Efficiency of fenticonazole for the treatment of vaginal candidiasis

Abstract

Introduction. Uncomplicated vulvovaginal candidiasis appears in 75% women of reproductive age. The most frequent causes are Candida albicans (85-95%) or C. glabrata, and infrequently C. krusei, C. tropicalis, C. parapsilosis, C. pseudotropicalis, etc. Objective. The aim of the study was to investigate efficiency and safety of fenticonazole for vaginal candidiasis treatment. Methods. Therapeutic effect of a single 600 mg fenticonasole vaginal capsule was observed in 417 women, aged 16-67, in five centers in Serbia. In all women, before the treatment, vaginal candidiasis was confirmed by testing of vaginal smear. Based on smear findings and associated symptoms observed on the 7th and 28th day after therapy administration, treatment results were evaluated. On the next day after drug application the patients recorded by using a questionnaire their own feelings on withdrawal symptoms and possible side effects in the period prior to the first control. Results. Control after seven days showed a statistically significant decrease of symptoms. In 385 women, vaginal smear was found negative to yeast and yeast blastospores. Within the first seven days after treatment 84 women had to repeat therapy due to the persistence of symptoms or positive vaginal smear. After 28 days we recorded full recovery in 392 patients, clinical improvement in eight, no change in 16, and deterioration in one patient only. Side effects were very seldom, mostly in the form of a slight redness of the vulva and vagina, and mild itching during several days. Conclusion. Our observations confirmed good efficacy and safety of fenticonazole in the treatment of vaginal candidiasis.Uvod. Nekomplikovana vulvovaginalna kandidijaza javlja se kod oko 75% zena u reproduktivnom periodu. Najcesci uzrocnik je gljivica Candida albicans (85-95%), zatim C. glabrata, a retko C. krusei, C. tropicalis, C. parapsilosis, C. pseudotropicalis itd. Cilj rada. Cilj rada bio je da se ispitaju efikasnost i bezbednost vaginalne primene fentikonazola u lecenju zena s vaginalnom kandidijazom. Metode rada. Terapijsko dejstvo leka fentikonazola od 600 mg u obliku jedne vaginalne kapsule posmatran je na 417 zena starosti 16-67 godina u pet centara na teritoriji Srbije. Kod svih zena je pre pocetka terapije pregledom vaginalnog brisa potvrdjena vaginalna kandidijaza. Na osnovu rezultata analiza i pratecih simptoma 7. i 28. dana od primene terapije, posmatran je rezultat lecenja. Prvog dana nakon primene leka ispitanice su putem upitnika belezile subjektivni osecaj povlacenja simptoma i eventualne nezeljene reakcije u periodu do prvog kontrolnog pregleda. Rezultati. Na kontrolnom pregledu nakon sedam dana primeceno je statisticki znacajno smanjenje simptoma. Kod 385 zena zabelezen je negativni vaginalni bris na kvasnice i blastospore kvasnica. Potreba da se terapija ponovi u prvih sedam dana bila je kod 84 zene, zbog odrzavanja simptoma ili pozitivnog vaginalnog brisa. Posle 28 dana potpuno su izlecene 392 zene, klinicko poboljsanje je utvrdjeno kod osam zena, stanje bez promena je zabelezeno kod 16, a svega kod jedne zene doslo je do pogorsanja stanja. Nezeljene reakcije su se javljale retko, najcesce u vidu blago izrazenog crvenila vulve i vagine i blagog peckanja koje je trajalo svega nekoliko dana. Zakljucak. Rezultati istrazivanja su potvrdili dobru efikasnost i bezbednost fentikonazola u terapiji vaginalne kandidijaze.