RESUMEN
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.
Asunto(s)
Antiinflamatorios/uso terapéutico , Clobetasol/uso terapéutico , Dexametasona/uso terapéutico , Enfermedad Injerto contra Huésped/tratamiento farmacológico , Trasplante de Células Madre Hematopoyéticas/métodos , Enfermedades de la Boca/tratamiento farmacológico , Acondicionamiento Pretrasplante/métodos , Trasplante Homólogo/métodos , Administración Tópica , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
Oral manifestations are common in patients who are diagnosed with chronic graft-versus-host-disease (cGVHD). These manifestations can present as oral mucosal lesions, salivary gland dysfunction, or reduction of the mouth opening due to cutaneous sclerosis. Although several studies have reported the prevalence of oral involvement in cGVHD, few have reported details of different types and severity of oral lesions of cGVHD, according to the NIH. Furthermore, the authors are aware of only one published study concerning oral manifestations of cGVHD in Brazil. The purpose of this study was to evaluate the prevalence and severity of oral involvement of cGVHD. Oral evaluation of hematopoietic stem cell transplant (HSCT) recipients was conducted on 22 patients (12 men and 10 women) from December 2007 to May 2009. The following categories were assessed: Age, gender, underlying disease, time postHSCT, history of GVHD, therapy for GVHD, oral lesions, xerostomia, resting salivary flow rate, and mouth opening. Oral lesions were classified according to NIH criteria, and the results were submitted to a descriptive analysis. According to the NIH, patients presented diagnostic (40.9%), distinctive (31.9%), and common (9.1%) features of oral cGVHD. Oral involvement of cGVHD was identified in 81.8% of patients, 68.2% as mucosal lesions and 59.1% as salivary gland dysfunction. Reduced mouth opening was observed in 12 patients (80%), with one case associated with cutaneous sclerosis. Oral involvement was frequent in these patients; for many, it was the first clinical manifestation of cGVHD.