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在健康志愿者中使用心理生理测量方法进行的关于吡拉西坦抗低氧作用的随机安慰剂对照双盲交叉研究。

Randomized placebo-controlled double-blind cross-over study on antihypoxidotic effects of piracetam using psychophysiological measures in healthy volunteers.

作者信息

Schaffler K, Klausnitzer W

机构信息

Institute for Pharmacodynamic Research, Munich, Fed. Rep. of Germany.

出版信息

Arzneimittelforschung. 1988 Feb;38(2):288-91.

PMID:3370078
Abstract

The effects of two acute doses (1600 mg, 2400 mg) of 2-oxo-pyrrolidine-1-acetamide (piracetam, Normabraïn) on hypoxia resistance were screened vs placebo in a randomized, double-blind 3-way change-over design in 9 healthy male volunteers (mean age: 26.4 +/- 3.5 years; mean body weight: 74.9 +/- 8.4 kg). Psychophysiological measurements were done with the oculodynamic test (ODT) for oculomotor, performatory and additional cardiorespiratory parameters. Intradiurnal assessments were done under normoxia (prevalue) and hypoxic hypoxidosis (1 hypoxic prevalue, 3 postdose values: 1.0, 2.5 and 4.0 h) with a content of 10.5% O2 and 89.5% N2 in inspired air (hypoxic hypoxidosis)--as a model of brain dysfunctions, related with several types of senile dementia (Primary Degenerative Dementia = Alzheimer type; Multi Infarct Dementia). The results indicate that piracetam especially in its higher dose (2400 mg) displays antihypoxidotic effects already after a single administration in oculomotor, performatory and cardiorespiratory parameters.

摘要

在9名健康男性志愿者(平均年龄:26.4±3.5岁;平均体重:74.9±8.4 kg)中,采用随机、双盲、三向交叉设计,将两种急性剂量(1600毫克、2400毫克)的2-氧代吡咯烷-1-乙酰胺(吡拉西坦,脑复康)与安慰剂进行对比,以筛选其对缺氧耐受性的影响。通过眼动力测试(ODT)对眼动、行为表现及其他心肺参数进行心理生理学测量。在常氧(预值)和低氧低氧血症(1个低氧预值、3个给药后值:1.0、2.5和4.0小时)条件下进行日内评估,吸入空气中氧气含量为10.5%,氮气含量为89.5%(低氧低氧血症)——作为与几种类型的老年痴呆(原发性退行性痴呆=阿尔茨海默型;多发梗死性痴呆)相关的脑功能障碍模型。结果表明,吡拉西坦尤其是高剂量(2400毫克)在单次给药后,在眼动、行为表现和心肺参数方面已显示出抗低氧血症作用。

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Randomized placebo-controlled double-blind cross-over study on antihypoxidotic effects of piracetam using psychophysiological measures in healthy volunteers.在健康志愿者中使用心理生理测量方法进行的关于吡拉西坦抗低氧作用的随机安慰剂对照双盲交叉研究。
Arzneimittelforschung. 1988 Feb;38(2):288-91.
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