We performed a multicenter clinical trial of cefuzonam (CZON) to evaluate its efficacy and safety in 21 patients over 65 years old with biliary tract infections. CZON was intravenously administered (2~4 g/day) to 11 patients with acute cholecystitis, 8 patients with acute cholangitis and 2 patients with acute cholecystitis plus cholangitis. Seven patients were concurrently treated by biliary drainage. The following results were obtained. 1) The overall clinical efficacy rate was 100%. 2) Bacteriological efficacy was assessed in 4 patients. Bacterial eradication was observed in 3 patients, and bacterial decrease was seen in 1 patient. 3) The clinical adverse effect, skin eruption, which was observed in only 1 patient (5%), was mild and transient. 4) The clinical usefulness rate was 100%. 5) The concentration of CZON in the bile 1 hour after intravenous injection of 1 g of the drug was very favorable, 588. 8±276. 9μg/ml (mean in 5 patients). The serum concentration of CZON 1 hour after intravenous injection of 1 g of the drug was 64.7±16.3μg/ml. We conclude that CZON is very effective and safe in patients over 65 years old with biliary tract infections.
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