Vol.53 No.S-1 July 2005
Basic and clinical studies on doripenem in obstetrics and gynecology
1)Department of Obstetrics and Gynecology, Saiseikai Suita Hospital,
1-2 Kawazono-cho, Suita, Osaka, Japan
2)Department of Obstetrics and Gynecology, Matsushita Memorial Hospital
3)Department of Obstetrics and Gynecology, Numakuma Hospital
4)Department of Obstetrics and Gynecology, Koto Hospital
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 μg/g, in uterine appendages<0.20-10.6 μg/g and in plasma 0.80-21.5 μg/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 μg/mL (250 mg infusion) and 9.53-13.9 μg/mL (500 mg infusion), and maximum plasma concentration (Cmax) at the end of infusion were 14.0-30.8 μg/mL (250 mg infusion) and 26.2-50.7 μg/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.
Key word
doripenem, antibacterial activity, pharmacokinetic, gynecology
Received
January 11, 2005
Accepted
February 23, 2005
Jpn. J. Chemother. 53 (S-1): 273-285, 2005
