Moser L, Gerdes H, Bückmann M, Hopmann G
Arzneimittelforschung. 1983;33(2):262-5.
In two consecutive partial studies conducted under double-blind conditions the potential effects of the antihistamine 1-(4-fluorophenylmethyl)-N-[1-[2-(4-methoxypenyl)ethyl]-4-piperidinyl]- 1H-benzimidazole-2-amine (astemizole) on the ability to drive and the safe operation of machinery was tested in a total of 85 volunteers. The test was performed with psychometrical methods and included the activation level (= objective tiredness), the subjective feeling of tiredness as well as their impact on concentration and reactivity. It was shown, that after a single administration (first partial study) there was no difference in performance between astemizole and placebo, whereas under the influence of the reference substance ketotifen concentration and reactivity were significantly impaired. It should be mentioned that the volunteers of the reference group did not yet experience a subjective feeling of tiredness, while their performance had already fallen off. Also after seven days of treatment (second partial study) with astemizole or placebo the active group did not exhibit any decline in performance. The authors advise against the generalized reference to a "possibly impaired reactivity" in the case of antihistamines.
在两项连续进行的双盲条件下的部分研究中,对总共85名志愿者测试了抗组胺药1-(4-氟苄基)-N-[1-[2-(4-甲氧基苯基)乙基]-4-哌啶基]-1H-苯并咪唑-2-胺(阿司咪唑)对驾驶能力和机械安全操作的潜在影响。该测试采用心理测量方法进行,包括激活水平(=客观疲劳)、主观疲劳感以及它们对注意力和反应能力的影响。结果表明,单次给药后(第一项部分研究),阿司咪唑和安慰剂之间在表现上没有差异,而在对照物质酮替芬的影响下,注意力和反应能力明显受损。应该提到的是,对照组的志愿者尚未体验到主观疲劳感,而他们的表现已经下降。同样,在使用阿司咪唑或安慰剂治疗七天后(第二项部分研究),活性组的表现没有任何下降。作者建议不要在抗组胺药的情况下一概而论地提及“可能受损的反应能力”。