托莫西汀治疗成人注意力缺陷多动障碍的长期开放标签安全性和疗效：一项4年研究的最终报告
Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD: final report of a 4-year study.
作者信息
Adler Lenard A, Spencer Thomas J, Williams David W, Moore Rodney J, Michelson David
机构信息
New York University, School of Medicine, New York, NY 10016, USA.
出版信息
J Atten Disord. 2008 Nov;12(3):248-53. doi: 10.1177/1087054708316250. Epub 2008 Apr 30.
OBJECTIVE
Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment.
METHOD
Results were derived from the study of 384 patients (125 patients remaining in the open-label trial since the interim report), receiving up to 221 weeks of treatment. Primary efficacy measure was the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom score. Adverse events and vital signs were assessed.
RESULTS
CAARS-Inv:SV Total ADHD Symptom scores decreased 30.2% (p < .001) during treatment. Similar, significant decreases were noted for the secondary efficacy measures, including the Sheehan Disability Scale Total score, which improved 25.3% (p < .001). Adverse events consisted primarily of pharmacologically (noradrenergic) expected effects.
CONCLUSIONS
Results of this open-label study support the long-term efficacy, safety, and tolerability of atomoxetine for the treatment of adult ADHD.
目的
此前，已有关于成人注意力缺陷多动障碍（ADHD）患者接受97周开放标签托莫西汀治疗的数据报道。本研究的最终报告展示了超过4年治疗期的结果。
方法
结果源自对384例患者的研究（自中期报告以来，有125例患者仍留在开放标签试验中），这些患者接受了长达221周的治疗。主要疗效指标为康纳斯成人ADHD评定量表-研究者评定：筛查版（CAARS-Inv:SV）ADHD症状总分。对不良事件和生命体征进行了评估。
结果
治疗期间，CAARS-Inv:SV ADHD症状总分下降了30.2%（p <.001）。次要疗效指标也出现了类似的显著下降，包括希恩残疾量表总分改善了25.3%（p <.001）。不良事件主要由药理学上（去甲肾上腺素能）预期的效应组成。
结论
这项开放标签研究的结果支持托莫西汀治疗成人ADHD的长期疗效、安全性和耐受性。
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