Fundamental and clinical studies on cefluprenam in the surgical field

The pharmacokinetics and clinical studies were undertaken to evaluate the effect of intravenously administered cefluprenam (CFLP) on the surgical infections. 1. Peritoneal exudate was collected for 3 consecutive days through a Foleys balloon catheter inserted to the subphrenic space at the end of surgery. One g of CFLP was administered twice a day to 3 patients after gastrectomy for gastric cancer. CFLP levels in exudate at 1, 2 and 3 postoperative days were 8.0, 11. 1 and 11.1μg/ml in avarage respectively. The relative mean concentration of CFLP was 5.1μg/ml and belonged to the high value group among 30 β-lactams. 2. Concentration of CFLP in choledocus bile was studied on 1 patient of choledocolithiasis after cholecytectomy and T-tube drainage. Bile levels at 1, 2, 4, 6 and 8 hours after CFLP (1.0g) administration were 0.3, 0.3, 1.9, 4.0 and 4.7μg/ml respectively. 3. In the clinical study, 16 patients received intravenous CFLP (1 or 2g), bid for 4 ~ 16 days. Sixteen patients consisted of 2 cholangitis, 2 panperitonitis, 5 localized peritonitis, 3 postoperative wound infection, 1 burn wound infection, 1 ileopsoas abscess, 1 abdominal wall abscess and 1 periproctal abscess. The clinical effects were excellent in 2 cases, good in 12 cases, fair in 1 case and poor in 1 case ; overall clinical response rate in 16 cases was 87.5%. No adverse drug reaction was noted but slight abnormal laboratory finding in S-GPT was recognized in 1 case. These results suggested CFLP may be useful drug to surgical infections including intraperitoneal infections.