Eficacia y seguridad de la administración de plasma de convaleciente en pacientes con COVID-19 / Efficacy and safety of convalescent plasma administration in patients with COVID-19 infection

Introducción Durante la pandemia de COVID-19 surgieron diversas estrategias para el manejo de la enfermedad, incluidos los tratamientos farmacológicos y no farmacológicos como el plasma convaleciente (PC). El uso de PC se sugirió debido a los resultados benéficos mostrados al tratar otras enfermedades virales. Objetivo Determinar la eficacia y la seguridad de la administración de PC obtenido de sangre total en pacientes con COVID-19. Métodos Ensayo clínico piloto en pacientes con COVID-19 de un hospital general. Los sujetos se separaron en 3 grupos que recibieron la transfusión de 400ml de PC (n=23) o 400ml de plasma estándar (PE) (n=19) y un grupo no transfundido (NT) (n=37). Los pacientes recibieron además, el tratamiento médico estándar disponible para COVID-19. El seguimiento de los sujetos se llevó a cabo diariamente desde el ingreso hasta el día 21. Resultados El PC no mejoró la curva de supervivencia en las variantes moderadas y graves de COVID-19, ni disminuyó el grado de severidad de la enfermedad evaluado con la escala de progresión clínica COVID-19, OMS y SOFA. Ningún paciente presentó una reacción postransfusional severa al PC. Conclusiones El tratamiento con PC no disminuye la mortalidad de los pacientes, aun cuando su administración tiene un alto grado de seguridad (AU)

Introduction During the COVID-19 pandemic, several strategies were suggested for the management of the disease, including pharmacological and non-pharmacological treatments such as convalescent plasma (CP). The use of CP was suggested due to the beneficial results shown in treating other viral diseases. Objective To determine the efficacy and safety of CP obtained from whole blood in patients with COVID-19. Methods Pilot clinical trial in patients with COVID-19 from a general hospital. The subjects were separated into three groups that received the transfusion of 400ml of CP (n=23) or 400ml of standard plasma (SP) (n=19) and a non-transfused group (NT) (n=37). Patients also received the standard available medical treatment for COVID-19. Subjects were followed up daily from admission to day 21. Results The CP did not improve the survival curve in moderate and severe variants of COVID-19, nor did it reduce the degree of severity of the disease evaluated with the COVID-19 WHO and SOFA clinical progression scale. No patient had a severe post-transfusion reaction to CP. Conclusions Treatment with CP does not reduce the mortality of patients even when its administration has a high degree of safety (AU)

[Efficacy and safety of convalescent plasma administration in patients with COVID-19 infection]. / Eficacia y seguridad de la administración de plasma de convaleciente en pacientes con COVID-19.

INTRODUCTION: During the COVID-19 pandemic, several strategies were suggested for the management of the disease, including pharmacological and non-pharmacological treatments such as convalescent plasma (CP). The use of CP was suggested due to the beneficial results shown in treating other viral diseases. OBJECTIVE: To determine the efficacy and safety of CP obtained from whole blood in patients with COVID-19. METHODS: Pilot clinical trial in patients with COVID-19 from a general hospital. The subjects were separated into three groups that received the transfusion of 400ml of CP (n=23) or 400ml of standard plasma (SP) (n=19) and a non-transfused group (NT) (n=37). Patients also received the standard available medical treatment for COVID-19. Subjects were followed up daily from admission to day 21. RESULTS: The CP did not improve the survival curve in moderate and severe variants of COVID-19, nor did it reduce the degree of severity of the disease evaluated with the COVID-19 WHO and SOFA clinical progression scale. No patient had a severe post-transfusion reaction to CP. CONCLUSIONS: Treatment with CP does not reduce the mortality of patients even when its administration has a high degree of safety.

Effects of resistant starch on glycemic response, postprandial lipemia and appetite in subjects with type 2 diabetes.

PURPOSE: Resistant starch (RS) content has exhibited beneficial effects on glycemic control; however, few studies have investigated the effects of this substance on postprandial responses and appetite in subjects with type 2 diabetes (T2D). Here, we aimed to examine the effects of RS from two sources on glycemic response (GR), postprandial lipemia, and appetite in subjects with T2D. METHODS: In a randomized and crossover study, 17 subjects with T2D consumed native banana starch (NBS), high-amylose maize starch (HMS) or digestible maize starch (DMS) for 4 days. On day 5, a 6-h oral meal tolerance test (MTT) was performed to evaluate glycemic and insulinemic responses as well as postprandial lipemia. Besides, subjective appetite assessment was measured using a visual analogue scale. RESULTS: NBS induced a reduction on fasting glycemia, glycemia peak and insulinemic response during MTT. However, no modifications on postprandial lipemia were observed after RS treatments. Both NBS and HMS reduced hunger and increased satiety. CONCLUSION: NBS supplementation induced more beneficial effects on glycemic metabolism than HMS even when all interventions were matched for digestible starch content. RS intake did not modify postprandial lipemia, however, positively affected subjective appetite rates. TRIAL REGISTRATION: This trial was retrospectively registered at www.anzctr.org.au (ACTRN12621001382864) on October 11, 2021.

