[Clinical effect and safety of miconazole nitrate 1200 mg in t...

OBJECTIVE: To investigate the clinical effect and safety of miconazole nitrate 1200 mg in treating vulvovaginal candidiasis (VVC). METHODS: An open, multicentre, non case control clinical trial was conducted in 568 patients suffering from VVC from Jul 1, 2006 to Nov 30, 2006. Routine examination, score of clinical symptoms and physical signs, mycetology test and safety evaluation were done in all patients before treatment, 7 - 14 days after treatment and 30 days after treatment. RESULTS: Seven to fourteen days after treatment, 563 patients could be followed and 323 patients (57.3%) were cured. The overall effective rate was 90.2%. The mycologic cure rate was 91.3% (514). Thirty days after treatment, 480 patients could be followed and 411 patients (85.6%) were cured. The total effective rate was 96.0%. Mycologic cure rate was 92.3% (443/480). Adverse effect rate was 2.7% (15/563) and they were relieved without any treatment in one or two days. CONCLUSIONS: Miconazole nitrate 1200 mg is effective in the treatment of VVC, with good compliance and few adverse effects. Moreover, it can be accepted easily.