Efficacy of oral terbinafine the treatment of onychomycosis / 대한피부과학회지

ABSTRACT

An open multicenter trial was conducted to assess the efficacy and tolerability of oral terbinafine in the treatment of onychomycosis during 10 months from April, 1992 to February, 1993. Of patients with clinically and mycologically proved onychomycosis recruited from the Department of Dermatology of 29 university and training hospitals in the Korea, 143 patients who could be followed up at the end of the study were evaluated. The group of fingernail infection received orally terbinafine 250mg once daily for 8 weeks and the group of toenail infection for 16 weeks. After stopping treatment, all patients were followed up for 12 weeks. The results were as follows: 1. On the mycological study at the initial visit, 101 causative organisms were isolated from 99 pateints and Trichophyton rubrum was common organism (40 strains). 2. The length of healthy, unaffected nail were increased significantly more than two-fold after the end of treatment and at the follow-up investigation, those were 11.8mm in fingernail group and 9.8mm in toenail group. 3. The mean of all clinical symptom scores on entry diminished significantly by the time of the end of treatment and cleared mostly at the follow-up. 4. The mycological cure rate(negative microscopy and culture) was 56.5% for fingernails and 69.3% for toenails at the end of treatment and 100% for fingernails and 89% for toenails at the follow-up investigation. 5. overall efficacy assessed by the patient and by the investigator were evaluated as more than moderate in 93.1% and 94.5% of patients and overall tolerability were evaluated as more than moderate in 100% of patients by both of them. 6. The adverse effects of terbinafine were noted in 10 patients(7%) out of the 143. The most frequent drug-related adverse events were mild-to-moderate gastrointestinal disturbances. Any changes in liver biochemical tests were not considered clinically relevant. In conclusion, oral terbinafine is effective and safe in the treatment of onychomycosis. Our results demonstrate that a treatment period of 8 weeks for fingernail onychomycosis and 16 weeks for toenail onychomycosis is sufficient.