RESUMO
RESUMEN Introducción: En Cuba se empezó la aplicación nasal de IFN alfa 2b recombinante humano (Nasalferon) en personal de riesgo para prevenir la infección por el SARS-CoV-2. Objetivo: caracterizar la seguridad de los expuestos al uso del Nasalferon en el Centro de Investigaciones Médico Quirúrgicas y explorar el efecto del uso profiláctico del fármaco contra cuadros respiratorios agudos causados preferentemente por el SARS-CoV-2. Material y Métodos: Estudio epidemiológico monocéntrico, prospectivo, abierto, de vigilancia temprana en trabajadores sanitarios, a los que se le administró nasalferon. Se realizó la vigilancia mediante el método de Vigilancia del Monitoreo de Eventos Adversos Ligados a la Prescripción. La variable principal fue la presencia de eventos adversos. Secundariamente se exploró el efecto del fármaco en la prevención de infección por el virus. Para el análisis de la variable principal se estimó la proporción de sujetos con cada uno de los eventos adversos que se presentaron. Se estimaron, además, la distribución de frecuencia del tipo de evento, intensidad, gravedad y la causalidad o imputabilidad. Resultados: Se incluyeron 86 sujetos, de ellos, 50 experimentaron 15 tipos de eventos adversos. No se reportaron eventos severos ni graves. Los catalogados como moderados fueron: cefalea, leucopenia, decaimiento e hipertensión arterial. Durante el tiempo que duró el tratamiento y hasta un mes después de este, ninguno de los sujetos incluidos presentó COVID-19 ni otros cuadros respiratorios agudos virales. Conclusiones: El Nasalferon resultó ser un fármaco seguro y tolerable y los sujetos incluidos no presentaron cuadros respiratorios agudos relacionados o no con la COVID-19.
ABSTRACT Introduction: In Cuba, the nasal application of recombinant human IFN-alpha- 2b (nasalferon) began in personnel at risk in order to prevent SARS-CoV-2 infection. Objective: To characterize the safety in those subjects exposed to the use of Nasalferon at the Surgical Medical Research Center and to explore the effect of the prophylactic use of the drug against acute respiratory symptoms mainly caused by SARS-CoV-2. Material and Methods: Monocentric, prospective, open, and early surveillance epidemiological study conducted in healthcare workers who were administered Nasalferon. Surveillance was performed using the Prescription-Related Adverse Event Monitoring Surveillance method. The main variable was the presence of adverse events. Secondarily, the effect of the drug in preventing virus infection was explored. For the analysis of the main variable, the proportion of subjects who experienced each of the adverse events was estimated. In addition, the frequency distribution of the type of event, intensity, severity, and causality or imputability were estimated. Results: A total of 86 subjects were included; 50 of them experienced 15 types of adverse events. No severe or serious events were reported. Headache, leukopenia, decay, and arterial hypertension were classified as moderate ones. During the whole duration of the treatment and until a month after it, none of the subjects included in the study presented COVID-19 or other viral acute respiratory symptoms. Conclusions: Nasalferon proved to be a safe and tolerable drug and the included subjects did not present acute respiratory symptoms related or unrelated to COVID-19.
Assuntos
HumanosRESUMO
INTRODUCTION: SARS-CoV-2 infection can produce endothelial injury and microvascular damage, one cause of the multiorgan failure associated with COVID-19. Cerebrovascular endothelial damage increases the risk of stroke in COVID-19 patients, which makes prompt diagnosis important. Endothelial dysfunction can be evaluated by using transcranial Doppler ultrasound to study cerebral hemodynamic reserve, but there are few of these studies in patients with COVID-19, and the technique is not included in COVID-19 action and follow-up guidelines nationally or internationally. OBJECTIVE: Estimate baseline cerebral hemodynamic patterns, cerebral hemodynamic reserve, and breath-holding index in recovered COVID-19 patients. METHOD: We conducted an exploratory study in 51 people; 27 men and 24 women 20-78 years of age, divided into two groups. One group comprised 25 recovered COVID-19 patients, following clinical and epidemiological discharge, who suffered differing degrees of disease severity, and who had no neurological symptoms or disease at the time they were incorporated into the study. The second group comprised 26 people who had not been diagnosed with COVID-19 and who tested negative by RT-PCR at the time of study enrollment. Recovered patients were further divided into two groups: those who had been asymptomatic or had mild disease, and those who had severe or critical disease. We performed transcranial Doppler ultrasounds to obtain baseline and post-apnea tests of cerebral hemodynamic patterns to evaluate cerebral hemodynamic reserve and breath-holding indices. We characterized the recovered patient group and the control group through simple descriptive statistics (means and standard deviations). RESULTS: There were no measurable differences in baseline cerebral hemodynamics between the groups. However, cerebral hemodynamic reserve and breath-holding index were lower in those who had COVID-19 than among control participants (19.9% vs. 36.8% and 0.7 vs. 1.2 respectively). These variables were similar for patients who had asymptomatic or mild disease (19.9% vs.19.8%) and for those who had severe or critical disease (0.7 vs. 0.7). CONCLUSIONS: Patients recovered from SARS-CoV-2 infection showed decreased cerebral hemodynamic reserve and breath-holding index regardless of the disease's clinical severity or presence of neurological symptoms. These abnormalities may be associated with endothelial damage caused by COVID-19. It would be useful to include transcranial Doppler ultrasound in evaluation and follow-up protocols for patients with COVID-19.
