Physical Activity in Cerebral Palsy: A Current State Study.

This document analyzes a survey conducted in three geographical areas in Spain, focusing on centers for individuals with cerebral palsy (CP). The study aims to determine the adherence rate to recommended physical activity guidelines, assess if there is a decline in interest in physical activity over time, identify the stage at which this decline occurs, and explore potential mechanisms, tools, or strategies to sustain long-term engagement in regular physical activity for this population. The 36-item questionnaire comprises multiple-choice, open-ended, and Likert scale-type questions. Data were collected on physical activity frequency and duration, daily living activities, and demographics. Statistical analysis identified patterns and relationships between variables. Findings reveal that only a 17.6% meets the World Health Organization (WHO) recommendations regarding regular physical activity (RPA), decreasing in frequency or number of days a week, (3.7 d/w to 2.9 d/w; p < 0.01) and duration (50.5 min/d to 45.2 min/d; p < 0.001) with age, especially for those with higher Gross Motor Function Classification System (GMFCS) mobility levels. Obesity slightly correlates with session duration (ρ = -0.207; p < 0.05), not mobility limitations. Gender has no significant impact on mobility, communication, or physical activity, while age affects variables such as body mass index (BMI) and engagement (p < 0.01). A substantial proportion follows regular physical activities based on health professionals' advice, with interest decreasing with age. To improve adherence, focusing on sports-oriented goals, group sessions, and games is recommended. These findings emphasize the importance of personalized programs, particularly for older individuals and those with greater mobility limitations.

Psychological impact of the COVID-19 pandemic and lockdown in a Spanish sample with anxiety disorder: sex differences.

The early psychological impact of the COVID-19 pandemic and lockdown is greater in people with mental disorders. This study explored the differences in the psychological impact on people with an anxiety disorder by sex in Spain.

Impacto psicológico de la pandemia de COVID-19 y el confinamiento en una muestra española con trastorno de ansiedad: diferencias entre sexos / Psychological impact of the covid-19 pandemic and lockdown in a spanish sample with anxiety disorder: sex differences

Introducción. El impacto psicológico en las etapas iniciales de la pandemia por COVID-19 y el confinamiento fue mayor en personas con trastornos mentales. En este estudio se exploraron las diferencias en el impacto psicológico según el sexo en personas con trastorno de ansiedad en España. Metodología. Estudio transversal, descriptivo y comparativo de los datos aportados por los participantes en una encuesta online anónima realizada entre el 19 y el 26 de marzo de 2020. El cuestionario ad hoc incluyó datos sociodemográficos, clínicos y variables relacionadas con COVID-19,junto con preguntas sobre estrategias de afrontamiento y las versiones en español de la Escala de Escalas de Depresión Ansiedad Estrés (DASS-21) y la Escala de Impacto del Estresor(IES). Se utilizaron análisis descriptivos bivariados y modelos de regresión logística. Resultados. De los 21.207 participantes, se analizaron1617 (7,6%) personas con trastorno de ansiedad autoinformado [1347 (83,3%) mujeres; 270 (16,7%) varones]. El impacto psicológico fue mayor en las mujeres que en los hombres con diferencias estadísticamente significativas en cada subescala del DASS-21 y subescalas del IES. Después de ajustar por posibles variables de confusión, se observó que ser mujer se asoció con puntuaciones más altas en las subescalas de pensamientos intrusivos y evitativos. Conclusiones. Nuestro estudio sugiere que las mujeres con trastorno de ansiedad son un grupo vulnerable a un mayor impacto negativo en la salud mental y, especialmente, en los síntomas relacionados con el trastorno de estrés postraumático. (AU)

