Clinical factors associated with discontinuation of ts/bDMARDs in rheumatic patients from the BIOBADASER III registry.

Biologic and targeted synthetic disease-modifying antirheumatic drugs (ts/bDMARDs) play a pivotal role in the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Persistence of therapy provides an index of a drug's overall effectiveness. The objective of the study was to identify factors associated with discontinuation of ts/bDMARDs in a real-world dataset. The study population comprised patients diagnosed with RA, PsA, and AS included in the BIOBADASER registry for whom follow-up data were available until November 2019. Patient features and treatment data were included in the analysis. The Kaplan-Meier method was used to study survival of the different drugs according to the reason for discontinuation. Factors associated with discontinuation were studied using Cox regression models and bivariate and multivariate analyses. P values of less than 0.05 were regarded as statistically significant. The study population comprised 4,752 patients who received a total of 8,377 drugs, of which 4,411 (52.65%) were discontinued. The Kaplan-Meier curves showed that survival for first-line treatment was greater in all 3 groups (p < 0.001). Patients with RA had a greater risk of discontinuation if they were younger (HR, 0.99; 95% CI 0.99-1.00), if they were receiving anti-TNFα agents (HR, 0.61; 95% CI 0.54-0.70), and if they had more comorbid conditions (HR, 1.09; 95% CI 1.00-1.17). Patients with PsA had a higher risk if they were women (HR, 1.36; 95% CI 1.15-1.62) and if they were receiving other ts/bDMARDs (HR, 1.29; 95% CI 1.05-1.59). In patients with AS, risk increased with age (HR, 1.01; 95% CI 1.00-1.02), as did the number of comorbid conditions (HR, 1.27; 95% CI 1.12-1.45). The factors that most affected discontinuation of ts/bDMARDs were line of treatment, age, type of drug, sex, comorbidity and the year of initiation of treatment. The association with these factors differed with each disease, except for first-line treatment, which was associated with a lower risk of discontinuation in all 3 diseases.

La osteocalcina: de marcador de formación ósea a hormona; y el hueso, un órgano endocrino / Osteocalcin: from marker of bone formation to hormone; and bone, an endocrine organ

La osteocalcina es una proteína sintetizada por el osteoblasto. Antes de ser liberada a la matriz extracelular, la osteocalcina humana sufre una gamma-carboxilación, al unirse en las posiciones 17, 21 y 24 el ácido gamma-carboxi-glutámico. A la circulación pasa parte de osteocalcina carboxilada y descarboxilada. Desde su descubrimiento a finales de los años 70, se ha utilizado como marcador de formación ósea al ser un producto osteoblástico, y desconociéndose su papel en el organismo. En estos últimos años se ha descubierto que la osteocalcina es, en realidad, una hormona, y el hueso un órgano endocrino. La osteocalcina que actúa como hormona es la forma descarboxilada. La osteocalcina interviene en la homeostasis de la glucosa, en el funcionamiento del músculo esquelético, en el desarrollo cerebral, la fertilidad masculina, la esteatosis hepática y la calcificación arterial. En realidad todos estos hechos se han probado en ratones, pero existen indicios importantes de que esto podría ocurrir en humanos. Nos encontramos ante hechos que, de probarse, tendrían una enorme trascendencia clínica. (AU)

Osteocalcin is a protein synthesized by the osteoblast. Before being released into the extracellular matrix, human osteocalcin undergoes gamma-carboxylation, as gamma-carboxy-glutamic acid binds at positions 17, 21 and 24. Part of the carboxylated and decarboxylated osteocalcin passes into the circulation. Since its discovery in the late 70s, it has been used as a marker of bone formation as it is an osteoblastic product and its role in the body is unknown. In recent years, osteocalcin has been identified as a hormone. Bone is considered an endocrine organ. Osteocalcin acting as a hormone is the decarboxylated form. Osteocalcin is involved in glucose homeostasis, skeletal muscle function, brain development, male fertility, hepatic steatosis, and arterial calcification. All of these facts have actually been tested in mice, but there is strong evidence that this could occur in humans. We are faced with facts that, if proven, would have enormous clinical significance. (AU)

Determinants of survival after severe acute respiratory syndrome coronavirus 2 infection in Mexican outpatients and hospitalised patients.

