Erythropoietin in Spinocerebellar Ataxia Type 2: Feasibility and Proof-of-Principle Issues from a Randomized Controlled Study.

BACKGROUND: Several pieces of evidence have shown the neurotrophic effect of erythropoietin (EPO) and its introduction in the therapeutic practice of neurological diseases. However, its usefulness in the treatment of spinocerebellar ataxia type 2 (SCA2) has not been proven despite the fact that it is endogenously reduced in these patients. OBJECTIVE: The study aims to investigate the safety, tolerability, and clinical effects of a nasally administered recombinant EPO in SCA2 patients. METHODS: Thirty-four patients were enrolled in this double-blind, randomized, placebo-controlled, phase I-II clinical trial of the nasally administered human-recombinant EPO (NeuroEPO) for 6 months. The primary outcome was the change in the spinocerebellar ataxia functional index (SCAFI), while other motor, neuropsychological, and oculomotor measures were assessed. RESULTS: The 6-month changes in SCAFI score were slightly higher in the patients allocated to NeuroEPO treatment than placebo in spite of the important placebo effect observed for this parameter. However, saccade latency was significantly decreased in the NeuroEPO group but not in placebo. The frequency and severity of adverse events were similar between both groups, without evidences of hematopoietic activity of the drug. CONCLUSIONS: This study demonstrated the safety and tolerability of NeuroEPO in SCA2 patients after 6 months of treatments and suggested a small clinical effect of this drug on motor and cognitive abnormalities, but confirmatory studies are warranted. © 2022 International Parkinson and Movement Disorder Society.

Evaluación de la glucemia a través de dos métodos analíticos en la atención de urgencia / Assessment of Blood Glucose Levels by Two Analytic Methods in the Emergency Room

Introducción: la medición de un mismo parámetro en Medicina por diferentes métodos exige comprobaciones de concordancia entre estos. Objetivo: determinar el desacuerdo, entre la glucemia obtenida mediante un glucómetro y el método habitual de laboratorio en pacientes atendidos en Cuerpo de Guardia. Métodos: estudio observacional descriptivo de serie de casos en pacientes que acudieron a Cuerpo de Guardia del Hospital Vladimir Ilich Lenin de Holguín, Cuba, durante marzo de 2013, que requirieron determinación de glucemia. El tamaño muestral se calculó sobre la base del 5 % de desacuerdo esperado por las normas de la International Organization for Standardization (ISO 15197:2003), resultaron 72 pacientes a los cuales se les aplicó además muestreo aleatorio simple y criterios de exclusión. La glucemia se determinó mediante el método de referencia (RapiglucoTest) y el glucómetro SUMASENSOR SXT. Resultados: los pacientes tenían 58,7 ± 18,3 años; 54,2 % eran mujeres; 51,4 % diabéticos y el 70,8 % no estaban en ayunas. El error medio absoluto fue 9,5 ± 8,07 %. El desacuerdo entre métodos fue del 4,8 %. El sesgo y la precisión fueron 0,40 mmol/L y ± 0,65 mmol/l, respectivamente. El 94,4 % de valores estuvieron entre los límites de concordancia de ± 1,96 desviaciones Standard (método de Bland-Altman). Resultaron altos los coeficientes de correlación intraclase (0,995) y de determinación (0,98). No contrastaron significativamente las diferencias absolutas según el estado de ayuno o no (p=0,3103). Conclusiones:el grado de desacuerdo se ajustó al valor aceptado por las normas ISO 15197. El análisis global demuestra que este glucómetro es suficientemente exacto y preciso para su uso en Cuerpo de Guardia, independientemente del estado de ayuno o no.

Introduction: measurement of a medical parameter through different methods demands assessment of the agreement between them. Objective: to determine the disagreement between glucose levels obtained by a glucometer and the customary method of laboratory, in the emergency room. Methods: an observational study was performed in patients attended at emergency room of Vladimir I. Lenin Hospital, in Holguín, Cuba, with requested determination of blood glucose levels. The study was carried out during March, 2013. The sample size was calculated taking into account a 5 % of accepted disagreement by the International Organization of Standardization criteria (ISO 15197:2003), being 72 the obtained number. A simple random sampling and exclusion criteria were also applied. Glucose blood levels were assessed using RapiglucoTest reference method and a glucometer SUMASENSOR SXT. Results: patients were 58.7± 18.3 years, 54.2 % were female, 51.4% diabetics, and 70.8 % nonfasting. Mean absolute relative error was 9.5± 8.07%. There was 4.8% of disagreement between methods. Skew and precision were 0.40 mmol/L and ± 0.65 mmol/l, respectively. 94.4% of values were between the limits of 1.96 standard deviation (Bland-Altman method). Both Intraclass coefficient correlation (0.995) and determination coefficient (0.98) reached high values. No significant disparity between absolute differences were assessed depending upon fasting state (p=0.3103). Conclusions:the disagreement between methods corresponded to the admissible threshold stablished by ISO criteria. This and the rest of the analysis indicate that this glucometer is both accurate and precise for its intended use in the emergency room setting, even in nonfasting individuals.

