A Double-Blind Placebo-Controlled Trial of Fluoxetine for Repetitive Behaviors and Global Severity in Adult Autism Spectrum Disorders
A Double-Blind Placebo-Controlled Trial of Fluoxetine for Repetitive Behaviors and Global Severity in Adult Autism Spectrum Disorders
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DOI：
10.1176/appi.ajp.2011.10050764
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发表时间：
2012-03-01
影响因子：
17.7
通讯作者：
Settipani, Cara
中科院分区：
文献类型：
--
作者：
Hollander, Eric;Soorya, Latha;Settipani, Cara
目的：比较氟西汀和安慰剂对自闭症谱系障碍（ASD）成人患者重复行为和整体严重程度的影响。
方法：自闭症谱系障碍成人患者参与一项为期12周的双盲安慰剂对照氟西汀试验。37名患者被随机分配接受氟西汀（N = 22）或安慰剂（N = 15）治疗。剂量遵循固定方案，起始为10毫克/天，并根据耐受情况增加至80毫克/天。重复行为采用耶鲁 - 布朗强迫量表的强迫子量表进行测量；临床总体印象（CGI）改善量表用于评估强迫症状和整体严重程度的改善情况。
结果：存在显著的治疗 - 时间交互作用，表明氟西汀在一段时间内对重复行为的减少程度显著大于安慰剂。将总体反应定义为CGI总体改善评分2分或更低时，氟西汀组在第12周的有效应答者显著多于安慰剂组。CGI总体改善的风险比为1.5（有效应答者：氟西汀组为35%；安慰剂组为0%），CGI评定的强迫症状改善的风险比为1.8（有效应答者：氟西汀组为50%；安慰剂组为8%）。仅观察到轻度和中度副作用。
结论：与安慰剂相比，根据耶鲁 - 布朗强迫子量表和CGI对强迫症状的评定以及CGI总体改善评定，氟西汀治疗在重复行为方面有显著更大的改善。氟西汀似乎耐受性良好。这些发现与西酞普兰治疗儿童自闭症的一项试验结果形成对比。
Objective: The effects of fiuoxetine and placebo on repetitive behaviors and global severity were compared in adults with autism spectrum disorders (ASDs).Method: Adults with ASDs were enrolled in a 12-week double-blind placebo-controlled fiuoxetine trial. Thirty-seven were randomly assigned to fiuoxetine (N=22) or placebo (N=15). Dosage followed a fixed schedule, starting at 10 mg/day and increasing as tolerated up to 80 mg/day. Repetitive behaviors were measured with the compulsion subscale of the Yale-Brown Obsessive Compulsive Scale; the Clinical Global Impression (CGI) improvement scale was used to rate improvement in obsessive-compulsive symptoms and overall severity.Results: There was a significant treatment-by-time interaction indicating a significantly greater reduction in repetitive behaviors across time for fiuoxetine than for placebo. With overall response defined as a CGI global improvement score of 2 or less, there were significantly more responders at week 12 in the fiuoxetine group than in the placebo group. The risk ratio was 1.5 for CGI global improvement (responders: fiuoxetine, 35%; placebo, 0%) and 1.8 for CGI-rated improvement in obsessive-compulsive symptoms (responders: fiuoxetine, 50%; placebo, 8%). Only mild and moderate side effects were observed.Conclusions: Fluoxetine treatment, compared to placebo, resulted in significantly greater improvement in repetitive behaviors, according to both the Yale-Brown compulsion subscale and CGI rating of obsessive-compulsive symptoms, as well as on the CGI overall improvement rating. Fluoxetine appeared to be well tolerated. These findings stand in contrast to findings in a trial of citalopram for childhood autism.