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Estudo cl?nico randomizado sobre a efic?cia da polihexanida no tratamento da mucosite oral em pacientes com c?ncer de cabe?a e pesco?o.

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Previous issue date: 2016-08-26 / Coordena??o de Aperfei?oamento de Pessoal de N?vel Superior - CAPES / Introduction: Malignant neoplasms represent one of the main causes of morbi-mortality in Brazil and worldwide. Radiotherapy, whether associated or not with chemotherapy, is the therapeutic modality most often used for cancer of the head and neck. However, it can trigger reactions at the oral level, such as oral mucositis, the most limiting side effect, with intense pain and difficulty eating, which may require the suspension of oncologic treatment for the patient. Polyhexanide has been used effectively and safely in the treatment of acute and chronic wounds. Objectives: To describe the clinical-epidemiologic profile and investigate the efficacy of polyhexanide in the treatment of oral mucositis and pain relief, in the period of 8-15 days, among patients with cancer of the head and neck undergoing treatment with radiotherapy (whether associated or not with chemotherapy). Methods: A randomized clinical trial was conducted, parallel and double-blind, among patients with cancer of the head and neck undergoing radiotherapy treatment with or without chemotherapy, in the High Complexity Oncology Unit of Feira de Santana, Bahia, who developed oral mucositis, were 18 years of age or older and consented to participation and signed informed consent forms in the period of July 2015 to May 2016. Two equal groups were formed by random allocation?an intervention group (polyhexanide gel) and a control group (gel without polyhexanide). These groups were reevaluated after 8 and 15 days of use of the gels. Clinical exams, evaluations of the medical records, and interviews with the application of a survey instrument used in the study were approved by the Committee for Ethics in Human Subjects Research of the State University of Feira de Santana, under the number 1.074.479/2015. Statistical analysis consisted of relative and absolute frequencies, averages, medians, and standard deviation, and the p-value?considered statistically signification when <0.05?were obtained by non-parametric Friedman tests, Wilcoxon the posts with signs and Wilcoxon-Mann-Whitney. Results: The findings were presented as an article. The mean age was 59.68 years; 58.8% men; 67.6% Brown/Black, and 79.4% with an elementary school education or less. The majority of tumors (64.7%) already presented in advanced stage, and the most frequent were those of the pharynx (23.5%) and the oral cavity (20.4%). Radiotherapy associated with chemotherapy was the most used therapy. Grades III and IV of oral mucositis were the most frequent in the third and fourth weeks of radiotherapy treatment. A total of 34 individuals were accompanied, 17 in the intervention group and 17 in the control group. After a period of 8 to 15 days, statistically significant differences were observed (p<0.05) in relation to the reduction in severity of the oral mucositis and pain, between the time points of gel use in the intervention group. Conclusions: Knowledge of the clinical-epidemiologic profile of patients undergoing oncology treatment with oral mucositis is important to establish potentially effective treatments. In this study polyhexanide represented an effective therapy in the treatment of oral mucositis and relief of pain, with positive results in the first 8 days of use. / As neoplasias malignas representam uma das principais causas de morbimortalidade no Brasil e no mundo. A Radioterapia, associada ou n?o a quimioterapia, ? a modalidade terap?utica mais empregada para o c?ncer de cabe?a e pesco?o. Todavia, pode desencadear rea??es em n?vel bucal, como a mucosite oral, o efeito mais limitante, com dor intensa e dificuldades na alimenta??o, podendo requerer at? a suspens?o do tratamento oncol?gico do paciente. A polihexanida tem sido empregada no tratamento de feridas agudas e cr?nicas, com efic?cia e seguran?a. Objetivos: Descrever o perfil cl?nico-epidemiol?gico e investigar a efic?cia da polihexanida no tratamento da mucosite oral e do al?vio da dor, no per?odo de 8 e 15 dias, em pacientes com c?ncer de cabe?a e pesco?o, sob tratamento com radioterapia associada ou n?o a quimioterapia. M?todos: Realizou-se um ensaio cl?nico randomizado, paralelo e duplo cego, com todos os pacientes com c?ncer de cabe?a e pesco?o sob tratamento com radioterapia associada ou n?o a quimioterapia, na Unidade de Alta Complexidade em Oncologia de Feira de Santana, Bahia, que desenvolveram mucosite oral, tinham 18 anos ou mais de idade e aceitaram participar assinando o termo de consentimento livre e esclarecido, no per?odo de julho de 2015 a maio de 2016. Dois grupos foram igualmente formados por aloca??o aleat?ria, o de interven??o (gel de polihexanida) e o grupo controle (gel sem polihexanida), e reavaliados nos intervalos de 8 e 15 dias de uso dos g?is. Avalia??es cl?nicas, de prontu?rios e entrevistas com aplica??o de formul?rio foram aplicadas neste estudo aprovado pelo Comit? de ?tica em Pesquisa com Seres Humanos da Universidade Estadual de Feira de Santana sob o n?mero 1.074.479/2015. Para a an?lise estat?stica empregaram-se as frequ?ncias relativas e absolutas, m?dias, medianas e desvio-padr?o, e o valor de p, considerado estatisticamente significativo quando ? 0,05 foi obtido por meio dos testes n?o param?tricos de Friedman, Wilcoxon dos postos com sinais e Wilcoxon-Mann-Whitney. Resultados: Os achados foram apresentados em forma de artigo. A m?dia de idade foi de 59,68 anos; 58,8% homens; 67,6% de cor parda e 79,4% analfabetos ou com baixo grau de escolaridade. A maioria (64,7%) dos tumores j? se apresentava em est?dio avan?ado, sendo os mais frequentes os da faringe (23,5%) e cavidade oral (20,4%). A Radioterapia associada ? quimioterapia foi a terap?utica mais empregada. Graus III e IV de mucosite oral foram mais frequentes nas 3? e 4? semanas de tratamento radioter?pico. Um total de 34 indiv?duos foi acompanhado, sendo 17 do grupo de interven??o e 17 do grupo controle. Ap?s um per?odo de 8 e 15 dias, observaram-se diferen?as estatisticamente significativas (p<0,05) em rela??o a redu??o da gravidade da mucosite oral e da dor, entre os tempos de uso do gel no grupo de interven??o. Conclus?es: O conhecimento do perfil cl?nico-epidemiol?gico de pacientes em tratamento oncol?gico com mucosite oral faz-se importante para se estabelecer terap?uticas potencialmente eficazes. Neste estudo a polihexanida apresentou-se como uma terap?utica eficaz no tratamento da mucosite oral e controle da dor, com resultados positivos ainda nos primeiros 8 dias de uso.

Identiferoai:union.ndltd.org:IBICT/oai:tede2.uefs.br:8080:tede/549
Date26 August 2016
CreatorsAndrade, Ana Paula Eufr?zio do Nascimento
ContributorsOliveira, M?rcio Campos
PublisherUniversidade Estadual de Feira de Santana, Mestrado Acad?mico em Sa?de Coletiva, UEFS, Brasil, DEPARTAMENTO DE SA?DE
Source SetsIBICT Brazilian ETDs
LanguagePortuguese
Detected LanguageEnglish
Typeinfo:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/masterThesis
Formatapplication/pdf
Sourcereponame:Biblioteca Digital de Teses e Dissertações da UEFS, instname:Universidade Estadual de Feira de Santana, instacron:UEFS
Rightsinfo:eu-repo/semantics/openAccess
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