Background: Severe neurological involvement in systemic lupus erythematosus (NPSLE) is one of the most dreadful complications of the disease. Objective: To identify the best drug, dose, and ...treatment. Patients and methods: The study was a controlled clinical trial at two tertiary care centres of patients with SLE according to the ACR criteria, with incident (no more than 15 days) onset of severe NP manifestations such as seizures, optic neuritis, peripheral or cranial neuropathy, coma, brainstem disease, or transverse myelitis. Induction treatment with 3 g of IV methylprednisolone (MP) followed by either IV monthly cyclophosphamide (Cy) versus IV MP bimonthly every 4 months for 1 year and then IV Cy or IV MP every 3 months for another year. The primary end point was response to treatment: at least 20% improvement from basal conditions on clinical, laboratory, or specific neurological testing variables. Results: Overall, a response rate of 75% was observed. Of the 32 patients studied, 18/19 receiving Cy and 7/13 receiving MP responded to treatment (p<0.03). Conclusions: Cy seems to be more effective than MP in the treatment of acute, severe NPSLE.
Abstract
Background
Few small studies have assessed the efficacy of topical therapy with tacrolimus in patients with ulcerative colitis (UC). The aim of our study was to evaluate its effectiveness ...and safety in a real-world setting.
Methods
A multicenter observational retrospective study at 25 Spanish GETECCU hospitals was performed. Adult patients with UC who received topical tacrolimus from January 2009 to January 2023 were eligible. Inclusion criteria were proctitis, left-sided, or extensive colitis with persistent distal colonic activity confirmed endoscopically during the previous 3 months. Clinical and biochemical data were collected at baseline, week 4, 8 and 54. Tacrolimus trough levels were evaluated in week 4 and 8. Primary outcome was clinical response at week 8, defined as a ≥3 points or ≥30% decrease of partial Mayo score with ≥1point reduction in the bleeding score. Mean partial mayo scores were compared using the t-test. A p<0.05 was considered statistically significant.
Results
106 patients, 59 (55.6%) males, median age 48.7 years (IQR:39.9-59.7), received rectal tacrolimus during a median of 9.7 weeks (IQR:5-18.7). Sixty-four patients (60.4%) received suppositories, 41 (38.7%) enemas and 1 patient an ointment (0.9%). Thirty (28.3%) were patients with proctitis, 45 (42.4%) with left colitis and 31 (29.2%) with extensive colitis. At baseline, 54 patients (50.9%) received concomitant biological/small molecules therapy, while 14 patients received immunomodulators. Most common dose was 2 mg (84%) Q24H (71.7%).
A significant decrease in mean partial mayo score was observed at week 4 and 8 (figure 1). Clinical response at week 8 was achieved in 63 patients (66.3%) and clinical remission in 42 (44.2%). 32 patients (33.7%) were non-responder at week 8. Clinical response and remission at week 4 were achieved in 56 (57.7%) and 33 (34.4%), respectively. Clinical response at week 8 was similar between the group with concomitant biological therapy and without (64.6.9% vs 68.1%, p=0.8). Clinical response at week 8 was similar among different extensions (proctitis: 55.6%; left colitis: 80%; extensive colitis 57.1%; p=0.052). Clinical outcomes are detailed in table 1.
Median tacrolimus trough levels at week 4 was 3.4 ng/ml (IQR 1.5-6.7) and 2.9 ng/ml (IQR 1.5-6) at week 8.
Adverse events were detected in 21 patients (19.8%), Thirteen were graded as mild and 8 moderate. Treatment was ceased due to adverse events in 11 (10.4%) patients.
Conclusion
Topical tacrolimus is effective in UC achieving clinical response in more than sixty percent at week 8 with even lower doses than reported in clinical trials. Adverse events reported in nearly 20% of patients were mostly mild.
