Botween April 1991 and March 1992, a multicenter open trial was done to evaluate the therapeutic efficacy of itraconazole in the treatment of onychomycosis, 116 patients with onychomycosis diagnosed by clinical and mycological finding were
recruited
from the 24 university hospitals in Korea. They received 100mg of oral itraconazole once a day until clinical improvement was evident or until 12 months. Response to treatment was evaluated clinically and mycologically. Cure was complete absence
of
clinical lesions and negative mycological results. Marked improvment was minimal clinical lesions with negative mycology. Moderate improvement was some residual clinical lesions with positive mycology. Unchanged was no clinical response until 4
months
after therapy. Obtained results were as follows.
1. Mean duration of treatment was 6.3±2.0 months (2-12), and 83 (70.7%) were cured, 27 (23.3%) showed marked improvement, 2 (1.7%) were moderately improved, 3 (2.6%) were unchanged, and 2 (1.7%) were excluded due to the possible side effect of
the
medication, although they showed moderate improvement.
2. When only fingernails were involved, mean duration of treatment was 5.3±2.0 months with cure rate of 81.8%. when toenails were involved, mean duration of treatment was 6.5±2.0 months, which was significantly longer than that in fingernail,
however
cure rate was 66.7%, which was not different from that in fingernail.
3. In cases that Candida spp. were causative organism, 91.7% were cured with marked improvement in another 8.3%. Onychomycosis due to dermatophytes were cured in 72.9%. However, when moulds or T. beigelii were isolated, only one out of six was
cured.
4. 9 out of the 116 subjects showed possible side effects during itraconazole treatment. Gastrointestinal troubles were noted in seven, whicn were mostly mild and self-limited, however, in one patient, medications were withdrawn due to
continuing
gastric upset. In another patient, transient visual disturbance was noted and medications were also withdrawn. However, this patient was already suffereing from glaucoma and causal relationshiop was not established. Shoulder pain was noted in
another
one, however it was regarded probably unrelated to the drug, and medications were contiued without aggravation of the symptoms.
5. 88 patients were followed with serial biochemical liver function tests for two month interval. None of them showed evidence of hepatic injury during the entire observation period.
From the above findings, oral itraconazole was regarded as more effective than the preexisting drugs in the treatment of onychomycosis, and also it was regarded safe in long term therapy. (Kor J Dermatol 1992;30(4) : 508-518)
|