DOUBLE-BLIND COMPARISON OF CEFAMANDOLE AND CEFAZOLIN

IN THE THERAPY OF RESPIRATORY TRACT INFECTIONS

Abstract

A cooperative study in 46 institutions and clinics in Tohoku and Hokkaido districts in Japan was carried out to compare the efficacy, usefulness and safety of cefamandole and cefazolin in treatment of respiratory tract infections by randomized double blind technique.
Two grams of either of the two cephalosporins were given by intravenous drip infusion to the two groups of patients aged over 16 years twicea day for 14 days.
Of a total of 232 patients included in the study, 120 patients were treated with cefamandole and 112 patients with cefazolin. Of these patients treated with either of the both drugs, 27 patients were excluded from evaluation for efficacy. All232 patients were adopted for analysis of side effects.
Characteristics of the population, sex and age distribution, severity of infections and infecting organisms before treatment were similar in eachtreatment group and no statistically significant differences could be found between the two groups. Both groups included nearly equal numbers of patients with underlying diseases or with complications. The patients pre-treated with other antibiotics before the start of the study or treated simultaneously with anti-inflammatory drugs were equally distributed in the both treatment groups.
Clinical cure rate was 69.2% in groups of the patients treated with cefamandole, whereas that in cefazolin treatment group was 62.2%. Thus, there was a difference of 7% in clinical cure rate between two treatment groups, though it was notstatistically significant. In groups of patients with acute bacterial pneumonia or lung abscess, clinical cure rate with cefamandole was76.7%, whereas that with cefazolin was 67.7%. Thus, the clinical cure rate was 9% higher in the group of patients treated with cefamandole, though the difference was again statistically not significant. In the group of patients with infections associated with chronic respiratory diseases, cefamandole cured SO% of the patients treated, whereas cefazolin cured 48.1%.
Comparison of the curves of cumulative distribution of MICsof cefamandole and cefazolin proved the superiority of cefamandole to cefazolin in antimicrobial activities against strains of various species isolated from the patients in the study. Rate of eradication of potential pathogenic microorganisms was 82.4% in the patients with pneumonia or lung abscess who were treated with cefamandole, whereas that was 66.7% in the patients treated with cefazolin.Thus eradication rate was higher by 15.7% in patients treated with cefamandole than in those treated with cefazolin and the difference in eradication rate was statistically significant (P <0.1).In patients with infections associated with chronic respiratory disease, bacterial eradication rate with cefamandole was 76.2%, whereas that with cefazolin was 83.3%.
Taking efficacy and adverse effects into consideration, usefulness of the two cephalosporins in the treatment of respiratory tract infections was evaluated by doctors in charge.In 33.3% of patients treated, cefamandole was evaluated as quite useful in the treatment of pneumonia or lung abscess.In contrast, cefazolin was evaluated as quite useful in only 18.3% of patient treated. This difference was statistically significant (P <0.1).In treatment of patients with infections associated with chronic respiratory disease, cefamandole and cefazolin were evaluated as quite useful or useful in 53.1% and in 51.8% of the patients treated with each drug, respectively.
Frequency and severity of adverse reactions to therapy was quite similar in the cefamandoleand cefazolin-treated groups.Comparison of laboratory test values obtained before, during and after the treatment with both agents showed that the two cephalosporins did not differ from each other in producing test values outside the normal limits and neither cephalosporin caused major toxic hepatic, renal and hematologic reactions.