[Comparison of efficacy of combination of ketokonazol 400 mg + clindamycin 100 mg with ketokonazol 800 mg + clindamycin 100 mg in the treatment of vaginitis due to Candida and bacterial vaginosis].
OBJECTIVE
To evaluate the effectiveness of the combination of ketoconazol 400 mg + clindamycin 100 mg for 6 days compared to ketoconazol 800 mg + clindamycin 100 mg in Candida vaginitis and bacterial vaginosis.


METHODS
Patients aged 18-60 years, with clinical diagnosis of Candida vaginitis and vaginosis confirmed by culture of genital secretions were included. Patients were assigned at random to one of two treatment groups: group 1 was given ketoconazol 400 mg + clindamycin 100 mg during six days (K/C6D); group 2 received ketoconazol 800 mg + clindamycin 100 mg for three days + placebo during three days (K/C3D). Patients were evaluated at days 7 and 11 after initiating treatment, at day 11 culture of vaginal secretion was repeated; along with treatment and follow up period patients were asked to report presence of adverse events.


RESULTS
Eighty-two patients were included, 41 in K/C6D group and 40 in K/C3D group. C. albicans was found at baseline in 19 patients in K/C6D group and in 15 in K/C3D group; at day 11 was cultured in 2/19 patients (10.52%) and in 2/15 (13.33%) (p = 0.626) respectively; G. vaginalis was cultured at baseline in 25 patients of each group, at day 11 was cultured in 1/25 patients (4.0%) of K/C6D group and in 4/ 25 (16.0%) of K/C3D group (p = 0.174). Clinical cure was found in 36/41 cases (87.8%) of K/C6D group and in 34/40 cases (85.00%) of K/C3D (p = 0.965) group. Only five patients presented adverse events, of which three were related to the treatment.


CONCLUSIONS
Treatment of vaginitis and bacterial vaginosis with anyone of both formulations has the same clinical and microbiological effectiveness, and is well tolerated by the patient. The fact that K/C3D formulation is as effective as K/C6D has the advantage of shortening the treatment time of vaginal infections, and allows a better patient compliance.
Godínez
Victor
V
UMAE Hospital de Gineco-Pediatría núm. 48, Centro Médico Nacional del Bajío, IMSS, León, Guanajuato.
Garibay
Miguel
M
Mirabent
Felio
F
Pérez Calderón
Araceli
A
D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000935:Antifungal Agents / Q000008:administration & dosage*; D002177:Candidiasis / Q000188:drug therapy*; D002981:Clindamycin / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage*; D008875:Middle Aged; D014627:Vaginitis / Q000188:drug therapy* / Q000382:microbiology*; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D000935:Antifungal Agents; D002981:Clindamycin; D007654:Ketoconazole