Analysis of the quality of anticoagulation with vitamin K antagonists in three clinical scenarios in Mexico.

INTRODUCTION: Vitamin K antagonists (VKA) are a therapeutic alternative in patients with venous thromboembolic disease; however, numerous factors affect their pharmacology. OBJECTIVE: To evaluate the quality of VKA anticoagulation at three different time periods in Mexico. METHODS: Prospective study, nested in patient cohorts at three different clinical scenarios between 2013 and 2019. Outpatients with indication for treatment with VKAs for at least 12 months were included. Patients were managed according to the criteria of the treating physician. RESULTS: Patient general characteristics were similar between groups, except for the VKA indication. The results of 4,148 patients and 38,548 INR assessments were analyzed. The times in therapeutic range during the three phases of the study and pooled data were significantly higher for the anticoagulation clinic. Only the number of patient visits was significantly associated with the results, unlike age, gender, and type of VKA. CONCLUSIONS: VKAs are widely used, but it is difficult for therapeutic goals to be achieved, especially in non-specialized clinical services. Creation of anticoagulation clinics is an urgent need for the Mexican health system.

INTRODUCCIÓN: Los antagonista de la vitamina K (AVK) son una alternativa terapéutica en los pacientes con enfermedad tromboembólica venosa; sin embargo, numerosos factores afectan su farmacología. OBJETIVO: Evaluar la calidad de la anticoagulación AVK durante tres diferentes periodos en México. MÉTODOS: Estudio prospectivo, anidado en cohortes de pacientes en tres escenarios clínicos entre los años 2013-2019. Se incluyeron pacientes no hospitalizados con indicación para recibir AVK por al menos 12 meses, quienes fueron manejados de acuerdo con el criterio del médico tratante. RESULTADOS: Las características generales de los pacientes fueron similares entre los grupos, excepto por la indicación para usar los AVK. Se analizaron los resultados de 4148 pacientes y 38 548 evaluaciones de INR. Los tiempos en rango terapéutico durante las tres fases del estudio y los datos acumulados fueron significativamente mayores en la clínica de anticoagulación. Solo el número de visitas de control de los pacientes se asoció significativamente con los resultados, a diferencia de la edad, el sexo y el tipo de AVK. CONCLUSIONES: Los AVK se utilizan ampliamente, pero es difícil alcanzar la meta terapéutica, sobre todo en servicios clínicos no especializados. La creación de clínicas de anticoagulación es una necesidad urgente en el sistema mexicano de salud.

Análisis de la calidad de la anticoagulación con antagonistas de la vitamina K en tres escenarios clínicos en México / Analysis of the quality of anticoagulation with vitamin K antagonists in three clinical scenarios in Mexico

Resumen Introducción: Los antagonista de la vitamina K (AVK) son una alternativa terapéutica en los pacientes con enfermedad tromboembólica venosa; sin embargo, numerosos factores afectan su farmacología. Objetivo: Evaluar la calidad de la anticoagulación AVK durante tres diferentes periodos en México. Métodos: Estudio prospectivo, anidado en cohortes de pacientes en tres escenarios clínicos entre los años 2013-2019. Se incluyeron pacientes no hospitalizados con indicación para recibir AVK por al menos 12 meses, quienes fueron manejados de acuerdo con el criterio del médico tratante. Resultados: Las características generales de los pacientes fueron similares entre los grupos, excepto por la indicación para usar los AVK. Se analizaron los resultados de 4148 pacientes y 38 548 evaluaciones de INR. Los tiempos en rango terapéutico durante las tres fases del estudio y los datos acumulados fueron significativamente mayores en la clínica de anticoagulación. Solo el número de visitas de control de los pacientes se asoció significativamente con los resultados, a diferencia de la edad, el sexo y el tipo de AVK. Conclusiones: Los AVK se utilizan ampliamente, pero es difícil alcanzar la meta terapéutica, sobre todo en servicios clínicos no especializados. La creación de clínicas de anticoagulación es una necesidad urgente en el sistema mexicano de salud.

