Presence of metallic components in transdermal drug delivery systems and risk of skin burns. / [Artículo traducido] Presencia de partículas metálicas en parches transdérmicos de medicamentos y riesgo de quemaduras.

OBJECTIVE: Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion or defibrillation procedures. The aim of the study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain. METHOD: For each presentation, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted. RESULTS: We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances. 59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%). A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields and references. CONCLUSION: More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.

Presence of metallic components in transdermal drug delivery systems and risk of skin burns.

OBJECTIVE: Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion, or defibrillation procedures. The aim of the study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain. METHOD: For each pharmaceutical form, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted. RESULTS: We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances. 59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%) A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields, and references. CONCLUSION: More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.

Small bowel obstruction secondary to distal migration of the intestinal probe in a patient with an endoscopic gastrostomy for continuous carbidopa-levodopa infusion / Obstrucción de intestino delgado secundaria a migración distal de la sonda intestinal en una paciente con gastrostomía endoscópica para la infusión continua de carbidopa-levodopa

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Non-occlusive mesenteric ischaemia: CT findings, clinical outcomes and assessment of the diameter of the superior mesenteric artery.

OBJECTIVE: Review of the experience of a tertiary care centre for almost 10 years in the CT diagnosis of non-occlusive mesenteric ischaemia (NOMI). Analysis of CT findings, correlation with clinical outcomes and evaluation of the usefulness of measuring the superior mesenteric artery (SMA) diameter for the diagnosis of NOMI. METHODS: 106 patients were diagnosed with NOMI in a biphasic CT examination from 2008 to 2017 in our hospital. Clinical outcomes and CT findings were reviewed. In 55 patients, the diameter of the SMA was compared with a previous CT scan where NOMI was not the diagnosis, and statistical analysis using paired t-test was performed. RESULTS: 81 patients (76%) had findings consistent with small bowel ischaemia and the ileum was the segment most commonly involved (47%). Lack of wall enhancement, pneumoperitoneum, pneumatosis intestinalis and portal venous gas were all considered signs of bowel necrosis and surgery was performed promptly. 70 patients had signs of vascular narrowing of the SMA branches and in the 55 cases with a previous CT scan, there were statistically significant differences regarding the SMA diameter with a mean reduction of the artery calibre and standard deviation of 1.93 ± 1.1 mm between the NOMI and non-NOMI scans (p < 0.001). CONCLUSION: Acknowledgment of characteristic bowel necrosis CT findings is crucial for determining the therapeutic attitude and the use of previous CT scans to compare the SMA diameter may help the radiologist to achieve an early diagnosis of NOMI in an often critically ill patient population. Advances in knowledge: Diagnosis of NOMI can be difficult in cases of partial mural ischaemia, thus objective data (diameter of the SMA) should be useful for the radiologist to include NOMI as the first diagnostic option in the differential diagnosis.

Immediate reactions to iodinated contrast media.

BACKGROUND: Immediate hypersensitivity reactions (IHRs) to iodinated contrast media (ICMs) remain a common clinical concern. Positive skin test and basophil activation test results suggest a specific IgE-mediated mechanism in some cases. Skin test and controlled challenge test (CCT) are useful to manage these patients. OBJECTIVE: To study clinical and allergologic features of IHRs to ICMs in a Spanish tertiary hospital during a 7-year period. METHODS: Demographic and clinical data concerning the reaction were recorded. Patients treated at the Allergy Department of Hospital General Universitario Gregorio Marañón, Madrid, Spain, underwent skin tests. In those with positive results, CCTs with an alternative skin-test-negative ICM was performed. Global reaction rate was calculated and compared for each ICM. RESULTS: A total of 342 reactions occurred in 329 patients. Cutaneous symptoms were the most common (87.7%). A total of 196 patients underwent an allergy workup, 15 (7.6%) of whom had positive skin test results. Reactions were more severe in patients with positive vs negative skin test results (grade 1, 46.7% vs 73.6%; grade 2, 33.3% vs 20.9%; grade 3, 20% vs 5.46%; P < .05). Three patients had cross-reactivity to 3 ICMs, all including ioversol and iomeprol. Six patients allergic to iopamidol tolerated ioversol and 1 tolerated iomeprol. Four patients allergic to ioversol and 1 allergic to iomeprol tolerated iopamidol. The global reaction rate was 0.2%, differing for each ICM (iopamidol, 0.14%; ioversol, 0.2%; and iomeprol, 0.4%; P < .001). Positive skin test results were found in a low percentage of patients in whom skin test-based CCT identified an alternative non-cross-reactive ICM. Low-grade cross-reactivity was found, especially between iopamidol and ioversol. Reactions were more severe in patients with positive skin test results. The reaction rate was greater for iomeprol compared with iopamidol (reaction rate, 2.8%) and ioversol (reaction rate, 2%). CONCLUSION: This study identified a possible underlying specific IgE-mediated mechanism by positive skin test result in a low percentage of patients with IHRs to ICMs. In these patients, the CCT based on skin test results was useful for identifying an alternative non-cross-reactive ICM. More studies are needed to investigate the underlying mechanism in patients with IHRs and negative skin test results.

