The efficacy and safety of Ketek ® tablets (telithromycin; TEL) were evaluated in outpatients aged 20 years or older with apparent symptoms of upper respiratory tract infections (sinusitis, tonsillitis or pharyngolaryngitis). The rates of the global clinical efficacy (effective rates) of TEL for acute sinusitis, an acute aggravation of chronic sinusitis and tonsillitis/pharyngolaryngitis were 63% (5/8), 60% (3/5) and 85% (18/21), respectively, and the overall effective rate was 77% (26/34). An adverse event of pharyngolaryngeal strange sensation occurred in one patient, and the incidence was 3% (1/40). The symptoms rapidly disappeared after discontinuing TEL administration. A total of 28 strains of the test-targeted strains (Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, and Moraxella catarrhalis) were isolated in a bacteriological test performed before TEL administration. TEL inhibited the growth of all these strains at a concentration of 1 ug/mL. This finding indicated that TEL has a potent antibacterial activity on the major causative bacteria of otorhinolaryngeal infections, and therefore it could be a useful therapeutic agent for these infectious diseases.
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