Laboratory and clinical studies were carried out to evaluate the effectiveness and safety of SY5555 for the treatment of otorhinolaryngological infections and the following results were obtaind:
1)The MICso values of SY5555 against clinical isolates from patients with infections in otorhinolaryngology were found to be 0.1mcg/ml against Streptococcus pneumoniae, 0.2mcg/ml against, Staphylococcus aureus, coagulase negative Staphylococcus and Moraxella catarrhalis, 0.39mcg/ml against Staphylococcus epidermidis and 0.78 mcg/ml against Haemophilus influenzae.
2)The clinical efficacy rates evaluated were 65.0% for otitis media, 69.6% for sinusitis, 87.2% for otitus externa, with an overall efficacy rate of 73.1%.
3)Bacteriological efficacy evaluations demonstrated eradication rates of 76.3% for monobacterial infections with Gram-positive organisms, 65.2% for monobacterial infections with Gram-negative organisms and 69.8% for polybacterial infections,while the overall eradication rate was 73.1%.
4)Side effects were observed in 17 of 244 patients (7.0%), while abnormal laboratory findings were observed in 12 of the 144 patients (8.3%) who underwent evaluation after treatment.
From the above results, SY5555 was shown to be highly useful for the treatment of various otorhinolaryngological infections such as otitis media, sinusitis, tonsillitis(including peritonsillitis and peritonsillar abscess) and otitis externa.
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