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一项针对患有自闭症谱系障碍的成年人的氟伏沙明双盲、安慰剂对照研究。

A double-blind, placebo-controlled study of fluvoxamine in adults with autistic disorder.

作者信息

McDougle C J, Naylor S T, Cohen D J, Volkmar F R, Heninger G R, Price L H

机构信息

Clinical Neuroscience Research Unit, Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, USA.

出版信息

Arch Gen Psychiatry. 1996 Nov;53(11):1001-8. doi: 10.1001/archpsyc.1996.01830110037005.

DOI:10.1001/archpsyc.1996.01830110037005
PMID:8911223
Abstract

BACKGROUND

Autistic disorder is characterized by a fundamental disturbance in social interaction, impairments in communication, and a markedly restricted repertoire of activities and interests. Abnormalities in the serotonin neurotransmitter system have been identified in some persons with autism. No consistently effective and safe drugs have been developed for treating the symptoms of autism.

METHODS

Thirty adults with autistic disorder completed a 12-week double-blind, placebo-controlled trial of the potent and selective serotonin uptake inhibitor fluvoxamine maleate. Behavioral ratings were obtained at baseline and after 4, 8, and 12 weeks of treatment.

RESULTS

Eight (53%) of 15 patients in the fluvoxamine-treated group were categorized as responders compared with none of 15 in the placebo group (P = .001). Fluvoxamine was superior to placebo in reducing repetitive thoughts and behavior (P < .001), maladaptive behavior (P < .001), and aggression (P < .03), and in improving some aspects of social relatedness (P < .04), especially language usage (P < .008). Treatment response was not correlated with age level of autistic behavior, or full-scale IQ. Other than mild sedation and nausea in a few patients, fluvoxamine was well tolerated. No dyskinesias, adverse cardiovascular events, or seizures occurred.

CONCLUSIONS

Fluvoxamine is more effective than placebo in the short-term treatment of the symptoms of autistic disorder in adults. Controlled studies of fluvoxamine and other potent and selective serotonin uptake inhibitors seem warranted in children and adolescents with autism.

摘要

背景

孤独症谱系障碍的特征是社交互动存在根本性障碍、沟通受损以及活动和兴趣范围明显受限。一些孤独症患者已被确认血清素神经递质系统存在异常。目前尚未研发出持续有效且安全的治疗孤独症症状的药物。

方法

30名成年孤独症谱系障碍患者完成了一项为期12周的双盲、安慰剂对照试验,试验药物为强效选择性血清素再摄取抑制剂马来酸氟伏沙明。在基线以及治疗4周、8周和12周后进行行为评分。

结果

氟伏沙明治疗组的15名患者中有8名(53%)被归类为有反应者,而安慰剂组的15名患者中无一人有反应(P = 0.001)。在减少重复思维和行为(P < 0.001)、适应不良行为(P < 0.001)和攻击行为(P < 0.03)以及改善社交相关性的某些方面(P < 0.04),尤其是语言使用方面(P < 0.008),氟伏沙明优于安慰剂。治疗反应与孤独症行为的年龄水平或全量表智商无关。除少数患者出现轻度镇静和恶心外,氟伏沙明耐受性良好。未发生运动障碍、不良心血管事件或癫痫发作。

结论

在短期治疗成年孤独症谱系障碍患者的症状方面,氟伏沙明比安慰剂更有效。对于患有孤独症的儿童和青少年,对氟伏沙明和其他强效选择性血清素再摄取抑制剂进行对照研究似乎是必要的。

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