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口服右旋芬氟拉明与神经内分泌激发试验:男性服用30毫克剂量时存在的问题。

Oral D-fenfluramine and neuroendocrine challenge: problems with the 30 mg dose in men.

作者信息

Goodwin G M, Murray C L, Bancroft J

机构信息

MRC Brain Metabolism Unit, Royal Edinburgh Hospital, UK.

出版信息

J Affect Disord. 1994 Feb;30(2):117-22. doi: 10.1016/0165-0327(94)90039-6.

DOI:10.1016/0165-0327(94)90039-6
PMID:8201126
Abstract

Ten healthy male volunteers of normal weight received 30 mg of D-fenfluramine, a putative selective releaser of 5-hydroxytryptamine (5-HT), and placebo by mouth in balanced order at a 1 week interval after a light breakfast. Blood was taken for estimation of plasma cortisol and prolactin, and the patients completed self rating scales for stress and arousal and rated themselves on visual analogue scales for mood, hunger and alertness at appropriate time points from 30 min before to 300 min after drug/placebo ingestion. There were no statistically discernible effects of D-fenfluramine on either hormone measures or subjective ratings. The failure to find effects may be due to a too low dose of D-fenfluramine and/or a lower sensitivity to the drug in men compared with women. More information is required on the dose/response relationship and drug absorption especially after food. However, the findings cast doubt on results already obtained employing this dose of the drug in studies that have included male subjects. Furthermore, the interpretation of earlier studies with D,L-fenfluramine at a dose of 60 mg is also made more uncertain by the failure to confirm that the more selective D-isomer produces equivalent effects.

摘要

10名体重正常的健康男性志愿者在早餐后,以1周的间隔,按平衡顺序口服30毫克右旋芬氟拉明(一种假定的5-羟色胺(5-HT)选择性释放剂)和安慰剂。采集血液以测定血浆皮质醇和催乳素水平,患者在服用药物/安慰剂前30分钟至服药后300分钟的适当时间点,完成压力和觉醒的自评量表,并在视觉模拟量表上对情绪、饥饿和警觉性进行自我评分。右旋芬氟拉明对激素指标或主观评分均无统计学上可辨别的影响。未能发现效果可能是由于右旋芬氟拉明剂量过低和/或男性对该药物的敏感性低于女性。关于剂量/反应关系和药物吸收,尤其是进食后的吸收情况,还需要更多信息。然而,这些发现对在包含男性受试者的研究中使用该剂量药物已获得的结果提出了质疑。此外,由于未能证实更具选择性的D-异构体产生等效效果,对之前使用60毫克消旋芬氟拉明的研究解释也变得更加不确定。

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