1994 Volume 42 Issue Supplement4 Pages 535-548
The pharmacokinetics of biapenem (BIPM) in the biliary system was studied in patients without infection, and in addition, 27 patients were treated with this drug. Serial samples of bile and blood were taken from three patients with bile drainage after the intravenous administration of 0.3 g of BIPM over 30 min. In the plasma, peak levels of BIPM were 12.6-17.5μg/ml at one hour after the start of administration, and the levels decreased to 0.6-1, 1μg/ml by 6h. In the bile, peak levels were 4.5-11.0μg/ml at 1 to 3 h and the levels decreased to 0.4-1.3μg/ml by 5 to 6 h.
Of the 26 surgical infections (25 patients) that were evaluated in 27 patients (the additional patients could not be evaluated), clinical efficacy was excellent in 14, good in five, fair in five, and poor in two, with an efficacy of 73%. For postoperative infection (n=17), efficacy judged to be “excellent” was more common (p=0.028) than for primary infection. The bacteriological response by 26 strains isolated was evaluated. Fifteen strains were eradicated, the number of colony-forming units decreased with four strains, and seven strains persisted, with an eradication rate of 58%. The bacteriological response in the host was evaluated for 16 infections. Bacteria were eradicated in seven infections, decreased in four infections, were replaced in one infection, and persisted in four infections, with an eradication rate of 50%. Three of six strains of Staphylococcus aureus were eradicated. The MIC was 25μg/ml or more for 10 of the 27 strains, examined. Fifteen (62%) of 24 strains, for which the MIC was calculated were eradicated, 10 of the 13 strains for which the MIC was less than 12.5μg/ml were eradicated, and 5 of the 11 strains for which the MIC was 12.5μg/ml or more were eradicated. The safety of this drug could be evaluated in all 27 infections, and abnormal changes in laboratory data were found in five patients. One change involved renal function, and according to the attending physicians, the drug might be the cause.
BIPM seemed to be fairy effective for surgical infections, including those involving the biliary system.
