Resistencia de unión de una resina autoadhesiva usando diferentes protocolos de adhesión sobre esmalte bovino

OBJETIVO: Evaluar la resistencia de unión de una resina fluida autoadhesiva Dyad Flow (DF, Kerr) usando diferentes protocolos de adhesión sobre esmalte bovino al cabo de 24 horas.MATERIALES Y MÉTODOS: Se utilizaron quince incisivos inferiores bovinos sanos, 5 por cada grupo. Se aplicó DF sobre el esmalte, utilizando un molde de teflón de 8 mm de diámetro interno y 4 mm de alto, usando tres diferentes protocolos: (I) DF (control); (II) ácido fosfórico 37.5% (Gel Etchant, GE, Kerr)+DF y (III) GE/adhesivo (Optibond S, OB, Kerr)+DF. Los especímenes de 1 mm2 de área transversal (n = 30 por grupo) se obtuvieron con una máquina de cortes tipo IsoMet y se almacenaron en agua destilada por 24 horas a 37 °C. La prueba de microtensión se realizó haciendo uso del Microtensile Tester (Bisco). Para el análisis estadístico se utilizó ANOVA y Tukey (p=0.05).RESULTADOS: La resina Dyad Flow siguiendo las indicaciones del fabricante presentó una resistencia de unión de 23.20 ± 5.97 MPa, no encontrándose diferencias significativas al compararlo con la aplicación previa de ácido fosfórico (26.26 ± 5.5 MPa) y ácido fosfórico más adhesivo (22.70 ± 5.40 MPa). Sin embargo, el protocolo II fue significativamente mayor que el protocolo III (p = 0.043).CONCLUSIÓN: La resistencia de unión de la resina fluida autoadhesiva Dyad Flow sobre esmalte bovino presentó una conducta adhesiva similar al ser comparada con previo grabado ácido y grabado ácido más adhesivo

Programas de cribado neonatal en España: Actualización y propuestas de futuro. Documento del consenso

Este documento tiene como objetivo principal aportar el conocimiento y la experiencia de los profesionales implicados en el diagnóstico, tratamiento y seguimiento de pacientes con enfermedades metabólicas hereditarias a la prevención de estos defectos. Cuenta con el apoyo incondicional de la Federación Española de Asociaciones de Padres de niños afectados por fenilcetonuria (PKU) y otros trastornos del metabolismo (OTM)

Postauthorization safety study of betaine anhydrous

Patient registries for rare diseases enable systematic data collection and can also be used to facilitate postauthorization safety studies (PASS) for orphan drugs. This study evaluates the PASS for betaine anhydrous (Cystadane), conducted as public private partnership (PPP) between the European network and registry for homocystinurias and methylation defects and the marketing authorization holder (MAH). Data were prospectively collected, 2013–2016, in a noninterventional, international, multicenter, registry study. Putative adverse and severe adverse events were reported to the MAH's pharmacovigilance. In total, 130 individuals with vitamin B6 nonresponsive (N = 54) and partially responsive (N = 7) cystathionine beta-synthase (CBS) deficiency, as well as 5,10-methylenetetrahydrofolate reductase (MTHFR; N = 21) deficiency and cobalamin C (N = 48) disease were included. Median (range) duration of treatment with betaine anhydrous was 6.8 (0–9.8) years. The prescribed betaine dose exceeded the recommended maximum (6 g/day) in 49% of individuals older than 10 years because of continued dose adaptation to weight; however, with disease-specific differences (minimum: 31% in B6 nonresponsive CBS deficiency, maximum: 67% in MTHFR deficiency). Despite dose escalation no new or potential risk was identified. Combined disease-specific treatment decreased mean ± SD total plasma homocysteine concentrations from 203 ± 116 to 81 ± 51 μmol/L (p < 0.0001), except in MTHFR deficiency. Recommendations for betaine anhydrous dosage were revised for individuals ≥ 10 years. PPPs between MAH and international scientific consortia can be considered a reliable model for implementing a PASS, reutilizing well-established structures and avoiding data duplication and fragmentation

Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb/V and dialysis in Spanish clinical practice – preliminary data Vie-KinD study

Poster presentatio

Muticenter spanish study for perioperative stroke risk prediction after isolated coronary artery bypass surgery: The PACK2 score

