Quantitative analysis of electroencephalography (EEG) is used increasingly to evaluate the pharmacodynamics of benzodiazepines. The present study aimed to apply the EEG method as well as more traditional approaches to an interaction study of bromazepam and fluconazole. Twelve healthy male volunteers participated in a randomized, double-blind, four-way crossover study. The subjects received single oral or rectal doses of bromazepam (3 mg) after 4-day pretreatment of oral fluconazole (100 mg daily) or its placebo. Plasma bromazepam concentrations were measured before and 0.5, 1, 2, 3, 4, 6, 12, 22, 46, and 70 hours after bromazepam administration. Pharmacodynamic effects of bromazepam were assessed using self-rated drowsiness, continuous number addition test, and EEG. Fluconazole caused no significant changes in pharmacokinetics and pharmacodynamics of oral or rectal bromazepam. Rectal administration significantly increased AUC (1.7-fold, p < 0.0001) and Cmax (1.6-fold, p < 0.0001) of bromazepam. These changes following rectal dose may be due to avoidance of degradation occurring in the gastrointestinal tract. Rectal bromazepam also increased the area under the effect curves assessed by EEG (p < 0.05) and subjective drowsiness (p < 0.05). EEG effects were closely correlated with mean plasma bromazepam concentrations (r = 0.92, p < 0.001 for placebo; r = 0.89, p < 0.0001 for fluconazole). Thus, the EEG method provided pharmacodynamic data that clearly reflected the pharmacokinetics of bromazepam.

译文

脑电图 (EEG) 的定量分析越来越多地用于评估苯二氮卓类药物的药效学。本研究旨在将EEG方法以及更传统的方法应用于溴西epa和氟康唑的相互作用研究。12名健康男性志愿者参加了一项随机,双盲,四向交叉研究。受试者在口服氟康唑 (每天100毫克) 或其安慰剂4天预处理后接受单次口服或直肠剂量的溴西epa (3毫克)。在给予溴西epa之前和0.5、1、2、3、4、6、12、22、46和70小时后测量血浆溴西epa浓度。使用自测嗜睡,连续加数试验和EEG评估溴马西泮的药效学作用。氟康唑对口服或直肠溴西epa的药代动力学和药效学没有显着变化。直肠给药显着增加了bromazepam的AUC (1.7倍,p <0.0001) 和Cmax (1.6倍,p <0.0001)。直肠剂量后的这些变化可能是由于避免了胃肠道中的降解。直肠溴西epa还增加了通过EEG评估的效应曲线下的面积 (p < 0.05) 和主观嗜睡 (p <0.05)。EEG效应与平均血浆溴西泮浓度密切相关 (r = 0.92,安慰剂p <0.001; r = 0.89,氟康唑p <0.0001)。因此,EEG方法提供的药效学数据清楚地反映了溴西epa的药代动力学。

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