Fundamental and clinical studies of ASPC administered by intramuscular injection showed the following results.
1) When 1g of ASPC was injected i. m. in patients with suppurative otitis media, the maximum concentration in the otorrhea fluid was 3.91-10.94μg/ml 2 hours later. It was still maintained 1.12-2.06μg/ml after 4.5-8.0 hours. After IV injection, the concentration in the otorrhea fluid reached its maximum (5.09-29.69μg/ml) at 0.5-2 hours.
2) The minimum inhibitory concentration (MIC) of ASPC was tested with 106 cells/ml. The peak MIC was 3.13μg/ml against S. aureus and ≤0.05μg/ml against S. pyogenes and S. viridans.
The distribution of MIC against E. coli, S. pneumoniae and S. nonhaemolyticus was less than 6.25μg/ml.
3) ASPC was given to 32 patients with otorhinolaryngological infections, including 14 with acute tonsillitis, 9 with paranasal sinusitis and 5 with suppurative otitis media. The clinical effect was excellent in 15 cases, good in 8, fair in 3, poor in 4 and unknown in 2. Thus, the efficacy rate was 76.7%.
4) No side effects or abnormal laboratory findings were noted.