Kline S S, Mauro V F, Forney R B, Freimer E H, Somani P
School of Allied Health, College of Ohio, Toledo 43699.
Antimicrob Agents Chemother. 1987 Sep;31(9):1328-31. doi: 10.1128/AAC.31.9.1328.
A double-blind, placebo-controlled study in eight healthy male volunteers was conducted to study possible disulfiram-type reactions and hypoprothrombinemia associated with cefotetan administration. Three doses of cefotetan (2 g) or of placebo were administered at 12-h intervals. Ethanol (0.5 g/kg of total body weight) was ingested 1 h after the third dose. Blood ethanol, serum acetaldehyde, and prothrombin times were measured throughout the study. Heart rate, blood pressure, and clinical signs as well as symptoms suggestive of a disulfiram-type reaction were also noted. Five of eight volunteers that received cefotetan showed significant flushing. A significant increase in heart rate also was noted. No change in mean arterial pressure was observed during the cefotetan phase, and no one experienced nausea or vomiting. No statistical differences were observed between phases with respect to ethanol area under the time-concentration curve, elimination rate, or serum acetaldehyde concentrations. A slight but statistically significant increase in prothrombin time also was observed with cefotetan. This study suggests that patients receiving cefotetan might be at risk to develop disulfiram-type reactions and hypoprothrombinemia.
在8名健康男性志愿者中进行了一项双盲、安慰剂对照研究,以研究与头孢替坦给药相关的可能的双硫仑样反应和低凝血酶原血症。以12小时间隔给予三剂头孢替坦(2g)或安慰剂。在第三剂给药后1小时摄入乙醇(0.5g/kg总体重)。在整个研究过程中测量血乙醇、血清乙醛和凝血酶原时间。还记录了心率、血压、临床体征以及提示双硫仑样反应的症状。接受头孢替坦的8名志愿者中有5名出现明显潮红。还观察到心率显著增加。在头孢替坦阶段未观察到平均动脉压变化,也没有人出现恶心或呕吐。在乙醇时间-浓度曲线下面积、消除率或血清乙醛浓度方面,各阶段之间未观察到统计学差异。使用头孢替坦时还观察到凝血酶原时间有轻微但具有统计学意义的增加。这项研究表明,接受头孢替坦的患者可能有发生双硫仑样反应和低凝血酶原血症的风险。