Vezekényi Z, Zolnai K, Nagy L
First Department of Medicine, University Medical School, Pécs, Hungary.
Acta Med Hung. 1987;44(1):55-64.
During the two-phase clinicopharmacological trial in humans of a new antihistaminic compound EGYT-2062, setastine developed by EGIS Pharmaceutical Company, Budapest, was tested the tolerance to the drug, its pharmacodynamic effect by i. c. histamine and acetylcholine tests, and its effect on the CNS by neuropsychiatric examination on eight healthy volunteers. The side-effects appearing during treatment were recorded. A self-controlled blind study was performed. The reference compound was clemastine. Based on the results, for prolonged use a dose of 2 mg three times/day (t.i.d.) is recommended. The antihistaminic effect of setastine almost equalled that of clemastine given in a dose of 1 mg t.i.d., while its antiacetylcholine effect exceeded it, and in view of its few psychic side-effects, might be tolerated better than clemastine.
在一项针对新型抗组胺化合物EGYT - 2062（由布达佩斯的EGIS制药公司研发的司他斯汀）进行的人体两阶段临床药理学试验中，对8名健康志愿者测试了该药的耐受性、通过皮内注射组胺和乙酰胆碱试验检测其药效学作用，以及通过神经精神检查评估其对中枢神经系统的影响。记录了治疗期间出现的副作用。进行了一项自身对照的盲法研究。对照化合物为氯马斯汀。根据结果，建议长期使用时剂量为每日三次，每次2毫克（t.i.d.）。司他斯汀的抗组胺作用几乎等同于每日三次给予1毫克氯马斯汀的效果，但其抗乙酰胆碱作用超过了氯马斯汀，并且鉴于其精神方面的副作用较少，可能比氯马斯汀更易于耐受。