Estudio preliminar de un enjuague bucal de solución salina como muestra diagnóstica para SARS-CoV-2 / Preliminary study of a saline mouthwash as a diagnostic sample for SARS-CoV-2

Resumen Objetivo: Evaluar la utilidad de un enjuague bucal con solución salina (EBSS) como muestra diagnóstica para la detección de SARS-CoV-2 en pacientes ambulatorios. Material y métodos: Este fue un estudio prospectivo realizado en el Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasús", se seleccionaron 34 muestras aleatorias pareadas EBSS/MNF (enjuague bucal con solución salina/muestra (clínica) de la nasofaringe) que se recolectaron durante la visita al centro de evaluación ambulatoria de dicho hospital. Las muestras se analizaron mediante la reacción en cadena de la polimerasa con transcripción inversa en tiempo real (RT-PCR) y se calculó la concordancia entre EBSS y MNF, la sensibilidad y especificidad del EBSS. Resultados: De las 34 muestras pareadas EBSS/MNF, 14 fueron positivas para SARS- CoV-2; 4 muestras de EBSS y 10 muestras de MNF. Los resultados concordantemente positivos en las muestras pareadas EBSS/MNF fueron 3 y las medias de CT de cada gen (RdRp, N, E) no mostraron diferencia significativa entre las muestras. Se observaron 8 discordancias entre los dos tipos de muestras (7 individuos dieron positivo por MNF y 1 por EBSS). La concordancia observada entre EBSS y MNF fue aceptable (coeficiente kappa 0.31). La sensibilidad de EBSS fue de 30% con una especificidad del 95.8%. Conclusiones: La sensibilidad de EBSS no es comparable con la sensibilidad de MNF para la detección de SARS-CoV-2, pero nuestros datos sugieren al EBSS como una herramienta no invasiva, permite la autocolección y no requiere personal de salud capacitado para su muestreo: asimismo, esta muestra podría ser alternativa ante la escasez de hisopos y medios de transporte viral. Además, el EBSS puede tener beneficio para poblaciones remotas, vulnerables o facilitar las pruebas a un gran número de individuos.

Abstract Objective: To assess the usefulness of a saline mouth rinse (SMR) as a diagnostic tool for the detection of SARS-CoV-2 in outpatients. Method: This was a prospective study carried out at the Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasús", 34 SMR/SNP (saline mouth rinse/sample (clinical) of nasopharyngeal) randomized paired samples were selected and collected in the outpatient clinic. The samples were analyzed by real-time reverse transcription polymerase chain reaction (RT-PCR) and the concordance between SMRs and SNP samples and the sensitivity and specificity of SMR were calculated. Results: Out of the 34 SMR/SNP paired samples, 14 samples were positive for SARS- CoV-2; 4 SMR samples and 10 SNP samples. We found 3 positive concordant results in the SMRs/SNP paired samples, the mean CT for each gene (RdRp, N, E) did not show a significant difference between the samples. Eight discrepancies were observed between the two types of samples (7 individuals were positive by SNP and 1 for SMR). The concordance observed between SMR and SNP was acceptable (kappa coefficient 0.31). The sensitivity of EBSS was 30% with a specificity of 95.8%. Conclusions: The SMR sensitivity is not comparable with SNP sensitivity for SARS- CoV-2 detection, but our data suggest SMR as a non-invasive tool that allows self- collection, and it does not require health trained personnel for its collection. Also, this sample could be an alternative to the lack of swabs and/or viral transportation media. Additionally, SMR may be of benefit in remote and vulnerable populations, and/or to facilitate the screening of SARS-CoV-2 in a large number of individuals.

Resistant Starch Consumption Effects on Glycemic Control and Glycemic Variability in Patients with Type 2 Diabetes: A Randomized Crossover Study.

We previously observed beneficial effects of native banana starch (NBS) with a high resistant starch (RS) content on glycemic response in lean and obese participants. Here, we aimed to determine the effects of NBS and high-amylose maize starch (HMS) on glycemic control (GC) and glycemic variability (GV) in patients with type 2 diabetes (T2D) when treatments were matched for digestible starch content. In a randomized, crossover study, continuous glucose monitoring (CGM) was performed in 17 participants (aged 28-65 years, BMI ≥ 25 kg/m2, both genders) consuming HMS, NBS, or digestible maize starch (DMS) for 4 days. HMS and NBS induced an increase in 24 h mean blood glucose during days 2 to 4 (p < 0.05). CONGA, GRADE, and J-index values were higher in HMS compared with DMS only at day 4 (p < 0.05). Yet, NBS intake provoked a reduction in fasting glycemia changes from baseline compared with DMS (p = 0.0074). In conclusion, under the experimental conditions, RS from two sources did not improve GC or GV. Future longer studies are needed to determine whether these findings were affected by a different baseline microbiota or other environmental factors.

