Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo

Detalhes bibliográficos
Ano de defesa: 2014
Autor(a) principal: Miranda, Amanda Rodrigues lattes
Orientador(a): Rezende, Kênnia Rocha lattes
Banca de defesa: Costa, Paulo Sérgio Sucasas da, Jardim, Paulo César Brandão Veiga, Ribeiro, Ana Maria Quinteiro, Sousa, Ana Luiza Lima
Tipo de documento: Dissertação
Tipo de acesso: Acesso aberto
dARK ID: ark:/38995/001300000840s
Idioma: por
Instituição de defesa: Universidade Federal de Goiás
Programa de Pós-Graduação: Programa de Pós-graduação em Ciências da Saúde (FM)
Departamento: Faculdade de Medicina - FM (RG)
País: Brasil
Palavras-chave em Português:
Palavras-chave em Inglês:
Área do conhecimento CNPq:
Link de acesso: http://repositorio.bc.ufg.br/tede/handle/tede/6126
Resumo: Vitiligo is a chronic disease of skin, acquired and idiopathic, characterized by circumscribed depigmented macules or patches. The treatment is still a challenge and don´t have an effective treatment that may improve all patients. The traditional psoralen photosensitizers are options for the treatment of vitiligo. In the Brazilian cerrado is popularly known action of Brosimum gaudichaudii Trécul (BGT), or mamacadela, which is an herbal psoralen. The goal of this study was evaluate the efficacy, safety and tolerability of BGT in adult patients with vitiligo, in topical and systemic presentations. A randomized controlled trial, double-blind and placebo-controlled was conducted. Of the 58 selected patients, 33 were randomized, 17 in the treatment group (G1) and 16 in the placebo group (G2). These remained until the end of the study 10 patients in G1 and G2 in 6 patients. The interventions were 800 mg / day of medication per orally and use of the ointment for 22 weeks, together with graded and daily photoexposure. The effectiveness of the BGT was assessed using the Vitiligo Area Score Index (VASI), applied by a dermatologist at all clinic visits. Already the safety and tolerability were assessed by laboratory tests before and during treatment, and observation of adverse events. All patients were classified with generalized vitiligo. The group that received the medication (G1) improved significantly VASI in intra-group evaluation (p <0.05) and also a higher proportion of repigmentation compared to G2. The VASI don´t have association with the analysis variables (gender, age, skin type, previous treatment, education, emotional stress, time of diagnosis, treatment adherence) (p> 0.05). Adherence to photoexposure was irregular in both groups, and don´t have statistically significant relationship with changes of VASI (p > 0.05). Laboratory tests showed no significant changes. Adverse events were mild and transient and the most common being erythema, and occurred predominantly in G1 patients. Therefore, it can be concluded that the BGT is effective in the treatment of vitiligo, with safe and well tolerated in the long term.
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spelling Rezende, Kênnia Rochahttp://lattes.cnpq.br/3337615895445199Sousa, Ana Luiza Limahttp://lattes.cnpq.br/3337615895445199Costa, Paulo Sérgio Sucasas daJardim, Paulo César Brandão VeigaRibeiro, Ana Maria QuinteiroSousa, Ana Luiza Limahttp://lattes.cnpq.br/9810674748387246Miranda, Amanda Rodrigues2016-09-06T13:30:11Z2014-12-03MIRANDA, A. R. Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo. 2014. 95 f. Dissertação (Mestrado em Ciências da Saúde) - Universidade Federal de Goiás, Goiânia, 2014.http://repositorio.bc.ufg.br/tede/handle/tede/6126ark:/38995/001300000840sVitiligo is a chronic disease of skin, acquired and idiopathic, characterized by circumscribed depigmented macules or patches. The treatment is still a challenge and don´t have an effective treatment that may improve all patients. The traditional psoralen photosensitizers are options for the treatment of vitiligo. In the Brazilian cerrado is popularly known action of Brosimum gaudichaudii Trécul (BGT), or mamacadela, which is an herbal psoralen. The goal of this study was evaluate the efficacy, safety and tolerability of BGT in adult patients with vitiligo, in topical and systemic presentations. A randomized controlled trial, double-blind and placebo-controlled was conducted. Of the 58 selected patients, 33 were randomized, 17 in the treatment group (G1) and 16 in the placebo group (G2). These remained until the end of the study 10 patients in G1 and G2 in 6 patients. The interventions were 800 mg / day of medication per orally and use of the ointment for 22 weeks, together with graded and