Laboratory and clinical studies were carried out to evaluate the effectiveness and safety of panipenem/ betamipron (PAPM/BP) in the treatment of infections in otorhinolaryngology. The following results were obtained:
1. MIC
80, values of PAPM against isolates from patients with infection in otorhinolaryngology were found to be 50.025mcg/ml against
S. aureus, S. pyogenes, S. pneumoniae and
B. catarrhalis, 0.39mcg/ml against CNS and
H. influenzae and 6.25mcg/ml against
P. aeruginosa.
2. Penetration of PAPM into various tissues after the intravenous drip infusion of PAPM/BP at doses of 500mg/500mg, was detected on average by 0.93mcg/g in the mucosae of middle ears of 4 patients at 60 minutes after onset of treatment, by 4.23mcg/g in the mucosae of maxillary sinuses of 9 patients at 48-95 minutes after onset of treatment, and by 2.02mcg/g in the tonsillar tissues of 8 patients at 35-94 minutes after onset of treatment.
3. Clinical efficacy rates evaluated by physicians in charge were 76.9% for otitis media, 75.0% for sinusitis, 98.6% for tonsillitis, 100% for peritonsillitis and 94.1% for peritonsillar abscess, showing an overall efficacy rate of 89.7%. The results of the unified evaluation were comparable, disclosing and overall efficacy rate of 84.1%.
4. Bacteriological efficacy evaluations demonstrated eradication rates of 95.2% for monobacterial infection with Gram-positive organisms, 81.6% for monobacterial infection with Gram-negative organisms and 86.1% for polybacterial infection, showing an overall eradication rate as high as 91.5%.
5. Side effects occurred in 6 of 243 patients (2.5%), including 3 cases of diarrhea, 1 case of vomiting, 1 case of back pain and 1 case of diarrhea and rash. Abnormal laboratory findings including impaired liver and renal function were observed in 23 of 165 patients (13.9%) eligible for the evaluation. From these results, PAPM/BP was shown to be highly useful for the treatment of various infections in otorhinolaryngology, such as otitis media, sinusitis and tonsillitis (including peritonsillitis and peritonsillar abscess).
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