10毫克、20毫克和30毫克剂量的H1组胺受体拮抗剂依巴斯汀以及10毫克曲普利啶对驾驶性能的急性和亚慢性影响。

Acute and subchronic effects of the H1-histamine receptor antagonist ebastine in 10, 20 and 30 mg dose, and triprolidine 10 mg on car driving performance.

Brookhuis K A, De Vries G, De Waard D

Traffic Research Centre, University of Groningen, Haren, The Netherlands.

Br J Clin Pharmacol. 1993 Jul;36(1):67-70. doi: 10.1111/j.1365-2125.1993.tb05894.x.

Abstract

The effects of a new antihistamine, ebastine (10, 20 and 30 mg), on several parameters of driving performance in actual traffic were studied in 15 healthy male volunteers. Subjects were treated for 5 days, and their driving performance tested on day 1 and day 5. The study was double-blind, placebo controlled and included the antihistamine triprolidine (10 mg sustained release) as an active drug control. 2. General tolerability was good except in one case following the reference compound triprolidine. No significant changes in driving performance were found with the new antihistamine ebastine at any dosage, on day 1 or day 5. Triprolidine (10 mg) significantly increased both the amount of weaving and the delay in following speed manoeuvres of a leading car, compared with placebo. 3. The results suggest that ebastine in doses up to 30 mg may be relatively safe for use by those who drive motor vehicles while under medication. The results do not warrant such a conclusion for triprolidine 10 mg.

摘要

在15名健康男性志愿者中研究了一种新型抗组胺药依巴斯汀（10毫克、20毫克和30毫克）对实际交通中驾驶性能若干参数的影响。受试者接受治疗5天，并在第1天和第5天测试其驾驶性能。该研究为双盲、安慰剂对照研究，且将抗组胺药曲普利啶（10毫克缓释剂）作为活性药物对照。2. 总体耐受性良好，但在使用参比化合物曲普利啶后出现了1例例外情况。在第1天或第5天，新型抗组胺药依巴斯汀在任何剂量下均未发现驾驶性能有显著变化。与安慰剂相比，曲普利啶（10毫克）显著增加了车道变换次数以及跟随前车速度操作的延迟。3. 结果表明，剂量高达30毫克的依巴斯汀对于服药期间驾驶机动车的人而言可能相对安全。对于10毫克的曲普利啶，该结果并不支持这一结论。