Effect of Butoconazole Nitrate 2% Vaginal Cream and Miconazole Nitrate 2% Vaginal Cream Treatments in Patients with Vulvovaginal Candidiasis

摘要

In a multicenter, randomized, invesgtigator-blind, parallel study, 398 patients were dispensed topicalbutoconazole nitrate 2% cream for 3 days (n = 199) or miconazole nitrate 2% cream for 7 days (n =199) for vaginal use. Efficacy analyses included 254 patients with culture-confirmedCandida(119butoconazole and 135 miconazole users). Of the 398 patients issued study medication, 9 were lostto follow-up. Therefore, safety analyses included 389 patients (197 butoconazole and 192 miconazoleusers). Evaluations upon admission and approximately 8 and 30 days post-treatment includedCandidacultures, potassium hydroxide (KOH) wet mounts, and vulvovaginal examinations, withrating of vulvovaginal signs and symptoms using a 4-point scale. Rates of clinical cure (based onsign/symptom scores), microbiologic cure (based on cultures and wet mounts), and therapeutic cure(both clinical and microbiologic cures) were assessed and were to be similar between the regimens.Therapeutic cure rates were 57.8% and 61.4% for butoconazole and miconazole, respectively.Three-day butoconazole treatment was as safe and effective as 7-day miconazole therapy in treatingvulvovaginal candidiasis.