催眠药物与驾驶安全：应用道路驾驶测试的随机对照试验的荟萃分析

Hypnotics and driving safety: meta-analyses of randomized controlled trials applying the on-the-road driving test.

作者信息

Verster Joris C, Veldhuijzen Dieuwke S, Patat Alain, Olivier Berend, Volkerts Edmund R

机构信息

Utrecht Institute for Pharmaceutical Sciences, Department of Psychopharmacology, University of Utrecht, PO BOX 80082, 3508 TB, Utrecht, The Netherlands.

出版信息

Curr Drug Saf. 2006 Jan;1(1):63-71. doi: 10.2174/157488606775252674.

DOI:10.2174/157488606775252674

PMID:18690916

Abstract

BACKGROUND

Many people who use hypnotics are outpatients and are likely to drive a car the day after drug intake. The purpose of these meta-analyses was to determine whether or not this is safe.

METHODS

Placebo-controlled, randomized, double-blind trials were selected if using the on-the-road driving test to determine driving ability the day following one or two nights of treatment administration. Primary outcome measure of the driving test was the Standard Deviation of Lateral Position (SDLP); i.e., the weaving of the car. Fixed effects model meta-analyses were performed. Effect size (ES) was computed using mean standardized (weighted) difference scores between treatment and corresponding placebo SDLP values.

RESULTS

Ten studies, published from 1984 to 2002 (207 subjects), were included in the meta-analyses. The morning following bedtime administration, i.e. 10-11 hours after dosing, significant driving impairment was found for the recommended dose of various benzodiazepine hypnotics (ES=0.42; 95% Confidence Interval (CI)=0.14 to 0.71). Twice the recommended dose impaired driving both in the morning (ES=0.68; CI=0.39 to 0.97) and afternoon, i.e. 16-17 hours after dosing (ES=0.57; CI=0.26 to 0.88). Zopiclone 7.5 mg also impaired driving in the morning (ES=0.89; CI=0.54 to 1.23). Zaleplon (10 and 20 mg) and zolpidem (10 mg) did not affect driving performance the morning after dosing. Following middle-of-the-night administration, significantly impaired driving performance was found for zopiclone 7.5 mg (ES=1.51, CI=0.85 to 2.17), zolpidem 10 mg (ES=0.66, CI=0.13 to 1.19) and zolpidem 20 mg (ES=1.16, CI=0.60 to 1.72). Zaleplon (10 and 20 mg) did not affect driving performance.

CONCLUSIONS

The analyses show that driving a car the morning following nocturnal treatment with benzodiazepines and zopiclone is unsafe, whereas the recommended dose of zolpidem (10 mg) and zaleplon (10 mg) do not affect driving ability.

摘要

背景

许多使用催眠药的人是门诊患者，服药后第二天可能会开车。这些荟萃分析的目的是确定这样做是否安全。

方法

如果研究采用道路驾驶测试来确定在接受一两个晚上的治疗后第二天的驾驶能力，则选择安慰剂对照、随机、双盲试验。驾驶测试的主要结果指标是横向位置标准差（SDLP），即汽车的摆动情况。进行固定效应模型荟萃分析。效应大小（ES）通过治疗组和相应安慰剂组的SDLP值之间的平均标准化（加权）差异分数来计算。

结果

1984年至2002年发表的10项研究（207名受试者）纳入了荟萃分析。睡前给药后的早晨，即给药后10 - 11小时，发现各种苯二氮䓬类催眠药的推荐剂量会导致显著的驾驶能力受损（ES = 0.42；95%置信区间（CI）= 0.14至0.71）。两倍推荐剂量在早晨（ES = 0.68；CI = 0.39至0.97）和下午，即给药后16 - 17小时（ES = 0.57；CI = 0.26至0.88）都会损害驾驶能力。7.5毫克佐匹克隆在早晨也会损害驾驶能力（ES = 0.89；CI = 0.54至1.23）。扎来普隆（10毫克和20毫克）和唑吡坦（10毫克）在给药后早晨不影响驾驶性能。午夜给药后，发现7.5毫克佐匹克隆（ES = 1.51，CI = 0.85至2.17）、10毫克唑吡坦（ES = 0.66，CI = 0.13至1.19）和20毫克唑吡坦（ES = 1.16，CI = 0.60至1.72）会显著损害驾驶性能。扎来普隆（10毫克和20毫克）不影响驾驶性能。