[Efficacy evaluation of aztreonam for suppurative otitis media]

Abstract

Preclinical and clinical studies were performed to evaluate usefulness and safety of aztreonam (AZT) in the treatment of acute otitis media, acute exacerbation of chronic otitis media and chronic otitis media and the following results were obtained. MICs for P. aeruginosa, P. mirabilis and P. inconstans isolated from the patients with suppurative otitis media were 1.56 micrograms/ml, less than or equal to 0.025 micrograms/ml and less than or equal to 0.025 micrograms/ml respectively in their peaks. In the intravenous injection of 1 g, AZT concentration in the mastoid cell mucosa was 7.52 micrograms/g on average and serum concentration 51.6 micrograms/ml sufficiently suggesting clinical efficacy of AZT. In the clinical trial by administering AZT 1-2 g/day for the patients with suppurative otitis media, effective rates were 2/3 (66.7%) for acute otitis media, 16/22 (72.7%) for acute exacerbation of chronic otitis media, 21/34 (61.8%) for chronic otitis media and 6/7 (85.7%) for cholesteatoma of the middle ear. Elimination rate of single Gram-negative pathogens was 82.1% in the bacteriological studies of AZT. As for abnormal laboratory findings, 7 cases showed GOT, GPT elevations. However, they were in minor degree and transient. Side effect was not noted except 1 case of flushing with itching. It was considered from the above results that AZT is a highly useful antibiotic for suppurative otitis media.