Background. The early psychological impact of the COVID-19 pandemic and lockdown is greater in peoplewith mental disorders. This study explored the differences in the psychological impact on people with an anxiety disorder by sex in Spain. Methods. Cross-sectional, descriptive, comparative study of the data provided by participants in an anonymous online survey between March 19 and 26, 2020. Thead hoc questionnaire included sociodemographic, clinical,and variable data related to COVID-19, along with questions about coping strategies, and the Spanish versions ofthe Depression, Anxiety, and Stress Scale (DASS-21) andImpact of Event Scale (IES). Descriptive bivariate analyses and logistic regression models were used. Results. Of the 21,207 participants, 1617 (7.6%) people with self-reported anxiety disorder were analyzed [1347(83.3%) females; 270 (16.7%) males]. The psychological impact was greater on women than men with statistically significant differences in each subscale of the DASS-21and subscales of the IES. After adjusting for potential confounding variables, it was observed that being awoman was associated with higher scores on the intrusiveand avoidant thoughts subscales. Conclusions. Our study suggests that women with ananxiety disorder are a group vulnerable to a greater negative impact on mental health and, especially, symptomsr elated to post-traumatic stress disorder. (AU)

Heartbeat detector from ECG and PPG signals based on wavelet transform and upper envelopes.

The analysis of cardiac activity is one of the most common elements for evaluating the state of a subject, either to control possible health risks, sports performance, stress levels, etc. This activity can be recorded using different techniques, with electrocardiogram and photoplethysmogram being the most common. Both techniques make significantly different waveforms, however the first derivative of the photoplethysmographic data produces a signal structurally similar to the electrocardiogram, so any technique focusing on detecting QRS complexes, and thus heartbeats in electrocardiogram, is potentially applicable to photoplethysmogram. In this paper, we develop a technique based on the wavelet transform and envelopes to detect heartbeats in both electrocardiogram and photoplethysmogram. The wavelet transform is used to enhance QRS complexes with respect to other signal elements, while the envelopes are used as an adaptive threshold to determine their temporal location. We compared our approach with three other techniques using electrocardiogram signals from the Physionet database and photoplethysmographic signals from the DEAP database. Our proposal showed better performances when compared to others. When the electrocardiographic signal was considered, the method had an accuracy greater than 99.94%, a true positive rate of 99.96%, and positive prediction value of 99.76%. When photoplethysmographic signals were investigated, an accuracy greater than 99.27%, a true positive rate of 99.98% and positive prediction value of 99.50% were obtained. These results indicate that our proposal can be adapted better to the recording technology.

Description of allergic phenotype in patients with eosinophilic oesophagitis: management protocol proposal.

There is a profile of patient with eosinophilic oesophagitis and atopic background, marked by the existence of IgE-mediated sensitizations. Our aim is to report the observed sensitivities to environmental and food allergens and panallergens in patients with eosinophilic oesophagitis with atopic background as well as characterizing other markers or analytical parameters. We suspect that the prevalence of sensitization to panallergens will be high and this will probably be relevant in terms of the onset and clinical course of the disease. We collated clinical and analytical data from 160 adult patients with a reported diagnosis of eosinophilic oesophagitis. These patients were studied between 1 January 2012 and 31 December 2020. During an initial visit skin tests were performed with full batteries of routine aero-allergens and foodstuffs. Patients were subsequently referred for blood test and determination of specific IgE, blood count and total IgE (in all cases), as well as eosinophilic cation protein and IMMUNOISAC in the centres in which this was available. We were able to detect a broad spectrum of sensitizations to environmental, foodstuffs and panallergens. The most common allergic disease was rhinoconjuntivitis. The sensitizations observed to foodstuffs were atypical for the adult population and were not responsible for manifestations compatible with immediate allergy. An important percentage of patients presented seasonal worsening of choking symptoms. We should be able to identify patients with eosinophilic oesophagitis and atopic background. Identifying this phenomenon would enable giving dietary and environmental recommendations as well as more specific and effective treatments to our patients.

Landscape genetics reveals contrasting patterns of connectivity in two newt species (Lissotriton montandoni and L. vulgaris).

