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评价健康男性志愿者使用驾驶模拟器评估普瑞巴林对模拟驾驶能力的影响。

Evaluation of the effect of pregabalin on simulated driving ability using a driving simulator in healthy male volunteers.

机构信息

Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Tohon Ehime, Japan.

出版信息

Int J Gen Med. 2014 Jan 29;7:103-8. doi: 10.2147/IJGM.S57392. eCollection 2014.

DOI:10.2147/IJGM.S57392
PMID:24501544
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3912019/
Abstract

Pregabalin, a novel agent for treating partial epilepsy and peripheral neuropathic and central pain, was studied for its effect on driving performance in healthy volunteers. Sixteen healthy male volunteers who drove regularly were enrolled in a double-blind, parallel-group, placebo-controlled study assessing the effect of pregabalin on driving performance. Subjects received an oral dose of pregabalin 75 mg or placebo, and a second dose 12 hours later. A driving simulator was used to test simple and complicated braking reaction time, and simple and complicated steering-wheel techniques before the first dose, and 1 hour and 3 hours after the second dose of pregabalin or placebo. The effect of training during the driving test on the driving performance of each group was also evaluated. There were no statistically significant differences in driving performance between the pregabalin and the placebo groups. However, the pregabalin group showed no significant improvement in steering-wheel skills with training, whereas the placebo group showed a significant (P<0.05) improvement with training. In this study using a driving simulator, pregabalin did not impair driving performance but mildly reduced the training effects of driving experiments. Although pregabalin caused sleepiness, it had no severe effect on driving ability after a second dose of 75 mg after the initial introduction of pregabalin.

摘要

普瑞巴林是一种治疗部分癫痫和周围神经痛及中枢痛的新型药物,研究其对健康志愿者驾驶表现的影响。本研究纳入 16 名经常驾驶的健康男性志愿者,进行一项双盲、平行组、安慰剂对照研究,评估普瑞巴林对驾驶表现的影响。受试者接受普瑞巴林 75mg 或安慰剂口服剂量,12 小时后给予第二剂。使用驾驶模拟器测试简单和复杂制动反应时间,以及简单和复杂转向技术,分别在第一次和第二次服用普瑞巴林或安慰剂后 1 小时和 3 小时进行。还评估了驾驶测试过程中训练对每组驾驶表现的影响。普瑞巴林组和安慰剂组之间的驾驶表现无统计学差异。然而,普瑞巴林组在训练中转向技能无明显改善,而安慰剂组则有显著改善(P<0.05)。在这项使用驾驶模拟器的研究中,普瑞巴林并未损害驾驶表现,但轻度降低了驾驶实验的训练效果。尽管普瑞巴林引起嗜睡,但在初次引入普瑞巴林后第二次服用 75mg 后,对驾驶能力无严重影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/013081907890/ijgm-7-103Fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/d68f958206df/ijgm-7-103Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/c2ea084ef742/ijgm-7-103Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/a7e01d506de2/ijgm-7-103Fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/013081907890/ijgm-7-103Fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/d68f958206df/ijgm-7-103Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/c2ea084ef742/ijgm-7-103Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/a7e01d506de2/ijgm-7-103Fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fed/3912019/013081907890/ijgm-7-103Fig4.jpg

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