Encefalopatía hiperamonémica como forma de presentación de un mieloma múltiple / Hyperammonemic encephalopathy as the presenting feature of multiple myeloma

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Serum ferritin as prognostic marker in classical Hodgkin lymphoma treated with ABVD-based therapy.

Ferritin levels might correlate with disease activity in classical Hodgkin lymphoma (cHL). We analyzed the prognostic significance of the ferritin value at diagnosis in 173 cHL patients treated with ABVD between 2003 and 2013. The 5-year overall survival (OS) and progression-free survival (PFS) probabilities were 80% and 64%, respectively. Patients with ferritin ≥ 350 µg/l [high ferritin group (HF), n = 62] were more likely to have advanced stage disease, B-symptoms and higher International Prognostic Score (IPS) compared with patients with ferritin < 350 µg/l [low ferritin group (LF), n = 111]. The complete remission (CR) rate and 5-year PFS and OS probabilities were lower in HF vs. LF patients (69% vs. 89%, p = 0.025; 40% vs. 78%, p < 0.001; 61% vs. 90%, p = 0.001; respectively). Multivariate analysis revealed that advanced stage (p = 0.001) and ferritin levels ≥ 350 µg/l (p = 0.002) were independent predictors for PFS. In conclusion, the ferritin level at diagnosis is a useful prognostic marker for cHL.

Prognostic significance of CD8 and CD4 T cells in chronic lymphocytic leukemia.

The prognostic value of the number of T cells and NK cells at diagnosis in CLL was analyzed in a cohort of 256 patients with CLL diagnosed between 1997 and 2007. Patients with leukemia showed elevated NK cells and T cell populations and CD4/CD8 ratio was inverted in 39.7% cases. Prognostic significance of lymphocytes was analyzed as a ratio of relative number of T cells to the size of the malignant monoclonal B-cell pool (T/NK cells:Malignant monoclonal B-cells ratio). Patients showed higher relative number of CD4 (p = 0.03), CD8 (p = 0.02), and NK cells (p = 0.01) in early Rai stage of disease. The multivariate Cox analysis identified the relative number of CD8 (hazard ratio (HR) = 1.464; p = 0.006) and CD4 T cells (HR = 0.091; p < 0.01) as independent predictors for survival. Additionally, patients with relative CD8 count > 0.074 or CD4 count > 0.1 had higher 10-year overall survival than patients with CD8 count ≤0.074 or CD4 count ≤0.1 (p = 0.002). Higher CD8 count was associated with significantly higher median time of survival of patients (149.33 vs. 82.06 months). Finally, association of the good prognostic factor of leukemia cells (CD38⁻ with high relative CD8 count identified a group of patients with an indolent clinical course with an overall survival probability at 10 years of 95%.

