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 first 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 fluconazole 150 mg is considerably expensive, a single dose of 100 mg ketoconazole and 40 mg fluconazole in combination has been tested for the treatment of VC. The results showed that from 11 women with confirmed 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 confirm the efficacy 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-fluco combination (n = 85) or fluconazole (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 efficacy evaluation. The mycological eradication in the keto-fluco group was 74.5% (41 patients from a total of 55 patients with available mycological culture), while that in the fluconazole group was 70.2% (40 patients from 57 patients with available culture) and this difference was not significant. The clinical favorable response (clinical cure and clinical improvement) in the keto-fluco arm (n = 60) was 98.3%, while that in the fluconazole group (n = 66) was 100%. Adverse events were found in 5 patients, 3 patients in the keto-fluco group (3/85 = 3.5%) and 2 patients in the fluconazole group (2/80 = 2.5%). Conclusion: The present study showed that the efficacy and safety of ketoconazole 100 mg and fluconazole 40 mg combination was not inferior compared to fluconazole 150 mg in single doses for the treatment of vaginal candidiasis.
Subject(s)
Candidiasis, Vulvovaginal , FluconazoleABSTRACT
Aim To identify the predictive factors and biomarkers in the progression of cervical precancer lesion or Cervical Intraepithelial Neoplasia (CIN). Methods The study was conducted from August 2007 to September 2008. Design of the study was case-control with stratifications of test dose response. The cases were patients with CIN. Control patients were non CIN patients. Bivariate analysis followed by multivariate analysis was conducted. Results There were 130 patients, consisting of 124 CIN patients divided into CIN 1, CIN 2 and CIN 3, with the following numbers of patients: 30, 41, and 33, respectively and 26 patients without CIN (non CIN). Bivariate analysis showed that age < 41 years, education ≥ 13 years, sexual partner ≥ 2, first sexual relationship at age < 22 years, smoking, the presence of sexuallly transmitted infections, positive HPV DNA, high p16INK4a, Ki-67, MCM5 and Survivin expression constituted independent variables for the occurrence of CIN with P value of < 0.05. However, on multivariate analysis, independent variables that emerged were age, education ≥ 13 years, sexual partner ≥ 2 persons, positive HPV DNA, and over expression of p16INK4a, Ki-67 and Survivin that showed a P value of < 0.005. Conclusion Younger ages, education age ≥ 13 years, sexual partner ≥ 2 persons, positive HPV DNA, high p16INK4a, Ki-67 and Survivin expression constituted the risk factors for the occurrence of the progress of CIN, and was used in the equation to predict the progress of cervical precancer lesion.