Min D I, Noormohamed S E, Flanigan M J
Division of Clinical and Administrative Pharmacy, College of Pharmacy, University of Iowa, Iowa City 52242, USA.
Pharmacotherapy. 1995 Mar-Apr;15(2):164-9.
To determine the effect of erythromycin on ethanol's pharmacokinetics and perception of intoxication.
Double-blind, randomized, placebo-controlled, crossover study.
A clinical research center.
Ten healthy volunteers.
Erythromycin base 500 mg or identical placebo was administered 3 times/day for 7 days. On day 8, ethanol 0.8 g/kg was administered by mouth concurrently with erythromycin or placebo. A 2-week washout period was allowed between each treatment arm.
Twelve blood samples were obtained over a 12-hour period to determine ethanol concentrations. Perception of intoxication was determined at each time point using a 10-cm visual analog scale. Ethanol concentrations were determined using a gas chromatographic method. Mean +/- SD ethanol pharmacokinetics for erythromycin versus placebo were time to peak ethanol plasma concentrations 1.1 +/- 0.4 hours versus 1.3 +/- 0.3 hours, peak ethanol concentrations 118 +/- 18 mg/dl versus 114 +/- 27 mg/dl, ethanol oral clearance (CL/F) 2.9 +/- 0.8 ml/min/kg versus 3.4 +/- 2.2 ml/min/kg, and area under the curve 481 +/- 104 mg.hour/dl versus 465 +/- 132 mg.hour/dl (p > 0.05). The blood ethanol concentrations and perception of intoxication scores on a visual analog scale were well correlated (r2 = 0.78, p < 0.01). Mean +/- SD areas under the effect versus time curve were 35.1 +/- 20.7 cm/hour and 31.5 +/- 18.2 cm/hour for erythromycin and placebo, respectively (p > 0.05).
Oral erythromycin base 1500 mg/day compared with placebo does not alter ethanol's pharmacokinetics or perception of intoxication in healthy volunteers.
确定红霉素对乙醇药代动力学及醉酒感觉的影响。
双盲、随机、安慰剂对照、交叉研究。
临床研究中心。
10名健康志愿者。
红霉素碱500毫克或相同安慰剂每日3次给药,共7天。在第8天,口服0.8克/千克乙醇,同时服用红霉素或安慰剂。每个治疗组之间有2周的洗脱期。
在12小时内采集12份血样以测定乙醇浓度。使用10厘米视觉模拟量表在每个时间点测定醉酒感觉。采用气相色谱法测定乙醇浓度。红霉素组与安慰剂组乙醇药代动力学的均值±标准差分别为:乙醇血浆浓度达峰时间1.1±0.4小时对1.3±0.3小时,乙醇峰值浓度118±18毫克/分升对114±27毫克/分升,乙醇口服清除率(CL/F)2.9±0.8毫升/分钟/千克对3.4±2.2毫升/分钟/千克,曲线下面积481±104毫克·小时/分升对465±132毫克·小时/分升(p>0.05)。视觉模拟量表上的血液乙醇浓度与醉酒感觉评分相关性良好(r2 = 0.78,p<0.01)。红霉素组和安慰剂组效应-时间曲线下面积的均值±标准差分别为35.1±20.7厘米/小时和31.5±18.2厘米/小时(p>0.05)。
与安慰剂相比,健康志愿者每日口服1500毫克红霉素碱不会改变乙醇的药代动力学或醉酒感觉。