Ecologically distinct species may respond to landscape changes in different ways. In addition to basic ecological data, the extent of the geographic range has been successfully used as an indicator of species sensitivity to anthropogenic landscapes, with widespread species usually found to be less sensitive compared to range-restricted species. In this study, we investigate connectivity patterns of two closely related but ecologically distinct newt species - the range-restricted, Lissotriton montandoni and the widespread, L. vulgaris - using genomic data, a highly replicated setting (six geographic regions per species), and tools from landscape genetics. Our results show the importance of forest for connectivity in both species, but at the same time suggest differential use of forested habitat, with L. montandoni and L. vulgaris showing the highest connectivity at forest-core and forest-edges, respectively. Anthropogenic landscapes (i.e., higher crop- or urban-cover) increased resistance in both species, but the effect was one to three orders of magnitude stronger in L. montandoni than in L. vulgaris. This result is consistent with a view of L. vulgaris as an ecological generalist. Even so, currently, the negative impact of anthropogenic landscapes is mainly seen in connectivity among L. vulgaris populations, which show significantly stronger isolation and lower effective sizes relative to L. montandoni. Overall, this study emphasizes how habitat destruction is compromising genetic connectivity not only in endemic, range-restricted species of conservation concern but also in widespread generalist species, despite their comparatively lower sensitivity to anthropogenic landscape changes.

Functional Variants in MicroRNAs (rs895819, rs11614913 and rs2910164) Are Associated with Susceptibility and Clinicopathological Features in Mexican Patients with Colorectal Cancer.

BACKGROUND: miRNAs are non-coding RNAs participating actively in the post-translational regulation of oncogenes, tumor suppressor, and DNA repair genes implicated in colorectal cancer (CRC). This study aims to examine the association of the variants miR-27a (rs895819 A>G), miR-196a2 (rs11614913 T>G) and miR-146a (rs2910164 C>G) in Mexican CRC patients. METHODS: DNA samples from 183 patients and 186 healthy Mexican subjects were analyzed. Variants were identified by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) methodology. Association was calculated by the odds ratio (OR) and adjusted by the Bonferroni test. RESULTS: Patients carrying the G/G genotype of the rs895819 variant in the miR-27a gene showed an increased risk of CRC (19% vs 12%, P=0.013). A similar tendency was noticed for patients younger than 50 years carrying A/G (48% vs 41%, P=0.014). The A/G genotype in TNM stages I+II (55.7% vs 40.8%, P=0.011) and tumor location in the colon (69.5 vs 40.8%, P=0.001) were also increased. For the variant rs11614913 of the miR-196a2 gene, carriers of the C/C genotype showed an increased risk of CRC (32% vs 22%, P=0.009). This genotype was more frequent in TNM stage III+IV (36.8% vs 22.5%, P=0.007) and the tumor had a more recurrent location in the rectum (31.6% vs 22.5%, P=0.013). The rs2910164 variant of the miR-146a gene was found to have no significant risk associations. CONCLUSION: Our results reveal that the rs895819 variant in miR-27a and rs11614913 in miR-196a2 have a substantial impact on the development of CRC.

RECK Variants are Associated with Clinicopathological Features and Decreased Susceptibility in Mexican Patients with Colorectal Cancer.

Colorectal cancer (CRC) is the third most common cancer and the second leading cause of death worldwide. Down-regulation of the cysteine-rich reversion-inducing protein with Kazal motifs (RECK) has been confirmed in numerous human cancers and is clinically associated with metastasis. This study aims to explore, for the first time, the possible association of the RECK variants rs11788747 and rs10972727 with CRC susceptibility and clinicopathological features. DNA from 130 CRC patients and 130 healthy blood donors was analyzed. Identification of genetic variants was performed by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) methodology. Association was calculated using the odds ratio (OR) test and P values were adjusted using the Bonferroni test. Individuals carrying the G/G genotype for the rs11788747 variant showed a lower risk of colorectal cancer (OR 0.33; 95% CI 0.16-0.70; P = 0.006). Patients older than 50 years who carry the G/G genotype have a lower risk of CRC (OR 0.26; 95% CI 0.09-0.73; P = 0.019) and of developing advanced tumor-nodule-metastasis (TNM) stages (OR 0.23; 95% CI 0.09-0.54; P = 0.001). Individuals carrying the A/A genotype of the rs10972727 variant also showed decreased risk of CRC (OR 0.38; 95% CI 0.19-0.77; P = 0.011), and were associated with age (over 50 years), sex, advanced TNM stages, and tumor location in the colon. Our results suggest that the RECK variants studied here (rs11788747 and rs10972727) are associated with decreased CRC risk, TNM stages and tumor location.

