Eficácia da fotobiomodulação sistêmica vascular via transcutânea em relação à carga viral, LT-CD4+ e LT-CD48+ nos pacientes vivendo com hiv/aids: ensaio clínico randomizado
Carregando...
Data
2023-02-09
Autores
Ramos, Fabiana Tomé
Título da Revista
ISSN da Revista
Título de Volume
Editor
Universidade Estadual Paulista (Unesp)
Resumo
Introdução: desde o pico de 1996 foram reduzidas em 54% o número de novas infecções por HIV. No entanto, em 2021 ainda houve 1,5 milhão novos infectados. Observa-se eficácia no uso da fotobiomodulação sistêmica vascular via transcutânea na prática clínica, porém há pouca evidência científicas para o aumento da resposta imune de pessoas vivendo com HIV/aids. Objetivo: avaliar a eficácia da fotobiomodulação sistêmica vascular via transcutânea relacionado à diminuição da carga viral carga viral e aumento dos LT-CD4+ e LT-CD8+ em pessoas vivendo com HIV/aids atendidos em serviço ambulatorial. Método: ensaio clínico, randomizado, unicego, realizado em um Serviço de Ambulatórios Especializados em Infectologia, localizado no interior de São Paulo, no período de fevereiro de 2021 a dezembro de 2022. Considerando a hipótese clínica que haja melhora superior a 0,5 log da carga viral no grupo tratado, dado até 5% de dropout, alfa de 5% (unicaudal) e poder de 80%, a amostra foi estimada em 86 participantes (43 pacientes cada grupo de tratamento). Foram incluídas: pessoas vivendo com HIV/aids, de ambos os sexos, com idade ≥ l8 anos, que realizam o tratamento ambulatorial, com carga viral detectável, em mesmo esquema terapêutico, sem déficit cognitivo. Os pacientes eleitos foram randomizados em dois grupos: Grupo Controle e Grupo fotobiomodulação (FBM). A sequência da randomização foi gerada por software computacional. O equipamento foi posicionado na artéria radial. O grupo FBM recebeu a aplicação por 30 minutos diários, durante 10 dias, folgando nos sábados, domingos e feriados, com pausa de 20 dias e, repetindo o protocolo para aplicação por mais 10 dias. O grupo controle realizou o mesmo esquema terapêutico, porém, com aparelho sem presença de luz. A coleta dos exames (carga viral, LT-CD4+ e LT-CD8+) de ambos os grupos foram realizadas no início e termino do protocolo. As variáveis foram analisadas, utilizando o Programa IBM SPSS 25.0. Com as variáveis quantitativas foram realizadas comparações dos dados basais entre os grupos pelo teste U de Mann-Whitney, e a comparação longitudinal entre os grupos foi realizada pelo modelo linear generalizado de efeitos mistos, com regressão gama. Resultados: A amostra foi composta por 28 participantes, sendo 15 no grupo controle e 13 no grupo FBM. Não houve redução significativa da carga viral e LT-CD4+. Houve redução não significativa de LT-CD8+ no grupo FBM. Apesar disso, os pacientes tratados que tiveram essa queda de LT-CD8+ apresentaram carga viral indetectável. Conclusão: análise estatística dos dados determinou que não houve diferenças significativas nas variáveis analisadas antes e após o tratamento com fotobiomodulação sistêmica vascular via transcutânea. Diante da escassez de estudos clínicos, acredita-se que o desenvolvimento de outros protocolos de estudo em pessoas vivendo com HIV/aids e com amostra maior, podem trazer resultados significativos diante desta temática.
