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个体精神运动损伤与佐匹克隆和血液乙醇浓度的关系——一项随机对照双盲试验。

Individual psychomotor impairment in relation to zopiclone and ethanol concentrations in blood--a randomized controlled double-blinded trial.

机构信息

Forensic Medicine and Drug Abuse Research, Norwegian Institute of Public Health, Oslo, Norway.

出版信息

Addiction. 2012 May;107(5):925-32. doi: 10.1111/j.1360-0443.2011.03693.x. Epub 2012 Feb 11.

DOI:10.1111/j.1360-0443.2011.03693.x
PMID:22008377
Abstract

AIMS

To investigate individual traffic-relevant impairment related to measured blood zopiclone and ethanol concentrations. Also, we aimed to study possible development of acute tolerance.

DESIGN

A randomized controlled four-way cross-over double-blind trial. Study drugs were zopiclone 5 or 10 mg, 50 g ethanol or placebo.

SETTING

Laboratory study with computerized tests: Connor's Continuous Performance test, Choice Reaction Time and Stockings of Cambridge. Altogether, the tests consisted of 15 test components, representing three levels of behaviour (automotive, control, executive planning), relevant to traffic safety.

PARTICIPANTS

Sixteen healthy male volunteers.

MEASUREMENTS

Each study day, 10 blood samples were collected from each volunteer. Fifteen psychomotor test components were registered at baseline and a further three times after intake. Impairment was defined as any individual deterioration in performance compared to individual baseline performance.

FINDINGS

Blood drug concentrations up to 74 µg/l zopiclone and 0.100% ethanol were measured. We found a clear positive concentration-effect relationship for zopiclone and ethanol for both automotive and control behaviours, and a modest relationship for executive planning behaviour. Significant impairment started to be observed at concentrations above 16 µg/l zopiclone (automotive and control behaviour) and above 0.026% ethanol (automotive behaviour). Acute tolerance was found for both drugs.

CONCLUSIONS

The hypnotic, zopiclone, can impair psychomotor performance at blood concentrations as low as 16 µg/l.

摘要

目的

研究与测量血中佐匹克隆和乙醇浓度相关的个体交通损害。此外,我们旨在研究急性耐受的可能发展。

设计

一项随机对照四交叉双盲试验。研究药物为佐匹克隆 5 或 10 毫克、50 克乙醇或安慰剂。

地点

实验室研究,采用计算机测试:Connor 的连续表现测试、选择反应时间和剑桥袜子。总共,这些测试包括 15 个测试组件,代表与交通安全相关的三个行为水平(汽车、控制、执行规划)。

参与者

16 名健康男性志愿者。

测量

每个研究日,从每个志愿者采集 10 份血样。15 个心理运动测试组件在基线和摄入后三次登记。损害定义为与个体基线表现相比任何个体表现的恶化。

发现

测量到高达 74µg/l 佐匹克隆和 0.100%乙醇的血药浓度。我们发现佐匹克隆和乙醇对汽车和控制行为均存在明显的正浓度效应关系,对执行规划行为则存在适度的关系。在佐匹克隆浓度高于 16µg/l(汽车和控制行为)和乙醇浓度高于 0.026%(汽车行为)时,开始观察到显著的损害。发现两种药物均存在急性耐受。

结论

催眠药佐匹克隆在血药浓度低至 16µg/l 时即可损害心理运动表现。

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