Pharmacokinetic profiles and clinical efficacy of doripenem in surgical infection

DOI 3 Citations 16 References

Bibliographic Information

Other Title
  • 外科感染症におけるdoripenemの体内動態と臨床効果

Search this article

Abstract

We conducted pharrnacoldnelic studies to determine the concentrations of doripenem (DRPM), a new carbapenem antibiotic with broad antibacterial activity, in bile and gallbladder tissue (early phase II study) and in peritoneal fluid (phase III study). A late phase II study and a phase III study were also conducted in patients with surgical infection to evaluate the clinical efficacy of DRPM. Results are as follows:<BR>1. Phamacokinenc profiles<BR>A single 30-minute intravenous infusion of DRPM (250mg) was administered to ten patients scheduled to undergo cholecystectomy. DRPM concentration in bile was<0.16-15.4μg/mL and in gall bladder tissue <0.10-1.87μg/g<BR>A single 30-minute intravenous infusion of DRPM (250mg) was administered to five patients who underwent abdominal surgery. Maximum plasma concentration was 10.5-24.4μg/mL and maximum peritoneal fluid concentration within the same period 2.36-5.17μg/mL.<BR>2. Clinical efficacy and safety<BR>safety Late phase II study (48patients): DRPM was administered at a dose of 250mg b. i. d., 250mg t. i. d., or 500mg b. i. d. for 3 to 14 days in 22 patients with postoperative infection, four with intraabdominal abscess, seven with peritonitis, four with liver abscess, six with cholecystitis, and five with cholangitis. Clinical efficacy was evaluated as “excellent” in 12, “good” in 31, “fair” in two, and “poor” in three, with efficacy of 89.6%(43/48). Bacterial eradication was 61.3%(19/31). Adverse drug reactions (symptoms) occurred in one of 48 (2.1%) and adverse drug reactions (abnormal laboratory findings) in seven of 46 (15.2%).<BR>Phase Ea study (15patients): DRPM was administered at a dose of 250mg b. i. d., 250mg t. i. d., or 500mg b. i. d. for 4 to 14 days in seven patients with intraabdominal abscess, two with liver abscess, and six patients with cholecystitis. Clinical efficacy was evaluated as “excellent” in two and “good” in 13, with efficacy of 100%. Bacterial eradication was 54.5%(6/11). Adverse drug reactions (abnormal laboratory findings) occurred in four of 15 (26.7%), with no adverse drug reactions (symptoms) reported in any.<BR>These results suggest that DRPM at a dose of 250mg b.i.d., 250mg t.i.d., or 500mg b.i.d. has a sufficient therapeutic effect on patients with surgical infection.

Journal

Citations (3)*help

See more

References(16)*help

See more

Keywords

Details 詳細情報について

Report a problem

Back to top