Basic and clinical evaluation of Cefotiam (CTM), a second generation cephem, was performed with reference to otorhinolaryngological infections.
1. The susceptibility of isolates from otorhinolaryngological infections to CTM was examined. The MICs of CTM were 0.1-0.39mcg/ml for β-Streptococci, 0.2-0.78mcg/ml for S. aureus, 0.1mcg/ml for S. pneumoniae, 0.39mcg/ml for H. influenzae, 0.1-0.78mcg/ml forPeptostreptococcus, 0.39mcg/ml for B. melaninogenicus, and 25mcg/ml for Fusobacterium.
2. Tissue concentrations of CTM were also examined. Mean concentrations in the palatine tonsilla after rapid intravenous injection of 0.5g in children and 1g in adults were 11.2-28.3mcg/g at 30 to 40 minutes, 1.8-7.4mcg/g at 45 to 60 minutes and 0.6mcg/g at 120 minutes, and 1.7-2.6mcg/g at 60 minutes, 3.3mcg/g at 110 to 150 minutes. Mean concentrations of CTM in the mucous membrane of the maxillary sinus after rapid intravenous injection of 1g was 10-13mcg/g at 30 to 40 minuts, 6.0-8.3mcg/g at 60 minutes, and 2.8-2.9mcg/g at 120 to 130 minutes. Mean concentrations of CTM in otitis media exudates after rapid intravenous injection of 1g were 32.6mcg/g at 30 minutes, 20.0mcg/g at 60 minutes and 1.4mcg/g even at 420 minutes in patients with serious infections, and in moderate infection, 9.2mcg/g at 30 minutes, 7.7-9.9 at 60 minutes and 12.7 at 90 minutes.
3. CTM was administered to 51 patients with otorhinilaryngological infections for 2 to 15 day at daily dosages of 0.5 to 1g by intramuscular injection or intravenous drip infusion (60 to 90 minutes) in one or two divided doses to evaluate clinical and bacteriologic efficacy. In the evaluation of clinical efficacy, 88% (22/25) were rated as effective in acute tonsillitis, 100% (5/5) in peritonsillar abscess, 57.1% (4/7) in chronic otitis media at acute excerbation stages, and 80% (4/5) in acute pharyngitis. The overall efficacy rate was 86.3%. Bacteriologically, eradication was noted in 91% for Gram-possitive cocci: 100% (18/18) for β-Streptococci, 78% (7/9) for S. aureus, 100% (3/3) for S. pneumoniae; 67% for Gram-negative bacilli: 100% (2/2) for H. influenzae; and 88% (7/8) for anaerobic organisms: 100% for Peptostreptococcus, 100% for B. melaninogenicus. Side effects, objective or subjective, or abnormal laboratory findings were not detected.
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