| Abstract: | Clinical efficacies of newly developed synthetic oral ampicillin prodrug lenampicillin (LAPC, KBT-1585) applied to 109 cases of oral infection were studied. There were 7 dropout cases. The results as determined on a point system are as follow: Remarkably effective, 26 cases; effective, 63 cases; and not effective, 13 cases, for an efficacy rate of 87.3%. When rated by the subjective judgement of the doctors in charge, these figures are as follow: remarkably effective, 21 cases, effective, 67 cases; slightly effective, 10 cases; and not effective, 4 cases. The rate of efficacy in this way being 86.3%. In either way, the results obtained were favorable. Among 102 cases in this study, pus was aspirated with sterile needle from obstructed abscesses in 65 cases, with the result that 161 strains of bacteria were isolated and identified. Most of infections were found mixed type by aerobic Gram-positive cocci and anaerobes. Especially, cases caused by alpha-Streptococcus were observed in 48 out of 55 mixed infective cases. LAPC's MIC distribution against the detected bacteria showed strong antibacterial effect as follows: against Gram-positive cocci, less than 0.39 micrograms/ml; against Gram-negative bacteria (excluding some insusceptible strains), less than 3.13 micrograms/ml. Thus, LAPC demonstrated a superiority when compared to CEX by 4 approximately 128-fold, and when compared to AMPC by about 2-fold. Adverse reactions among the 109 cases consisted of 6 cases of gastro-intestinal disorders including 3 cases of diarrhea. Recognized cases of abnormal laboratory findings were 3 cases out of 76 (3.9%), but none were serious. |
