1983 Volume 57 Issue 8 Pages 695-723
The clinical efficacy and safety of cefpiramide (SM-1652, CPM) were compared with those of cefmetazole (CMZ) in patients with complicated urinary tract infections by double-blind method.
Either of CPM or CMZ was assigned to each patient at random. Administration was performed by intravenous drip infusion for a fixed period of 5 days and daily dosage was fixed at each 2 g for CPM or CMZ.
Out of 249 patients, 211 patients (CPM; 110 cases, CMZ: 101 cases) were evaluated for clinical efficacy by the criteria proposed by UTI committee in Japan. It was indicated that there was no significant difference between the two groups (CPM group and CMZ group) regarding the all of background factors.
Overall clinical effectiveness; Response was excellent in 27.7%, moderate in 39.8% and poor in 32.5% of the CPM group, excellent in 17.3%, moderate in 33.3% and poor in 49.3% of the CMZ group. Response rate inclusive of excellent and moderate was significantly higher in the CPM group than in the CMZ (p<0.05).
Effect on pyuria; Rate of improvement (Cleared and Decreased) on pyuria was 44.6% in the CPM group and 36.0% in the CMZ group. There was no significant difference between the two groups.
Effect on bacteriuria; Rate of improvement (Eliminated and Decreased) on bacteriuria was 60.2% in the CPM group and 46.7% in the CMZ group. There was no significant difference between the two groups.
Bacteriological response; The eradication rate for all organisms isolated before treatment was 75.8% in the CPM group and 80.2% in the CMZ group. There was no significant difference between the two groups.
The incidence rate of side effects and abnormal laboratory findings were 2 cases (eruption 2) and 3 cases (elevation of transaminase), respectively in the CPM group and 1 case (itching and pericheiloparalysis) and 4 cases (elevation of transaminase or BUN), respectively in the CMZ group, with no significant differences between the two groups.
These results indicate that CPM is a useful drug for the treatment of complicated urinary tract infections.