Estudio epidemiológico y comparación de los índices pronósticos del MD Anderson Cancer Center y el índice del Gruppo Italiano Malattie Ematologiche Maligne dell2 Adulto en pacientes con leucemia linfática crónica de células B / B-chronic lymphocytic leukemia: epidemiological study and comparison of MDACC and GIMENA pronostic indexes

Fundamento y objetivo: El curso clínico de los pacientes con leucemia linfática crónica de células B (LLCB) es extremadamente heterogéneo y no hay índices pronósticos (IP) que permitan clasificar bien a estos pacientes. En este estudio se han analizado 2 nuevos IP propuestos por el MDACC (MD Anderson Cancer Center) y por el grupo GIMEMA (Gruppo Italiano Malattie Ematologiche Maligne dell2 Adulto). Pacientes y método: Se ha realizado un estudio de seguimiento de una cohorte de pacientes diagnosticados de LLCB (265 casos) en el área sanitaria de Gijón durante 10 años (de 1997 a 2007), y de la supervivencia de los pacientes según los sistemas de estadificación clásica (Rai y Binet) y los nuevos IP. Resultados: Las tasas bruta y ajustada fueron de 8,99 y de 3,47 cada 100.000 habitantes por año, respectivamente. El índice GIMEMA no fue útil para predecir la supervivencia global. La distribución según el IP MDACC fue la siguiente: el 31,4% de bajo riesgo, el 62% de riesgo intermedio y el 6,6% de alto riesgo. La probabilidad de supervivencia a los 5 y 10 años fue del 87 y el 73% para el bajo riesgo, del 75 y el 49% para el riesgo intermedio, y del 29 y el 16% para el de alto riesgo. Conclusiones: Las tasas de incidencia de LLCB son superiores a las descritas hasta ahora, posiblemente debido a una mejor recogida de datos y a un diagnóstico más precoz. En este estudio se demuestra por primera vez en una población no seleccionada de pacientes que el IP MDCAA predice mejor la supervivencia que los sistemas de estadificación clásica. Dada su simplicidad, este modelo pronóstico puede ser muy útil para el manejo de los pacientes en la práctica clínica (AU)

Background and objective: The clinical course of B-chronic lymphocytic leukemia (B-CLL) patients is highly heterogeneous and the prognosis of these patients is difficult to predict. In this study, we analysed two new prognostic indexes proposed by the MDACC and GIMEMA group in a random population of B-CCL patients. Patients and methods: A follow up study of a cohort of patients was carried out. 265 B-CLL patients diagnosed in the Area Sanitaria de Gijón during 10 years (1997 2007) were analysed in this study. The overall survival of the patients was analysed by the Rai and Binet staging systems and the prognostic indexes proposed by the MDACC and GIMEMA group. Results: The crude rate was 8.99 per 100.000 populations for year and the adjusted-age rate was 3.47 per 100.000 populations for year. The distribution of patients based on the MDACC index was: 31.4% had low risk, 62% had intermediate risk and 6.6% had high risk. The percentage of 5- and 10-years survival probabilities were 87% and 73% for low risk, 75% and 49% for intermediate risk and 29% and 16% of high risk. The GIMEMA index was unable to predict the overall survival in our patients. Conclusions: he rates of B-CLL are higher in our population than previously described, which is probably caused by an earlier diagnosis. Our results indicate that the MDACC prognostic index predicted the overall survival and the prognosis of a random population of patients better than the classical staging systems. The simplicity and utility of this prognostic index may help clinicians in clinical decision and therapeutical management (AU)

[B-chronic lymphocytic leukemia: epidemiological study and comparison of MDACC and GIMENA pronostic indexes]. / Estudio epidemiológico y comparación de los índices pronósticos del MD Anderson Cancer Center y el índice del Gruppo Italiano Malattie Ematologiche Maligne dell' Adulto en pacientes con leucemia linfática crónica de células B.