Evaluación de la glucemia a través de dos métodos analíticos en la atención de urgencia / Assessment of Blood Glucose Levels by Two Analytic Methods in the Emergency Room

Introducción: la medición de un mismo parámetro en Medicina por diferentes métodos exige comprobaciones de concordancia entre estos.Objetivo: determinar el desacuerdo, entre la glucemia obtenida mediante un glucómetro y el método habitual de laboratorio en pacientes atendidos en Cuerpo de Guardia.Métodos: estudio observacional descriptivo de serie de casos en pacientes que acudieron a Cuerpo de Guardia del Hospital Vladimir Ilich Lenin de Holguín, Cuba, durante marzo de 2013, que requirieron determinación de glucemia. El tamaño muestral se calculó sobre la base del 5 por ciento de desacuerdo esperado por las normas de la International Organization for Standardization (ISO 15197:2003), resultaron 72 pacientes a los cuales se les aplicó además muestreo aleatorio simple y criterios de exclusión. La glucemia se determinó mediante el método de referencia (RapiglucoTest) y el glucómetro SUMASENSOR SXT.Resultados: los pacientes tenían 58,7 ± 18,3 años; 54,2 por ciento eran mujeres; 51,4 por ciento diabéticos y el 70,8 por ciento no estaban en ayunas. El error medio absoluto fue 9,5 ± 8,07 por ciento. El desacuerdo entre métodos fue del 4,8 por ciento. El sesgo y la precisión fueron 0,40 mmol/L y ± 0,65 mmol/l, respectivamente. El 94,4 por ciento de valores estuvieron entre los límites de concordancia de ± 1,96 desviaciones Standard (método de Bland-Altman). Resultaron altos los coeficientes de correlación intraclase (0,995) y de determinación (0,98). No contrastaron significativamente las diferencias absolutas según el estado de ayuno o no (p=0,3103).Conclusiones:el grado de desacuerdo se ajustó al valor aceptado por las normas ISO 15197. El análisis global demuestra que este glucómetro es suficientemente exacto y preciso para su uso en Cuerpo de Guardia, independientemente del estado de ayuno o no(AU)

Introduction: measurement of a medical parameter through different methods demands assessment of the agreement between them.Objective: to determine the disagreement between glucose levels obtained by a glucometer and the customary method of laboratory, in the emergency room.Methods: an observational study was performed in patients attended at emergency room of Vladimir I. Lenin Hospital, in Holguín, Cuba, with requested determination of blood glucose levels. The study was carried out during March, 2013. The sample size was calculated taking into account a 5 percent of accepted disagreement by the International Organization of Standardization criteria (ISO 15197:2003), being 72 the obtained number. A simple random sampling and exclusion criteria were also applied. Glucose blood levels were assessed using RapiglucoTest reference method and a glucometer SUMASENSOR SXT.Results: patients were 58.7± 18.3 years, 54.2 percent were female, 51.4% diabetics, and 70.8 percent nonfasting. Mean absolute relative error was 9.5± 8.07 percent. There was 4.8 por ciento of disagreement between methods. Skew and precision were 0.40 mmol/L and ± 0.65 mmol/l, respectively. 94.4 percent of values were between the limits of 1.96 standard deviation (Bland-Altman method). Both Intraclass coefficient correlation (0.995) and determination coefficient (0.98) reached high values. No significant disparity between absolute differences were assessed depending upon fasting state (p=0.3103).Conclusions:the disagreement between methods corresponded to the admissible threshold stablished by ISO criteria. This and the rest of the analysis indicate that this glucometer is both accurate and precise for its intended use in the emergency room setting, even in nonfasting individuals(AU)