Impact of the coronavirus outbreak on mental health in the different Spanish regions.

COVID-19 is an infectious disease that has affected millions of people worldwide, Spain being one of the countries most affected by the pandemic. It is key to study its impact on the mental health of the Spanish population during the lockdown situation.

Impacto de la pandemia COVID-19sobre la salud mental en las diferentescomunidades autónomas españolas / Impact of the COVID-19 pandemic on mental health in different countries on mental health in the different Spanish Spanish autonomous communities

Introducción: La COVID-19 es una enfermedad infecciosa que está afectando a millones de personas alrededor delmundo, siendo España uno de los países más afectados porla pandemia. Es fundamental evaluar el impacto en la saludmental de la población española durante el periodo de confinamiento. El objetivo es analizar las respuestas desadaptativas en cada comunidad autónoma durante las dos primerassemanas tras la declaración del estado de alarma en España.Metodología. A través de un cuestionario “online”, serecogieron variables clínicas y sociodemográficas de los participantes del 19 al 26 de marzo. Para estudiar las respuestasdesadaptativas, se utilizaron los cuestionarios DASS-21 y EIE.Resultados. 21.152 personas completaron el cuestionario.La edad media fue 39,75 (DE 14,039) y el 69,6 % eran mujeres.La mayoría de los participantes vivía en Asturias (36,2 %) yCantabria (11,9 %). La respuesta desadaptativa más frecuentede la muestra fueron los síntomas depresivos (46,7 %), seguidadel estrés (33,2 %) y la ansiedad (10,7 %). Los resultados dela DASS-21 desvelaron que en Andalucía [n = 1979 (9,3 %)]se observó un mayor porcentaje en los tres dominios: síntomas depresivos (59,7 %), estrés (41,7 %) y ansiedad (16,2 %).Castilla-La Mancha tuvo el porcentaje más alto de respuestaintrusiva (31,2 %) y Andalucía de respuesta evitativa (55,7 %).Conclusiones. Casi la mitad de la muestra presentórespuestas desadaptativas, siendo los síntomas depresivos yla conducta evitativa las más frecuentes. El impacto sobrela salud mental durante y tras eventos traumáticos de granescala debería de abordarse minuciosamente para minimizarlas respuestas desadaptativas en la población general. (AU)

Introduction: COVID-19 is an infectious disease that hasaffected millions of people worldwide, Spain being one ofthe countries most affected by the pandemic. It is key tostudy its impact on the mental health of the Spanish population during the lockdown situation.The aim is to analyse maladaptive responses in eachautonomous community during the first two weeks afterthe state of emergency was declared in Spain.Material and Methods. Through an online questionnaire, clinical and sociodemographic information was collected from participants between 19 and 26 March 2020. TheDASS-21 and the IES questionnaires were used to evaluatethe maladaptive psychological responses.Results. A total of 21,152 people completed the questionnaire. Mean age was 39.75 (SD 14.039), and 69.6% werewomen. Most of the participants lived in Asturias (36.2%)and Cantabria (11.9%). In the sample as a whole, among themaladaptive responses, depressive symptoms represented thehighest percentage (46.7%), followed by stress (33.2%) andanxiety (10.7%) symptoms. The results of the DASS-21 revealed that a higher proportion of the people from Andalusia[n = 1979 (9.3%))]were affected in all three domains: depressive (59.7%), stress (41.7 %), and anxiety (16.2%) symptoms,Castilla La Mancha had the highest percentage of intrusiveresponse (31.2%), while Andalusia had the highest percentage of avoidance behaviour (55.7%). Conclusions. Almost half of the sample showed maladaptive reactions, depressive symptoms and avoidance behaviour being the most common responses. Repercussionson mental health during and after large-scale traumaticevents should be addressed carefully to minimize maladaptive responses in the general population. (AU)

Genomic Characterization of a Rare, de Novo Unbalanced ins(3;1)(p25.3;q21.3q23.3) in a Female Child with Multiple Congenital Anomalies.

