Matsuda S, Hirayama H, Oh K
Department of Obstetrics and Gynecology, School of Medicine, Juntendo University.
Jpn J Antibiot. 1991 Jun;44(6):669-73.
Pharmacokinetic and clinical studies of flomoxef (FMOX) in perinatal period were carried out and the following results were obtained. 1. Concentrations of FMOX in maternal serum, umbilical cord serum and amniotic fluid were determined subsequently to intravenous injection (4 cases) and intravenous drip infusion method (20 cases) of 1 g FMOX. Maternal serum levels were similar to those of healthy adults, and peak levels of umbilical cord sera and amniotic fluids were 12.0 micrograms/ml and 12.05 micrograms/ml, respectively, using intravenous drip infusion. The levels in amniotic fluids were higher than those in umbilical cord sera at 2 hours after treatment in either administration method. Parameters T 1/2 (beta) and AUC were 1.05 hours and 74.1 micrograms.hr/ml, respectively. 2. In the treatment of 4 cases with perinatal infection and in prophylaxis cases, clinical efficacies of FMOX were all good with 1 g twice daily treatment using intravenous drip infusion. No side effects nor abnormal laboratory test values due to the drug were observed in any cases. These results indicate that single intravenous drip infusion of FMOX 1-2 g twice daily is effective for the treatment and the prophylaxis of perinatal infections.
进行了氟氧头孢（FMOX）围产期的药代动力学和临床研究，并获得了以下结果。1. 在静脉注射1g FMOX（4例）和静脉滴注法（20例）后，随后测定了母体血清、脐带血清和羊水中FMOX的浓度。母体血清水平与健康成年人相似，采用静脉滴注时，脐带血清和羊水的峰值水平分别为12.0微克/毫升和12.05微克/毫升。在任何一种给药方法中，治疗后2小时羊水水平均高于脐带血清水平。参数T 1/2（β）和AUC分别为1.05小时和74.1微克·小时/毫升。2. 在4例围产期感染治疗和预防病例中，采用静脉滴注每日2次、每次1g的治疗方案，FMOX的临床疗效均良好。在任何病例中均未观察到因该药物引起的副作用或实验室检查值异常。这些结果表明，每日2次、单次静脉滴注1 - 2g FMOX对围产期感染的治疗和预防有效。
