[Clinical studies of S6472 in otorhinolaryngologic infections]

A multicenter cooperative clinical trial was carried out on S6472 (a long-acting preparation of cefaclor (CCL)) to evaluate its effectiveness and safety in the treatment of infectious diseases in the field of otorhinolaryngology. The results are as follows: The clinical efficacy of the drug could be evaluated in 114 patients. An efficacy rate of 65.8% was obtained. The efficacy rate for each disease was found to be 60.0% for acute suppurative otitis media, 12.5% for chronic suppurative otitis media and 44.4% for acute exacerbation of chronic suppurative otitis media. The overall efficacy rate for all cases of suppurative otitis media was 46.4%. The efficacy rate for acute tonsillitis was found to be 93.1%. In the treatment of acute exacerbation of chronic tonsillitis, the efficacy of the drug was rated as excellent or good in all cases. The overall efficacy rate for all cases of tonsillitis was found to be 93.9%. In the treatment of other infectious diseases, the efficacy was rated as excellent or good in all cases. When the cases by resistant organisms to CCL were excluded from the evaluation, the overall efficacy rate of the drug was found to be 74.2%. The bacteria could be identified in 106 cases. Regarding the bacteriological efficacy of single infections, its bacterial elimination rate was found to be 81.1% for Gram-positive bacteria including S. aureus, S. epidermidis, etc., while it was 42.9% for Gram-negative bacteria. The overall elimination rate of bacteria in single infections was 73.1%. The bacterial elimination rate for mixed infections was found to be 85.7%, whereas it was 76.8% when the single and mixed infections were combined. Regarding side effects, 1 case each of diarrhea, soft stool and rash, or 3 cases in total (2.4%), were recorded in a total of 123 patients. However, the severity of each side effect was mild. Regarding abnormal laboratory findings, there were 1 case each of an increase in S-GPT, leukopenia and complication of eosinophilia and thrombocytopenia, or 3 cases in total (7.0%). Each of these adverse reactions was, however, transient in nature, and no serious cases were observed. On the basis of the above results, it was concluded that S6472 can provide sufficient clinical efficacy when it is administered at daily dosage of 750 mg or 1,500 mg in 2 divided doses after the breakfast and dinner.