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健康志愿者中适应性追踪、眼动分析和视觉模拟评分对替马西泮递增剂量效应的敏感性比较。

A comparison of the sensitivities of adaptive tracking, eye movement analysis and visual analog lines to the effects of incremental doses of temazepam in healthy volunteers.

作者信息

van Steveninck A L, Schoemaker H C, Pieters M S, Kroon R, Breimer D D, Cohen A F

机构信息

Centre for Human Drug Research, University Hospital, Leiden, The Netherlands.

出版信息

Clin Pharmacol Ther. 1991 Aug;50(2):172-80. doi: 10.1038/clpt.1991.122.

Abstract

The effects of single oral doses of 5, 10, and 20 mg temazepam were evaluated with the adaptive tracking test, analysis of smooth-pursuit and saccadic eye movements, and visual analog lines in a placebo-controlled, double-blind, crossover experiment with 12 healthy volunteers. Pharmacodynamic testing was performed until 10 hours and pharmacokinetics were evaluated until 24 hours. Temazepam, 20 mg, caused effects in all tests, with peak effects occurring at 30 minutes. The 10 mg dose caused effects on saccadic eye movements and subjective scores of alertness, whereas 5 mg temazepam was detected only by analysis of saccadic eye movements. Linear relationships between plasma concentrations and effects were found in nine subjects for saccadic peak velocity and eight subjects for subjective scores of alertness. The results of this study demonstrate manifest differences in the sensitivities of performance tests and stress the importance of validation of methods when effects of drugs on human performance are studied.

摘要

在一项有12名健康志愿者参与的安慰剂对照、双盲、交叉实验中,采用适应性跟踪测试、平稳跟踪和扫视眼动分析以及视觉模拟线,评估了单次口服5毫克、10毫克和20毫克替马西泮的效果。药效学测试持续到10小时,药代动力学评估持续到24小时。20毫克的替马西泮在所有测试中均产生效果,峰值效应出现在30分钟。10毫克剂量对扫视眼动和警觉性主观评分产生影响,而仅通过扫视眼动分析才检测到5毫克替马西泮的作用。在9名受试者中发现血浆浓度与扫视峰值速度之间存在线性关系,在8名受试者中发现血浆浓度与警觉性主观评分之间存在线性关系。本研究结果表明性能测试的敏感性存在明显差异,并强调在研究药物对人体性能的影响时方法验证的重要性。

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