Biehl B
Curr Med Res Opin. 1979;6(1):62-9. doi: 10.1185/03007997909109399.
Studies were carried out in normal healthy male subjects to assess the effects on psychomotor functions and subjective ratings of performance after acute administration of azatadine maleate, a potent antihistamine with additional antiserotonin activity. In the first trial, 2 mg azatadine was compared with another new antihistamine Sch 12169 (2 mg) and placebo. In a second trial, higher doses of azatadine (4 mg and 8 mg) were compared with dexchlorpheniramine (4 mg) and placebo. Both trials were of a double-blind, randomized Latin square design and subjects were assessed using a battery of tests, after administration of each trial drug. The time and sequence of tests were standarized, with a 1-week interval between test sessions. The results showed that azatadine did not produce significant impairment of psychomotor function at either the standard 2 mg or the maximum recommended 4 mg per day dosage level. Permormance was only significantly impaired, compared with that after placebo, at the 8 mg dose level and was of a similar order to that observed after dexchlorpheniramine at the usual 4 mg dosage. It is suggested, therefore, that at the normal recommended dosage of 2 mg per day, azatadine is not likely to impair driving ability.
在正常健康男性受试者中开展了多项研究，以评估急性给予马来酸氮卓斯汀（一种具有额外抗血清素活性的强效抗组胺药）后对精神运动功能和主观性能评分的影响。在第一项试验中，将2毫克氮卓斯汀与另一种新型抗组胺药Sch 12169（2毫克）及安慰剂进行比较。在第二项试验中，将更高剂量的氮卓斯汀（4毫克和8毫克）与右氯苯那敏（4毫克）及安慰剂进行比较。两项试验均采用双盲、随机拉丁方设计，在给予每种试验药物后，使用一系列测试对受试者进行评估。测试的时间和顺序是标准化的，测试环节之间间隔1周。结果表明，在标准的每日2毫克或最大推荐剂量每日4毫克的剂量水平下，氮卓斯汀均未对精神运动功能产生显著损害。与安慰剂给药后相比，仅在8毫克剂量水平时性能出现显著受损，且与右氯苯那敏通常4毫克剂量给药后观察到的情况处于相似水平。因此，有人提出，在每日2毫克的正常推荐剂量下，氮卓斯汀不太可能损害驾驶能力。