Abstract Introduction: Vitamin K antagonists (VKA) are a therapeutic alternative in patients with venous thromboembolic disease; however, numerous factors affect their pharmacology. Objective: To evaluate the quality of VKA anticoagulation at three different time periods in Mexico. Methods: Prospective study, nested in patient cohorts at three different clinical scenarios between 2013 and 2019. Outpatients with indication for treatment with VKAs for at least 12 months were included. Patients were managed according to the criteria of the treating physician. Results: Patient general characteristics were similar between groups, except for the VKA indication. The results of 4,148 patients and 38,548 INR assessments were analyzed. The times in therapeutic range during the three phases of the study and pooled data were significantly higher for the anticoagulation clinic. Only the number of patient visits was significantly associated with the results, unlike age, gender, and type of VKA. Conclusions: VKAs are widely used, but it is difficult for therapeutic goals to be achieved, especially in non-specialized clinical services. Creation of anticoagulation clinics is an urgent need for the Mexican health system.

von Willebrand Disease and other hereditary haemostatic factor deficiencies in women with a history of postpartum haemorrhage.

INTRODUCTION: Postpartum haemorrhage (PPH) is the main cause of maternal morbidity and mortality globally, but it is far more important in non-developed countries. PPH represents 25% of all maternal deaths worldwide. Women with von Willebrand disease (VWD) and other inherited haemorrhagic disorders are at increased risk of PPH. Our aim was to establish a probable association of severe PPH in women with a history of haemostatic abnormalities. METHODS: An observational, controlled study of adult women with a one or more episodes of severe PPH requiring treatment in an intensive care unit or >10 units of blood products during the 24-hour period after diagnosis and their controls. The tests performed were blood cell count, blood group, renal, viral, liver function and haemostatic tests, fibrinogen, activity of the plasma factors and specific test to diagnose and classify VWD. RESULTS: We included 124 women with 133 PPH events and their controls. The median age at the first event was 25.5 years old. Results were significantly different between the groups in terms of fibrinogen concentration, VWF:Ag, VWF:RCo and FVIII. A specific diagnosis was established in 69 (55.6) and 4 (3.2%) patients in the PPH group and controls, respectively. Of 61 patients with VWD, 57 had type 1, two had type 2A, and another two had type 2B. CONCLUSION: Our results show a relationship between PPH and inherited haemostatic disorders. VWD was the most frequent diagnosis. Appropriate and opportune diagnosis before pregnancy of inherited haemostatic disorders may be important to effectively prevent and treat PPH.

The Effect of Second-Generation Antidepressant Treatment on the Memory of Patients With Major Depressive Disorder: A Meta-analysis Study With Structural Equation Models.

BACKGROUND: Major depressive disorder (MDD) has been linked to episodic memory deficits that may be improved after pharmacological treatment, but it is unclear whether there is a class of antidepressants that is more effective than others to ameliorate these deficits in MDD. In addition, the possible effects of clinical and sociodemographic variables on the improvement of MDD memory deficits after pharmacological treatment are currently unknown. Our aims are to study the possible neuropsychological effects of second-generation antidepressant classes on the episodic memory of MDD patients and to study the potential effects of clinical and demographic variables as moderators of the effects of antidepressants on the memory of depressed patients through a meta-analysis approach. PROCEDURES: Nine articles were included in our study. A structural equation model meta-analysis was performed. RESULTS: Our results suggest that selective serotonin reuptake inhibitors and serotonine-noradrenaline reuptake inhibitors would bring about a substantial improvement in the memory of depressed patients, whereas other antidepressant classes would cause rather modest effects. Our results also suggest that clinical and demographic variables play a very important role as mediators of memory improvement after MDD treatment. Thus, a relatively low level of symptom severity, a high degree of clinical improvement, a younger age, and more years of education were positively related to memory improvement after MDD treatment. CONCLUSIONS: Although antidepressant class is an important variable linked to memory improvement in MDD, overall, the degree of memory amelioration in depression is very closely related to clinical and demographic variables of patients with depression.

Intima media thickness in children undergoing dialysis.