BACKGROUND AND OBJECTIVE: The clinical course of B-chronic lymphocytic leukemia (B-CLL) patients is highly heterogeneous and the prognosis of these patients is difficult to predict. In this study, we analysed two new prognostic indexes proposed by the MDACC and GIMEMA group in a random population of B-CCL patients. PATIENTS AND METHODS: A follow up study of a cohort of patients was carried out. 265 B-CLL patients diagnosed in the Area Sanitaria de Gijón during 10 years (1997-2007) were analysed in this study. The overall survival of the patients was analysed by the Rai and Binet staging systems and the prognostic indexes proposed by the MDACC and GIMEMA group. RESULTS: The crude rate was 8.99 per 100.000 populations for year and the adjusted-age rate was 3.47 per 100.000 populations for year. The distribution of patients based on the MDACC index was: 31.4% had low risk, 62% had intermediate risk and 6.6% had high risk. The percentage of 5- and 10-years survival probabilities were 87% and 73% for low risk, 75% and 49% for intermediate risk and 29% and 16% of high risk. The GIMEMA index was unable to predict the overall survival in our patients. CONCLUSIONS: The rates of B-CLL are higher in our population than previously described, which is probably caused by an earlier diagnosis. Our results indicate that the MDACC prognostic index predicted the overall survival and the prognosis of a random population of patients better than the classical staging systems. The simplicity and utility of this prognostic index may help clinicians in clinical decision and therapeutical management.

Elevación persistente del dímero D en el posparto / No disponible

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The concentrations of soluble vascular cell adhesion molecule-1 and lipids are independently associated with venous thromboembolism.

BACKGROUND AND OBJECTIVES: Venous thromboembolism (VTE) involves inflammation and a relation with dyslipidemia which remains controversial. The vascular cell adhesion molecule-1 (VCAM-1) is a ligand expressed by activated endothelium (and recruits leukocytes) whose soluble form (sVCAM-1) increases in atherosclerosis, severe hypertriglyceridemia or deep vein thrombosis (DVT) in acute phase. We analyzed the association between VTE (> 6 months after), sVCAM-1 and lipid concentrations. DESIGN AND METHODS: Case-control study involving 126 consecutive patients (aged 25-80 years, 49% males) and 125 controls of similar age and gender. RESULTS: The patients had a more unfavorable lipid profile than controls [higher triglycerides (p<0.001), LDLc/HDLc ratio (p<0.01) or total cholesterol (TC) (p=0.07)] and higher sVCAM-1 concentration (p<0.01) even adjusting for arterial diseases. VTE was associated with extreme values of TC, LDL-c, triglycerides (>P90) and HDL-c (P90) (OR=4.2)(p<0.0001). The sVCAM-1 values were age-related (r=0.26, p<0.001) but independent of lipid levels. Hazards ratios from five-fold to ten-fold appeared when combining the sVCAM-1 top quartile (>970 ng/mL) with TC >250 mg/dL or HDL-c <45 mg/dL (p<0.01) irrespective of thrombophilic status. Recurrent or severe VTE cases (pulmonary embolism or proximal DVT vs. distal DVT) showed higher sVCAM-1 values (p<0.05). All the associations weakened among females. In stepwise logistic regression, obesity (p<0.001), sVCAM-1 (p<0.001) and LDL-c (p=0.004) in men and sVCAM-1 (p=0.02) and triglycerides (p=0.04) in women retained their independent association. INTERPRETATION AND CONCLUSIONS: Although the exact mechanisms linking abnormal lipid and sVCAM-1 concentrations to VTE await clarification, both seem to be independently associated.

Reducción de concentraciones elevadas de homocisteína con ácido fólico y vitaminas b en pacientes con tromboembolia venosa: relación entre respuesta y genotipo c677t de la metilén tetrahidrofólico reductasa (mthfr) / Lowering high levels of fasting total homocysteine with folic acid and vitamins B in patients with venous thromboembolism: relationship between response and the C677T methylenetetrahydrofolate reductase (MTHFR) genotype

