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 600mg once daily for 5 days to patients with cervicitis caused by Chiamydia trachomatis or Neisseria gonorrhoeae were conducted, withthe 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 600mg was 1.22μg/g in portio vaginalis, 1.97μg/g in cervix uteri, 2.37μg/g in endometrium, and 2.61μg/g g in myometrium, and distribution ratios (tissue concentration/plasma concentration) ranged from 2.29 to 4.90.
2.Clinical efficacy
TEL 600mg 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.trachoma tis was 80.4%(37/46) on Day 14 and 95.3%(41/43) on Day 28, and for N. gunorrhoeae 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 600mg 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.
