Division of Mental Health and Addiction, Vestfold Hospital Trust, N-3101 Tønsberg, Norway; University of Oslo, N-0318 Oslo, Norway.
University of Oslo, N-0318 Oslo, Norway; Department of Oncology, Oslo University Hospital, Radiumhospitalet, N-0424 Oslo, Norway.
Eur Neuropsychopharmacol. 2014 Dec;24(12):1873-84. doi: 10.1016/j.euroneuro.2014.09.013. Epub 2014 Oct 18.
How to generalize from randomized placebo controlled trials of ADHD drug treatment in adults to 'real-world' clinical practice is intriguing. This open-labeled prospective observational study examined the effectiveness of long-term stimulant and non-stimulant medication in adult ADHD including dose, side-effects and comorbidity in a clinical setting. A specialized ADHD outpatient clinic gave previously non-medicated adults (n=250) with ADHD methylphenidate as first-line drug according to current guidelines. Patients who were non-tolerant or experiencing low efficacy were switched to amphetamine or atomoxetine. Primary outcomes were changes of ADHD-symptoms evaluated with the Adult ADHD Self-Report Scale (ASRS) and overall severity by the Global Assessment of Functioning (GAF). Secondary outcomes were measures of mental distress, and response on the Clinical-Global-Impressions-Improvement Scale. Data at baseline and follow-ups were compared in longitudinal mixed model analyses for time on-medication, dosage, comorbidity, and side-effects. As results, 232 patients (93%) completed examination at the 12 month endpoint, and 163 (70%) remained on medication. Compared with the patients who discontinued medication, those still on medication had greater percentage reduction in ASRS-scores (median 39%, versus 13%, P<0.001) and greater improvement of GAF (median 20% versus 4%, P<0.001) and secondary outcomes. Continued medication and higher cumulated doses showed significant associations to sustained improvement. Conversely, psychiatric comorbidity and side-effects were related to lower effectiveness and more frequent termination of medication. Taken together, one-year treatment with stimulants or atomoxetine was associated with a clinically significant reduction in ADHD symptoms and mental distress, and improvement of measured function. No serious adverse events were observed.
如何将成人注意力缺陷多动障碍（ADHD）药物治疗的随机安慰剂对照试验结果推广到“真实世界”临床实践中是一个有趣的问题。这项开放性、前瞻性观察研究在临床环境中检查了长期兴奋剂和非兴奋剂药物治疗成人 ADHD 的有效性，包括剂量、副作用和合并症。一个专门的 ADHD 门诊为以前未经药物治疗的成年人（n=250）根据当前指南提供了哌醋甲酯作为一线药物。对不耐受或疗效低的患者，换用安非他命或托莫西汀。主要结局是使用成人 ADHD 自评量表（ASRS）评估 ADHD 症状的变化和总体功能障碍严重程度的全球评估（GAF）。次要结局是精神困扰的衡量指标，以及临床总体印象改善量表的反应。在纵向混合模型分析中，对用药时间、剂量、合并症和副作用进行了比较。结果，232 名患者（93%）在 12 个月的随访中完成了检查，163 名患者（70%）仍在用药。与停药患者相比，仍在用药的患者的 ASRS 评分降低幅度更大（中位数 39%，而 13%，P<0.001），GAF 改善更大（中位数 20%，而 4%，P<0.001）和次要结局。持续用药和累积剂量更高与持续改善显著相关。相反，精神共病和副作用与较低的疗效和更频繁的停药有关。总之，使用兴奋剂或托莫西汀治疗一年与 ADHD 症状和精神困扰的显著减少以及测量功能的改善相关。未观察到严重不良事件。