[ES] Objetivos: Desarrollar un modelo predictivo multivariante del accidente cerebrovascular (ACV) intrahospitalario tras cirugía de bypass coronario. Métodos: Veintiséis mil trescientos cuarenta y siete pacientes incluidos en el estudio procedentes de 21 bases de datos de hospitales españoles. El análisis de regresión logística fue utilizado para predecir el riesgo de ACV perioperatorio (ictus o accidente isquémico transitorio). El modelo predictivo fue desarrollado a partir de un subgrupo de datos «de prueba» y validado en otro subgrupo independiente, ambos seleccionados aleatoriamente del total de la muestra. La capacidad predictiva del modelo se relacionó con el área bajo la curva ROC (ABC). Las variables consideradas fueron: preoperatorias (edad, sexo, diabetes mellitus, hipertensión arterial, ACV previo, insuficiencia cardiaca y/o fracción de eyección del ventrículo izquierdo < 40%, prioridad de la intervención no electiva, arteriopatía extracardiaca, insuficiencia renal crónica y/o creatininemia &#8805; 2 mg/dl y fibrilación auricular) e intraoperatorias (cirugía coronaria con/sin circulación extracorpórea). Resultados: Incidencia global de ACV perioperatorio 1,38%. La prioridad no electiva de la cirugía (priority; OR = 2,32), arteriopatía extracardiaca (arteriopathy; OR = 1,37), insuficiencia cardiaca (cardiac; OR = 3.64) e insuficiencia renal crónica (kidney; OR = 6,78) fueron identificados como factores de riesgo independientes de ACV perioperatorio en los modelos uni y multivariante en el subgrupo de prueba; p < 0,0001; ABC = 0,77, IC del 95%, 0,73-0,82. El modelo PACK2 de ACV perioperatorio tras cirugía de bypass coronario se estableció con 1 punto para cada ítem, excepto para la insuficiencia renal crónica que se le otorgaron 2 puntos (rango 0-5 puntos); ABC = 0,76, IC del 95%, 0,72-0,80. En pacientes con puntuación PACK2 &#8805; 2 puntos, la cirugía coronaria sin circulación extracorpórea redujo la incidencia de ACV en un 2,3% cuando se comparó con el grupo con cirugía realizada con circulación extracorpórea. Conclusiones: La escala de riesgo PACK2 muestra una buena capacidad predictiva en los datos analizados y podría ser útil en la toma de decisiones y selección de pacientes de la práctica clínica.[EN] Objectives: To develop a multivariate predictive risk score of perioperative in-hospital stroke after coronary artery bypass grafting (CABG) surgery. Methods: A total of 26,347 patients were enrolled from 21 Spanish hospital databases. Logistic regression analysis was used to predict the risk of perioperative stroke (stroke or transient ischaemic attack). The predictive scale was developed from a training set of data and validated by an independent test set, both selected randomly from the global sample. The assessment of the accuracy of prediction was related to the area under the ROC curve (AUC). The variables considered were: preoperative (age, gender, diabetes mellitus, arterial hypertension, previous stroke, cardiac failure and/or left ventricular ejection fraction < 40%, non-elective priority of surgery, extracardiac arteriopathy, chronic kidney failure and/or serum creatinine ≥2 mg/dl, and atrial fibrillation) and intra-operative (on/off-pump). Results: The overall perioperative stroke incidence was 1.38%. Non-elective priority of surgery (priority; OR = 2.32), vascular disease (arteriopathy; OR = 1.37), heart failure (cardiac; OR = 3.64), and chronic kidney failure (kidney; OR = 6.78) were found to be independent risk factors for perioperative stroke in uni- and multivariate models in the training set of data; P < .0001; AUC = 0.77, 95% CI 0.73–0.82. The PACK2 stroke CABG score was established with 1 point for each item, except for chronic kidney failure with 2 points (range 0–5 points); AUC = 0.76, 95% CI 0.72–0.80. In patients with PACK2 score ≥2 points, off-pump reduced perioperative stoke incidence by 2.3% when compared with on-pump CABG. Conclusions: PACK2 risk scale shows good predictive accuracy in the data analysed and could be useful in clinical practice for decision making and patient selection.Martín, E.; Hornero, F.; Rodríguez, R.; Castellà, M.; Porras, C.; Romero, B.; Maroto, L.... (2014). Estudio multicéntrico español para la predicción del riesgo perioperatorio de accidente cerebrovascular tras cirugía de bypass coronario aislada: el modelo PACK2. Cirugia Cardiovascular. 21(3):175-180. doi:10.1016/j.circv.2014.02.009S17518021