BACKGROUND: Uremic vasculopathy, including vascular calcification, increases the risk for cardiovascular disease and mortality in chronic kidney disease (CKD) patients. We have investigated the prevalence and factors associated with vasculopathy in children undergoing peritoneal dialysis (PD) or hemodialysis (HD) in a single center. METHODS: Common carotid intima media thickness (cIMT) and its relation with demographics, biochemical parameters and medication was analyzed in 60 patients (mean age 12.9 ± 3.4 years; 27 girls) treated with PD (n = 31) or HD (n = 29) for 34 ± 34 months. Patients were divided into two groups: normal cIMT and increased cIMT. RESULTS: Mean levels of calcium, phosphate and calcium/phosphate product were in the normal range, the but parathyroid hormone level, 729 ± 670 pg/mL, was higher than the National Kidney Foundation Kidney Disease Outcome Quality Iniative (K/DOQI) recommendations. Twenty-nine patients had increased cIMT, which was associated with time on dialysis of >2 years, hypercalcemia, higher daily dose of calcitriol and HD (vs. PD). In the multivariate analysis, accounting for time on dialysis, HD persisted as a risk for increased cIMT. CONCLUSIONS: The prevalence of increased cIMT in children on dialysis is similar to that reported in adults with CKD and increased with time on dialysis. HD was associated with increased cIMT, independently of time on dialysis; however, the results should be interpreted with caution due to the possible impact of confounding factors. These results underline the need to monitor and, if possible, prevent and treat increased cIMT in children on dialysis.

[Design of a HACCP plan for the industrial process of frozen sardines]. / Diseño de un plan HACCP en el procesamiento industrial de sardinas congeladas.

The Hazard Analysis and Critical Control Point (HACCP) is a system to identify, assess and control the hazards related with production, processing, distribution and consumption in order to get safe food. The aim of this study was to design a HACCP plan for implementing in processing line of frozen whole sardine (Sardinella aurita). The methodology was based in the evaluation of the accomplishment of the pre-requisite programs (GMP/SSOP in a previous study), the application of the principles of the HACCP and the sequence of stages settles down by the COVENIN Venezuelan standard No 3802. Time-temperature was recorded in each processing step. Histamine was determined by VERATOX NEOGEN. Results showed that some sardine batches arrived to the plant with high time-temperature records, finding up to 5 ppm of histamine due to the abuse of temperature during transportation. A HACCP plan is proposed with the scope, the selection of the team, the description of the product and the intended use, the flow diagram of the process, hazard analysis and identification of CCP, monitoring system, corrective actions and records. The potential hazards were identified as pathogen growth, presence of histamine and physical objects in the sardines. The control measures of PCC are referred as control of time-temperature during transportation and processing, monitoring of ice supplies and sanitary conditions in the process.

Diseño de un plan HACCP en el procesamiento industrial de sardinas congeladas / Design of a HACCP Plan for the industrial process of frozen sardines

El Análisis de Peligros y Puntos de Control Críticos (HACCP) es un sistema para identificar, evaluar y controlar los peligros relacionados con producción, procesamiento, distribución y consumo a fin de obtener alimentos inocuos. El objetivo de esta investigación fue diseñar un plan HACCP para implementarlo en la línea de sardina (Sardinella aurita) entera congelada. La metodología se basó en la evaluación del cumplimiento de los programas pre-requisitos (POES/BPF en estudio previo), aplicación de los principios del HACCP y la secuencia de etapas establecidas por la norma venezolana COVENIN N° 3802. Se efectuaron registros de tiempo y temperatura en cada etapa del proceso. Se determinó histamina mediante VERATOX® NEOGEN. Los resultados mostraron que algunos lotes de sardinas llegaron a la planta con altos registros de tiempo-temperatura, encontrándose hasta 5 ppm de histamina debido a abuso de temperatura durante el transporte. Se propone un plan HACCP con el alcance, selección del equipo, descripción del producto y su uso previsto, diagrama de flujo del proceso, análisis de peligros, identificación de PCC y límites críticos, sistema de vigilancia, acciones correctivas, verificación y registros. Los peligros potenciales hallados fueron el crecimiento de patógenos, presencia de histamina y objetos físicos en las sardinas. Las medidas de control de los PCC se refieren al control de tiempo-temperatura durante el transporte y procesamiento, vigilancia del suministro de hielo y de las condiciones de saneamiento en el proceso.

The Hazard Analysis and Critical Control Point (HACCP) is a system to identify, assess and control the hazards related with production, processing, distribution and consumption in order to get safe food. The aim of this study was to design a HACCP plan for implementing in processing line of frozen whole sardine (Sardinella aurita). The methodology was based in the evaluation of the accomplishment of the pre-requisite programs (GMP/SSOP in a previous study), the application of the principles of the HACCP and the sequence of stages settles down by the COVENIN Venezuelan standard N° 3802. Time-temperature was recorded in each processing step. Histamine was determined by VERATOX® NEOGEN. Results showed that some sardine batches arrived to the plant with high time-temperature records, finding up to 5 ppm of histamine due to the abuse of temperature during transportation. A HACCP plan is proposed with the scope, the selection of the team, the description of the product and the intended use, the flow diagram of the process, hazard analysis and identification of CCP, monitoring system, corrective actions and records. The potential hazards were identified as pathogen growth, presence of histamine and physical objects in the sardines. The control measures of PCC are referred as control of time-temperature during transportation and processing, monitoring of ice supplies and sanitary conditions in the process.

