Avaliação da eficácia e segurança do tacrolimo pomada 0,03% no tratamento da dermatite atópica em pacientes pediátricos

• Autor(a) principal: Gontijo, Bernardo
• Data de Publicação: 2008
• Outros Autores: Duarte, Ida A. Gomes, Sittart, José Alexandre de Souza, Pires, Mario Cezar, Takaoka, Roberto, Cestari, Silmara da Costa Pereira [UNIFESP], Cestari, Tania Ferreira, Aun, Wilson Tartuce, Oliveira, Zilda Najjar P. de, La Scala, Cintia Sayuri Kurokawa [UNIFESP]
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Repositório Institucional da UNIFESP
• Texto Completo: https://dx.doi.org/10.1590/S0365-05962008000600003; https://repositorio.unifesp.br/handle/11600/4673
• topic: Child; Dermatitis; Dermatitis, atopic; Eczema; Tacrolimus; Criança; Dermatite; Dermatite atópica; Eczema; Tacrolimo

BACKGROUND: Tacrolimus ointment has been shown to be effective in treatment of atopic dermatitis. OBJECTIVES: To evaluate the efficacy and safety of 0.03% tacrolimus ointment (Protopic®) in pediatric patients with mild, moderate and severe atopic dermatitis. METHODS: Open, non-comparative, multicentric study carried out in Brazil. 174 patients (ages from two to 10) with mild to severe atopic dermatitis were included. Patients were instructed to apply Protopic® twice a day for six weeks. Primary efficacy criterion was clinical improvement > 90% assessed by the physician (Clinical Response Global Evaluation Scale). Other efficacy criteria included reduction of the Eczema Area Severity Index (EASI), decrease of the affected body surface area (%BSA) and evaluation of the itching by the patients or their guardians (visual analogical scale). Safety was evaluated by adverse events reported by patients and/or guardians or by investigators. RESULTS: Thirty-three percent of patients showed clinical improvement > 90%. 45.5% of patients (1st week) decreased EASI and 61.8% (6th week) (p<0,001). %BSA decreased 30.4% and 55.5% in the first and sixth week. Improvement was also significant when measured by itching (p<0,001). Most frequentadverse effects were: burning and itching. CONCLUSION: 0.03% tacrolimus ointment is a safe and effective therapy for mild to severe atopic dermatitis in pediatric patients.