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阿斯巴甜的不良反应:对弱势群体患者的双盲激发试验

Adverse reactions to aspartame: double-blind challenge in patients from a vulnerable population.

作者信息

Walton R G, Hudak R, Green-Waite R J

机构信息

Department of Psychiatry, Northeastern Ohio Universities College of Medicine, Youngstown.

出版信息

Biol Psychiatry. 1993;34(1-2):13-7. doi: 10.1016/0006-3223(93)90251-8.

DOI:10.1016/0006-3223(93)90251-8
PMID:8373935
Abstract

This study was designed to ascertain whether individuals with mood disorders are particularly vulnerable to adverse effects of aspartame. Although the protocol required the recruitment of 40 patients with unipolar depression and a similar number of individuals without a psychiatric history, the project was halted by the Institutional Review Board after a total of 13 individuals had completed the study because of the severity of reactions within the group of patients with a history of depression. In a crossover design, subjects received aspartame 30 mg/kg/day or placebo for 7 days. Despite the small n, there was a significant difference between aspartame and placebo in number and severity of symptoms for patients with a history of depression, whereas for individuals without such a history there was not. We conclude that individuals with mood disorders are particularly sensitive to this artificial sweetener and its use in this population should be discouraged.

摘要

本研究旨在确定情绪障碍患者是否特别容易受到阿斯巴甜不良反应的影响。尽管方案要求招募40名单相抑郁症患者和数量相近的无精神病史个体,但由于有抑郁症病史的患者组内反应严重,在总共13名个体完成研究后,该项目被机构审查委员会叫停。在交叉设计中,受试者接受30毫克/千克/天的阿斯巴甜或安慰剂,为期7天。尽管样本量小,但有抑郁症病史的患者在症状数量和严重程度上,阿斯巴甜组与安慰剂组之间存在显著差异,而无此类病史的个体则不存在这种差异。我们得出结论,情绪障碍患者对这种人工甜味剂特别敏感,应不鼓励在该人群中使用。

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