Marchant Barrie K, Reimherr Fred W, Halls Corinne, Williams Erika D, Strong Robert E, Kondo Douglas, Soni Poonam, Robison Reid J
Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA.
Atten Defic Hyperact Disord. 2011 Sep;3(3):237-44. doi: 10.1007/s12402-011-0054-2. Epub 2011 Mar 27.
A three-year open-label study of atomoxetine in adults with ADHD followed two multicenter, double-blind trials. In the double-blind trials, female gender and higher levels of emotional symptoms were associated with better outcome. Following a 4-week placebo washout period, 384 (of 536) subjects continued into the open-label study. 61% of subjects entering this open-label study remained after 6 months at an average dose of 100 mg/day. Subjects who had previously responded to double-blind atomoxetine achieved maximum response after 8 weeks of open-label medication, but others continued to improve for 36 weeks. Women improved more (7.7 ± 6.4) than men (6.1 ± 6.4) on the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) (P = .007) and the Conners' Adult ADHD Rating Scale (P = .03). Subjects with emotional dysregulation improved more than others on the WRAADDS (P = .001). Responders ultimately improved approximately 60% in attentional, hyperactive/impulsive, and emotional symptoms. Thirty-nine percent of atomoxetine double-blind non-responders became responders during open-label treatment.
一项针对成人注意力缺陷多动障碍（ADHD）患者的托莫西汀三年开放标签研究，是在两项多中心双盲试验之后开展的。在双盲试验中，女性以及较高水平的情绪症状与更好的治疗结果相关。在为期4周的安慰剂洗脱期之后，536名受试者中的384名继续进入开放标签研究。进入该开放标签研究的受试者中，61%在6个月后仍在继续参与研究，平均剂量为每日100毫克。之前在双盲试验中对托莫西汀有反应的受试者，在开放标签用药8周后达到最大反应，但其他受试者在36周内持续改善。在温德-赖姆赫尔成人注意力缺陷障碍量表（WRAADDS）（P = 0.007）和康纳斯成人ADHD评定量表（P = 0.03）上，女性（改善值为7.7±6.4）比男性（改善值为6.1±6.4）改善得更多。在WRAADDS量表上，情绪调节障碍的受试者比其他受试者改善得更多（P = 0.001）。反应者在注意力、多动/冲动和情绪症状方面最终改善了约60%。39%在双盲试验中对托莫西汀无反应的受试者在开放标签治疗期间变成了反应者。
