Comparative Clinical Study of Cefpiramide (SM-1652) and Cefmetazole for Respiratory Tract Infections by a Double-Blind Method

Abstract

The clinical efficacy and safety of cefpiramide (SM-1652, CPM) were compared with those of cefmetazole (CMZ) in 284 patients with respiratory tract infections by a double-blind study at 42 institutions in Japan.
Either of CPM or CMZ was assigned to each patient at random. Administration was performed by intravenous drip infusion for a fixed period of 14 days and the daily dosage was fixed at 2g for CPM or 4g for CMZ.
A committee consisting of several physicians who had not been informed of the name of actually given drug, made a judgement on the severity, therapeutic results and presence or absence of side effects in each patient based on the detailed subjective and objective symptoms, laboratory findings and chest X-ray films. Subsequently, the key code for the drug administered to each patient was opened, and a statistical analysis was carried out by a comparison between two groups (CPM group and CMZ group) with respect to background factors, clinical effectiveness, bacteriological effectiveness, degree of improvement and side effects.
Out of 284 cases, 236 cases were evaluted for clinical efficacy (CPM; 119 cases, CMZ; 117 cases) with 141 cases of pneumonia (CPM; 69 cases, CMZ; 72 cases) and 95 cases of chronic respiratory tract infection (CPM; 50 cases, CMZ; 45 cases), and 272 cases for tolerability (CPM; 140 cases, CMZ; 132 cases).
It was indicated that there was no significant difference between the two groups regarding background factors except CRP and initial degree of chest X-ray findings in patients with pneumonia.
The severe cases of initial chest X-ray findings in patients with pneumonia were existed significantly more in CMZ group than in CPM group.
With regard to the therapeutic effect of CPM and CMZ in the treatment of respiratory tract infection, those drugs were rated as effective in 91.3% of cases in the CPM group and 83.3% of cases in the CMZ group against pneumonia, and in 78.0% of cases in the CPM group and 80.0% of cases in the CMZ group against chronic respiratory tract infection. There were no statistically significant differences between the two groups concerning clinical effectiveness, bacteriological effectiveness and degree of improvement.
The incidence rate of side effects and abnormal laboratory findings was 4.3% and 18.6% in the CPM group, and 6.1% and 22.0% in the CMZ group, respectively, without significant differences between the two groups.
These results indicate that CPM is a usefull drug for the treatment of respiratory tract infections.