Abstract
We conducted basic and clinical studies on 6315-S (flomoxef), a new oxacephem, in the field of obstetrics and gynecology, and obtained the following results
1) MIC's (106cells/ml) for S. aureus and E. faecalis were 0.39, and 100μg/ml, while MIC's for E. coli, K. pneumoniae, P. mirabilis, P. vulgaris and S. marcescens were 0.05-0.10, 0.05, 0.39, 1.56, 0.39-1.56μg/ml, respectively. All MIC's for P. aeruginosa were>100μg/ml.
2) When pregnant women were injected i. v. with 1.0g, maximum level in mothers and in umbilical serum was 86μg/ml 6 min, and 36μg/ml 50 min, and in amniotic fluid 50μg/ml 4 h 31 min after injection. At 3 h after injection, the level of in neonatal blood reached 2, 8-1.05μg/ml 3 h and in maternal milk 0.43μg/ml (mean value).
3) In the clinical study, 6315-S was administered i. v. g by single-dose i. v. injection or i. v. drip injection twice daily for 3-12 days to 5 patients (puerperal endometritis, 1; adnexitis, 1; operative wound infection, 1; and acute cystitis, 2). Clinical efficacy was excellent in 2 patients and good in 3. No side-effects or abnormal laboratory findings due to 6315-S were observed.