澳大利亚皇家儿童医院联合悉尼大学医学院的研究人员在最新研究中，探讨了氟西汀对自闭症谱系障碍儿童和青少年强迫行为的影响。2019年10月22日出版的《美国医学会杂志》刊登了这一成果。
据悉，选择性5-羟色胺受体抑制剂被用来降低自闭症谱系障碍核心行为的严重程度，但其疗效仍不确定。
2010年11月至2017年4月，研究组在澳大利亚3个三级卫生中心进行了这项多中心、随机、安慰剂对照的临床试验，采用针对普遍性发展障碍修订的儿童耶鲁-布朗强迫症量表（CYBOCS-PDD）对强迫症行为进行评估，0-20分，得分越高说明病情越严重。共招募了146名年龄为7.5-18岁，患有自闭症谱系障碍，CYBOCS-PDD评分6分及以上的患者。将这些患者随机分组，其中75例接受氟西汀治疗，71例接受安慰剂治疗。
146名参与者中85%为男性，平均年龄为11.2岁，共有109名完成了试验。氟西汀组有31人，安慰剂组有21人退出或未完成治疗。治疗16周后，氟西汀组的CYBOCS-PDD评分从基线时的12.80分降至9.02分，安慰剂组从13.13分降至10.89分。氟西汀组与安慰剂组治疗16周后CYBOCS-PDD评分的平均差异是-2.01分，校正后为-1.17分。
该研究表明，采用氟西汀治疗自闭症谱系障碍的儿童和青少年，与安慰剂相比，可显著降低16周时的强迫症行为得分。
Objective To determine the efficacy of fluoxetine for reducing the frequency and severity of obsessive-compulsive behaviors in autism spectrum disorders.
Design, Setting, and Participants Multicenter, randomized, placebo-controlled clinical trial. Participants aged 7.5-18 years with autism spectrum disorders and a total score of 6 or higher on the Children’s Yale-Brown Obsessive Compulsive Scale, modified for pervasive developmental disorder (CYBOCS-PDD) were recruited from 3 tertiary health centers across Australia. Enrollment began November 2010 and ended April 2017. Follow-up ended August 2017.Interventions Participants were randomized to receive fluoxetine (n = 75) or placebo (n = 71). Study medication was commenced at 4 or 8 mg/d for the first week, depending on weight, and then titrated to a maximum dose of 20 or 30 mg/d over 4 weeks. Treatment duration was 16 weeks.
Main Outcomes and Measures The primary outcome was the total score on the CYBOCS-PDD (scores range from 0-20; higher scores indicate higher levels of maladaptive behaviors; minimal clinically important difference, 2 points) at 16 weeks postrandomization, analyzed with a linear regression model adjusted for stratification factors (site, age at baseline, and intellectual disability), with an additional prespecified model that included additional adjustment for baseline score, sex, communication level, and imbalanced baseline and demographic variables.Results Among the 146 participants who were randomized (85% males; mean age, 11.2 years), 109 completed the trial; 31 in the fluoxetine group and 21 in the placebo group dropped out or did not complete treatment. The mean CYBOCS-PDD score from baseline to 16 weeks decreased in the fluoxetine group from 12.80 to 9.02 points (3.72-point decrease; 95% CI, −4.85 to −2.60) and in the placebo group from 13.13 to 10.89 points (2.53-point decrease; 95% CI, −3.86 to −1.19). The between-group mean difference at 16 weeks was −2.01 (95% CI, −3.77 to −0.25; P = .03) (adjusted for stratification factors), and in the prespecified model with further adjustment, it was −1.17 (95% CI, −3.01 to 0.67; P = .21).
Conclusions and Relevance In this preliminary study of children and adolescents with autism spectrum disorders, treatment with fluoxetine compared with placebo resulted in significantly lower scores for obsessive-compulsive behaviors at 16 weeks. Interpretation is limited by the high dropout rate, null findings of prespecified analyses that accounted for potentially confounding factors and baseline imbalances, and CIs for the treatment effect that included the minimal clinically important difference. JAMA-Journal of The American Medical Association：《美国医学会杂志》，创刊于1883年。隶属于美国医学协会，最新IF：51.273
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投稿链接：http://manuscripts.jama.com/cgi-bin/main.plex