Avaliação da eficácia e tolerabilidade do uso de óvulos vaginais contendo metronidazol e nitrato de miconazol no tratamento de vaginites

Abstract

Infections of the lower female genital tract are one of the principal reasons for women to seek gynecological care. Throughout their lifetime, 75% of women will have at least one episode of this affliction. A projection for Brazil estimates that the costs resulting from vaginitis are close to 80 million dollars annually. Bacterial vaginosis, candidiasis andtrichomonas are together responsible for more than 90% of all vaginal infections. Vaginal applications of miconazole nitrate are known to give excellent results in the treatment of fungal vaginitis, and vaginally applied metronidazole is effective in the treatment of bacterial vaginosis. The principal objective of this study was to evaluate the efficacy andtolerability of a vaginal pessary containing 750 mg of metronidazole and 200 mg of miconazole nitrate used daily for seven days in the treatment of vaginitis caused by Candida sp., Trichomonas vaginalis and bacterial vaginosis. An open, non-comparative, prospective, multicenter, phase III trial was carried out in five research centers in Brazil. The protocol of the study was approved by the internal review board of each center and bythe National Ethics Committee of the Brazilian Ministry of Health (CONEP). Ninety-two women with vaginitis participated in this study and inserted one vaginal pessary daily for seven days. Gynecological and microbiological evaluations were carried out prior to and following treatment. McNemars test was used for comparison of qualitative variables. Wilcoxons test was used for the comparison of quantitative variables. Reductions occurred in symptoms and signs of vaginitis. Clinical cure rate was 87.7%, while the cure rates according to microscopy and Candida albicans culture were 81.8% and 73.9%,respectively. The cure rate for bacterial vaginosis was 80% and culture of Gardnerella vaginalis turned negative in 63.6% of cases following treatment. The medication was well-tolerated. Use of the combination of 750 mg of metronidazole and 200 mg of miconazole in one single daily application was found to be effective in the treatment of the most common causes of vaginitis and was well-tolerated.