Laser de CO2, radiofrequência e promestrieno no tratamento da síndrome genitourinária da menopausa em usuárias de antiestrogênios com câncer de mama – avaliação histomorfométrica do vestíbulo vulvar: resultados preliminares de um ensaio clínico randomizado
Data
2022-08-10
Autores
Fernandes, Marcela Furtado Roberto 
Orientadores
Patriarca, Marisa Teresinha
Tipo
Dissertação de mestrado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Objetivo: Avaliar os efeitos clínicos e histológicos no vestíbulo vulvar, antes e após os tratamentos com laser de CO2 fracionado microablativo (LCO2), radiofrequência fracionada microablativa (RF) e promestrieno (CT), em pacientes com câncer de mama em uso de antiestrogênios e com Síndrome Genitourinária da Menopausa (SGUM). Métodos: Foram selecionadas 100 mulheres com câncer de mama em uso de antiestrogênios com sinais e/ou sintomas de SGUM de intensidade moderada a grave, de acordo com a Escala Visual Analógica (EVA 4). Após assinatura do termo de consentimento, foi realizado exame ginecológico e biópsia do vestíbulo vulvar. As participantes eram randomizadas para um dos três grupos de tratamento: CT, LCO2 ou RF. O grupo CT fazia uso domiciliar de Promestrieno creme por via vaginal 1g/d, por 21 dias e, em seguida, duas vezes por semana, por quatro meses. Nos grupos LCO2 e RF, foram realizadas três sessões mensais para aplicação das energias na região vulvovaginal. O seguimento foi realizado 120 dias após o início das terapias, com avaliação dos mesmos parâmetros aferidos inicialmente, bem como da impressão subjetiva sobre os efeitos dos tratamentos pela escala de 5 pontos de LIKERT. Resultados: 94 mulheres foram randomizadas da seguinte forma: 32 no grupo CO2L, 32 no RF e 30 no CT. Setenta pacientes concluíram o estudo e tinham amostras pré e pós-tratamento adequadas para análise, 23 no grupo CO2L, 21 no RF e 26 no promestrieno. Após as terapias, houve melhora significativa da sintomatologia expressa pela redução da nota do EVA nos três grupos avaliados (p<0.05) e sem diferença entre eles. A melhora subjetiva foi alcançada de modo semelhante, em todos os grupos LCO2 4,783 (0,518), RF 4,150 (0,813), CT 4,280 (1.13) (p =0,055) acessada por meio da escala de LIKERT. Somente 4 (5.71%) das amostras revelaram atrofia histológica pré-tratamento, mostrando, portanto, dissociação clínico-histológica. Não foram identificadas alterações estruturais epiteliais ou estromais significativas após os tratamentos. Nenhuma injuria à estrutura tecidual do vestíbulo vulvar ou evento adverso clínico relevante foram identificados após os tratamentos com energias. Conclusão: Os tratamentos com LCO2, RF e promestrieno proporcionaram melhora significativa e semelhante da SGUM em mulheres com câncer de mama em uso de antiestrogênios. O uso das energias não provocou dano tecidual estrutural ou complicações clínicas relevantes, o que demonstra a segurança da aplicação dessas tecnologias no vestíbulo vulvar para tratamento da SGUM.
Objective: To evaluate the clinical and histological effect on the vulvar vestibule before and after treatment with CO2 laser (CO2L), fractional radiofrequency microablative (RF) and promestriene (CT) in breast cancer patients in use of antiestrogens therapy with genitourinary syndrome of menopause. Methods: 100 women with breast cancer using antiestrogens with GSM signs and/or symptoms of moderate to severe intensity according to the Visual Analog Scale (VAS 4) were eligible. After providing written informed consent, a gynecological examination and biopsy of the vulvar vestibule were performed. Participants were randomized to one of three treatment groups: CT, LCO2, or RF. The CT group used Promestriene cream vaginally at home at 1 g/d for 21 days and then twice a week for four months. In the LCO2 and RF groups, three monthly sessions were performed for the application of energies in the vulvovaginal region. Follow-up was performed 120 days after therapies start, with evaluation of the same parameters measured initially, as well as the subjective impression of the effects of treatment using the 5-point LIKERT scale. Results: 94 were randomized as follows: 32 in the CO2L group, 32 in the RF and 30 in the CT. Seventy patients concluded the treatment and had adequate pre and post treatment material to analysis, 23 in the CO2L group, 21 in the RF and 26 in the promestriene. After therapies, there was a significant symptoms improvement expressed by the VAS score reduction in the three assessment groups (p<0.05) with no difference between them. Was also reported a high satisfaction after the treatment protocol in all groups evaluated by Likert Scale (CO2L 4,783 (0,518), RF 4,150 (0,813) , CT 4,280 (1.13)), p=0,055. Histological vulvar atrophy was identified in only 4 (5.7%) pre-treatment vulvar samples (2 RF, 2 CT) showing, therefore, clinical-histological dissociation. No injuries to the histological structure of the vulvar vestibule or relevant clinical adverse events were identified post-treatment. Conclusion: Treatment with CO2L, RF and promestriene provided significant and similar improvement in GSM in women with breast cancer using antiestrogens. The energy did not cause any structural tissue damage or relevant clinical complications, which demonstrates the safety of the application of those technologies in the vulvar vestibule for the GSM treatment.
Objective: To evaluate the clinical and histological effect on the vulvar vestibule before and after treatment with CO2 laser (CO2L), fractional radiofrequency microablative (RF) and promestriene (CT) in breast cancer patients in use of antiestrogens therapy with genitourinary syndrome of menopause. Methods: 100 women with breast cancer using antiestrogens with GSM signs and/or symptoms of moderate to severe intensity according to the Visual Analog Scale (VAS 4) were eligible. After providing written informed consent, a gynecological examination and biopsy of the vulvar vestibule were performed. Participants were randomized to one of three treatment groups: CT, LCO2, or RF. The CT group used Promestriene cream vaginally at home at 1 g/d for 21 days and then twice a week for four months. In the LCO2 and RF groups, three monthly sessions were performed for the application of energies in the vulvovaginal region. Follow-up was performed 120 days after therapies start, with evaluation of the same parameters measured initially, as well as the subjective impression of the effects of treatment using the 5-point LIKERT scale. Results: 94 were randomized as follows: 32 in the CO2L group, 32 in the RF and 30 in the CT. Seventy patients concluded the treatment and had adequate pre and post treatment material to analysis, 23 in the CO2L group, 21 in the RF and 26 in the promestriene. After therapies, there was a significant symptoms improvement expressed by the VAS score reduction in the three assessment groups (p<0.05) with no difference between them. Was also reported a high satisfaction after the treatment protocol in all groups evaluated by Likert Scale (CO2L 4,783 (0,518), RF 4,150 (0,813) , CT 4,280 (1.13)), p=0,055. Histological vulvar atrophy was identified in only 4 (5.7%) pre-treatment vulvar samples (2 RF, 2 CT) showing, therefore, clinical-histological dissociation. No injuries to the histological structure of the vulvar vestibule or relevant clinical adverse events were identified post-treatment. Conclusion: Treatment with CO2L, RF and promestriene provided significant and similar improvement in GSM in women with breast cancer using antiestrogens. The energy did not cause any structural tissue damage or relevant clinical complications, which demonstrates the safety of the application of those technologies in the vulvar vestibule for the GSM treatment.