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.
In a 4-week double-blind trial, Daktacort® cream was compared with each of its constituents (i.e. miconazole 2% and hydrocortisone 1%) in a total of 63 patients (aged 12–60 years) with inflamed skin infections of bacterial or mycotic origin. Daktacort treatment induced a significant improvement of all symptoms within 1 week and was superior to both miconazole and hydrocortisone in suppressing the inflammation. This tendency persisted throughout the trial but at the end miconazole treatment proved also superior to hydrocortisone.
Oxatomide was evaluated in a double-blind study of 35 patients with chronic urticaria. For 5 weeks patients received at random either 30 mg oxatomide b.i.d. or a placebo. Oxatomide significantly reduced not only the duration of the attacks but also the severity of erythema, lesions and itching. This lower level of suffering was clearly reflected by a diminished need for additional antiallergic medication. The overall response to treatment was rated excellent or good in 72% of the oxatomide-treated patients against only 23% of the controls which is a significant difference. Sleepiness was reported in 1 patient of each group.
Cardiotoxicity by 5-fluorouracil has been reported as a rare complication in treatment protocols for adult patients with different malignant diseases. The combination with folinic acid as a biomodulatory substance and other cytotoxic drugs has been introduced to render protocols more effective and less toxic. We report severe but completely reversible cardiotoxicity of a treatment protocol for nasopharyngeal tumor (Schmincke tumor) of pediatric patients consisting of 5-fluorouracil, methotrexate, cisplatin and folinic acid in a 14-year-old boy who had no preexisting cardiac disease. The pathomechanism is briefly discussed.
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