OBJECTIVES: This study aimed to evaluate the association of chronic diseases and indigenous ethnicity on the poor prognosis of outpatients with coronavirus disease 2019 (COVID-19) and hospitalised patients in Mexico. STUDY DESIGN: The study design is an observational study of consecutive COVID-19 cases that were treated in Mexican healthcare units and hospitals between February 27 and April 27, 2020. METHODS: Epidemiological, clinical and sociodemographic data were analysed from outpatients and hospitalised patients. Cox regression models were used to analyse the risk of mortality after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. RESULTS: In total, 15,529 patients with COVID-19 were characterised; 62.6% of patients were aged older than 40 years, 57.8% were men and 1.4% were of indigenous ethnicity. A high proportion had a history of diabetes (18.4%), hypertension (21.9%) and obesity (20.9%). Among hospitalised patients, 11.2% received health care in the intensive care unit. Advanced age, male sex, indigenous ethnicity and having a history of chronic diseases, such as hypertension, diabetes and obesity, were significantly associated with a high risk of death after SARS-CoV-2 infection. Diabetes and obesity were the comorbidities most highly associated with death through the models used in this study. Moreover, living in Mexico City and Mexico State (where there is easy access to medical services) and walking (rather than driving or getting public transport) were negatively associated with mortality after SARS-CoV-2 infection. CONCLUSIONS: Diabetes, hypertension and obesity combined with older age, male sex and indigenous ethnicity increase the risk of death after SARS-CoV-2 infection in the Mexican population. It is recommended that the incidence of COVID-19 is monitored in indigenous communities, and access to health services is increased nationwide.

Aceite de oliva y salud ósea / Olive oil and bone health

OBJETIVO: Existen en la literatura una serie de trabajos que demuestran que la incidencia de osteoporosis y fracturas asociadas es menor en países en los que la dieta mediterránea es predominante. El aceite de oliva es la principal característica común de toda la dieta mediterránea suponiendo un tercio de la ingesta de grasas vegetales. Se ha realizado una amplia revisión de trabajos que demuestran que la ingesta de aceite de oliva, tanto en animales de experimentación, en especial ratas ovariectomizadas, como en humanos, produce acciones positivas sobre el hueso. Se han revisado los efectos de diferentes componentes del aceite de oliva virgen como la oleuropeína, un compuesto fenólico, y otros alcoholes fenólicos como el tirosol y el hidrotirosol. La oleuropeína no sólo ejerce acciones sobre el hueso de ratas ovariectomizadas, sino que produce acciones sobre la formación de osteoblastos y desciende la formación de células "osteoclasto-like". Los compuestos fenólicos del aceite de oliva han demostrado ejercer acciones anti-oxidantes in vitro e in vivo. El tirosol y el hidrotirosol ejercen acciones sobre la pérdida de hueso en ratas ovariectomizadas e inhiben la formación de osteoclastos de modo dosis-dependiente. Un trabajo realizado por nuestro grupo ha demostrado que el aceite de oliva virgen ejerce también acciones sobre los parámetros biomecánicos del hueso como el módulo de Young y la dimensión fractal en ratas ovariectomizadas. Los resultados de esta revisión muestran que el aceite de oliva ejerce una acción positiva sobre la salud ósea. Sus componentes poseen propiedades anti-oxidantes y anti-inflamatorias, siendo candidatos potenciales para la prevención de la osteoporosis

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Efectos del tratamiento con bazedoxifeno sobre la calidad ósea en ratas ovariectomizadas / Effects of bazedoxifene treatment on the bone quality of ovariectomized rats

