Author/Editor		De Cuyper, Christa
Title		Dolgoročni uspehi zdravljenja onihomikoze nohtov nog
Translated title		Long term outcomes in the treatment of toenail onychomycosis
Type		članek
Source		Zdrav Vestn
Vol. and No.		Letnik 68, št. Suppl 2
Publication year		1999
Volume		str. II-13-6
Language		slo
Abstract		Background. Little is known about the long term outcome of patients treated for toenail onychomycosis with the new antifungals terbinafine and itraconazole. Material and methods. Between 1991 and 1994 our center participated in two multicenter trials, the first comparing two doses of terbinafine 250 mg/day (group I) and 500 mg/day (group II), in a 16-week treatment of toenail onychomycosis, the second comparing terbinafine 250 mg daily and itraconazile 200 mg daily in a 12 week oral treatment of toenail onychomycosis. We analyzed the data of our patients separately and performed a long term follow-up of more than two years after the end of each study. Results. A total of 45 patients were enrolled in the first study, 37 completed the study protocol and were evaluated at week 48 (end of the study). In group I, 89% were clinically cured or had minimal residual lesions; 84% were mycologically negative. In group II, 94% were clinically cured or had minimal residual lesions, 94% were mycologically negative. Thirty-five patients returned for long term follow-up. In group I, 82% were clinically healed of had minimal residual leisons and 82% had negative mycology. In group II, 94% were clinically cured or had minimal lesions and 83% were mycologically negative. In the second study comparing terbinafine with itraconazole a total of 42 patients were included, 37 completed the study protocol, 34 returned for control two years later. At week 48, 75% in the terbinafine group were clinically cured or had minimal residual lesions, 90% were mycologically negative. (Abstracts truncated at 2000 characters).
Summary		Izhodiš!a. Pri bolnikih z onihomikozo nohtov nog je malo znanega o dolgoročnih uspehih zdravljenja z novima antimikotikoma - terbinafinom in itrakonazolom. Material in metode. Med letoma 1991 in 1994 smo sodelovali v dveh multicentričnih študijah. Prva je primerjala dva dnevna odmerka terbinafrina - 250 mg (skupina 1) s 500 mg (skupina 2) v 16-tedendkem zdravljenju onihomikoze nohtov nog, druga pa terbinafin 250 mg dnevno z itrakonazolom 200 mg dnevno v 12-tedenskem sistemskem zdravljenju onihomikoze nohtov nog. Pri bolnikih smo izsledke analizirali ločeno in opravili ponovno oceno več kot dve leti po koncu vsake študije. Rezultati. V prvo študijo smo vključili 45 bolnikov, od njih je 37 izpolnilo protokol študije in bilo ocenjenih v 48. tednu, ob koncu študije. V skupini 1 je bilo 89% klinično ozdravljenih ali so imeli minimalne rezidualne spremembe; 84% je imelo negativen mikološki izvid. V skupini 2 je bilo 94% bolnikov klinično ozdravljenih ali so imeli minimalne rezidualne spremembe; 94% je imelo negativen mikološki izvid. 35 bolnikov smo ponovno pregledali po daljšem času. V skupini 1 je bilo 83% klinično ozdravljenih ali so imeli minimalne spremembe, 82% je imelo negativen mikološki izvid. V skupini 2 je bilo 95% klinično ozdravljenih ali so imeli minimalne rezidualne spremembe in 83% z negativnim mikološkim izvidom. V drugo študijo, ki je primerjalna terbinafin z itrakonazolom, smo vključili 42 bolnikov, med njimi jih je 37 zaključilo protokol študije, 34 pa se jih je vrnilo na kontrolo po dveh letih. V 48 tednu je bilo v skupini, zdravljeni s terbinafinom, 75% klinično ozdravljenih ali so imeli minimalne rezidualne spremembe, 90% pa je imelo negativen mikološki izvid. (Izvleček prekinjen pri 2000 znakih).
Descriptors		ONYCHOMYCOSIS ANTIFUNGAL AGENTS ITRACONAZOLE DOUBLE-BLIND METHOD TREATMENT OUTCOME