Girre C, Hirschhorn M, Bertaux L, Palombo S, Fournier P E
Unité de Pharmacologie Clinique, Hôpital Fernand Widal, Paris, France.
Int Clin Psychopharmacol. 1991 Winter;6(4):227-38. doi: 10.1097/00004850-199100640-00004.
The interaction between a single dose of 20 mg of prazepam and 0.5 g/kg body weight ethanol was investigated in 12 healthy male volunteers by nine objective performance tests, eight visual analogue self-rating scales and measurement of prazepam and ethanol plasma concentrations, using a double-blind three-way crossover design. The volunteers were each given three treatments (prazepam+ethanol, placebo+ethanol and prazepam alone), separated by a 2-week interval. They completed the performance tests before treatment and 1.5 and 4 h thereafter, and the self-rating scales before treatment, 1.5, 4 and 8 thereafter. To determine prazepam and ethanol plasma levels, venous blood samples were drawn before drug intake and 0.25, 0.5, 1, 1.5, 3, 4, 5 and 8 h thereafter. In two of the performance tests: auditory reaction time and digit symbol substitution, the combination of prazepam and ethanol was shown to impair performance more than either drug taken alone 1.5 h after their administration. A similar result was found for the drowsiness scored in the self-ratings. The time needed to complete the two-symbol cancellation test was longer when the subjects received prazepam either alone or combined with ethanol. Simultaneous ingestion of prazepam and ethanol did not alter the bioavailability of either drug.
采用双盲三交叉设计，通过9项客观性能测试、8项视觉模拟自评量表以及对普拉西泮和乙醇血浆浓度的测定，在12名健康男性志愿者中研究了单剂量20毫克普拉西泮与0.5克/千克体重乙醇之间的相互作用。志愿者每人接受三种治疗（普拉西泮+乙醇、安慰剂+乙醇和单独使用普拉西泮），间隔2周。他们在治疗前、治疗后1.5小时和4小时完成性能测试，在治疗前、治疗后1.5小时、4小时和8小时完成自评量表。为了测定普拉西泮和乙醇的血浆水平，在服药前以及服药后0.25、0.5、1、1.5、3、4、5和8小时采集静脉血样。在两项性能测试中：听觉反应时间和数字符号替换，结果显示，普拉西泮和乙醇联合使用在给药后1.5小时对性能的损害比单独使用任何一种药物都更大。自评量表中记录的嗜睡情况也有类似结果。当受试者单独服用普拉西泮或与乙醇合用时，完成双符号消除测试所需的时间更长。同时摄入普拉西泮和乙醇并未改变任何一种药物的生物利用度。