OBJETIVO: El bazedoxifeno es un SERM de 3ª generación con efectos agonistas sobre el hueso y sobre el útero y el tejido mamario. Nuestro objetivo ha sido estudiar los efectos del bazedoxifeno sobre la calidad ósea en un modelo experimental de ratas ovariectomizadas. MATERIAL Y MÉTODOS: Se utilizaron 3 grupos de 15 ratas Wistar hembras de 6 meses de edad: uno control; otro de ratas ovariectomizadas; y un tercer grupo de ratas ovariectomizadas tratadas con bazedoxifeno (0,33 mg/kg/día). Tras 8 meses se estudiaron la densitometría ósea lumbar y femoral, los parámetros microtomográficos, los marcadores bioquímicos de remodelado y los parámetros biomecánicos del hueso. RESULTADOS: La ovariectomía descendió la densidad ósea femoral y lumbar. La última se recuperó parcialmente con bazedoxifeno. El remodelado óseo aumentó, recuperando el bazedoxifeno los niveles de formación. El bazedoxifeno recuperó la fracción volumétrica ósea (BV/TV), la densidad de superficie ósea (BS/TV), el aumento en la separación trabecular (Tb. Sp), la disminución en el número de trabéculas (Tb. N), el aumento del factor de patrón trabecular (Tb. Pf) y el índice de modelo estructural (SMI). La superficie relativa cortical aumentó tras la ovariectomía, normalizándose con bazedoxifeno. También recuperó la deformación máxima antes de la rotura producida por la ovariectomía, y amortiguó parcialmente la ganancia de peso de las ratas ovariectomizadas. CONCLUSIONES: Nuestro estudio muestra resultados positivos del bazedoxifeno sobre la calidad ósea. Este fármaco podría estar especialmente indicado para mujeres jóvenes postmenopáusicas con osteoporosis o en riesgo de padecerla

OBJETIVE: Bazedoxifene is a 3rdgeneration SERM with agonistic effects on the bones, uterus and breast tissue. Our goalhas been to study the effects of bazedoxifene on bone quality of an experimental group of ovariectomized rats. MATERIAL AND METHODS:3 groups of 15 6‐month‐old Wistar female rats were used: a control group, a group of untreatedovariectomized rats and a group of ovariectomized rats treated with bazedoxifene (0.33 mg/kg/day). After 8 monthswe studied the lumbar and femur bone densitometry, the microtomographic parameters, the biochemical markers forbone remodelling and the bone biomechanical parameters. RESULTS:The ovariectomy depleted the femur and lumbar bone density. After receiving bazedoxifene, the lumbar bonedensity showed partial healing. Bone remodelling increased recovering bazedoxifene formation levels. Bazedoxifenepromoted the recovery of the bone volume fraction (BV/TV), the bone surface density (BS/BV), the trabecular number(Tb. N), the trabecular spacing (Tb. Sp), the trabecular pattern factor (Tb. Pf) and the structural model index (SMI). Thecortical surface increased after the ovariectomy and returned to normal levels with the administration of bazedoxifene. The maximum deformation showed before the ovariectomy was also restored, partially cushioning the ovariectomizedrats' weight gain. CONCLUSIONS:Our study has shown bazedoxifene positive results on bone quality. This specific drug could be particularlysuitable for young postmenopausal women suffering or at risk of suffering osteoporosis

Prevalence of ankylosing spondylitis in Spain: EPISER2016 Study.

Objective: The aim of this study was to estimate the prevalence of ankylosing spondylitis (AS) in Spain.Method: This is a cross-sectional, population-based study of people aged 20 years or older in Spain. Randomly selected individuals were contacted by telephone and rheumatic disease screening was performed. If the first screening was positive, medical records were then reviewed and/or a telephone questionnaire was conducted by a rheumatologist, followed by an appointment if necessary. Cases had to fulfil the modified New York (mNY) criteria.Results: In total, 4916 individuals were included, of whom 355 had a positive screening result for AS. Of these, 11 were classified as AS. An additional individual who reported a prior diagnosis of rheumatoid arthritis had a diagnosis of AS confirmed on review of the medical records. Estimated prevalence was 0.26% (95% CI 0.14-0.49).Conclusion: EPISER2016 is the first population-based study to estimate the prevalence of AS in Spain, which has been estimated as being similar to that in other European countries.

Eficacia y seguridad a largo plazo del polimetilmetacrilato (PMMA) en pacientes osteoporóticos tratados mediante vertebroplastia percutánea / Long-term efficacy and safety of polymethylmethacrylate (PMMA) in osteoporotic patients treated by percutaneous vertebroplasty

