯缓释片（MPH-MLR）关键研究开放标签剂量优化阶段的注意力缺陷多动障碍（ADHD）儿童和青少年的症状改善、功能改善与缓解之间的关系。
评估包括Weiss功能损害评定量表家长版（WFIRS-P）和第四版ADHD评定量表（ADHD-RS-IV）。定义如下：症状改善（ADHD-RS-IV总分降低≥30%）；症状缓解（ADHD-RS-IV总分≤18）；功能改善（WFIRS-P总分降低≥0.25[最小重要差异]）；以及功能缓解（WFIRS-P总分≤0.65）。
200名儿童完成了开放标签阶段。在初始评估时，所有WFIRS-P领域均存在明显的功能损害，儿童和青少年之间相似。初治者的功能损害更严重（WFIRS-P总分：0.82对0.70，p = 0.02）。在开放标签阶段结束时，所有WFIRS-P领域均有显著改善（p < 0.001），学习领域改善最大。在开放标签阶段结束时，94%的儿童和青少年症状改善，其中57%也显示功能改善，75%的儿童和青少年症状缓解，其中81%也显示功能缓解。
接受MPH-MLR治疗的儿童和青少年在3个月的治疗期间，整体及特定领域的功能均有中度至大幅改善。然而，相当数量被视为有症状反应者的功能未得到改善或仍有明显的功能损害。MPH-MLR治疗表明，症状缓解和功能缓解都是可以实现的目标。识别那些症状已成功治疗但仍有功能损害的儿童和青少年，将使我们能够在药物治疗之外提供额外的针对性治疗干预措施来解决残留困难。
