Vol.53 No.3 March 2005
Penetration of telithromycin into gynecological tissues and efficacy and safety in cervicitis patients
1)Department of Obstetrics and Gynecology, Aichi Medical University,
21 Azakarimata, Yasago, Nagakute-cho, Aichi, Japan
2)Department of Gynecology, Asoka Hospital (formerly Department of Obstetrics and Gynecology, Juntendo University Urayasu Hospital)
3)Department of Obstetrics and Gynecology, Matsushita Memorial Hospital
4)Division of Anaerobe Research, Life Science Research Center, Gifu University
4)Department of Obstetrics and Gynecology, Gifu University Hospital
5)Aventis Pharma Ltd.
Abstract
A clinical pharmacological study to evaluate telithromycin (TEL), an oral ketolide antibiotic, for its penetration of female genital organ tissues, and a clinical study of administration of TEL 600 mg once daily for 5 days to patients with cervicitis caused by Chlamydia trachomatis or Neisseria gonorrhoeae were conducted, with the following results:
1. Distribution to female genital organ tissues (clinical pharmacological study)
In the 11 patients evaluated, mean tissue concentration in female genital organs at 180-435 minutes after a single dose of TEL 600 mg was 1.22 μg/g in portio vaginalis, 1.97 μg/g in cervix uteri, 2.37 μg/g in endometrium, and 2.61 μg/g in myometrium, and distribution ratios (tissue concentration/plasma concentration) ranged from 2.29 to 4.90.
2. Clinical efficacy
TEL 600 mg was administered once daily for 5 days, and clinical efficacy was evaluated on Days 14 and 28. Efficacy on Days 14 (53 patients) and 28 (50 patients) was 81.1% (43/53) and 96.0% (48/50).
3. Bacteriological efficacy
Bacteriological efficacy on Days 14 (53 patients) and 28 (50 patients) was 81.1% (43/53) and 96.0% (48/50). Eradication for C. trachomatis was 80.4% (37/46) on Day 14 and 95.3% (41/43) on Day 28, and for N. gonorrhoeae was 90.0% (9/10) on Day 14 and 100.0% (9/9) on Day 28.
4. Safety
Safety was evaluated in 58 patients, and the incidence of side effects in 56, excluding 2 for whom incidence could not be determined, was 26.8% (15/56). All side effects observed were either mild or moderate.
Results show that the administration of TEL 600 mg once daily for 5 days is clinically highly effective for cervicitis caused by C. trachomatis and N. gonorrhoeae, and this was backed by the fact that TEL was well distributed in female genital organ tissues.
Key word
telithromycin, uterine cervicitis, clinical efficacy, penetration
Received
December 16, 2004
Accepted
January 5, 2005
Jpn. J. Chemother. 53 (3): 225-238, 2005
