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三种抗眩晕药物对健康志愿者警觉性的影响。

Influence of 3 antivertiginous medications on the vigilance of healthy volunteers.

作者信息

Schneider D, Kiessling B, Wieczorek M, Bognar-Steinberg I, Schneider L, Claussen C F

机构信息

Department of Neurootology, ENT Clinic, University of Würzburg, Germany.

出版信息

Int J Clin Pharmacol Ther. 2003 Apr;41(4):171-81. doi: 10.5414/cpp41171.

Abstract

In the present randomized, comparative, double-blind, 3-way crossover study, possible effects of 3 antivertiginous medications on vigilance were investigated. 30 healthy volunteers received single doses of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg (Arlevert, ARL), dimenhydrinate 50 mg, or betahistine dimesylate 12 mg, in randomized order at 1-week intervals. Spontaneous brain electrical activity (EEG), acoustic late evoked potentials (ALEP) with P300, and reaction time were measured before and 90 (t90) and 180 minutes (t180) after drug intake. All 3 medications led to a delay of P300 (primary criterion) and a decrease of its amplitude. The maximum delay at t180 was found for dimenhydrinate (16.42 ms) and the lowest for betahistine (6.33 ms). Differences ARL vs dimenhydrinate and ARL vs betahistine were not statistically significant (p > 0.05). Spectral analysis of spontaneous EEG showed slight and similar decreases in the power in the a-band under dimenhydrinate and ARL (p = 0.07 and p = 0.03 with respect to baseline, respectively), but basically no change under betahistine. There was no effect on reaction time by either medication. None of the subjects reported drowsiness or any other adverse event. The findings confirm the reported suitability of P300 latency for measurement of drug effects on brain activity, but provide no indication of concomitant impairment of performance capacity by the tested drugs. Global assessment of the results suggests that the fixed combination cinnarizine 20 mg/dimenhydrinate 40 mg exerts only a minor effect on vigilance, not significantly different from betahistine, which is commonly regarded as a non-sedating antivertiginous drug

摘要

在这项随机、对照、双盲、三向交叉研究中,研究了3种抗眩晕药物对警觉性的可能影响。30名健康志愿者按随机顺序,每隔1周接受单剂量的20毫克桂利嗪和40毫克茶苯海明的固定组合(Arlevert,ARL)、50毫克茶苯海明或12毫克甲磺酸倍他司汀。在服药前以及服药后90分钟(t90)和180分钟(t180)测量自发脑电活动(EEG)、伴有P300的听觉晚期诱发电位(ALEP)和反应时间。所有3种药物均导致P300延迟(主要标准)及其波幅降低。在t180时,茶苯海明的最大延迟为16.42毫秒,甲磺酸倍他司汀的最小延迟为6.33毫秒。ARL与茶苯海明以及ARL与甲磺酸倍他司汀之间的差异无统计学意义(p>0.05)。自发EEG的频谱分析显示,茶苯海明和ARL作用下α波段的功率有轻微且相似的降低(相对于基线,p分别为0.07和0.03),但甲磺酸倍他司汀作用下基本无变化。两种药物对反应时间均无影响。没有受试者报告嗜睡或任何其他不良事件。这些发现证实了所报道的P300潜伏期适用于测量药物对脑活动的影响,但未表明受试药物会同时损害执行能力。对结果的总体评估表明,20毫克桂利嗪/40毫克茶苯海明的固定组合对警觉性的影响很小,与通常被视为非镇静性抗眩晕药物的甲磺酸倍他司汀无显著差异。

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