Introduction: since the 1996 peak, the number of new HIV infections has been reduced by 54%. However, in 2021 there were still 1.5 million newly infected. Efficacy is observed in the use of transcutaneous photobiomodulation (FBM) in clinical practice, but there is little scientific evidence for increasing the immune response of people living with HIV/AIDS (PLWHA). Objective: To evaluate the effectiveness of the transcutaneous FBM protocol related to the decrease in viral load (VC) and increase in LT-CD4+ and LT-CD8+ in people living with HIV/AIDS treated at an outpatient servisse. Method: clinical, randomized, singleblind trial, carried out at the Specialized Outpatient Service in Infectious Diseases "Domingos Alves Meira" - SAEI, located in the state of São Paulo, in the period from February 2021 to December 2022. Considering the clinical hypothesis that there is an improvement of more than 0.5 log of viral load in the treated group, given up to 5% dropout, alpha of 5% (one-tailed) and power of 80%, the sample was estimated at 86 participants (43 patients each treatment group). The following were included: PLWHA, of both sexes, aged ≥ 18 years, who undergo outpatient treatment at the SAEI, with detectable VC, on the same therapeutic regimen, without cognitive impairment. The selected patients were randomized into two groups: Control Group and FBM Group. The randomization sequence was generated by computational software. The equipment was positioned on the radial artery. The FBM group received the application for 30 minutes a day, for 10 days, with Saturdays, Sundays and holidays off, with a 20-day break, and repeating the application protocol for another 10 days. The control group performed the same therapeutic scheme, however, with a device without the presence of light. The collection of exams (CV, LT-CD4+ and LT-CD8+) of both groups were performed at the beginning and end of the protocol. The variables were analyzed using the IBM SPSS 25.0 program. With the quantitative variables, comparisons of baseline data between groups were performed using the MannWhitney U test, and the longitudinal comparison between groups was performed using the generalized linear model of mixed effects, with gamma regression. Results: The sample consisted of 28 participants, 15 in the control group and 13 in the FBM group. There was no significant reduction in VC in either group. There was no significant reduction in VC in both groups and there was a reduction in CD4 and CD8 in the treated group. However, it is noteworthy that despite this, treated patients who had this drop in LT-CD4+ and LT-CD8+ had undetectable VC. Conclusion: This was the first blinded randomized clinical trial performed in PLWHA undergoing transcutaneous systemic vascular photobiomodulation. And, given the scarcity of clinical studies, it is believed that the development of other study protocols in PLWHA and with a larger sample, can bring significant results on this theme.
Introduction: since the 1996 peak, the number of new HIV infections has been reduced by 54%. However, in 2021 there were still 1.5 million newly infected. Efficacy is observed in the use of transcutaneous photobiomodulation (FBM) in clinical practice, but there is little scientific evidence for increasing the immune response of people living with HIV/AIDS (PLWHA). Objective: To evaluate the effectiveness of the transcutaneous FBM protocol related to the decrease in viral load (VC) and increase in LT-CD4+ and LT-CD8+ in people living with HIV/AIDS treated at an outpatient servisse. Method: clinical, randomized, singleblind trial, carried out at the Specialized Outpatient Service in Infectious Diseases "Domingos Alves Meira" - SAEI, located in the state of São Paulo, in the period from February 2021 to December 2022. Considering the clinical hypothesis that there is an improvement of more than 0.5 log of viral load in the treated group, given up to 5% dropout, alpha of 5% (one-tailed) and power of 80%, the sample was estimated at 86 participants (43 patients each treatment group). The following were included: PLWHA, of both sexes, aged ≥ 18 years, who undergo outpatient treatment at the SAEI, with detectable VC, on the same therapeutic regimen, without cognitive impairment. The selected patients were randomized into two groups: Control Group and FBM Group. The randomization sequence was generated by computational software. The equipment was positioned on the radial artery. The FBM group received the application for 30 minutes a day, for 10 days, with Saturdays, Sundays and holidays off, with a 20-day break, and repeating the application protocol for another 10 days. The control group performed the same therapeutic scheme, however, with a device without the presence of light. The collection of exams (CV, LT-CD4+ and LT-CD8+) of both groups were performed at the beginning and end of the protocol. The variables were analyzed using the IBM SPSS 25.0 program. With the quantitative variables, comparisons of baseline data between groups were performed using the MannWhitney U test, and the longitudinal comparison between groups was performed using the generalized linear model of mixed effects, with gamma regression. Results: The sample consisted of 28 participants, 15 in the control group and 13 in the FBM group. There was no significant reduction in VC in either group. There was no significant reduction in VC in both groups and there was a reduction in CD4 and CD8 in the treated group. However, it is noteworthy that despite this, treated patients who had this drop in LT-CD4+ and LT-CD8+ had undetectable VC. Conclusion: This was the first blinded randomized clinical trial performed in PLWHA undergoing transcutaneous systemic vascular photobiomodulation. And, given the scarcity of clinical studies, it is believed that the development of other study protocols in PLWHA and with a larger sample, can bring significant results on this theme.
Descrição
Palavras-chave
Terapia com luz de baixa intensidade, Bioestimulação a Laser, HIV, AIDS (Doença), Carga viral, Ensaio Clínico Controlado Aleatório