Laboratory and clinical findings on L-627 (Biapenem) in otorhinolaryngological infections

Abstract

Laboratory and clinical studies were carried out to evaluate the effectiveness and safty of L-627 in the treatment of otorhinolaryngological infections. The following results were obtained:
1. The L-627 concentrations in the paranasal tissue after an intravenous administration of 300 mg were 0.44-1.57μg/g in the mucous membrane of the auris media at from 55-120 minutes, 0.20-2.66μg/g in the mucous membrane of the maxillary sinus at 52-140 minutes, 0.28-1.6μg/g in the tonsillar tissue at 60-120 minutes.
2. The clinical efficacy rates were 69.2% for the otitis media, 91.3% for sinusitis, 83.3% for tonsillitis, 82.6% for peritonsillar abscess, while demonstrating an overall efficacy rate of 81.9%.
3. The MIC90 values of L-627 against isolates from patients with otorhinolaryngological infections were found to be 0.05μg/ml against S. pyogenes, 0.1μg/ml against S. aureus (MSSA), 0.2μg/ml against CNS, S. pneumoniae and Enterobacteriaceae, 0.78μg/ml against Streptococcus sp., Haemophilus sp. and P. aeruginosa 3.13μg/ml against other NE-GNR, 50μg/ml against S. aureus (MRSA), 100μg/ml against Corynebacterium sp.
4. Bacteriological efficacy evaluations demonstrated eradication rates of 87.2% for monomicrobial infections with gram-positive organisms, 93.3% for those with gram-negative organisms, 83.3% for those with anaerobic organisms and 78.3% for polymicrobial infections, while showing an overall eradication rate of 85.7%.
5. Side effects occured in 3 of 133 patients (2.3%), including 2 cases of rash and one case of diarrhea. Abnormal laboratory findings were observed in 5 of the 107 patients (4.7%)that were elegible for the evaluation.