THE CLINICAL USEFULNESS AND TRANSFERENCE OF CEFCAPENE PIVOXIL (CFPN-PI) INTO THE MATERNAL CUBITAL BLOOD, UMBILICAL BLOOD AND AMNIOTIC FLUID IN PREMATURE RUPTURE OF THE MEMBRANES
2001 Volume 54 Issue 2 Pages 95-102
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2001 Volume 54 Issue 2 Pages 95-102
We studied the transference of cefcapene pivoxil (CFPN-PI) into the maternal cubital blood, umbilical blood and amniotic fluid as well as its clinical usefulness. 58 pregnant women without complications who had a premature rupture of membranes after day 0 of the 36 th week of pregnancy and delivered a child with a normal transvaginal labor were enrolled this study. As a result, we found that the maternal serum level of CFPN-PI reached a detectable level at 1 hr 15 min post dose, reached the maximum (Cmax) at 2hr 30min, and was maintained at 0.15-1.14μg/ml until 4hr 35min. In the umbilical serum, the drug concentration reached a detectable level at 1 hr 45 min post dose, was maintained at Cmax of 0.40 μg/ml from 3 hr 3 min until 4 hr 27 min, and showed a level as high as 0.14μg/ml at 7 hr 7min. In the amniotic fluid, the drug concentration reached a detectable level of 0.09 μg/ml at 2 hr 48 min post dose, reached Cmax at 3 hr 55 min, and was maintained at 0.15-0.61μg/ml until 13 hr 37 min. Concerning the prophylactic effects of CFPN-PI against infections, one case of puerperal intrauterine infection in the parent and two cases of neonatal infection were observed, showing an effectiveness of 95%. In terms of adverse events, neither abnormality in maternal laboratory test data suspected as due to CFPN-PI, nor abnormality in subjective and objective findings was observed. In the neonates, no abnormality suspected as due to CFPN-PI was detected, either, including growth retardation until the 3-month medical examination. We think that CFPN-PI can be a first choice drug for prophylaxis of infections in cases of premature rupture of membranes after the 36th week of pregnancy, because of convenience of oral administration, coupled with excellent safety and potent prophylactic effectiveness against infections resulting from a long term maintenance of high levels in the umbilical blood and amniotic fluid.
