Basic and clinical studies on doripenem in obstetrics and gynecology

Accession number;05A0663330
Title;Basic and clinical studies on doripenem in obstetrics and gynecology
Author; OKADA HIROJI (Osakafusaiseikai Suitairyofukushise) YASUDA JINSUKE (Matsushita Health Insurance Organization, Matsushita Memorial Hospital, JPN) HIRABAYASHI KOJI (Shonankai Numakumabyoin) MATSUDA SEIJI (Koto Hospital, JPN)
Journal Title;Japanese Journal of Chemotherapy
Journal Code:F0608A
ISSN:1340-7007
VOL.53;NO.Supplement 1;PAGE.273-285(2005)
Figure&Table&Reference;FIG.3, TBL.13, REF.23
Pub. Country;Japan
Language;Japanese
Abstract;We conducted basic and clinical studies on doripenem (DRPM), a new carbapenem antibiotic, in obstetrics and gynecology, with the following results. 1. Tissue penetration of genital organs; We studied DRPM concentration in internal genital organs and plasma after intravenous drip infusion of 250 mg. DRPM concentration in the uterus was 0.33-9.89 .MU.g/g, in uterine appendages < 0.20-10.6 .MU.g/g and in plasma 0.80-21.5 .MU.g/mL 40-360 min after administration. We studied DRPM concentration in retroperitoneal fluid and plasma after intravenous drip infusion of 250 mg and 500 mg. After a 30 min-infusion of DRPM (250 mg and 500 mg), the maximum concentration in retroperitoneal fluid was 3.15-9.82 .MU.g/mL (250 mg infusion) and 9.53-13.9 .MU.g/mL (500 mg infusion), and maximum plasma concentration (Cmax) at the end of infusion were 14.0-30.8 .MU.g/mL (250 mg infusion) and 26.2-50.7 .MU.g/mL (500 mg infusion). 2. clinical evaluation; The 54 patients evaluable for clinical efficacy (intrauterine infection: 9; uterine adnexitis: 10; parametritis: 18; pelvic peritonitis: 14; and Douglas abscess: 3) had an efficacy of 88.9% (48/54). In microbiological efficacy, eradication was 80.0% (24/30). Adverse reactions observed in 2 patients consisted of drug eruption (1), tongue numbness, and hand-foot and general malaise (1), all of which were mild and disappeared during administration. Abnormal laboratory findings were observed in 22.0% of patients (11/50), most being slight elevations in liver function test such as GOT/GPT, with no severe changes reported. We concluded that DRPM is highly useful for treating gynecological infection. (author abst.)