Efeito do tratamento com simbiótico em portadores de estomatite aftosa recorrente
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Data
2013
Autores
Mimura, Maria Angela Martins [UNIFESP]
Orientadores
Penido, Norma de Oliveira [UNIFESP]
Tipo
Tese de doutorado
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Resumo
A estomatite aftosa recorrente (EAR) e uma doenca inflamatoria cronica que se caracteriza por surtos de lesoes ulcerativas na mucosa oral. Ha evidencias que na EAR a polarizacao da resposta imune para o tipo Th1 tem papel importante na etiopatogenia da doenca e que, a utilizacao de simbioticos poderia estimular maior atividade dos linfocitos T reguladores, influenciando favoravelmente a evolucao da EAR. Objetivos: Avaliar a evolucao clinica dos portadores de estomatite aftosa recorrente frente ao uso do simbiotico Lactofos®/Simbioflora®, analisando a sintomatologia, a frequencia das crises, numero, duracao e tamanho das lesoes. Comparar o perfil imunologico dos pacientes portadores de estomatite aftosa recorrente, por meio dos niveis de citocinas com os controles e entre si, antes e apos o tratamento. Metodo: Realizamos ensaio clinico duplo cego randomizado placebo controlado, com 3 grupos. Um grupo controle composto por 30 individuos saudaveis e 2 grupos com EAR (grupo Lactofos® com 22 pacientes, grupo placebo com 23 pacientes). Os dois grupos foram instruidos a tomar 2 saches ao dia durante 120 dias. Foram realizadas coletas de sangue em 3 momentos, no momento inicial (pre-tratamento, T0), 120 dias apos o inicio do tratamento (final do tratamento T4) e 2 meses apos a interrupcao do medicamento (T6). Foram feitas analises das citocinas no soro, em sobrenadante de cultura estimulada por fitohemaglutinina (PHA) e nao estimulada de celulas mononucleares de sangue periferico(PBMC) utilizando o kit Kit MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel, HCYTOMAG-60K (Millipore u Missouri, EUA). Na analise estatistica foram utilizados testes ANOVA, Mann-Whitney e t-student. Resultados: Pacientes que fizeram uso de Lactofos®/Simbioflora® apresentaram melhora na variavel clinica DOR quando comparados ao grupo placebo (p=0,027), nao havendo diferenca para as outras variaveis clinicas avaliadas. Os efeitos colaterais observados foram semelhantes nos dois grupos, mas a flatulencia (p=0,003) e o intestino solto (p=0,04) foram significantes para os pacientes em uso de Lactofos®/Simbioflora®. Constatamos diferenca significante nas citocinas IFN-γ, IL-4 e IL-6 no soro dos PBMCs dos pacientes ao comparar o grupo controle e o grupo EAR. Em relacao ao tratamento ao longo do tempo pudemos observar que o IFN-γ (p=0,023), IL-4(p=0,045), IL-10 (p=0,000) e Il-12p70 (p=0,027) apresentaram diferenca significante entre os tratamentos e ou entre os momentos (T0, T4 e T6). Conclusao: O simbiotico Lactofos®/Simbioflora® foi eficiente na melhora de uma unica variavel clinica, a DOR quando comparado com o placebo. Os pacientes portadores de estomatite aftosa recorrente apresentam perfil misto de resposta imune Th1/Th2 quando comparados com o grupo controle no momento inicial do estudo. O simbiotico Lactofos®/Simbioflora® induz resposta Th1 por meio de aumento de IL-12 e IFN-γ, e resposta Th2 devido ao aumento de IL-4 e IL-10
Recurrent aphthous stomatitis (RAS) is a chronic inflammatory disease characterized by relapses of ulcerative lesions in the oral mucosa. There is evidence that the RAS polarization of the immune response towards a Th1 response plays an important role in the pathogenesis of the disease and the use of symbiotic could stimulate greater activity of regulatory T lymphocytes, favorably influencing the evolution of the RAS. Objectives: To evaluate the clinical outcome of patients with recurrent aphthous stomatitis towards the use of symbiotic Lactofos ® / Simbioflora ®, analyzing symptoms, frequency, number, duration and size of the lesions. Compare the immunological profile of patients with recurrent aphthous stomatitis, through cytokine levels with the controls and with each other before and after treatment.Method: We conducted double blind randomized clinical trial placebo controlled study with 3 arms. A control group of 30 healthy individuals and two arms with RAS(Lactofos®/Simbioflora® group with 22 patients, 23 patients in the placebo group). Both groups were instructed to take 2 sachets daily for 120 days. Blood samples were collected in 3 times at baseline (pre-treatment T0), and 120 days after beginning the treatment (end of treatment T4) and 2 months after discontinuation of the drug (T6). Analyzes were conducted on serum cytokines in the culture supernatants stimulated by phytohemagglutinin (PHA) stimulated and not peripheral blood mononuclear cells (PBMC) using the kit MILLIPLEX MAP Human Cytokine / Chemokine Magnetic Bead Panel HCYTOMAG-60K (Millipore - Missouri, USA). Statistical analysis used ANOVA, Mann-Whitney and t-student tests. Results: Patients who used Lactofos® /Simbioflora® showed improvement in symptoms compared to placebo (p = 0.027), with no statistical difference for the other clinical variables assessed. The side effects observed were similar in both groups, but the flatulence (p= 0.003) and diarrhrea (p = 0.04) were significant for patients using Lactofos ®. We found significant differences in cytokine IFN - γ, IL - 4 and IL - 6 in serum of PBMCs of patients when compared the control group and RAS group. Regarding treatment over time we observed that IFN - γ (p = 0.023), IL - 4 (p = 0.045), IL - 10 (p = 0.000) and IL - 12p70 (p = 0.027) showed significant difference or between treatments and between times (T0, T4 and T6). Conclusion: The symbiotic Lactofos® /Simbioflora® was effective in improving one clinical variable, pain compared to placebo. Patients with recurrent aphthous stomatitis have mixed profile of Th1/Th2 immune response when compared with the control group at baseline. The symbiotic Lactofos® /Simbioflora® induces Th1 response by increasing IL - 12 and IFN - γ and the Th2 response due to increased IL - 4 and IL - 10
Recurrent aphthous stomatitis (RAS) is a chronic inflammatory disease characterized by relapses of ulcerative lesions in the oral mucosa. There is evidence that the RAS polarization of the immune response towards a Th1 response plays an important role in the pathogenesis of the disease and the use of symbiotic could stimulate greater activity of regulatory T lymphocytes, favorably influencing the evolution of the RAS. Objectives: To evaluate the clinical outcome of patients with recurrent aphthous stomatitis towards the use of symbiotic Lactofos ® / Simbioflora ®, analyzing symptoms, frequency, number, duration and size of the lesions. Compare the immunological profile of patients with recurrent aphthous stomatitis, through cytokine levels with the controls and with each other before and after treatment.Method: We conducted double blind randomized clinical trial placebo controlled study with 3 arms. A control group of 30 healthy individuals and two arms with RAS(Lactofos®/Simbioflora® group with 22 patients, 23 patients in the placebo group). Both groups were instructed to take 2 sachets daily for 120 days. Blood samples were collected in 3 times at baseline (pre-treatment T0), and 120 days after beginning the treatment (end of treatment T4) and 2 months after discontinuation of the drug (T6). Analyzes were conducted on serum cytokines in the culture supernatants stimulated by phytohemagglutinin (PHA) stimulated and not peripheral blood mononuclear cells (PBMC) using the kit MILLIPLEX MAP Human Cytokine / Chemokine Magnetic Bead Panel HCYTOMAG-60K (Millipore - Missouri, USA). Statistical analysis used ANOVA, Mann-Whitney and t-student tests. Results: Patients who used Lactofos® /Simbioflora® showed improvement in symptoms compared to placebo (p = 0.027), with no statistical difference for the other clinical variables assessed. The side effects observed were similar in both groups, but the flatulence (p= 0.003) and diarrhrea (p = 0.04) were significant for patients using Lactofos ®. We found significant differences in cytokine IFN - γ, IL - 4 and IL - 6 in serum of PBMCs of patients when compared the control group and RAS group. Regarding treatment over time we observed that IFN - γ (p = 0.023), IL - 4 (p = 0.045), IL - 10 (p = 0.000) and IL - 12p70 (p = 0.027) showed significant difference or between treatments and between times (T0, T4 and T6). Conclusion: The symbiotic Lactofos® /Simbioflora® was effective in improving one clinical variable, pain compared to placebo. Patients with recurrent aphthous stomatitis have mixed profile of Th1/Th2 immune response when compared with the control group at baseline. The symbiotic Lactofos® /Simbioflora® induces Th1 response by increasing IL - 12 and IFN - γ and the Th2 response due to increased IL - 4 and IL - 10
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MIMURA, Maria Angela Martins. Efeito do tratamento com simbiótico em portadores de estomatite aftosa recorrente. 2013. 112 f. Tese (Doutorado em Ciências) - Escola Paulista de Medicina, Universidade Federal de São Paulo. São Paulo, 2013.