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Randomized double-blind clinical trial comparing clobetasol and dexamethasone for the topical treatment of symptomatic oral chronic graft-versus-host disease.
Noce, Cesar W; Gomes, Alessandra; Shcaira, Vanessa; Corrêa, Maria Elvira P; Moreira, Maria Cláudia R; Silva Júnior, Arley; Gonçalves, Lúcio Souza; Garnica, Marcia; Maiolino, Angelo; Torres, Sandra R.
Afiliación
  • Noce CW; Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
  • Gomes A; Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
  • Shcaira V; Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil.
  • Corrêa ME; Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil.
  • Moreira MC; Hematology Service, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
  • Silva Júnior A; Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
  • Gonçalves LS; Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
  • Garnica M; Hematology Service, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
  • Maiolino A; Hematology Service, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil. Electronic address: maiolino@hucff.ufrj.br.
  • Torres SR; Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
Biol Blood Marrow Transplant ; 20(8): 1163-8, 2014 Aug.
Article en En | MEDLINE | ID: mdl-24727333
Patients who undergo allogeneic stem cell transplantation frequently develop an immunologic disease caused by the reactivation of the graft to the host tissues. This disease is called graft-versus-host disease (GVHD) and it is usually a systemic disorder. In a large proportion of cases, oral disorders that are related to a chronic phase of GVHD (cGVHD) occur, and their treatment involves the use of topical immunosuppressive drugs. Several medications have been studied for this purpose, but only a small number of clinical trials have been published. The present study is a randomized, double-blind clinical trial that compares topical clobetasol and dexamethasone for the treatment of symptomatic oral cGVHD. Patients were randomly assigned to treatment with clobetasol propionate .05% or dexamethasone .1 mg/mL for 28 days. In both arms, nystatin 100,000 IU/mL was administered with the corticosteroid. Oral lesions were evaluated by the modified oral mucositis rating scale (mOMRS) and symptoms were registered using a visual analogue scale. Thirty-five patients were recruited, and 32 patients were randomized into the study groups: 18 patients (56.3%) to the dexamethasone group and 14 patients (43.8%) to the clobetasol group. The use of clobetasol resulted in a significant reduction in mOMRS total score (P = .04) and in the score for ulcers (P = .03). In both groups, there was significant symptomatic improvement but the response was significantly greater in the clobetasol group (P = .02). In conclusion, clobetasol was significantly more effective than dexamethasone for the amelioration of symptoms and clinical aspects of oral lesions in cGVHD.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante Homólogo / Clobetasol / Dexametasona / Trasplante de Células Madre Hematopoyéticas / Acondicionamiento Pretrasplante / Enfermedad Injerto contra Huésped / Antiinflamatorios / Enfermedades de la Boca Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Biol Blood Marrow Transplant Asunto de la revista: HEMATOLOGIA / TRANSPLANTE Año: 2014 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante Homólogo / Clobetasol / Dexametasona / Trasplante de Células Madre Hematopoyéticas / Acondicionamiento Pretrasplante / Enfermedad Injerto contra Huésped / Antiinflamatorios / Enfermedades de la Boca Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Biol Blood Marrow Transplant Asunto de la revista: HEMATOLOGIA / TRANSPLANTE Año: 2014 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Estados Unidos