OBJETIVO: Actualmente, existen pocos datos sobre la influencia a largo plazo del polimetilmetacrilato (PMMA) en la integridad de los cuerpos vertebrales tras la vertebroplastia percutánea (VP). Resulta de interés investigar la posible relación entre esta técnica y la aparición con el tiempo de fenómenos de osteólisis o la fragmentación del cemento en las vértebras intervenidas. El objetivo de este trabajo fue investigar si, a largo plazo, existe una pérdida de efectividad y/o seguridad de la VP con PMMA. MATERIAL Y MÉTODOS: Se analizaron radiografías de pacientes intervenidos correspondientes al post-operatorio inmediato y al estudio radiológico más reciente (VP hace más de 15 años). Con ambos estudios radiológicos, describimos: la altura del cuerpo vertebral, la angulación de platillos y la presencia de osteólisis alrededor del cemento en el tiempo. RESULTADOS: Un total de 7 pacientes intervenidos mediante VP con PMMA hace 15 o más años accedieron a realizarse una nueva radiografía en nuestro Centro. Tras el análisis de sus imágenes post-operatorias (inmediatas y a 15 ó más años de la cirugía), no se observó en ninguna de las vértebras intervenidas pérdida de altura del cuerpo vertebral cementado, diferencias de angulación en los platillos, presencia de osteólisis alrededor del cemento o fragmentación del PMMA inyectado. CONCLUSIÓN: El PMMA inyectado en el cuerpo vertebral mantiene una situación estable en el tiempo (más de 15 años). No se observan cambios en la interfaz hueso-PMMA, osteólisis y/o cambios en la altura de los cuerpos vertebrales en los casos analizados

OBJETIVE: Currently, there are limited data on the long-term influence of polymethylmethacrylate (PMMA) on the integrity of vertebral bodies after percutaneous vertebroplasty (PVP). Interesting investigation is being carried out into the possible relationship between this technique and the appearance over time of osteolytic phenomena or cement fragmentation in the intervened vertebrae. The objective of our study was to investigate whether there is a loss of effectiveness and/or safety of PVP with PMMA in the long term. MATERIAL AND METHOD: X-rays were analyzed of intervened patients corresponding to the immediate post-operative and the most recent radiological study (PVP more than 15 years previous). With both radiological studies, we describe: the height of the vertebral body, the angulation of lamellar plates and osteolytic presence around the cement over time. RESULTS: A total of 7 patients operated by PVP with PMMA 15 or more years earlier agreed to have a new radiograph in our center. After the analysis of their post-operative images (immediate and 15 or more years after surgery), no loss of height of the cemented vertebral body, differences in angulation in the lamellar plates, presence of osteolysis around the vertebrae was observed in any of the involved vertebrae cement or fragmentation of the injected PMMA. CONCLUSIONS: PMMA injected into the vertebral body remains stable over time (more than 15 years). There are no changes in the bone-PMMA interface, osteolysis and/or changes in the height of the vertebral bodies in the cases analyzed

Effects of Cyclosporine, Tacrolimus, and Rapamycin on Osteoblasts.

PURPOSE: One factor that can contribute to severe bone loss after transplantation is the direct action of immunosuppressants on bone cells. The aim of this work was to study the effects of cyclosporine (CsA), tacrolimus (FK-506), and rapamycin (RAPA) on the release of three local factors directly implicated in bone-remodeling regulation and apoptosis of human osteoblasts: interleukin (IL)-6, osteoprotegerin, and receptor activator of nuclear factor κß (RANKL). BASIC PROCEDURES: Human osteoblasts were obtained from five different patients who underwent orthopedic surgery. These cells were treated with what are considered to be a clinically high dose and an acceptable dose of each immunosuppressant-RAPA 50 ng/mL and 12 ng/mL, FK-506 20 ng/mL and 5 ng/mL, CsA 1000 ng/mL and 250 ng/mL-or vehicle. Apoptotic cell death was quantified using flow cytometry of DNA content in permeabilized, propidium iodide-stained cells. IL-6 was measured using enzyme-linked immunosorbent assay (ELISA; Quantikine Human IL6, R&D Systems, Minneapolis, Minn, United States). Messenger RNA (mRNA) expression of osteoprotegerin, RANKL, and IL-6 was measured using quantitative RT-PCR. MAIN FINDINGS: A significant increase in IL-6 (mRNA and released protein) was observed in the presence of FK-506 and RAPA. Addition of RAPA to the cultures of osteoblasts produced a significant increase in the OPG/RANKL ratio. A significant increase in osteoblast apoptosis was observed in the cells treated with FK-506 and RAPA 24 hours after the addition of immunosuppressants. CsA did not produce any significant changes in osteoblasts. PRINCIPAL CONCLUSIONS: These results suggest that an increase in osteoblast apoptosis by osteoblasts may be one of the mechanisms by which bone loss occurs after RAPA and FK-506 treatments.

The use of lactic acid bacteria to reduce mercury bioaccessibility.

