Abstract
A number of clinical studies have been reported concerning the clinical efficacy of oral antifungal drug therapy for onychomycosis. However, the reported success rate varies widely among studies. One possible reason for this is the enrolment of patients with different severity levels of the disease in the clinical studies. The severity of the disease in the previously reported clinical studies was mostly evaluated based on the nail discoloration ratio, with less importance being attached to other potentially important factors, such as the nail growth rate (factor determining the treatment period) and degree of nail thickening (factor determining the distribution of the orally administered antifungal drug to the lesion site). In our recent study conducted to evaluate the clinical efficacy of itraconazole against toenail tinea, we assessed the severity of the disease using the SCIO (Scoring Clinical Index for Onychomycosis)proposed by Dr.Sergeev. All of the patients with toenail tinea enrolled in our study had a relatively high SCIO score(20.5, on average) immediately before the start of the study, and many were classified as severe cases for whom the SCIO-based guidelines recommend treatment with a combination of oral antifungal drug + topical therapy (removal of sick nails with urea preparations, etc., or denailing). By six months after the start of the pulsed itraconazole therapy using 400 mg of the drug, the average SCIO score in the patients had decreased to 7.5. Overall evaluation of the clinical efficacy revealed a healing rate of 52.6% and response rate of 89.4%; thus, the therapy was found to be highly effective. The response rate to pulsed itraconazole therapy was also high even in those patients who had high SCIO scores at the start of the therapy. Thus, evaluation using the SCIO also revealed the usefulness of pulsed itraconazole therapy for toenail tinea.