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新型抗组胺药咪唑斯汀与劳拉西泮对健康志愿者精神运动表现和记忆的相互作用缺乏研究。

Lack of interaction between a new antihistamine, mizolastine, and lorazepam on psychomotor performance and memory in healthy volunteers.

作者信息

Patat A, Perault M C, Vandel B, Ulliac N, Zieleniuk I, Rosenzweig P

机构信息

Synthélabo Recherche, Clinical Research Department, Bagneux, France.

出版信息

Br J Clin Pharmacol. 1995 Jan;39(1):31-8. doi: 10.1111/j.1365-2125.1995.tb04406.x.

Abstract
  1. The possible interaction between a new H1 antihistamine, mizolastine, and lorazepam was assessed in a randomised, double-blind, cross-over, placebo-controlled study involving 16 healthy young male volunteers who received mizolastine 10 mg or placebo once daily for 8 days with a 1 week wash-out interval. The interaction of mizolastine, at steady-state, with a single oral dose of lorazepam or placebo was assessed on days 6 or 8 of each treatment period. 2. Psychomotor performance and cognitive function were evaluated using objective tests (critical flicker fusion threshold, choice reaction time, tapping, arithmetic calculation, body sway) and self-ratings (visual analogue scale, ARCI) before and at 2, 4, 6 and 8 h after dosing. Short-term memory (Sternberg memory scanning immediate free recall of a word list) and long-term memory (delayed free recall and recognition of words and pictures) were assessed before and at 3 h after dosing. Pharmacodynamic interactions were evaluated by repeated measures ANOVA in a 2 x 2 factorial interaction model. 3. Mizolastine, 10 mg once daily, at steady-state, was devoid of sedation and detrimental effect on skilled performance and memory. 4. In contrast, a single 2 mg dose of lorazepam produced marked impairment of psychomotor performance, cognitive functions (significant reduction in flicker fusion threshold, tapping and arithmetic calculation and increase in reaction times and body sway) and subjective sedation from 2 to 8 h after dosing. In addition, lorazepam induced an anterograde amnesia, characterised by a decrease in delayed free recall and recognition, and a deficit in short term memory.(ABSTRACT TRUNCATED AT 250 WORDS)
摘要
  1. 在一项随机、双盲、交叉、安慰剂对照研究中,评估了新型H1抗组胺药咪唑斯汀与劳拉西泮之间可能的相互作用。该研究纳入了16名健康年轻男性志愿者,他们每天接受一次10毫克咪唑斯汀或安慰剂治疗,为期8天,中间有1周的洗脱期。在每个治疗周期的第6天或第8天,评估稳态下咪唑斯汀与单剂量口服劳拉西泮或安慰剂之间的相互作用。2. 在给药前以及给药后2、4、6和8小时,使用客观测试(临界闪烁融合阈值、选择反应时间、敲击、算术计算、身体摆动)和自我评分(视觉模拟量表、ARCI)评估精神运动表现和认知功能。在给药前以及给药后3小时评估短期记忆(斯特恩伯格记忆扫描对单词列表的即时自由回忆)和长期记忆(单词和图片的延迟自由回忆和识别)。在2×2析因相互作用模型中,通过重复测量方差分析评估药效学相互作用。3. 每天一次10毫克的稳态咪唑斯汀对熟练操作和记忆没有镇静作用和不良影响。4. 相比之下,单剂量2毫克的劳拉西泮在给药后2至8小时对精神运动表现、认知功能(闪烁融合阈值、敲击和算术计算显著降低,反应时间和身体摆动增加)以及主观镇静产生明显损害。此外,劳拉西泮引起顺行性遗忘,表现为延迟自由回忆和识别减少以及短期记忆缺陷。(摘要截断于250字)

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