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Low-dose ketoconazole-fl uconazole combination versus fl uconazole in single doses for the treatment of vaginal candidiasis
Article from Journal - ilmiah nasional - terakreditasi DIKTI
Medical Journal of Indonesia vol. 20 no. 3 (Aug. 2011)
low-dose ketoconazole-fl uconazole combination
Volume 20, Issue 3, August 2011 - Low-dose ketoconazole-fl uconazole combination versus fl uconazole in single doses for the treatment of vaginal candidiasis.pdf
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Abstract Background: Vaginal candidiasis (VC) is one of the most common fungal diseases. Candida albicans is the most common causative fungus and has been isolated from more than 80% of specimens obtained from women with VC. Ketoconazole is the fi rst orally active antifungal, the dosage for VC is 200 mg twice daily for 5 days. Fluconazole is the newer oral antifungal, its dosage for VC is a single oral dose of 150 mg. Since fl uconazole 150 mg is considerably expensive, a single dose of 100 mg ketoconazole and 40 mg fl uconazole in combination has been tested for the treatment of VC. The results showed that from 11 women with confi rmed VC, 1-2 weeks after drug administration, the mycological culture was negative in 8 women, positive in 1 woman, and 2 woman lost to follow-up. This promising result led to the present study with the objective to confi rm the effi cacy and safety of the above combination in a formal clinical trial. Methods: A total of 165 female patients, aged 18 years or older, with the diagnosis of VC from clinical symptoms (pruritus or burning or excessive discharge) and positive microscopic smear (pseudohyphae and/or yeast cells) were randomized to receive a single dose of either keto-fl uco combination (n = 85) or fl uconazole (n = 80), and returned for follow-up visit on day 8. Results: Among these patients, 39 patients had negative baseline culture, leaving 126 patients eligible for effi cacy evaluation. The mycological eradication in the keto-fl uco group was 74.5% (41 patients from a total of 55 patients with available mycological culture), while that in the fl uconazole group was 70.2% (40 patients from 57 patients with available culture) and this difference was not signifi cant. The clinical favorable response (clinical cure and clinical improvement) in the keto-fl uco arm (n = 60) was 98.3%, while that in the fl uconazole group (n = 66) was 100%. Adverse events were found in 5 patients, 3 patients in the keto-fl uco group (3/85 = 3.5%) and 2 patients in the fl uconazole group (2/80 = 2.5%). Conclusion: The present study showed that the effi cacy and safety of ketoconazole 100 mg and fl uconazole 40 mg combination was not inferior compared to fl uconazole 150 mg in single doses for the treatment of vaginal candidiasis.
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