Abstract Background and aims The aim of this study is to validate a semi-quantitative Food Frequency Questionnaire (FFQ) used for general population in Spain, in patients with familial ...hypercholesterolaemia (FH). Subjects and Methods Subjects with genetic diagnosis of FH were randomly selected from the Spanish FH Registry. They completed an FFQ based in 113 food items at inclusion (FFQ1) and after 1 year (FFQ2), and a 3-day dietary records (DR) every 3 months. Detailed instruction about how to register foods and beverages was given by a trained nutritionist. Each DR and FFQ was systematically coded, and the daily nutrients intake in absolute, percentage and nutrient density terms were estimated using a software system based on food composition tables. Pearson correlation coefficient was calculated with correction-repeated measurements to assess the reproducibility of both FFQ and the four 3-day DRs, as well as the validity of FFQ comparing to the mean of 3 days’ DR. Results A total of 112 subjects (58 females and 54 males, aged 43 ± 16 years) finished the study. There were no differences between FFQ1, FFQ2 and mean FFQ (FFQa) in mean absolute and percentage values of selected daily nutrients’ intake. Comparison between FFQ1, FFQ2, FFQa and the mean of four 3-day DRs was statistically significant in all absolute values, but not in percentage or nutrient density terms. Corrected Pearson correlation coefficient ranged from 0.470 to 0.952 for mean values of all nutrients, except alcohol. Conclusion This study demonstrated that FFQ is a reliable tool to assess the dietary pattern in FH patients.
Abstract Background: Physical fitness is gaining in importance in all population groups, including elderly, but data are still scarce. The aim of this study was to report gender and age specific ...physical fitness levels in non-institutionalized Spanish elderly. Methods: A representative sample of 3136 elderly (≥65 y), 724 men and 2412 women, from 6 Regions of Spain: Madrid, Aragón, Castilla y León, Castilla-La Mancha, Extremadura and Canarias were assessed in the elderly EXERNET multi-center study between 2008 and 2009. The authors assessed static balance, muscular strength, flexibility, agility, walking speed and cardiorespiratory fitness using eight different fitness tests: one leg balance, chair stand, arm curl, chair sit-and-reach, back scratch, 8-foot up-and-go, 30-m walk, and 6 min walk tests. Results: The authors derived gender and age-specific normative values for physical fitness in the non-institutionalized Spanish elderly. The figures showed greater physical fitness in the elderly men than in women, except for the flexibility test, and a trend toward decreased physical fitness in both genders as their age increased. Conclusions: The normative values hereby provided will enable evaluation and correct interpretation of independent non-institutionalized Spanish elderly fitness status.
Introducción. La enseñanza de la patología médica a través de imágenes es clave para conseguir habilidad clínica en el diagnóstico. Objetivos. Comparar la eficacia docente de un método de enseñanza ...basado en imágenes en un 'entorno no presencial' frente a la enseñanza tradicional en un 'entorno presencial', y evaluar el grado de satisfacción del alumno sobre este método de innovación docente en la enseñanza de la patología médica. Materiales y métodos. El estudio se realizó durante el curso 2005-2006 entre 62 alumnos de Patología médica, de la Facultad de Medicina de Córdoba. Se compararon los dos métodos de enseñanza: el presencial (en cada seminario se expusieron verbalmente 15 imágenes) y el no presencial (imágenes clínicas expuestas en la página web de la Facultad de Medicina con tutorización a través del correo electrónico). La evaluación consistió en la valoración clínica de 16 imágenes (ocho imágenes de cada modelo de enseñanza). Se comparó la puntuación del examen teórico con la de las imágenes clínicas. Tras el examen fi-nal, el alumno realizó un cuestionario de evaluación. Resultados. La calificación media final de las imágenes (sobre 10 puntos) fue de: 6,8 ± 1,5 y la del test (sobre 10 puntos) fue de 7,3 ± 0,9. La calificación media de las imágenes expuestas en la web (7,4 ± 1,6) fue superior a la del modelo presencial (6,3 ± 1,7) p < 0,0001. Existía