Abstract
A double-blind comparison of biapenem (BIPM), a new parenteral carbapenem, and imipenem/cilastatin (IPM/CS) was carried out in the treatment of complicated urinary tract infection. Patients were randomly assigned to receive either 300 mg b. i. d. of BIPM or 500mg/500mg b.i.d. of IPM/CS for 5 days by intravenous drip infusion. All patients were shown to have pyuria of at least 5 WBC per high power field, bacteriuria of at least 104 CFU per ml of urine and identifiable underlying urinary tract disease. Overall chinical efficacy was evaluated on the basis of criteria proposed by the Japanese UTI Committee as “excellent, ” “moderate” or “poor.” Of the 200 patients evaluated for clinical efficacy, 98 patients received BIPM and 102 received IPM/CS. No significant differences were observed in the background characteristics between the two treatment groups except that the age distribution in the BIPM group was higher than that in the IPM/CS group (p<0.1). The overall efficacy rate was 82.7% in the BIPM group and 77.5% in the IPM/CS group. The difference was not statistically significant. The bacteriological eradication rate was 90.2% of 163 strains in the BIPM group and 86.3% of 161 strains in the IPM/CS group, the difference being not statistically significant. Clinical adverse reactions were experienced in 1.9% of 107 patients in the BIPM group and in 1.8% of 112 patients in the IPM/CS group. Laboratory adverse reactions were observed in 9.5% of 105 patients in the BIPM group and in 7.3% of 109 patients in the IPM/CS group, with no significant differences regarding the incidences of either clinical or laboratory adverse reactions. Global safety and clinical value were not significantly different between the two treatment groups. From the results obtained in this study, we concluded that treatment of complicated urinary tract infection with 300mg b.i.d. of BIPM is as effective and well tolerated as that with 500 mg/500mg b.i.d. of IPM/CS.