Mercury in food is present in either inorganic [Hg(II)] or methylmercury (CH3Hg) form. Intestinal absorption of mercury is influenced by interactions with other food components. The use of dietary components to reduce mercury bioavailability has been previously proposed. The aim of this work is to explore the use of lactic acid bacteria to reduce the amount of mercury solubilized after gastrointestinal digestion and available for absorption (bioaccessibility). Ten strains were tested by addition to aqueous solutions containing Hg(II) or CH3Hg, or to food samples, and submission of the mixtures to gastrointestinal digestion. All of the strains assayed reduce the soluble fraction from standards of mercury species under gastrointestinal digestion conditions (72-98%). However their effectiveness is lower in food, and reductions in bioaccessibility are only observed with mushrooms (⩽68%). It is hypothesized that bioaccessible mercury in seafood forms part of complexes that do not interact with lactic acid bacteria.

Hiperparatiroidismo secundario al déficit de vitamina D / Secondary hyperparathyroidism due to vitamin D deficiency

Introducción: Cada vez está más demostrado el papel de la vitamina D en múltiples patologías, una de ellas el desarrollo de un hiperparatiroidismo secundario al déficit de vitamina D. Los métodos de laboratorio de cuantificación de vitamina D en suero no estaban bien estandarizados hasta ahora, por lo que no podía establecerse con certeza a partir de qué niveles de vitamina D se producían determinadas anomalías como la elevación de la PTH. Nuestro estudio pretende determinar por debajo de qué niveles de vitamina D nos encontraremos con niveles de PTH anormalmente elevados, realizando la determinación de vitamina D en el laboratorio con una técnica debidamente estandarizada y fiable. Métodos: El estudio descriptivo y retrospectivo se realizó con pacientes mayores de 18 años en los que se hicieron simultáneamente determinaciones de PTH, 25(OH) vitamina D (25OHD) y que además tuvieran valores normales de calcio, filtrado glomerular y fósforo. Para la determinación de vitamina D se utilizó un método de electroquimioluminiscencia estandarizado con respecto a la técnica de gases-masas. Por el programa estadístico Stava versión 11 se calculó el valor de 25OHD para el que la PTH se elevaba por encima de 70 pg/ml con la mayor sensibilidad y especificidad. Resultados: Se incluyeron 4.083 pacientes, de los que 2.858 eran mujeres (70%) y 1.225 (30%) varones. La edad media de la población estudiada fue 60,60 años (desviación estándar, 15,29). El 74% de la población tenía una PTH en suero por debajo de 70 pg/ml (valores considerados normales) y el 26% mayor de 70 pg/ml. Al construir la curva de ROC de los niveles de 25OHD, en función de valores de PTH por debajo o por encima de 70 pg/ml, el área bajo la curva fue 0,5962 (p<0,0001). El punto de corte teniendo en cuenta conjuntamente la sensibilidad y la especificidad que determinaban los valores de vitamina D para predecir los valores de PTH por encima de 70 pg/ml fue 24 ng/ml. De los pacientes con PTH normal, el 71% tenían valores de vitamina D normales, mientras que, de los pacientes con PTH elevada (mayor de 70 pg/ml), casi la mitad presentaban una vitamina D menor de 24 ng/ml, porcentaje que aumentaba según se iba elevando la PTH. Conclusiones: El valor de 25OHD que muestra una mejor especificidad y sensibilidad para predecir valores anormalmente elevados de PTH es 24 ng/ml, valor superior al presentado en trabajos anteriores (alrededor de 18 ng/ml). Con los resultados de este estudio, realizado con un método debidamente calibrado, se puede decir que el 44,9% de pacientes con valores de vitamina D menores de 24 ng/ml presenta niveles de PTH anormalmente elevados, con una función renal normal y valores de calcio y fósforo normales. Este porcentaje es menor entre los 18 y 40 años (24%) y llega al 49% por encima de los 60 años. Estos pacientes podrían tratarse con vitamina D para evitar un posible hiperparatiroidismo secundario al déficit de dicha vitamina. Es importante tener en cuenta que el método de determinación de vitamina D utilizado debe estar debidamente estandarizado con respecto al método de gases-masas (AU)

