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Giornale Italiano di Dermatologia e Venereologia 2000 June;135(3):399-406


language: Italian

Pooled analysis of 4 italian clinical studies on the efficacy and tolerability of fluconazole 100 mg/die in the treatment of cutaneous mycoses

Aste N.

Università degli Studi - Cagliari Dipartimento di Dermatologia


Background. Four comparative clinical studies were pooled to analyze data of patients receiving fluconazole 100 mg/day for the treatment of dermatomycoses (from 1992 to 1997).
Methods. A total of 358 patients was analyzed, 332 of whom were evaluated for the clinical and mycological efficacy. The principal clinical diagnoses were T. corporis (40.1%), T. pedis (26.5%) and T. cruris (18.7%). Most frequent fungal patogens were T. rubrum (30.7%), M. canis (17.2%), E. floccosum (16.0%) and T. mentagrophytes (15.7%).
Results. Clinical cure was observed in 273 patients (82%), while 44 patients (13%) showed improvement of their condition and 15 patients (5%) did not respond to therapy. Overall, 95.5% of patients were cured or improved at the end of therapy. Mycological eradication was obtained in 280 patients (84.3%). Persistence of the causative pathogen was recorded in 56 cases (17%) and superinfection in 3 (1%) cases (data missing for 9 patients). Mean duration of therapy was 20.9 days, with 45.2% of patients treated for less than 17 days. The analysis of duration of therapy by clinical diagnosis did not show any substantial difference, with the exception of a slightly longer mean duration of treatment for T. pedis (25.9 days). A total of 11 patients (3%) presented 13 adverse events of mild to moderate intensity, mostly related to the gastrointestinal tract. Eleven adverse events were thought to be related to the drug studied; in 3 cases (4 events), the treatment was interrupted as a result of the adverse event; in 2 cases (2 events), dose was reduced.
Conclusions. The high clinical and mycological efficacy of fluconazole is associated with a good safety: therefore, fluconazole is considered as therapy of choice for cutaneous mycoses, in particular when there is a extensive or atypical pathology.

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