Garriga M M, Berkebile C, Metcalfe D D
Mast Cell Physiology Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
J Allergy Clin Immunol. 1991 Apr;87(4):821-7. doi: 10.1016/0091-6749(91)90128-b.
Aspartame is an O-methyl ester composed of phenylalanine and aspartic acid. After its final approval as a sweetener in 1981, a number of reports of adverse reactions to aspartame appeared in the literature. To explore the pathogenesis of such reactions, we initiated a study in July 1986 to identify subjects with hypersensitivity reactions to aspartame with blinded challenge procedures. The study was closed after 32 months. During that time, we advertised in local newspapers and worked closely with the local community of allergists and dermatologists in an attempt to recruit subjects with hypersensitivity reactions to aspartame. A total of 61 self-referrals and physician referrals were screened, with 20 referrals evaluated in clinic. After this evaluation, 12 patients underwent single- and double-blind challenge with up to 2000 mg of aspartame. No subject with a clearly reproducible adverse reaction to aspartame was identified. In summary, we found that it is difficult to recruit study subjects with a history of hypersensitivity reactions to aspartame and that subjects who believed themselves allergic to aspartame did not have reproducible reactions.
阿斯巴甜是一种由苯丙氨酸和天冬氨酸组成的O-甲基酯。1981年它作为甜味剂最终获批后，文献中出现了一些关于阿斯巴甜不良反应的报告。为探究此类反应的发病机制，我们于1986年7月启动了一项研究，采用盲法激发试验程序来确定对阿斯巴甜过敏的受试者。该研究在32个月后结束。在此期间，我们在当地报纸上刊登广告，并与当地过敏症专科医生和皮肤科医生群体密切合作，试图招募对阿斯巴甜过敏的受试者。共筛选了61例自荐者和医生推荐者，其中20例推荐者在诊所接受了评估。经过此次评估，12名患者接受了高达2000毫克阿斯巴甜的单盲和双盲激发试验。未发现对阿斯巴甜有明显可重复不良反应的受试者。总之，我们发现很难招募到有阿斯巴甜过敏反应史的研究对象，而且那些自认为对阿斯巴甜过敏的受试者并没有可重复的反应。
