Eficácia e segurança do creme de Fluorouracil 5% versus peeling com solução de Jessner e Fluorouracil 5% loção no tratamento do campo de cancerização cutâneo: um ensaio clínico randomizado
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Data
2021-12-17
Autores
Shwetz, Ana Claudia Athanasio
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Universidade Estadual Paulista (Unesp)
Resumo
Fundamentos: A estabilização e tratamento das queratoses actínicas (QA) e campo de cancerização cutâneo (CCC) pode diminuir a incidência de neoplasias cutâneas. O 5-Fluorouracil (5-FU) 5% é a terapia padrão ouro no tratamento do CCC. O peeling com solução de Jessner pode ser utilizado como meio para permitir maior penetração do 5-FU, sem a necessidade de aplicação diária – conferindo melhor posologia ao medicamento. Objetivos: Avaliar a eficácia e segurança do peeling com a solução de Jessner associado ao 5-FU 5% loção versus o 5-FU 5% em creme no tratamento de QAs e do campo de cancerização dos antebraços. Métodos e casuística: Ensaio clínico randomizado, autocontrolado, aberto, em que 15 pacientes com três a dez QAs por antebraços foram randomizados para obter 5-FU 5% creme (uma vez ao dia por quatro semanas – grupo 5-FU) ou peeling de solução de Jessner associado ao 5-FU 5% loção (uma vez por semana, por quatro semanas – grupo peeling). O objetivo principal foi o clareamento total de lesões após 180 dias do início do tratamento. Os objetivos secundários foram clareamento parcial (>50%) e redução da atividade do CCC, avaliada através do escore de gravidade das QAs (EGQA) e escala do fotoenvelhecimento dos antebraços (EFA) antes do início dos tratamentos e ao final de 180 dias. Os efeitos colaterais foram avaliados após 30, 60 e 180 dias. Todos os pacientes incluídos no estudo e randomizados fizeram parte da população ITT (intention to treat). A contagem de Qas, EGQA e EFA foram comparadas de acordo com o tempo e para grupos (ao longo do tempo) pelo modelo linear generalizado de efeitos mistos. A significância adotada de p (bicaudal) foi de <0.05. Resultados: Foram avaliados 15 pacientes, com predomínio do sexo masculino (67%), fototipos I e II e mediana de idade de 73 anos. Não houve dropouts. Constatou-se um clearance total no D180 de 13,33% com o peeling e de 26,67% com o 5-FU 5% creme; clearance parcial (>50%) em 73,33% no grupo peeling e 80% no grupo 5-FU. O ECGA diminuiu 55% e 74% com o uso do peeling e 5-FU, respectivamente. Ambos os tratamentos melhoraram os sinais de fotoenvelhecimento nos antebraços. O principal efeito colateral relatado após 30 dias em ambos os grupos foi a dor. A ulceração significativamente mais no grupo 5-FU. Conclusão: O tratamento com peeling de solução de Jessner com 5-FU 5% loção semanal e o 5-FU 5% creme uma vez ao dia, são seguros e eficazes no tratamento de QAs e do campo de cancerização.
Background: Stabilization and treatment of actinic keratoses (AK) and skin field of cancerization (SFC) can reduce the incidence of skin cancer. 5% 5-Fluorouracil (5-FU) is the gold standard therapy in the treatment of SFC. The peeling with Jessner's solution can be used as a means to allow greater penetration of 5-FU, without the need for daily application – providing a better dosage of the drug. Objectives: To evaluate the efficacy and safety of peeling with Jessner's solution associated with 5-FU 5% lotion versus 5-FU 5% cream in the treatment of AK and the field of cancerization of the forearms. Methods and casuistry: Randomized, self-controlled, open clinical trial, in which 15 patients with three to ten AKs per forearm were randomized to obtain 5-FU 5% cream (once a day for four weeks - 5-FU group) or peeling Jessner's solution associated with 5- FU 5% lotion (once a week for four weeks – peeling group). The main objective was the total clearence of lesions 180 days after the start of treatment. Secondary objectives were partial clearence (>50%) and reduction of CCC activity, assessed through the AKs severity score (AKSS) and forearm photoaging scale (FPS) before the start of treatments and at the end of 180 days. Side effects were evaluated after 30, 60 and 180 days. All patients included in the study and randomized were part of the ITT (intention to treat) population. The AKs, AKSS and FPS counts were compared according to time and for groups (over time) by the generalized linear mixed effects model. The adopted significance of p (twotailed) was <0.05. Results: 15 patients were evaluated, predominantly male (67%), phototypes I and II and a median age of 73 years. There were no dropouts. There was a total clearance of 13.33% with peeling and 26.67% with 5-FU 5% cream; partial clearance (>50%) in 73.33% in the peeling group and 80% in the 5-FU group. AKSS decreased by 55% and 74% with the use of peeling and 5-FU, respectively. Both treatments improved the signs of photoaging in the forearms. The main side effect reported after 30 days in both groups was pain. Ulceration was significantly more commom in the 5-FU group. Conclusion: Jessner's solution peel treatment with 5-FU 5% lotion weekly and 5-FU 5% cream once daily are safe and effective in the treatment of AKs and the field of cancerization.
Background: Stabilization and treatment of actinic keratoses (AK) and skin field of cancerization (SFC) can reduce the incidence of skin cancer. 5% 5-Fluorouracil (5-FU) is the gold standard therapy in the treatment of SFC. The peeling with Jessner's solution can be used as a means to allow greater penetration of 5-FU, without the need for daily application – providing a better dosage of the drug. Objectives: To evaluate the efficacy and safety of peeling with Jessner's solution associated with 5-FU 5% lotion versus 5-FU 5% cream in the treatment of AK and the field of cancerization of the forearms. Methods and casuistry: Randomized, self-controlled, open clinical trial, in which 15 patients with three to ten AKs per forearm were randomized to obtain 5-FU 5% cream (once a day for four weeks - 5-FU group) or peeling Jessner's solution associated with 5- FU 5% lotion (once a week for four weeks – peeling group). The main objective was the total clearence of lesions 180 days after the start of treatment. Secondary objectives were partial clearence (>50%) and reduction of CCC activity, assessed through the AKs severity score (AKSS) and forearm photoaging scale (FPS) before the start of treatments and at the end of 180 days. Side effects were evaluated after 30, 60 and 180 days. All patients included in the study and randomized were part of the ITT (intention to treat) population. The AKs, AKSS and FPS counts were compared according to time and for groups (over time) by the generalized linear mixed effects model. The adopted significance of p (twotailed) was <0.05. Results: 15 patients were evaluated, predominantly male (67%), phototypes I and II and a median age of 73 years. There were no dropouts. There was a total clearance of 13.33% with peeling and 26.67% with 5-FU 5% cream; partial clearance (>50%) in 73.33% in the peeling group and 80% in the 5-FU group. AKSS decreased by 55% and 74% with the use of peeling and 5-FU, respectively. Both treatments improved the signs of photoaging in the forearms. The main side effect reported after 30 days in both groups was pain. Ulceration was significantly more commom in the 5-FU group. Conclusion: Jessner's solution peel treatment with 5-FU 5% lotion weekly and 5-FU 5% cream once daily are safe and effective in the treatment of AKs and the field of cancerization.
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Palavras-chave
Abrasão química, Oncologia, Ceratose actínica, Flourouracila, Dermatologia, Peeling, Oncology, Actinic keratosis, Flourouracil, Dermatology