Sherman J, Factor D C, Swinson R, Darjes R W
TRE-ADD, Thistletown Regional Centre, Rexdale, Ontario, Canada.
J Autism Dev Disord. 1989 Dec;19(4):533-43. doi: 10.1007/BF02212856.
Fifteen autistic individuals were involved in an investigation using fenfluramine and placebo in a double-blind crossover design. Subjects were assessed using IQ tests, the Real Life Rating Scale (RLRS), the Adaptive Behavior Scale-School Edition (ABS-SE), and videotaped play data on 8 of 12 visits, including 2 follow-up visits. Serotonin level in platelet-poor plasma was assessed on all 12 visits. Serotonin levels decreased with the administration of fenfluramine, and increased with the reinstatement of placebo. Statistical tests revealed no significant differences on the IQ scores, the RLRS, or the ABS-SE for the drug versus the placebo conditions. Videotaped data favored the subjects while on placebo. Group and individual data were analyzed over time and indicated no significant improvements due to the drug. The implications of this research make it difficult to recommend fenfluramine as a treatment for autism.
15名自闭症患者参与了一项使用芬氟拉明和安慰剂的双盲交叉设计研究。使用智商测试、现实生活评定量表(RLRS)、适应行为量表学校版(ABS-SE)以及在12次就诊中的8次(包括2次随访)的录像游戏数据对受试者进行评估。在所有12次就诊时均评估了血小板贫乏血浆中的血清素水平。服用芬氟拉明后血清素水平下降,恢复使用安慰剂后血清素水平上升。统计测试显示,在药物组与安慰剂组之间,智商得分、RLRS或ABS-SE均无显著差异。录像数据显示受试者在服用安慰剂时情况更佳。对组数据和个体数据进行了长期分析,结果表明该药物未带来显著改善。这项研究的结果使得难以推荐将芬氟拉明作为自闭症的一种治疗方法。