The polygenic basis of relapse after a first episode of schizophrenia

Little is known about genetic predisposition to relapse. Previous studies have linked cognitive and psychopathological (mainly schizophrenia and bipolar disorder) polygenic risk scores (PRS) with clinical manifestations of the disease. This study aims to explore the potential role of PRS from major mental disorders and cognition on schizophrenia relapse. 114 patients recruited in the 2EPs Project were included (56 patients who had not experienced relapse after 3 years of enrollment and 58 patients who relapsed during the 3-year follow-up). PRS for schizophrenia (PRS-SZ), bipolar disorder (PRS-BD), education attainment (PRS-EA) and cognitive performance (PRS-CP) were used to assess the genetic risk of schizophrenia relapse.Patients with higher PRS-EA, showed both a lower risk (OR=0.29, 95% CI [0.11–0.73]) and a later onset of relapse (30.96± 1.74 vs. 23.12± 1.14 months, p=0.007. Our study provides evidence that the genetic burden of neurocognitive function is a potentially predictors of relapse that could be incorporated into future risk prediction models. Moreover, appropriate treatments for cognitive symptoms appear to be important for improving the long-term clinical outcome of relapse

Clonal chromosomal mosaicism and loss of chromosome Y in elderly men increase vulnerability for SARS-CoV-2

The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID-19) had an estimated overall case fatality ratio of 1.38% (pre-vaccination), being 53% higher in males and increasing exponentially with age. Among 9578 individuals diagnosed with COVID-19 in the SCOURGE study, we found 133 cases (1.42%) with detectable clonal mosaicism for chromosome alterations (mCA) and 226 males (5.08%) with acquired loss of chromosome Y (LOY). Individuals with clonal mosaic events (mCA and/or LOY) showed a 54% increase in the risk of COVID-19 lethality. LOY is associated with transcriptomic biomarkers of immune dysfunction, pro-coagulation activity and cardiovascular risk. Interferon-induced genes involved in the initial immune response to SARS-CoV-2 are also down-regulated in LOY. Thus, mCA and LOY underlie at least part of the sex-biased severity and mortality of COVID-19 in aging patients. Given its potential therapeutic and prognostic relevance, evaluation of clonal mosaicism should be implemented as biomarker of COVID-19 severity in elderly people. Among 9578 individuals diagnosed with COVID-19 in the SCOURGE study, individuals with clonal mosaic events (clonal mosaicism for chromosome alterations and/or loss of chromosome Y) showed an increased risk of COVID-19 lethality

Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study

Limited data are available on the effectiveness and tolerability of direct-acting antivirals (DAAs) therapies in the real world for HCV-infected patients with comorbidities. This study aimed to describe the effectiveness of OBV/PTV/r ± DSV (3D/2D regimen) with or without ribavirin (RBV) in HCV or HCV/HIV co-infected patients with GT1/GT4 and CKD (IIIb-V stages), including those under hemodialysis and peritoneal dialysis in routine clinical practice in Spain in 2015.Non-interventional, retrospective, multicenter data collection study in 31 Spanish sites. Socio-demographic, clinical variables, study treatment characteristics, effectiveness and tolerability data were collected from medical records.Data from 135 patients with a mean age (SD) of 58.3 (11.4) years were analyzed: 92.6% GT1 (81.6% GT1b and 17.6% GT1a) and 7.4% GT4, 14 (10.4%) HIV/HCV co-infected, 19.0% with fibrosis F3 and 28.1% F4 by FibroScan®, 52.6% were previously treated with pegIFN and RBV. 11.1%, 14.8% and 74.1% of patients had CKD stage IIIb, IV and V respectively. 68.9% of patients were on hemodialysis; 8.9% on peritoneal dialysis and 38.5% had history of renal transplant. A total of 125 (96.2%) of 135 patients were treated with 3D, 10 (7.4%) with 2D and 30.4% received RBV. The overall intention-to-treat (ITT) sustained virologic response at week 12 (SVR12) was 92.6% (125/135) and the overall modified-ITT (mITT) SVR12 was 99.2% (125/126). The SVR12 rates (ITT) per sub-groups were: HCV mono-infected (91.7%), HCV/HIV co-infected (100%), GT1 (92.0%), GT4 (100%), CKD stage IIIb (86.7%), stage IV (95%) and stage V (93%). Among the 10 non-SVR there was only 1 virologic failure (0.7%); 4 patients had missing data due lost to follow up (3.0%) and 5 patients discontinued 3D/2D regimen (3.7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision.These results have shown that 3D/2D regimens are effective and tolerable in patients with advanced CKD including those in dialysis with GT 1 or 4 chronic HCV mono-infection and HIV/HCV coinfection in a real-life cohort. The overall SVR12 rates were 92.6% (ITT) and 99.2% (mITT) without clinically relevant changes in eGFR until 12 weeks post-treatment. These results are consistent with those reported in clinical trials