Análise do potencial da irradiação sublingual transvascular sanguínea com LED em pacientes com COVID-19: estudo clínico piloto, duplo-cego, randomizado - fase 3

Abstract

INTRODUCTION: The COVID-19 pandemic that has globally affected the 21st century, incurs a serious infection by SARS-CoV-2, affecting the health of all world population, with consequences of high morbidity and mortality. Population vaccination has contributed as a specific protective measure for primary prevention to reduce morbidity and mortality, but there are no specific treatments against this virus so far. Then, an effective, non-invasive, prophylactic or even adjuvant techniques are needed that should be prioritized in the treatment of COVID-19, with photobiomodulation therapy (PBMT) being highlighted. PURPOSE: Evaluation of photobiomodulation therapy through the application of sublingual transvascular blood irradiation in individuals with COVID-19. SPECIFIC OBJECTIVES: To observe the demand for supplemental oxygen and serum oxygen levels through arterial blood gases; in addition, to assess the impact on the length of hospital stay. METHODOLOGY: This is a pilot, randomized, prospective, horizontal clinical study that evaluated COVID-19 patients diagnosed that were admitted to the ventilatory care unit, and undergoing a treatment protocol by irradiation of LED light, by transvascular application over the sublingual vessels, daily. 14 patients were selected and divided into two groups: 1. Placebo group (n = 7) received the device off (LED-off) and 2. PBMT group (n = 7), which corresponds to the study group with LED irradiation. A daily LED application in the PBMT group in patients from the ventilatory care ward (COVID-19) were performed. The dosimetric parameters used were: λ ± 660 nm, power of 5 mW/point, power density (radiant exposure) of 19.09 mW/cm2, total power of 15 mW; total application time of 7 minutes (420 seconds); effective illumination area of each light source (without overlapping) of 1 cm2; energy density (fluence) of 2.1 J/cm2. The clinical course of respiratory impairment, markers of inflammation in the blood, demand for supplemental oxygen, stay length, morbidity and mortality were evaluated. A statistical analysis was performed using the Student test, ANOVA and the linear regression model with random effects. RESULTS: There was a significant clinical improvement in the patients in the PBMT Group compared to the Placebo Group. All patients in the PBMT Group had SatO2 normalized, whereas a quarter of the patients in the Placebo Group required O2 supplementation until the day of hospital discharge. The number of days that required O2 was lower in the PBMT group, with statistical significance. Furthermore, there was a statistically significant reduction in serum creatinine and fewer days of hospital stay in the PBMT Group. CONCLUSION: The observation of clinical improvement indicated that the daily application of Photobiomodulation Therapy was able to reduce the length of hospital stay, in addition to preserving the renal function of patients affected by COVID-19, being an adjuvant, safe, easy to apply and non-invasive.