Effects of Non-Nutritive Sweeteners on Energy Intake, Body Weight and Postprandial Glycemia in Healthy and with Altered Glycemic Response Rats.

The aim of this study was to evaluate the effects of non-nutritive sweeteners (NNS) consumption on energy intake, body weight and postprandial glycemia in healthy and with altered glycemic response rats. Animals on normal diet (ND) or high-fat diet (HFD) were divided to receive NNS (sucralose, aspartame, stevia, rebaudioside A) or nutritive sweeteners (glucose, sucrose) for 8 weeks. The NNS were administered at doses equivalent to the human acceptable daily intake (ADI). A test using rapidly digestible starch was performed before and after treatments to estimate glycemic response. No effects of NNS consumption were observed on energy intake or body weight. Sucrose provoked an increased fluid consumption, however, energy intake, and weight gain were not altered. In ND, no effects of NNS on glycemic response were observed. In HFD, the glycemic response was increased after sucralose and stevia when only the final tolerance test was considered, however, after including the baseline test, these results were no longer significant compared to glucose. These findings provide further evidence suggesting that at the recommended doses, NNS do not alter feeding behavior, body weight or glycemic tolerance in healthy and with altered glycemic rats.

Effects of Resistant Starch Ingestion on Postprandial Lipemia and Subjective Appetite in Overweight or Obese Subjects.

Reports surrounding the role of resistant starch (RS) on postprandial lipemia in humans are scarce. The aim of the present study is to examine the effects of resistant starch on the postprandial lipemic response, subjective measures of appetite, and energy intake in overweight and obese subjects. In a randomized, single-blind, crossover study, 14 overweight/obese participants ate a high-fat breakfast (679 kcal, 58% from fat) and a supplement with native banana starch (NBS), high-amylose maize starch (HMS), or digestible maize starch (DMS) on three separate occasions. All supplements provided were matched by the available carbohydrate content, and the RS quantity in NBS and HMS supplements was identical. Appetite was estimated using visual analogue scale (VAS) and an ad libitum test meal. Postprandial glycemia, triglycerides, cholesterol, high-density lipoprotein (HDL) cholesterol, and insulin excursions did not differ between treatments. Subjective appetite measures of satiety were significantly increased after HMS; however, no effects on energy intake were observed during the ad libitum test meal. These findings suggest that a single acute dose of RS cannot be expected to improve postprandial lipemia in subjects with overweight or obesity on a high-fat meal. However, the potential benefits of long-term supplementation should not be ruled out based on these results.

Acute Consumption of Resistant Starch Reduces Food Intake but Has No Effect on Appetite Ratings in Healthy Subjects.

Previous studies have shown the benefits of native banana starch (NBS) supplementation in improving glucose metabolism and reducing body weight (BW) in humans. However, the effect of this starch on appetite regulation is unknown. The aim of this study was to examine the effects of NBS rich resistant starch on subjective measurements of appetite, energy intake, and appetite hormones in healthy subjects. Postprandial glucose and insulin responses were also assessed. In a randomized, single-blind, crossover study, 28 healthy young subjects consumed a beverage containing either 40 g of NBS or 40 g of digestible corn starch (DCS) on two separate occasions. Effects on appetite were estimated using visual analogue scales (VAS) and satiety hormone responses. At the end of the intervention, participants were provided with a pre-weighed ad libitum homogeneous test meal. After a washout period of 1 week, subjects received the alternative treatment. NBS supplementation induced a reduction in food intake, glucose area under the curve (AUC)-180 min, and insulin AUC-180 min. However, there was no associated effect on the subjective appetite ratings or gut hormones. NBS supplementation may help to reduce meal size and control BW.

Effects of Acute Ingestion of Native Banana Starch on Glycemic Response Evaluated by Continuous Glucose Monitoring in Obese and Lean Subjects.

An abnormal glycemic profile, including postprandial glycemia and acute glucose spikes, precedes the onset of overt diabetes in obese subjects. Previous studies have shown the beneficial effects of chronic native banana starch (NBS) supplementation. In this study, we examined the effects of acute ingestion of NBS on glycemic profiles by means of continuous glucose monitoring in obese and lean subjects. In a crossover study, obese and lean subjects consumed beverages containing either 38.3 g of NBS or 38.3 g of digestible corn starch (DCS) twice daily during 4 days. On day 5, a 3-h meal tolerance test (MTT) was performed to evaluate glucose and insulin responses. After 1 week of washout period, treatments were inverted. NBS supplementation reduced the 48-h glycemia AUC in lean, obese, and in the combined group of lean and obese subjects in comparison with DCS. Postprandial glucose and insulin responses at MTT were reduced after NBS in comparison with DCS in all groups. However, no changes were observed in glycemic variability (GV) indexes between groups. In conclusion, acute NBS supplementation improved postprandial glucose and insulin responses in obese and lean subjects during 48 h of everyday life and at MTT. Further research to elucidate the mechanism behind these changes is required.