RESUMO
El procedimiento de registro de medicamentos centralizado implica una evaluación conjunta por todas las Agencias Reguladoras de los Estados miembros de la Unión Europea que es coordinada por la Agencia Europea de Medicamentos. Desde su implantación en 1995, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha contribuido de forma activa al Comité de medicamentos de uso humano. Las áreas terapéuticas en las que la AEMPS tiene más presencia son cardiovascular, órganos de los sentidos (fundamentalmente oftalmología) y genitourinario-hormonas sexuales. A esta labor contribuyen con sus conocimientos y su extensa experiencia los técnicos de la propia AEMPS así como profesionales del sistema sanitario español que actúan en calidad de expertos externos aportando su visión clínica y acercando la práctica diaria a la evaluación de medicamentos. Como sucede con otros espacios de decisión europeos, la participación del conjunto de Estados miembro no es homogénea siendo todavía una minoría de países los que lideran la mayoría de las evaluaciones del Comité de medicamentos de uso humano, aunque todos los países toman parte en la opinión final (AU)
The centralized procedure for registering medicinal products involves a joint assessment by all regulatory agencies of European Union member states, which are coordinated by the European Medicines Agency. Since its implementation in 1995, the Spanish Agency for Medicines and Healthcare Products (AEMPS) has actively contributed to the committee on medicinal products for human use. The therapeutic areas in which AEMPS has the greatest presence are cardiovascular, sensory organs (mainly ophthalmology) and genitourinary/sexual hormones. The technical staff of AEMPS contributes their expertise and extensive experience to this task, as do the practitioners of the Spanish healthcare system who act as external experts, providing their clinical vision and bringing the daily clinical practice to the evaluation of medicinal products. As with other European decision spaces, the joint participation of the member states is not homogeneous, with a minority of countries still heading the majority of assessments for the committee on medicinal products for human use, although all member countries take part in the final decision (AU)
Assuntos
Humanos , Aprovação de Drogas , Avaliação de Medicamentos , Controle de Medicamentos e Entorpecentes/organização & administração , Comercialização de MedicamentosRESUMO
The centralized procedure for registering medicinal products involves a joint assessment by all regulatory agencies of European Union member states, which are coordinated by the European Medicines Agency. Since its implementation in 1995, the Spanish Agency for Medicines and Healthcare Products (AEMPS) has actively contributed to the committee on medicinal products for human use. The therapeutic areas in which AEMPS has the greatest presence are cardiovascular, sensory organs (mainly ophthalmology) and genitourinary/sexual hormones. The technical staff of AEMPS contributes their expertise and extensive experience to this task, as do the practitioners of the Spanish healthcare system who act as external experts, providing their clinical vision and bringing the daily clinical practice to the evaluation of medicinal products. As with other European decision spaces, the joint participation of the member states is not homogeneous, with a minority of countries still heading the majority of assessments for the committee on medicinal products for human use, although all member countries take part in the final decision.
RESUMO
INTRODUCTION: Quality of life (QL) is an important objective in the treatment of patients with heart failure (HF). We have measured QL and different factors that can affect it in a group of patients hospitalized with HF. METHODS: 34 patients with HF were cross-examined by means of a specific questionnaire: The "Minnesota Living With Heart Failure Questionnaire" (MLWHFQ). Blood analyses, ecocardiographic measurements and specific questionnaires, were also carried out in order to evaluate other parameters which could affect QL: Age, sex, comorbidity, number of drugs taken, left ventricular ejection fraction, nutritional status, cognitive function, depression and functional capacity in daily life. RESULTS: QL measured by means of the MLWHFQ was quite high (mean: 34.3). The other tests yielded values within normality or next to normality. Depression was the factor more clearly associated with patients quality of life (p = 0.0001). We also found a statistically significant association with left ventricular ejection fraction (p = 0.03), age (p = 0.008) and albuminemia (p = 0.01). CONCLUSIONS: In our group of patients, QL was conditioned by depression, left ventricular ejection fraction, age and albuminemia.
Assuntos
Insuficiência Cardíaca , Qualidade de Vida , Idoso , Feminino , Insuficiência Cardíaca/complicações , Departamentos Hospitalares , Humanos , Medicina Interna , Masculino , Inquéritos e QuestionáriosRESUMO
Introducción: la calidad de vida (CV) es un objetivo importante del tratamiento de los pacientes con insuficiencia cardiaca (IC). Hemos medido la CV en una muestra de pacientes ingresados que presentan IC y diversos factores que pueden influir en ella. Métodos: se evaluó a 34 pacientes con IC utilizando un cuestionario específico, el Minnesota Living With Heart Failure Questionnaire (MLWHFQ). Además se realizaron mediciones analíticas y de ecocardiografía y se aplicaron cuestionarios específicos con el fin de evaluar otros parámetros que pueden influir en la CV: la edad, el sexo, la comorbilidad, la medicación habitual, la fracción de eyección del ventrículo izquierdo, el estado nutricional, la función cognitiva, la depresión y la capacidad funcional en la vida diaria. Resultados: la CV medida mediante el cuestionario MLWHFQ de los pacientes del estudio fue alta (media: 34,3). Los otros tests realizados dieron valores dentro de la normalidad o próximos a ella. La depresión fue el factor que con más claridad se asoció con la CV de los pacientes (p = 0,0001). También demostraron una asociación estadísticamente significativa la fracción de eyección del ventrículo izquierdo (p=0.03), la edad (p = 0,008) y la albuminemia (p = 0,01). Conclusiones: En nuestra muestra, la CV de los pacientes estaba condicionada por la depresión, la fracción de eyección del ventrículo izquierdo, la edad y la albuminemia
Introduction: Quality of life (QL) is an important objective in the treatment of patients with heart failure (HF). We have measured QL and different factors that can affect it in a group of patients hospitalized with HF. Methods: 34 patients with HF were cross-examined by means of a specific questionnaire: The Minnesota Living With Heart Failure Questionnaire (MLWHFQ). Blood analyses, ecocardiographic measurements and specific questionnaires, were also carried out in order to evaluate other parameters which could affect QL: Age, sex, comorbilidity, number of drugs taken, left ventricular ejection fraction, nutritional status, cognitive function, depression and functional capacity in daily life. Results: QL measured by means of the MLWHFQ was quite high (mean: 34.3). The other tests yielded values within normality or next to normality. Depression was the factor more clearly associated with patients quality of life (p = 0.0001 ). We also found a statistically significant association with left ventricular ejection fraction (p = 0.03), age (p = 0.008 ) and albuminemia (p = 0.01 ). Conclusions: In our group of patients, QL was conditioned by depression, left ventricular ejection fraction, age and albuminemia