Fundamento: Las concentraciones plasmáticas elevadas de homocisteína total (tHcy) se asocian con enfermedad trombótica arterial o venosa. Dependen principalmente del estado nutricional para el ácido fólico y vitaminas B12 o B6 pero también de la actividad enzimática desarrollada por la metilén tetrahidrofólico reductasa (MTHFR). Evaluamos el grado de respuesta de la hiperhomocisteinemia (HHcy) a un sencillo esquema de suplementación vitamínica respecto al genotipo de MTHFR. Pacientes y métodos: Se seleccionaron 227 pacientes, diagnosticados de tromboembolia venosa (TEV) y que fueron analizados para tHcy (ayunas) y para el polimorfismo genético MTHFR-C677T. Cuando la tHcy excedió el límite normal (varones = 16 y mujeres = 15 µmol/l), los pacientes recibieron el equivalente a 1 mg de ácido fólico, 0,2 mg de vitamina B12 y 100 mg de vitamina B6, diariamente durante 6 semanas. Posteriormente fueron reanalizados y la reducción fue comparada por genotipos MTHFR, buscando cualquier diferencia en el grado de respuesta. Resultados: La tHcy media fue de 12,3 µmol/l (DE = 8). Los 51 pacientes hiperhomocisteinémicos (22 por ciento) tenían edad superior (65,1 años) a los no-HHcy (55,0 años) (p = 0,0001). La cumplimentación del tratamiento fue apropiada en 46 pacientes (90 por ciento). La tHcy media pretratamiento fue de 23,2 µmol/l (DE = 10,5), y se redujo a 13,0 (DE = 5,9), el 42,1 por ciento (p = 0,0001). Por genotipos, los pacientes C/C de 21,0 a 13,2 µmol/l (37 por ciento) (n = 18), los C/T de 25,0 a 12,6 µmol/l (46 por ciento) (n = 24), y los homozigotos anormales T/T de 22,7 a 14,5 µmol/l (39 por ciento) (n = 4), aunque sin evidenciarse diferencias estadísticamente significativas. La respuesta fue completa (normalizándose la tHcy) en el 80 por ciento de los casos (37/46). Se observó una correlación negativa (r = -0.471) (p = 0,005) entre edad y respuesta. Conclusiones: El tratamiento con AF/B6/B12 reduce en forma sencilla, rápida y eficaz (> 40 por ciento en 6 semanas) los valores patológicos de tHcy sin ninguna influencia del genotipo MTHFR. Dado que la HHcy parece relacionarse con las recidivas de trombosis venosa, parece prudente determinar la tHcy sistemáticamente en pacientes con TEV, para intentar su reducción en casos seleccionados (AU)

Background: High levels of plasma total homocysteine (tHcy) are involved in arterial or venous occlusive diseases. It esentially depends on the nutritional status of folic acid (FA) and vitamins B12 or B6, but also on the methylenetetrahydrofolate reductase (MTHFR) enzymatic activity. We aim to evaluate the response of the hyperhomocysteinemia (HHcy) to a standard schedule of vitamin supplementation, according with the MTHFR genotype. Patients and methods: 227 patients, diagnosed with venous thromboembolism (VTE) were analysed for tHcy (in fasting conditions), and for the MTHFR-C677T gene polymorphism. When the tHcy exceeded the cut-off point (men = 16, women = 15 µmol/l), the patients were supplemented with a dose equivalent to 1 mg FA, 0.2 mg B12 and 100 mg of B6, daily by 6 weeks. Afterwards they were reanalysed and the reduction was stratified by MTHFR genotype, looking for any difference in the response. Results: The mean fasting tHcy was 12.3 µmol/l (SD = 8). The 51 hyperhomocysteinemic patients (22%) were older (65.1 y) than the normal ones (55.0 y) (p = 0.0001). The treatment was carried out properly in 46 patients (90%). The pre-treatment mean Hcy was 23.2 (SD = 10.5) µmol/l, and it was reduced to 13.0 (SD = 5.9) (p = 0.0001) (mean reduction = 42.1%). By genotype, the C/C reduced from 21.0 to 13.2 µmol/l (37%) (n = 18), the C/T from 25.0 to 12.6 µmol/l (46%) (n = 24), and the abnormal homozygotes T/T from 22.7 to 14.5 µmol/l (39%) (n = 4), although no statistical significant differences were found. In 80% of cases (37/46), tHcy values normalised. A negative correlation (r = ­0.471) (p = 0.005) was observed between age and response. Conclu sions: The FA/B6/B12 based therapy reduces in a simple, quick and effective way (> 40% in 6 weeks) the pathologic tHcy levels on a VTE population and this is not influenced by the MTHFR genotype. As HHcy seems related with recurrences of venous thrombosis, we could speculate if it would be useful to analyse routinely the tHcy, attempting reduction in selected cases (AU)