[Evaluation of prerequisites programs for a HACCP plan for frozen sardine plant]. / Evaluación de los programas pre-requisitos del plan HACCP en una planta de sardinas congeladas.

Good manufacturing practices (GMP) and sanitation standard operating procedures (SSOP) are prerequisites programs for the application of the Hazard Analysis and Critical Control Point (HACCP) system as a food safety approach during processing. The aim of this study was to evaluate GMP/SSOP prerequisites in processing line of frozen whole sardine (Sardinella aurita). The GMP compliance was verified according to a standard procedure of the Ministry for the Health of Venezuela, and the SSOP were assessed according to a checklist proposed by the FDA. GMP and SSOP were evaluated following a demerit-based approach. A percentage value was calculated and referred to as sanitary effectiveness. Results indicated that the plant had a good level of compliance with GMP from assessment of buildings and facilities, equipment and tools, hygienic requisites of the production, assurance of the hygiene quality, storage and transportation, and the percentage of sanitary effectiveness was 84%. The level of compliance for SSOP was 53,12% with demerits found in all assessed aspects consisting of inexistent guidelines, lack of control in the sanitary plan and lack of leadership in applying corrective actions. Thus, an improvement in the plant sanitation program was designed targeting SSOP.

Evaluación de los programas pre-requisitos del plan HACCP en una planta de sardinas congeladas

Las buenas prácticas de fabricación (BPF) y los procedimientos operativos estándares de saneamiento (POES) en planta son considerados los pre-requisitos esenciales para la implementación del sistema de análisis de peligros y puntos de control crítico (HACCP) como una herramienta para la inocuidad de alimentos durante su procesamiento. El objetivo de esta investigación fue la evaluación de las BPF/POES en una línea de sardina (Sardinella aurita) entera congelada. Se verificó el cumplimiento de las BPF mediante la planilla de evaluación del MSAS (Ministerio de Salud) de Venezuela y de los POES a través de un cuestionario propuesto por la FDA. Las BPF y los POES fueron evaluados en base a deméritos, se obtuvo un valor en porcentaje por cada pre-requisito y fue referido como efectividad higiénica. Los resultados obtenidos de la evaluación de las BPF indicaron que la planta cumple con la mayoría de las condiciones de edificaciones e instalaciones, equipos y utensilios, requisitos higiénicos de la producción, aseguramiento de la calidad higiénica, almacenamiento y transporte, obteniendo una efectividad higiénica satisfactoria de un 84%. El nivel de cumplimiento de los POES fue de un 53,12% con deméritos en todos los aspectos evaluados, debido a la inexistencia de un documento guía, carencia de controles en el plan de saneamiento y de liderazgo en ejecutar acciones correctivas. Por lo tanto, se diseñó un programa de control sanitario basado en los POES.

Evaluation of prerequisites programs for a HACCP plan for frozen sardine plant. Good manufacturing practices (GMP) and sanitation standard operating procedures (SSOP) are prerequisites programs for the application of the Hazard Analysis and Critical Control Point (HACCP) system as a food safety approach during processing. The aim of this study was to evaluate GMP/SSOP prerequisites in processing line of frozen whole sardine (Sardinella aurita). The GMP compliance was verified according to a standard procedure of the Ministry for the Health of Venezuela, and the SSOP were assessed according to a checklist proposed by the FDA. GMP and SSOP were evaluated following a demerit-based approach. A percentage value was calculated and referred to as sanitary effectiveness. Results indicated that the plant had a good level of compliance with GMP from assessment of buildings and facilities, equipment and tools, hygienic requisites of the production, assurance of the hygiene quality, storage and transportation, and the percentage of sanitary effectiveness was 84%. The level of compliance for SSOP was 53,12 % with demerits found in all assessed aspects consisting of inexistent guidelines, lack of control in the sanitary plan and lack of leadership in applying corrective actions. Thus, an improvement in the plant sanitation program was designed targeting SSOP.

