[Fundamental and clinical studies on imipenem/cilastatin sodium in the field of obstetrics and gynecology].

Fundamental and clinical studies on imipenem/cilastatin sodium (MK-0787/MK-0791), a new carbapenem antibiotic, were performed and the following results were obtained. Concentrations of MK-0787 and MK-0791 in serum, internal genital organs and retroperitoneal fluid were determined after a 30 minutes drip infusion of 500 mg/500 mg dose. Venous serum levels of MK-0787 and MK-0791 were 47.3 to 67.5 micrograms/ml and 44.2 to 61.4 micrograms/ml, respectively, at the end of the administration. Sufficient transfer of MK-0787 and MK-0791 to internal genital organs and retroperitoneal fluid was demonstrated. In clinical trials, MK-0787/MK-0791 was given to 18 cases with obstetrical and gynecological infections, such as endometritis, puerperal fever, pelvic peritonitis, parametritis and lymphocystitis. The clinical efficacy was evaluated as excellent in 1 case, good in 14 and poor in 3. The efficacy rate was 83.3%. In a bacteriological study, 43 strains were isolated from 16 cases and the eradication rate was 61.1%. No side effects were observed in any of the cases. In laboratory findings, a transient elevation of GOT, GPT was noted in 1 case. From the above results, it was concluded that MK-0787/MK-0791 was useful drug for infections in the field of obstetrics and gynecology.