RESUMEN
BACKGROUND: Cyclosporin A (CsA) has been shown to be highly effective in the therapy of atopic dermatitis (AD). However, little information exists on the treatment of AD patients with Sandimmun Neoral(R) (Neoral), a microemulsion of CsA with improved pharmacokinetic properties in comparison to Sandimmun(R). OBJECTIVE: We have compared the efficacy and tolerability of Sandimmun and Neoral. METHODS: In a randomised, monocentric, double-blind, cross-over pilot study (n = 14), each formulation was administered for 8 weeks, followed by switching to the other treatment group for another 8 weeks. RESULTS: After 2 weeks of therapy, the improvement under Neoral therapy was significantly higher than with Sandimmun (disease activity p = 0.047; extent of disease p = 0.016). In contrast, after 8 weeks of therapy, both formulations yielded similar improvement in the patients' condition. CONCLUSION: While both formulations are effective and well tolerated in the treatment of severe AD, Neoral may have a faster onset of action and higher initial efficacy, which makes it an adequate replacement for Sandimmun.
Asunto(s)
Ciclosporina/uso terapéutico , Dermatitis Atópica/tratamiento farmacológico , Inmunosupresores/uso terapéutico , Adulto , Estudios Cruzados , Ciclosporina/administración & dosificación , Ciclosporina/efectos adversos , Método Doble Ciego , Emulsiones , Femenino , Cefalea/inducido químicamente , Humanos , Inmunosupresores/administración & dosificación , Inmunosupresores/efectos adversos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Proyectos Piloto , Prurito/inducido químicamente , Índice de Severidad de la Enfermedad , Trastornos del Sueño-Vigilia/inducido químicamente , Factores de Tiempo , Resultado del TratamientoRESUMEN
An open multicentre trial was conducted by 40 dermatologists in Switzerland involving 188 patients with onychomycosis of either the toenails or fingernails. Of these patients, 145 who had positive microscopy and culture of dermatophyte infection were evaluable: of the dermatophytes identified at the initial visit, 80% were Trichophyton rubrum and 12.4% were T. mentagrophytes. Only the most affected nail was evaluated during the observation period. Daily dosage was 250 mg of terbinafine (Lamisil) orally for up to 6 months. The cure rate (negative microscopy and culture) at the end of treatment was 77% for toenails and 100% for fingernails. A follow-up investigation was made 6 months after the end of treatment: of the 88 patients examined with onychomycosis of the toenail and the 14 with fingernail onychomycosis, 90.9% and 85.7%, respectively, remained free of recurrence. Of the 26 patients who had shown improvement, but not cure, by the end of the treatment period, 15 were clinically and mycologically cured at the time of the follow-up investigation. Terbinafine was generally well tolerated; the most frequent drug-related adverse events were mild-to-moderate gastrointestinal disturbances. Changes in liver or renal biochemical tests were not considered clinically relevant.