Comparação da eficácia e segurança de diferentes tipos de escleroterápicos utilizados rotineiramente na esclerose de telangiectasias e veias reticulares: estudo experimental em coelhos
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Data
2017-05-23
Autores
Lúcio Filho, Carlos Eduardo Pinheiro [UNESP]
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Universidade Estadual Paulista (Unesp)
Resumo
Introdução: A escleroterapia é um procedimento usado para ocluir varizes. Esse tratamento, em geral de fim estético, pode apresentar complicações como flebite, úlcera e hiperpigmentação. Devido à escassez e heterogeneidade de estudos clínicos no tratamento de telangiectasias e veias reticulares, estudos em modelo animal podem trazer respostas mais específicas sobre eficácia e segurança dos agentes esclerosantes. Objetivos: O objetivo deste estudo foi avaliar a eficácia e segurança de agentes escleroterápicos, utilizando a veia dorsal marginal da orelha do coelho como modelo experimental. Materiais e Métodos: Estudo experimental randomizado aberto utilizando 30 coelhos (60 orelhas) da raça Norfolk. As orelhas foram divididas em 5 grupos (12 orelhas por grupo), sendo injetado polidocanol líquido a 1% (Grupo Polidocanol), polidocanol espuma a 1% (Grupo Espuma), solução de polidocanol 0,2% com glicose70% (Grupo PG), glicose 75%(Grupo Glicose) e salina a 0,9% (Grupo Controle). Foram realizadas fotografias nos momentos antes da injeção, e no 7o, 14o e 21o dias após a escleroterápia. A análise macroscópica foi conduzida por cirurgião vascular sem conhecimento prévio dos grupos. Como parâmetros macroscópicos, avaliaram-se a eficácia do agente, pela presença de esclerose do vaso, e suas complicações (flebite, neovascularização, úlcera em sítio de punção, necrose e processo inflamatório), comparando-se as fotografias pré-tratamento e após 21dias de tratamento. No 21o dia, procedeu-se a biópsia da orelha do coelho para avaliação histológica (coloração hematoxilina-eosina e elástica van Gieson) e imuno-histoquímica com os marcadores endoteliais CD31 e CD34. Valores de p<0,05 foram considerados estatisticamente significantes. Resultados: Quanto ao resultado de eficácia, a presença de esclerose foi observada em 76,9% das orelhas tratadas com espuma, sendo superior estatisticamente a todos os grupos (p<0,001), exceto o grupo polidocanol (33,3%). Quanto aos resultados de segurança, o grupo espuma teve o maior número de efeitos adversos somando 30,7% de orelhas com necrose (p=0,003), 46,15% com úlcera (p=0,003) e 69,2% com processo inflamatório (p<0,0001), sendo estatisticamente superior aos demais grupos. Apesar de maior frequência de neovascularização no grupo espuma (n=7) em relação aos grupos polidocanol líquido (n=3) e glicose (n=3), não houve diferença significativa entre esses grupos. A flebite no 21o dia esteve presente em 38,46% no grupo espuma e em 8,33% no grupo glicose. À microscopia, o grupo espuma foi superior em relação aos demais quanto ao número de casos de esclerose – eficácia (n=9, p=0,0024) e de necrose - segurança (n=3, p=0,03). Conclusão: O presente estudo apontou eficácia macroscópica semelhante entre o polidocanol liquido a 1% e espuma de polidocanol a 1% em promover a esclerose da veia. Microscopicamente, o grupo esmpuma foi o mais eficaz, porém foi o esclerosante que apresentou mais reações adversas neste modelo experimental.
