Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II

Detalhes bibliográficos
Ano de defesa: 2001
Autor(a) principal: Lordêllo, Inácia Gonçalves Simões
Orientador(a): Moraes, Maria Elisabete Amaral de
Banca de defesa: Não Informado pela instituição
Tipo de documento: Dissertação
Tipo de acesso: Acesso aberto
Idioma: por
Instituição de defesa: Não Informado pela instituição
Programa de Pós-Graduação: Não Informado pela instituição
Departamento: Não Informado pela instituição
País: Não Informado pela instituição
Área do conhecimento CNPq:
Link de acesso: http://repositorio.ufc.br/handle/riufc/77318
Resumo: Osteoarthritis (OA) is the most common rheumatic disease. It is a joint disease characterized by degeneration of the articular cartilage, hypertrophy of the bone at the margins, and changes in the synovial membrane. Pain and stiffhess accompany it, particularly after prolonged activiiy. Non-steroidal anti- inflammatory drugs are used for the symptomatic treatment of osteoarthritis. Products as the shark cartilage (SC) are growing popular among patients with chronic and inflammatory disorders. The SC anti-angiogenic, anti-inflammatory and analgesic activities have been demonstrated in clinicai trials with a variety of results. The aim of this study was to evaluate the possible therapeutic potential, safety, tolerability (tolerance or toxicity) of 3g per day of SC in patients with knee OA for 16 weeks. 20 patients with ages between 40 and 80 years (media 57.7±7.79) and diagnosed with OA, as assessed by clinicai and laboratory test evaluations in accordance with the inclusion and exclusion criteria (pre- established), concluded the study. Clinicai and Laboratory test evaluations were accomplished before the beginning of the study, after 2, 4, 8 and 16 weeks of treatment and one week after the end of the study. The patients did not show significant changes in clinicai or laboratory test evaluations. In accordance with the radiological index ofDA, 4% of the patients were in levei I; 14% were in levei II; 68% were in levei III and 14% in levei IV. 75% of the sample presented 100% of adherence to the treatment. The VAS (Visual Analogic Scale) of pain and the Index of Lequesne showed significant changes from baseline (66.84±19.74; 14.18±0.73) in the 12th week (50.63* ± 24.07; 11.73* ± 1.10), 16th week (49.33* ± 25.77; 11.17* ± 1.31) and in the post study (54.21* ± 25.46; 12.18* ± 0.98) respectively. The HAQ (Health Assessment Questionnaire) presented reductien compared to the baseline (1.56 ± 0.07) in the 16th week (1.30* ± 0.15) and in the post study (1.35* ± 0.10). The SSS (Symptoms and Signs Scale) also showed reduction compared to the baseline of the 2nd week to the 16th week. The SC Selachii was well tolerated and safe, however it did not show efficacy in control of signs and symptoms of OA when administered in the dosage of 3g per day.
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spelling Lordêllo, Inácia Gonçalves SimõesMoraes, Maria Elisabete Amaral de2024-07-18T14:44:01Z2024-07-18T14:44:01Z2001LORDÊLLO, Inácia Gonçalves Simões. Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II. 2001. 188 f. Dissertação (Mestrado em Farmacologia) - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, 2001. Disponível em: http://www.repositorio.ufc.br/handle/riufc/ 77318. Acesso em: 18 jul. 2024.http://repositorio.ufc.br/handle/riufc/77318Osteoarthritis (OA) is the most common rheumatic disease. It is a joint disease characterized by degeneration of the articular cartilage, hypertrophy of the bone at the margins, and changes in the synovial membrane. Pain and stiffhess accompany it, particularly after prolonged activiiy. Non-steroidal anti- inflammatory drugs are used for the symptomatic treatment of osteoarthritis. Products as the shark cartilage (SC) are growing popular among patients with chronic and inflammatory disorders. The SC anti-angiogenic, anti-inflammatory and analgesic activities have been demonstrated in clinicai trials with a variety of results. The aim of this study was to evaluate the possible therapeutic potential, safety, tolerability (tolerance or toxicity) of 3g per day of SC in patients with knee OA for 16 weeks. 20 patients with ages between 40 and 80 years (media 57.7±7.79) and diagnosed with OA, as assessed by clinicai and laboratory test evaluations in accordance with the inclusion and exclusion criteria (pre- established), concluded the study. Clinicai and Laboratory test evaluations were accomplished before the beginning of the study, after 2, 4, 8 and 16 weeks of treatment and one week after the end of the study. The patients did not show significant changes in clinicai or laboratory test evaluations. In accordance with the radiological index ofDA, 4% of the patients were in levei I; 14% were in levei II; 68% were in levei III and 14% in levei IV. 75% of the sample presented 100% of adherence to the treatment. The VAS (Visual Analogic Scale) of pain and the Index of Lequesne showed significant changes from baseline (66.84±19.74; 14.18±0.73) in