una correlación entre la puntuación total de la imagen y la del test (r: 0,584, p <0,0001). Asimismo, se correlacionaba la calificación de la imagen del modelo presencial y la de la imagen expuesta en la web (r: 0,697, p < 0,0001). Conclusiones. Las calificaciones de los casos expuestos en la web fueron superiores a las de los casos expuestos en los seminarios presenciales. La enseñanza de la patología médica a través de imágenes clínicas fue un método muy bien considerado por los alumnos.Introduction. The teaching of Internal Medicine through images is the key for the achievement of clinical skills in the diagnosis. Aims. To compare the efficiency of a teaching method based on images in a face-to-face learning situation with the traditional teaching methods, and to evaluate the degree of satisfaction amongst the alumni regarding the new teaching method within the Internal Medicine. Materials and methods. The study was carried out throughout the academic year 2005/06 amongst 62 Internal Medicine students in the School of Medicine in Córdoba. Two teaching methods were compared: (i) face-to-face -15 images were exposed in workshops, and (ii) distance- clinical images were exposed at the School of Medicine web site through a tutorial system based on e-mail. The evaluation consisted in a clinical evaluation of 16 images -8 images for each teaching method. The results from the multiple choice exam and the clinical images exam were also compared. Finally, students answered an assessment questionnaire. Results. The final average qualification -out of 10- for the images was: 6.8 ± 1.5 and for the multiple choice exam -out of 10- was 7.3 ± 0.9. The average qualification was higher for the images exposed at the web site than for the face-to-face model: (7.4 ± 1.6) vs (6.3 ± 1.7) p < 0.0001. There was a correlation between the total punctuation for the images and the examination (r: 0.584, p < 0.0001). Moreover, there was also a correlation between the qualification obtained for the images in the face-to-face method and the images exposed on-line (r: 0.697, p < 0.0001). Conclusions. Qualifications for the cases displayed on the website were higher than those for the cases exposed on the face-to-face workshops. In addition to this, students had a very positive opinion regarding the new teaching method for Internal Medicine based on clinical images.
Introducción. La enseñanza de la patología médica a través de imágenes es clave para conseguir habilidad clínica en el diagnóstico. Objetivos. Comparar la eficacia docente de un método de enseñanza ...basado en imágenes en un ‘entorno no presencial' frente a la enseñanza tradicional en un ‘entorno presencial', y evaluar el grado de satisfacción del alumno sobre este método de innovación docente en la enseñanza de la patología médica. Materiales y métodos. El estudio se realizó durante el curso 2005-2006 entre 62 alumnos de Patología médica, de la Facultad de Medicina de Córdoba. Se compararon los dos métodos de enseñanza: el presencial (en cada seminario se expusieron verbalmente 15 imágenes) y el no presencial (imágenes clínicas expuestas en la página web de la Facultad de Medicina con tutorización a través del correo electrónico). La evaluación consistió en la valoración clínica de 16 imágenes (ocho imágenes de cada modelo de enseñanza). Se comparó la puntuación del examen teórico con la de las imágenes clínicas. Tras el examen fi-nal, el alumno realizó un cuestionario de evaluación. Resultados. La calificación media final de las imágenes (sobre 10 puntos) fue de: 6,8 ± 1,5 y la del test (sobre 10 puntos) fue de 7,3 ± 0,9. La calificación media de las imágenes expuestas en la web (7,4 ± 1,6) fue superior a la del modelo presencial (6,3 ± 1,7) p < 0,0001. Existía una correlación entre la puntuación total de la imagen y la del test (r: 0,584, p <0,0001). Asimismo, se correlacionaba la calificación de la imagen del modelo presencial y la de la imagen expuesta en la web (r: 0,697, p < 0,0001). Conclusiones. Las calificaciones de los casos expuestos en la web fueron superiores a las de los casos expuestos en los seminarios presenciales. La enseñanza de la patología médica a través de imágenes clínicas fue un método muy bien considerado por los alumnos.
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