Introduction: Sclerotherapy is a common treatment for reticular veins and telangiectasias. This treatment, usually with aesthetic purpose, may present complications such as phlebitis, ulcer and hyperpigmentation. Clinical trials involving patients with telangiectasias and reticular veins are limited. This study aims to evaluate the efficacy and safety of sclerotherapic agents using the marginal dorsal vein of rabbit ear as an experimental model. Methods: The study design was an open randomized experimental study using 30 Norfolk rabbits (60 ears). The ears were divided into 5 groups (12 ears per group), in which were injected 1% liquid polidocanol (Polidocanol Group), 1% foaming polidocanol (Foam Group), solution of 0.2% polidocanol-glucose 75% (PG Group), Glucose 75% (Glucose Group) and 0.9% saline (Control Group). Photographs were taken before the moment of the injection, and at 7th, 14th and 21st days after the infusion of the sclerotherapic agent. A vascular surgeon without previous knowledge of the groups conducted the macroscopic analysis. The following macroscopic findings were evaluated: efficacy of the agent (vessel sclerosis) and complications (phlebitis, neovascularization, ulcer at puncture site, necrosis and local inflammation). On the 21st day after the injection, the rabbits’ ears were biopsied for histological analysis with hematoxylin-eosin and Elastica van Gieson staining and immunohistochemistry was conducted using CD31 and CD34 endothelial markers. P values < 0.05 were considered statistically significant. Results: The presence of sclerosis was observed in 76.9% of the Foam Group, and had significantly higher frequency than all other groups (p<0.001), except for the polidocanol group (33.3%). The foam group had the highest number of adverse effects, accounting for 30.7% of ears with necrosis (p=0.003), 46.15% with ulcer (p=0.003) and 69.2% with local inflammation (p<0.0001). Despite the greater frequency of neovascularization in the foam group (n = 7) in relation to polidocanol (n = 3) and glucose (n = 3) groups, no significant difference was verified. At the 21st day, there was 38.46% of phlebitis in the foam group and 8.33% in the glucose group. Regarding microscopic analysis, the number of cases of sclerosis (n = 9, p=0.0024) and necrosis (n = 3, p=0.03) in the foam group was also higher than others. Conclusion: The present study found similar efficacy between 1% liquid polidocanol and 1% polidocanol foam in a macroscopic analysis. Microscopicaly, the foam group was the most effective, but revealed more adverse effects.
Introduction: Sclerotherapy is a common treatment for reticular veins and telangiectasias. This treatment, usually with aesthetic purpose, may present complications such as phlebitis, ulcer and hyperpigmentation. Clinical trials involving patients with telangiectasias and reticular veins are limited. This study aims to evaluate the efficacy and safety of sclerotherapic agents using the marginal dorsal vein of rabbit ear as an experimental model. Methods: The study design was an open randomized experimental study using 30 Norfolk rabbits (60 ears). The ears were divided into 5 groups (12 ears per group), in which were injected 1% liquid polidocanol (Polidocanol Group), 1% foaming polidocanol (Foam Group), solution of 0.2% polidocanol-glucose 75% (PG Group), Glucose 75% (Glucose Group) and 0.9% saline (Control Group). Photographs were taken before the moment of the injection, and at 7th, 14th and 21st days after the infusion of the sclerotherapic agent. A vascular surgeon without previous knowledge of the groups conducted the macroscopic analysis. The following macroscopic findings were evaluated: efficacy of the agent (vessel sclerosis) and complications (phlebitis, neovascularization, ulcer at puncture site, necrosis and local inflammation). On the 21st day after the injection, the rabbits’ ears were biopsied for histological analysis with hematoxylin-eosin and Elastica van Gieson staining and immunohistochemistry was conducted using CD31 and CD34 endothelial markers. P values < 0.05 were considered statistically significant. Results: The presence of sclerosis was observed in 76.9% of the Foam Group, and had significantly higher frequency than all other groups (p<0.001), except for the polidocanol group (33.3%). The foam group had the highest number of adverse effects, accounting for 30.7% of ears with necrosis (p=0.003), 46.15% with ulcer (p=0.003) and 69.2% with local inflammation (p<0.0001). Despite the greater frequency of neovascularization in the foam group (n = 7) in relation to polidocanol (n = 3) and glucose (n = 3) groups, no significant difference was verified. At the 21st day, there was 38.46% of phlebitis in the foam group and 8.33% in the glucose group. Regarding microscopic analysis, the number of cases of sclerosis (n = 9, p=0.0024) and necrosis (n = 3, p=0.03) in the foam group was also higher than others. Conclusion: The present study found similar efficacy between 1% liquid polidocanol and 1% polidocanol foam in a macroscopic analysis. Microscopicaly, the foam group was the most effective, but revealed more adverse effects.
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Palavras-chave
Veias varicosas, Escleroterapia, Soluções esclerosantes, Modelos de animal experimental, Eficácia, Segurança