ABSTRACT
Se reseñan los medicamentos ya evaluados por la Agencia Española de Medicamentos y Productos Sanitarios hechos públicos en el segundo trimestre de 2012, y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento (AU)
The drugs assessed by the Spanish Agency for Medicines and Health Products made public in the second quarter of 2012, and con-sidered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product (AU)
Subject(s)
Humans , Drug Evaluation/statistics & numerical data , Drugs, Investigational/standards , Pharmaceutical Preparations , Clinical Trials as TopicABSTRACT
BACKGROUND AND OBJECTIVES: Chronic obstructive pulmonary disease (COPD) is accompanied by muscle involvement. Pseudouridine, a catabolite of RNA, has been used in other conditions to assess muscle catabolism. We have examined the excretion of pseudouridine in patients with different stages of COPDs evolution. SUBJECTS AND METHODS: We have defined four population groups: control group (without disease), chronic bronchitis group, emerging COPD group, and advanced COPD group. Pseudouridine was determined by high performance liquid chromatography, RESULTS: Pseudouridine extraction (pseudouridine/creatinine ratio) was (mean+19.9 (6.6) µmol/mmol in control group and was found to be very increased in all the patients with pulmonary condition: chronic bronchitis, 44.1 (60.75) µmol/mmol, 81.6 (56.8) µmol/mmol in emerging COPD group and 140.1 (68) µmol/mmol in advanced COPD for all the comparisons with normal subjects and among patients with lung disease). Age and gender did not affect pseudouridine excretion. CONCLUSIONS: The urinary excretion of pseudouridine is increased in chronic bronchitis and COPD and is related to disease stage. Its excretion is independent of age and gender.
Subject(s)
Muscles/metabolism , Pseudouridine/urine , Pulmonary Disease, Chronic Obstructive/urine , Aged , Aged, 80 and over , Biomarkers/urine , Bronchitis, Chronic/physiopathology , Bronchitis, Chronic/urine , Chromatography, High Pressure Liquid , Creatinine/urine , Cross-Sectional Studies , Female , Forced Expiratory Volume , Humans , Male , Middle Aged , Pulmonary Disease, Chronic Obstructive/physiopathologyABSTRACT
Se reseñan los medicamentos ya evaluados por la A gencia E spañola de M edicamentos y Productos S anitarios hechos públicos en el segundo trimestre de 2011, y considerados de mayor interés para el profesional sanitario. S e trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento (AU)
The drugs assessed by the S panish A gency for M edicines and Health Products made public in the second quarter of 2011, and considered of interest to the healthcare professional, are reviewed. T hese are positive technical reports prior to the authorization and placing on the market of the product (AU)
Subject(s)
Humans , Drug Evaluation , Drugs, Investigational , Clinical Trials, Phase I as TopicABSTRACT
Se reseñan los medicamentos ya evaluados por la Agencia Española de Medicamentos y Productos Sanitarios hechos públicos en el último trimestre de 2010, y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento (AU)
The drugs assessed by the Spanish Agency for Medicines and Health Products made public in the last quarter of 2010, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product (AU)
Subject(s)
Humans , Drugs, Investigational/pharmacology , Reference DrugsABSTRACT
Introducci¨®n: La enfermedad pulmonar obstructiva cr¨®nica (EPOC) es la cuarta causa de muerte en el mundo, en la que se aprecia afectaci¨®n muscular, en estadios iniciales asintom¨¢ticos, producto del desequilibrio proteico que ha sido medido en otros procesos mediante la excreci¨®n urinaria de pseudouridina. Objetivos: Investigar, mediante la excreci¨®n urinaria de pseudouridina, si el catabolismo muscular en EPOC est¨¢ elevado, y en qu¨¦ medida se relaciona con la edad y con el sexo. Material y m¨¦todos: El estudio se basa en un an¨¢lisis prospectivo y aleatorio de una poblaci¨®n control y otra con EPOC. La determinaci¨®n simult¨¢nea de pseudouridina y creatinina en orina se lleva a cabo por cromatograf¨ªa l¨ªquida de alta resoluci¨®n (HPLC). Se realiza un estudio estad¨ªstico descriptivo de las variables edad, sexo, excreci¨®n de pseudouridina y, mediante curva ROC de la variable pseudouridina excretada, se determina el punto de corte con mayor sensibilidad y especificidad entre ambas poblaciones. Resultados: No se observan diferencias estad¨ªsticamente significativas en la pseudouridina excretada, ni con respecto a la edad ni al sexo, en los grupos estudiados. La excreci¨®n de pseudouridina fue significativamente mayor en los pacientes con EPOC, 94,40 (87,64) ¦Ìmol/mmol con respecto al grupo control, 19,90 (6,6) ¦Ìmol/mmol Md (IQR) (p < 0,001). En el an¨¢lisis mediante curva ROC, el punto de corte ¨®ptimo con mayor sensibilidad y especificidad para distinguir personas con un catabolismo muscular alterado es el correspondiente a una excreci¨®n de pseudoridina de 29,39 ¦Ìmol/mmol. Conclusiones: La medida de la pseudouridina excretada en orina, realizada con este m¨¦todo,puede ser utilizada como control del catabolismo muscular. En nuestro estudio, el ¨¢rea bajo la curva para la excreci¨®n urinaria de pseudouridina fue de 0,972 y el punto de corte obtenido, fue 29,39 ¦Ìmol/mmol y corresponder¨¢ a individuos con un catabolismo incrementado debido a la EPOC (AU)
Introduction: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the world, appreciating muscle involvement, asymptomatic in early stages, which is due to a protein imbalance that has been measured in other processes by the urinary excretion of pseudouridine. Objectives: To research, using urinary excretion of pseudouridine, if muscle catabolism in COPD is high and until what extent is related to age and gender. Material and methods: The study is based on an analysis of a prospective randomized control group and one with COPD. Simultaneous determination of pseudouridine and creatinine in urine was performed by high-performance liquid chromatography (HPLC). We performed a descriptive statistical study of the variables age, gender, excretion of pseudouridine, and a ROC curve of the variable pseudouridine excretion, determines the cut point with higher sensitivity and specificity between the two populations. Results: No statistically significant differences were found in the pseudouridine excreted, with respect to age or gender, in the groups studied. Pseudouridine excretion was significantly higher in patients with COPD, 94.40 (87.64) ¦Ìmol/mmol, with respect to the control group, 19.90 (6.6) ¦Ìmol/mmol Md (IQR) (p <0.001). In the ROC curves analysis, pseudouridine excretion had area under the curve 0.972 and the optime cut point for pseudouridine excretion in our trial was 29.39 ¦Ìmol/mmol (Sensibility 93.1% and Specificity 100%) and can be used to distinguish people with altered muscle catabolism. Conclusions: The measure of pseudouridine excreted in urine, performed by this method, can be used as a control of muscle breakdown. In our study, the cut point was 29.39 ¦Ìmol/ mmol which means, that people with a pseudouridine excretion 29.39 ¦Ìmol/mmol, shall be individuals with an increased catabolism due to COPD (AU)
Subject(s)
Humans , Pulmonary Disease, Chronic Obstructive/metabolism , Pseudouridine/urine , Creatinine/urine , Muscles/metabolism , Chromatography, High Pressure Liquid/methodsABSTRACT
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