Introduction: Vitamin D is increasingly recognized as playing a significant role in combatting many diseases. One is the development of secondary hyperthyroidism due vitamin D deficiency. To date, laboratory quantification methods of serum vitamin D were not well standardized. It could not be established with certainty from which levels of vitamin D certains abnormalities take place, like an elevation of PTH. The present study was aimed at determining below what vitamin D levels we will find abnormally high levels of PTH, carrying out the vitamin D determination in the laboratory with a standardized, reliable technique. Methods: This descriptive, retrospective study was conducted with patients over 18 years in which determinations were made simultaneously with PTH, 25 (OH) vitamin D (25OHD) and which also have normal values of calcium, glomerular filtration rate and phosphorus. For determining vitamin D, standardized electrochemiluminescence method was used with gas chromatography- mass spectrometry method. Using the Stava version 11 statistical program, the 25OHD was calculated where PTH value was above 70 pg/ml with greater sensitivity and specificity. Results: In all, 4,083 patients were included, of whom 2,858 were women (70%) and 1,225 (30%) males. The mean age of the study population was 60.60 years (standard deviation, 15.29). 74% of the population had a serum PTH under 70 pg/ml (normal values) and 26% had a serum PTH higher tan 70 ng/ml. By constructing the ROC curve levels of 25OHD, depending on PTH values below or above 70 pg/ml, the area under the curve was 0.5962 (p<0.0001). The cut having jointly account the sensitivity and specificity that determined vitamin D levels to predict PTH values above 70 pg/ml was 24 ng/ml. Of the patients with normal PTH, 71% presented normal vitamin D values, while patients with elevated PTH (Greater than 70 pg/ml), almost half had a vitamin D below 24 ng / ml, which increased as the PTH percentage was elevated. Conclusions: The 25OHD value that presents better specificity and sensitivity to predict abnormally high PTH is 24 ng/ml, which is higher than the level reported in previous work, (about 18 ng/ml) value. The results of this study, carried out with an appropriately calibrated method, showed that 44.9% of patients with vitamin D values of less than 24 ng/ml PTH had abnormally high levels, with a normal value of calcium and phosphorus and normal renal function. This percentage is less in those individuals between 18 and 40 years (24%) and reaches 49% beyond 60 years. These patients could be treated with vitamin D to prevent possible secondary hyperparathyroidism due to vitamin deficiency. It is noteworthy that the method of determining vitamin D used must be properly standardized with respect to gas chromatography-tandem mass spectrometry method (AU)

Comparación entre dos inmunoensayos automatizados por quimioluminiscencia para la cuantificación de 25(OH) vitamina D / Comparison between two automated chemiluminescence immunoassays for quantifying 25 (OH) vitamin D

Introducción: La cuantificación de 25(OH) vitamina D total en sangre es el marcador más preciso del estado de vitamina D en un individuo. La técnica patrón-oro para su medición es la cromatografía líquida/ espectrometría de masas en tándem (LC-MS/MS), aunque actualmente los laboratorios clínicos utilizan de rutina técnicas de quimioluminiscencia. El objetivo del estudio fue comparar las concentraciones de 25(OH) vitamina D obtenidas mediante dos métodos automatizados comerciales y estudiar la correlación de dichos métodos con la técnica de referencia LC-MS/MS. Material y método: Se cuantificaron los niveles de 25(OH) vitamina D en 1.000 muestras de suero del laboratorio de Bioquímica de la Fundación Jiménez Díaz mediante 2 métodos automatizados comerciales por detección de quimioluminiscencia: ADVIA CENTAURO® (SIEMENS) y LUMIPULSE® G1200 (FUJIREBIO). Entre todas las muestras analizadas, las 50 más discordantes entre sí se enviaron para ser evaluadas por la técnica de referencia LC-MS/MS. Resultados: Los resultados obtenidos indican que existe una buena correlación entre los dos métodos: CCI=0,923 (0,914-0,932), siendo los valores de LUMIPULSE® G1200 un 10% superiores a los de CENTAURO ®. Con respecto a las 50 muestras seleccionadas, podemos observar que existe una buena correlación entre los dos inmunoensayos con la técnica LC-MS/MS, aunque ambos métodos infraestiman considerablemente los resultados de 25(OH) vitamina D con respecto al patrón-oro. Discusión: Aunque ambas técnicas son adecuadas para su utilización, habría que plantearse si la «epidemia» mundial de hipovitaminosis D se debe a la metodología de análisis utilizada. Esta variabilidad entre inmunoensayos se solucionaría estandarizando las diferentes técnicas comerciales con los materiales de referencia elaborados por el NIST (AU)

