[Experimental and clinical evaluation of cefotetan in pediatrics].

Fundamental and clinical studies of cefotetan (CTT) were made in pediatric field and the following results were obtained. Antimicrobial activity MIC80 values of CTT against clinically isolated S. aureus (32 strains), E. coli (33 strains) and K. pneumoniae (33 strains) were 25, 0.1 and 0.1 microgram/ml respectively. Antimicrobial activities of CTT against E. coli and K. pneumoniae were superior to those of CMZ, though the activity against S. aureus was inferior to that of CMZ. Pharmacokinetics When 20 mg/kg of CTT was administered to 3 children, who were 3 to 8 years of age, by a intravenous bolus injection, the mean serum concentrations of the drug after 1/2, 1, 2, 4, 6 and 8 hours were 110.7 +/- 9.2, 81.7 +/- 10.1, 50.0 +/- 7.5, 25.3 +/- 4.6, 14.9 +/- 5.5 and 7.7 +/- 2.8 micrograms/ml respectively, and the mean half-life (beta) was 2.01 +/- 0.32 hours. The mean concentrations of the drug in urine after 0-2, 2-4, 4-6 and 6-8 hours were 1,377 +/- 787, 1,045 +/- 689, 1,067 +/- 680 and 358 +/- 80 micrograms/ml respectively, and the mean recovery rate by 8 hours was 67.3 +/- 16.2%. Clinical study CTT was administered to 42 children of 2 monthes to 14 years of age, and clinical response, bacteriological effect and adverse reaction of the drug were studied. Clinical effects were evaluated in 8 cases of acute purulent tonsillitis, each 1 case of acute otitis media and acute bronchitis, 16 cases of acute bronchopneumonia or acute lobar pneumonia, 9 cases of acute pyelonephritis and 1 case of erysipelas, the results were excellent in 30 cases, good in 3, fair in 2 and poor in 1, and thus 91.7% of efficacy rate was obtained. Out of suspected causative organisms including 12 strains of H. influenzae, 1 strain of H. parainfluenzae, 7 strains of E. coli, 2 strains of S. pyogenes, 2 strains of S. pneumoniae and each 1 strain of S. epidermidis and S. faecalis, all the strains except each 1 strain of H. influenzae and S. faecalis disappeared after the treatment. Thus 92.3% of eradication rate was obtained. No side effects were recognized. Though abnormal laboratory findings were observed in 3 cases (7.1%), including elevation of GOT and GPT in 2 cases and eosinophilia in 1 case, those findings came to be normal after the treatment.