Sympathetic pharmacological denervation in ageing rats: effects on ovulatory response and follicular population.

The present study analyses the participation of ovarian innervation during reproductive senescence. We use the model of acute peripheral pharmacological sympathetic denervation with guanethidine in young (3 months old), middle-aged (12 months old) or old (18 months old) rats with spontaneous or induced ovulation. Ovarian levels of norepinephrine (NE) were measured by HPLC and the oestrous cycle, the number of ovulating animals and the percentage of atretic follicles were also assessed. Aged animals showed a progressive reduction in ovulatory capacity and an increase in ovarian NE content. Acute denervation increased the percentage of healthy follicles in 12- and 18-month-old rats compared with control adult animals. Combined treatment of denervation plus stimulation with gonadotrophins doubled the number of ova shed in young adult rats and restablished a partial ovulation in 12-month-old rats. The results suggest that ovarian noradrenergic innervation plays a modulator role in ovarian physiology during the ageing ovary process. The action of ovarian noradrenergic innervation seems to be associated with folliculogenesis and the ovarian response to gonadotrophins.

Adequaçäo dos descritores em Ciência da Saúde para a indexaçäo de dissertaçöes acadêmica, na área de doenças respiratórias / Suitability of Hearth Science key words for indexing master's degree theses and dissertations in the area of respiratory diseases

INTRODUÇÄO: O processo de indexaçäo consiste e duas fases: primeiro, indentificar e representar o contéudo intelectual de um documento; sengundo, traduzir a análise do assunto para uma linguagem específica, utilizando descritores. Na biblioteca do Instituto de Doença do Tórax da UFRJ, a indexaçäo era realizada por meio de um vocabulário controlado - DeCS (Descritores em Ciência da Saúde). O objetivo deste trabalho foi verificar se säo adequados. para indexaçäo, os descritores empregados pelos autores de teses e dissertaçöes de mestrado, na área de doenças respiratória. MÉTODO: Os descritores de 29 teses e dissertaçöes de mestrado em Tisiologia e Pneumologia, de 1990 a 1996, foram estudados. RESULTADOS: A coleta de dados evidenciou que 29 autores empregaram 101 descritores (3,48 descritores/autor). Dos 101 descritores, 47 (47 por cento) eram adequados. CONCLUSÄO: Quarenta e sete por cento dos descritores empregados, nas teses e dissertaçöes do Curso de Mestrado em Tsiologia e Pneumologia do IDT-UFRJ (1990 a 1996), säo adequados segundo o DeSC

DESCRITORES EM CIÊNCIAS DA SAÚDE NAS TESES E DISSERTAÇÕES DE MESTRADO, NA ÁREA DE DOENÇAS RESPIRATÓRIAS

The process of indexing consisted of two phases: firstly, to identify and represent the intellectual contents of a document; and secondly, the translation of the subject analysis into a specified languague, with the aid of subject headings. At the Instituto de Doenças do Tórax da UFRJ medical library, the indexing of biomedical journals and theses was performed through a controlled vocabulary - the DeCS (Subject Headings on Health Sciences). The purpose of this study was to identify if the authors of Master Degree thesis on respiratory diseases were using the DeCS for indexing. The subject headings of 29 Master theses from 1990 through 1996 were studied. The data collection showed that 29 authors employed 101 subject headings (3,48 headings/author). Four (14%) of authors utilized adequate subject headings from the DeCS. In conclusion: fourteen per cent of authors of Master theses on respiratory diseases employed correctly the subject headings.

O processo de indexação consiste em duas fases: primeira, identificar e representar o conteúdo intelectual de um documento; segunda, traduzir a análise do assunto para uma linguagem específica, utilizando descritores. Na biblioteca do Instituto de Doenças do Tórax da UFRJ, a indexação de periódicos biomédicos e teses era realizada por meio de um vocabulário controlado - DeCS (Descritores em Ciências da Saúde). O objetivo desta pesquisa era identificar se os autores das teses de Mestrado em doenças respiratórias estavam usando o DeCS para indexar. Os descritores de 29 teses de Mestrado de Tisiologia e Pneumologia, de 1990 a 1996, foram estudados. A coleta de dados evidenciou que 29 autores empregaram 101 descritores (3,48 descritores/autor). Quatro (14%) dos autores utilizaram adequadamente os descritores do DeCS. Em conclusão: catorze por cento dos autores de teses de Mestrado empregaram corretamente os descritores.