Introduction: Quantifying total blood 25 (OH) vitamin D is the most accurate marker of an individual’s vitamin D status. The gold standard technique for measurement is liquid chromatography tandem mass spectrometry (LC-MS/MS), although currently clinical laboratories tend to use chemiluminescence techniques. The objective of this study was to compare 25 (OH) vitamin D concentrations obtained by two commercially-produced automated methods and study the correlation of these methods with the LC-MS/MS reference technique. Material and methods: The 25(OH) vitamin D levels were quantified in 1,000 serum samples from the Jimenez Diaz Biochemistry Foundation Laboratory using 2 automated methods for chemiluminescence detection: ADVIA CENTAURO® (SIEMENS) and LUMIPULSE® G1200 (Fujirebio). Among all the samples tested, the 50 most discordant to each other were sent to be evaluated by LC-MS/MS reference technique. Results: The results indicate that there is good correlation between the two methods: CCI=0.923 (0.914-0.932), with the G1200 LUMIPULSE® values 10% being higher than CENTAURO®. Regarding the 50 samples selected, we can see that there is a good correlation between the two immunoassays with LC-MS/MS, although both methods significantly underestimate 25 (OH) vitamin D results with respect to the gold standard. Discussion: Although both techniques are suitable for use, it is worth considering whether the worldwide vitamin D deficiency epidemic is due to the analysis methodology used. This variability between immunoassays could be solved by standardizing the different commercial techniques in line with NIST produced reference materials (AU)

Toxic trace elements at gastrointestinal level.

Many trace elements are considered essential [iron (Fe), zinc (Zn), copper (Cu)], whereas others may be harmful [lead (Pb), cadmium (Cd), mercury (Hg), arsenic (As)], depending on their concentration and chemical form. In most cases, the diet is the main pathway by which they enter our organism. The presence of toxic trace elements in food has been known for a long time, and many of the food matrices that carry them have been identified. This has led to the appearance of legislation and recommendations concerning consumption. Given that the main route of exposure is oral, passage through the gastrointestinal tract plays a fundamental role in their entry into the organism, where they exert their toxic effect. Although the digestive system can be considered to be of crucial importance in their toxicity, in most cases we do not know the events that occur during the passage of these elements through the gastrointestinal tract and of ascertaining whether they may have some kind of toxic effect on it. The aim of this review is to summarize available information on this subject, concentrating on the toxic trace elements that are of greatest interest for organizations concerned with food safety and health: Pb, Cd, Hg and As.

Usefulness of bone turnover markers as predictors of mortality risk, disease progression and skeletal-related events appearance in patients with prostate cancer with bone metastases following treatment with zoledronic acid: TUGAMO study.

BACKGROUND: Owing to the limited validity of clinical data on the treatment of prostate cancer (PCa) and bone metastases, biochemical markers are a promising tool for predicting survival, disease progression and skeletal-related events (SREs) in these patients. The aim of this study was to evaluate the predictive capacity of biochemical markers of bone turnover for mortality risk, disease progression and SREs in patients with PCa and bone metastases undergoing treatment with zoledronic acid (ZA). METHODS: This was an observational, prospective and multicenter study in which ninety-eight patients were included. Patients were treated with ZA (4 mg every 4 weeks for 18 months). Data were collected at baseline and 3, 6, 9, 12, 15 and 18 months after the beginning of treatment. Serum levels of bone alkaline phosphtase (BALP), aminoterminal propeptide of procollagen type I (P1NP) and beta-isomer of carboxiterminal telopeptide of collagen I (ß-CTX) were analysed at all points in the study. Data on disease progression, SREs development and survival were recorded. RESULTS: Cox regression models with clinical data and bone markers showed that the levels of the three markers studied were predictive of survival time, with ß-CTX being especially powerful, in which a lack of normalisation in visit 1 (3 months after the beginning of treatment) showed a 6.3-times more risk for death than in normalised patients. Levels of these markers were also predictive for SREs, although in this case BALP and P1NP proved to be better predictors. We did not find any relationship between bone markers and disease progression. CONCLUSION: In patients with PCa and bone metastases treated with ZA, ß-CTX and P1NP can be considered suitable predictors for mortality risk, while BALP and P1NP are appropriate for SREs. The levels of these biomarkers 3 months after the beginning of treatment are especially important.