the 12th week (50.63* ± 24.07; 11.73* ± 1.10), 16th week (49.33* ± 25.77; 11.17* ± 1.31) and in the post study (54.21* ± 25.46; 12.18* ± 0.98) respectively. The HAQ (Health Assessment Questionnaire) presented reductien compared to the baseline (1.56 ± 0.07) in the 16th week (1.30* ± 0.15) and in the post study (1.35* ± 0.10). The SSS (Symptoms and Signs Scale) also showed reduction compared to the baseline of the 2nd week to the 16th week. The SC Selachii was well tolerated and safe, however it did not show efficacy in control of signs and symptoms of OA when administered in the dosage of 3g per day.A osteoartrite (OA) é a moléstia reumática mais comum. É uma doença eminentemente articular caracterizada por: degeneração da cartilagem articular, hipertrofia óssea marginal e mudanças da membrana sinovial. É acompanhada de dor e rigidez articular principalmente após atividade prolongada. Os antiinflamatórios não esteroidais (AINEs) são os fármacos mais utilizados no tratamento sintomático da OA. Produtos como a cartilagem de tubarão (CT) vêm ganhando popularidade crescente entre pacientes com desordens inflamatórias crônicas e imunes. Os efeitos antiangiogênicos, antiinflamatórios e analgésicos da CT têm sido demonstrados em estudos experimentais e clínicos, porém com resultados variáveis. O objetivo desse estudo foi avaliar o possível potencial terapêutico, bem com a segurança e a tolerabilidade (tolerância ou toxicidade) de 3g ao dia da CT em pacientes com osteoartrite de joelho (OAJ) por 16 semanas. Concluíram o estudo 20 pacientes de 40 a 80 anos (média 57,7 ± 7,79) com diagnóstico de OAJ' de acordo com os critérios de inclusão e exclusão estabelecidos. As avaliações clínicas e laboratoriais foram efetuadas previamente ao estudo (pré estudo), após 2, 4, 8, 12, 16 semanas de tratamento e uma semana após o encerramento do estudo (pós estudo). Os pacientes não apresentaram alterações clínicas ou laboratoriais significativas. De acordo com o índice radiológico de OA, 4% dós pacientes apresentavam Grau I; 14%, Grau II; 68,%, Grau III e 14%, Grau IV. Cerca de 75% da amostra apresentou adesão de 100% r ao tratamento. A EVA de dor e o índice de Lequesne mostraram valores estatisticamente diferentes na 12a (50,63* ± 24,07; 11,73* ± 1,10), 16a (49,33* ± 25,77; 11,17* ± 1,31) semanas de tratamento e no pós estudo (54,21*± 25,46; 12,18 ± 0,98), respectivamente, quando comparados ao pré estudo (66,84 ± 19,74; 14,18 ± 0,73). Os escores da capacidade funcional medida pelo HAQ (Health Assessment Questionnaire) apresentaram reduções significantes na 16a semana de tratamento (1,30 ± 0,15) e no pós estudo (1,35 ± 0,10) quando comparados ao pré estudo (1,56 ± 0,07). A Escala de Sinais e Sintomas da Artrose (ESSA) também demonstrou redução comparada à linha de base da 2a à 16a semana de tratamento. A CT Selachii foi bem tolerada e segura, porém não apresentou eficácia no controle dos sinais e sintomas da OAJ quando administrada na dose de 3g ao dia.Este documento está disponível online com base na Portaria Nº 348, de 08 de dezembro de 2022, Disponível em: http://biblioteca.ufc.br/wp-content/uploads/2022/12/portaria348-2022.pdf que autoriza a digitalização e a disponibilização no Repositório Institucional (RI) da coleção retrospectiva de TCC, dissertações e teses da UFC, sem o termo de anuência prévia dos autores. Em caso de trabalhos com pedidos de patente e/ou de embargo, cabe, exclusivamente, ao autor(a) solicitar a restrição de acesso ou retirada de seu trabalho do RI, mediante apresentação de documento comprobatório à Direção do Sistema de Bibliotecas.Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase IISafety and efficacy of the Shark Cartilage on knee osteoarthritis: Phase II study.info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisOsteoartriteAgentes antiinflamatóriosTraumatismos do JoelhoOsteoarthritisAnti-Inflammatory AgentsKnee InjuriesCNPQ::CIENCIAS DA SAUDE::FARMACIAinfo:eu-repo/semantics/openAccessporreponame:Repositório Institucional da Universidade Federal do Ceará (UFC)instname:Universidade Federal do Ceará (UFC)instacron:UFChttps://orcid.org/0000-0002-6826-8930http://lattes.cnpq.br/3565768281344086ORIGINAL2001_dis_igslordello.pdf2001_dis_igslordello.pdfapplication/pdf54401078http://repositorio.ufc.br/bitstream/riufc/77318/1/2001_dis_igslordello.pdf4fafc2571ec383fbf2029ae1a3d4c9c9MD51LICENSElicense.txtlicense.txttext/plain; charset=utf-81748http://repositorio.ufc.br/bitstream/riufc/77318/2/license.txt8a4605be74aa9ea9d79846c1fba20a33MD52riufc/773182024-07-18 11:44:41.945oai:repositorio.ufc.br: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Repositório InstitucionalPUBhttp://www.repositorio.ufc.br/ri-oai/requestbu@ufc.br || repositorio@ufc.bropendoar:2024-07-18T14:44:41Repositório Institucional da Universidade Federal do Ceará (UFC) - Universidade Federal do Ceará (UFC)false
dc.title.pt_BR.fl_str_mv Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II
dc.title.en.pt_BR.fl_str_mv Safety and efficacy of the Shark Cartilage on knee osteoarthritis: Phase II study.
title Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II
spellingShingle Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II
Lordêllo, Inácia Gonçalves Simões
CNPQ::CIENCIAS DA SAUDE::FARMACIA
Osteoartrite
Agentes antiinflamatórios
Traumatismos do Joelho
Osteoarthritis
Anti-Inflammatory Agents
Knee Injuries
title_short Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II
title_full Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II
title_fullStr Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II
title_full_unstemmed Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II
title_sort Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II
author Lordêllo, Inácia Gonçalves Simões
author_facet Lordêllo, Inácia Gonçalves Simões
author_role author
dc.contributor.author.fl_str_mv Lordêllo, Inácia Gonçalves Simões
dc.contributor.advisor1.fl_str_mv Moraes, Maria Elisabete Amaral de
contributor_str_mv Moraes, Maria Elisabete Amaral de
dc.subject.cnpq.fl_str_mv CNPQ::CIENCIAS DA SAUDE::FARMACIA
topic CNPQ::CIENCIAS DA SAUDE::FARMACIA
Osteoartrite
Agentes antiinflamatórios
Traumatismos do Joelho
Osteoarthritis
Anti-Inflammatory Agents
Knee Injuries
dc.subject.ptbr.pt_BR.fl_str_mv Osteoartrite
Agentes antiinflamatórios
Traumatismos do Joelho
dc.subject.en.pt_BR.fl_str_mv Osteoarthritis
Anti-Inflammatory Agents
Knee Injuries
description Osteoarthritis (OA) is the most common rheumatic disease. It is a joint disease characterized by degeneration of the articular cartilage, hypertrophy of the bone at the margins, and changes in the synovial membrane. Pain and stiffhess accompany it, particularly after prolonged activiiy. Non-steroidal anti- inflammatory drugs are used for the symptomatic treatment of osteoarthritis. Products as the shark cartilage (SC) are growing popular among patients with chronic and inflammatory disorders. The SC anti-angiogenic, anti-inflammatory and analgesic activities have been demonstrated in clinicai trials with a variety of results. The aim of this study was to evaluate the possible therapeutic potential, safety, tolerability (tolerance or toxicity) of 3g per day of SC in patients with knee OA for 16 weeks. 20 patients with ages between 40 and 80 years (media 57.7±7.79) and diagnosed with OA, as assessed by clinicai and laboratory test evaluations in accordance with the inclusion and exclusion criteria (pre- established), concluded the study. Clinicai and Laboratory test evaluations were accomplished before the beginning of the study, after 2, 4, 8 and 16 weeks of treatment and one week after the end of the study. The patients did not show significant changes in clinicai or laboratory test evaluations. In accordance with the radiological index ofDA, 4% of the patients were in levei I; 14% were in levei II; 68% were in levei III and 14% in levei IV. 75% of the sample presented 100% of adherence to the treatment. The VAS (Visual Analogic Scale) of pain and the Index of Lequesne showed significant changes from baseline (66.84±19.74; 14.18±0.73) in the 12th week (50.63* ± 24.07; 11.73* ± 1.10), 16th week (49.33* ± 25.77; 11.17* ± 1.31) and in the post study (54.21* ± 25.46; 12.18* ± 0.98) respectively. The HAQ (Health Assessment Questionnaire) presented reductien compared to the baseline (1.56 ± 0.07) in the 16th week (1.30* ± 0.15) and in the post study (1.35* ± 0.10). The SSS (Symptoms and Signs Scale) also showed reduction compared to the baseline of the 2nd week to the 16th week. The SC Selachii was well tolerated and safe, however it did not show efficacy in control of signs and symptoms of OA when administered in the dosage of 3g per day.
publishDate 2001
dc.date.issued.fl_str_mv 2001
dc.date.accessioned.fl_str_mv 2024-07-18T14:44:01Z
dc.date.available.fl_str_mv 2024-07-18T14:44:01Z
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dc.identifier.citation.fl_str_mv LORDÊLLO, Inácia Gonçalves Simões. Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II. 2001. 188 f. Dissertação (Mestrado em Farmacologia) - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, 2001. Disponível em: http://www.repositorio.ufc.br/handle/riufc/ 77318. Acesso em: 18 jul. 2024.
dc.identifier.uri.fl_str_mv http://repositorio.ufc.br/handle/riufc/77318
identifier_str_mv LORDÊLLO, Inácia Gonçalves Simões. Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II. 2001. 188 f. Dissertação (Mestrado em Farmacologia) - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, 2001. Disponível em: http://www.repositorio.ufc.br/handle/riufc/ 77318. Acesso em: 18 jul. 2024.
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