daily photoexposure. The effectiveness of the BGT was assessed using the Vitiligo Area Score Index (VASI), applied by a dermatologist at all clinic visits. Already the safety and tolerability were assessed by laboratory tests before and during treatment, and observation of adverse events. All patients were classified with generalized vitiligo. The group that received the medication (G1) improved significantly VASI in intra-group evaluation (p <0.05) and also a higher proportion of repigmentation compared to G2. The VASI don´t have association with the analysis variables (gender, age, skin type, previous treatment, education, emotional stress, time of diagnosis, treatment adherence) (p> 0.05). Adherence to photoexposure was irregular in both groups, and don´t have statistically significant relationship with changes of VASI (p > 0.05). Laboratory tests showed no significant changes. Adverse events were mild and transient and the most common being erythema, and occurred predominantly in G1 patients. Therefore, it can be concluded that the BGT is effective in the treatment of vitiligo, with safe and well tolerated in the long term.O vitiligo é dermatose crônica adquirida, idiopática, que se manifesta por manchas acrômicas e bem delimitadas. Seu tratamento ainda é um desafio e não existe até o momento intervenção completamente eficaz. Os psoralenos são fotossensibilizantes tradicionais utilizados para o tratamento do vitiligo. No cerrado brasileiro é popularmente conhecida a ação da planta mamacadela (Brosimum gaudichaudii Trécul (BGT)) devido a presença de derivados psoralênicos em sua composição . O presente estudo teve como objetivo avaliar a eficácia, segurança e tolerabilidade de formulações farmacêuticas contendo extrato de raízes de BGT em pacientes adultos portadores de vitiligo, nas apresentações tópica e sistêmica. Foi realizado ensaio clínico randomizado, duplo-cego e placebo-controlado. Dos 58 pacientes selecionados, 33 foram randomizados, sendo 17 no grupo 1 (G1), de tratamento, e 16 no grupo 2 (G2), placebo. Destes, permaneceram até o final do estudo 10 pacientes no G1 e 6 pacientes no G2. Foram administrados 800 mg/dia da medicação, via oral, além da pomada, durante 22 semanas, associados a fotoexposição diária e gradativa. A eficácia do BGT foi avaliada através do Vitiligo Area Score Index (VASI), aplicado por dermatologista em todas as visitas clínicas. Já a segurança e tolerabilidade foram avaliadas pela realização de exames laboratoriais, antes e durante o tratamento, além da observação de eventos adversos. Todos os pacientes foram classificados com vitiligo generalizado. O grupo que recebeu a medicação (G1) apresentou melhora significativa do VASI na avaliação intragrupos (p<0,05) e também maior proporção de repigmentação quando comparado ao G2. O VASI não demonstrou associação com as variáveis de análise (sexo, idade, fototipo, tratamento prévio, escolaridade, estresse emocional, tempo de diagnóstico, adesão ao tratamento) (p>0,05). A adesão à fotoexposição foi irregular em ambos os grupos e não apresentou relação estatisticamente significante com as alterações do VASI (p>0,05). Em consonância, os exames laboratoriais não apresentaram alterações significativas. Os eventos adversos foram leves e transitórios, sendo mais comum o eritema, e ocorreram predominantemente nos pacientes do G1. Portanto, pode-se concluir que o BGT é eficaz no tratamento do vitiligo, sendo seguro e bem tolerado a longo prazo.application/pdfporUniversidade Federal de GoiásPrograma de Pós-graduação em Ciências da Saúde (FM)UFGBrasilFaculdade de Medicina - FM (RG)http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessVitiligoPsoralenoEnsaio clínicoMamacadelaVitiligoPsoralenClinical trialMamacadelaMEDICINA::CLINICA MEDICAEstudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligoStudy of effectiveness, safety and tolerability of Brosimum gaudichaudii Trécul in adults vitiligo holdersinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesis-100686431261774531060060060015457724759504863383318295306015800370reponame:Repositório Institucional da UFGinstname:Universidade Federal de Goiás (UFG)instacron:UFGLICENSElicense.txtlicense.txttext/plain; charset=utf-82165http://repositorio.bc.ufg.br/tede/bitstreams/a526ba2e-f65f-4225-a1eb-51da39992257/downloadbd3efa91386c1718a7f26a329fdcb468MD51CC-LICENSElicense_urllicense_urltext/plain; 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dc.title.por.fl_str_mv Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo
dc.title.alternative.eng.fl_str_mv Study of effectiveness, safety and tolerability of Brosimum gaudichaudii Trécul in adults vitiligo holders
title Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo
spellingShingle Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo
Miranda, Amanda Rodrigues
Vitiligo
Psoraleno
Ensaio clínico
Mamacadela
Vitiligo
Psoralen
Clinical trial
Mamacadela
MEDICINA::CLINICA MEDICA
title_short Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo
title_full Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo
title_fullStr Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo
title_full_unstemmed Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo
title_sort Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo
author Miranda, Amanda Rodrigues
author_facet Miranda, Amanda Rodrigues
author_role author
dc.contributor.advisor1.fl_str_mv Rezende, Kênnia Rocha
dc.contributor.advisor1Lattes.fl_str_mv http://lattes.cnpq.br/3337615895445199
dc.contributor.advisor-co1.fl_str_mv Sousa, Ana Luiza Lima
dc.contributor.advisor-co1Lattes.fl_str_mv http://lattes.cnpq.br/3337615895445199
dc.contributor.referee1.fl_str_mv Costa, Paulo Sérgio Sucasas da
dc.contributor.referee2.fl_str_mv Jardim, Paulo César Brandão Veiga
dc.contributor.referee3.fl_str_mv Ribeiro, Ana Maria Quinteiro
dc.contributor.referee4.fl_str_mv Sousa, Ana Luiza Lima
dc.contributor.authorLattes.fl_str_mv http://lattes.cnpq.br/9810674748387246
dc.contributor.author.fl_str_mv Miranda, Amanda Rodrigues
contributor_str_mv Rezende, Kênnia Rocha
Sousa, Ana Luiza Lima
Costa, Paulo Sérgio Sucasas da
Jardim, Paulo César Brandão Veiga
Ribeiro, Ana Maria Quinteiro
Sousa, Ana Luiza Lima
dc.subject.por.fl_str_mv Vitiligo
Psoraleno
Ensaio clínico
Mamacadela
topic Vitiligo
Psoraleno
Ensaio clínico
Mamacadela
Vitiligo
Psoralen
Clinical trial
Mamacadela
MEDICINA::CLINICA MEDICA
dc.subject.eng.fl_str_mv Vitiligo
Psoralen
Clinical trial
Mamacadela
dc.subject.cnpq.fl_str_mv MEDICINA::CLINICA MEDICA
description Vitiligo is a chronic disease of skin, acquired and idiopathic, characterized by circumscribed depigmented macules or patches. The treatment is still a challenge and don´t have an effective treatment that may improve all patients. The traditional psoralen photosensitizers are options for the treatment of vitiligo. In the Brazilian cerrado is popularly known action of Brosimum gaudichaudii Trécul (BGT), or mamacadela, which is an herbal psoralen. The goal of this study was evaluate the efficacy, safety and tolerability of BGT in adult patients with vitiligo, in topical and systemic presentations. A randomized controlled trial, double-blind and placebo-controlled was conducted. Of the 58 selected patients, 33 were randomized, 17 in the treatment group (G1) and 16 in the placebo group (G2). These remained until the end of the study 10 patients in G1 and G2 in 6 patients. The interventions were 800 mg / day of medication per orally and use of the ointment for 22 weeks, together with graded and daily photoexposure. The effectiveness of the BGT was assessed using the Vitiligo Area Score Index (VASI), applied by a dermatologist at all clinic visits. Already the safety and tolerability were assessed by laboratory tests before and during treatment, and observation of adverse events. All patients were classified with generalized vitiligo. The group that received the medication (G1) improved significantly VASI in intra-group evaluation (p <0.05) and also a higher proportion of repigmentation compared to G2. The VASI don´t have association with the analysis variables (gender, age, skin type, previous treatment, education, emotional stress, time of diagnosis, treatment adherence) (p> 0.05). Adherence to photoexposure was irregular in both groups, and don´t have statistically significant relationship with changes of VASI (p > 0.05). Laboratory tests showed no significant changes. Adverse events were mild and transient and the most common being erythema, and occurred predominantly in G1 patients. Therefore, it can be concluded that the BGT is effective in the treatment of vitiligo, with safe and well tolerated in the long term.
publishDate 2014
dc.date.issued.fl_str_mv 2014-12-03
dc.date.accessioned.fl_str_mv 2016-09-06T13:30:11Z
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identifier_str_mv MIRANDA, A. R. Estudo da eficácia, segurança e tolerabilidade do Brosimum gaudichaudii Trécul em indivíduos adultos portadores de vitiligo. 2014. 95 f. Dissertação (Mestrado em Ciências da Saúde) - Universidade Federal de Goiás, Goiânia, 2014.
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