Roseeuw D, Willemsen M, Kint R T, Peremans W, Mertens R L, Van Cutsem J
Department of Dermatology, Free University of Brussels, Belgium.
Clin Exp Dermatol. 1990 Mar;15(2):101-4. doi: 10.1111/j.1365-2230.1990.tb02041.x.
Ninety-four patients with dermatophytosis and 16 patients with pityriasis versicolor were assigned under double-blind conditions to oral itraconazole (100 mg once daily) or placebo. The medication consisted of two capsules, each containing 50 mg of active substance, or placebo and was given for 15 or 30 days in patients with dermatophytosis and for 15 days in patients with pityriasis versicolor. Patients with pityriasis versicolor who had not responded at the end of the double-blind period were treated on an open basis with itraconazole (100 mg once daily) for 15 days. In the treatment of dermatophyte infections for 30 days, both clinical response and mycological cure were significantly superior in the itraconazole group compared with placebo. Oral administration of itraconazole (100 mg once daily) was also highly efficacious in the treatment of pityriasis versicolor. None of the placebo patients was clinically or mycologically cured at the end of the double-blind phase compared to seven out of eight itraconazole patients. All placebo patients who entered the open phase responded to itraconazole treatment. Three itraconazole-treated patients and nine placebo-treated patients reported side-effects.
94例皮肤癣菌病患者和16例花斑癣患者在双盲条件下被分配接受口服伊曲康唑（每日1次，每次100mg）或安慰剂治疗。药物由两粒胶囊组成，每粒含50mg活性物质或安慰剂，皮肤癣菌病患者服用15或30天，花斑癣患者服用15天。双盲期结束时无反应的花斑癣患者接受开放治疗，口服伊曲康唑（每日1次，每次100mg），疗程15天。在治疗皮肤癣菌感染30天时，伊曲康唑组的临床反应和真菌学治愈率均显著优于安慰剂组。口服伊曲康唑（每日1次，每次100mg）治疗花斑癣也非常有效。双盲期结束时，安慰剂组患者无一例临床或真菌学治愈，而伊曲康唑组8例中有7例治愈。所有进入开放期的安慰剂组患者对伊曲康唑治疗均有反应。3例接受伊曲康唑治疗的患者和9例接受安慰剂治疗的患者报告有副作用。