"Simple" 1-way interchromosomal insertions involving an interstitial 1q segment are rare, and therefore, their characterization at the base pair level remains understudied. Here, we describe the genomic characterization of a previously unreported de novo interchromosomal insertion (3;1) entailing an about 12-Mb pure gain of 1q21.3q23.3 that causes typical (microcephaly, developmental delay, and facial dysmorphism) and atypical (interauricular communication, small feet with bilateral deep plantar creases, syndactyly of II-IV toes, and mild pachyonychia of all toes) clinical manifestations associated with this region. Based on our analyses, we hypothesize that the duplication of a subset of morbid genes (including LMNA, USF1, VANGL2, LOR, and POGZ) could account for most clinical findings in our patient. Furthermore, the apparent disruption of a promoter region (between CPNE9 and BRPF1) and a topologically associated domain also suggests likely pathogenic reconfiguration/position effects to contribute to the patient's phenotype. In addition to further expanding the clinical spectrum of proximal 1q duplications and evidencing the phenotypical heterogeneity among similar carriers, our genomic findings and observations suggest that randomness - rather than lethality issues - may account for the paucity of "simple" interchromosomal insertions involving the 1q21.3q23.3 region as genomic donor and distal 3p25.3 as receptor. Moreover, the microhomology sequence found at the insertion breakpoint is consistent with a simple nonhomologous end-joining mechanism, in contrast to a chromothripsis-like event, which has previously been seen in other nonrecurrent insertions. Taken together, the data gathered in this study allowed us to inform this family about the low recurrence risk but not to predict the reproductive prognosis for hypothetical carriers. We highlight that genomic-level assessment is a powerful tool that allows the visualization of the full landscape of sporadic chromosomal injuries and can be used to improve genetic counseling.

Early psychological impact of the 2019 coronavirus disease (COVID-19) pandemic and lockdown in a large Spanish sample.

BACKGROUND: Epidemic outbreaks have significant impact on psychological well-being, increasing psychiatric morbidity among the population. We aimed to describe the early psychological impact of COVID-19 and its contributing factors in a large Spanish sample, globally and according to mental status (never mental disorder NMD, past mental disorder PMD, current mental disorder CMD). METHODS: An online questionnaire was conducted between 19 and 26 March, five days after the official declaration of alarm and the lockdown order. Data included sociodemographic and clinical information and the DASS-21 and IES questionnaires. We analysed 21 207 responses using the appropriate descriptive and univariate tests as well as binary logistic regression to identify psychological risk and protective factors. RESULTS: We found a statistically significant gradient in the psychological impact experienced in five domains according to mental status, with the NMD group being the least affected and the CMD group being the most affected. In the three groups, the depressive response was the most prevalent (NMD = 40.9%, PMD = 51.9%, CMD = 74.4%, F = 1011.459, P < 0.001). Risk factors were female sex and classification as a case in any psychological domain. Protective factors were younger age and ability to enjoy free time. Variables related to COVID-19 had almost no impact except for having COVID-19 symptoms, which was a risk factor for anxiety in all three groups. CONCLUSIONS: Our results can help develop coping strategies addressing modifiable risk and protective factors for each mental status for early implementation in future outbreaks.

Cognitive impairment and C-reactive protein in clinically stable schizophrenia outpatients: a focus on sex differences.

Although previous findings identified an association between C-reactive protein (CRP) levels, and impaired cognitive functions in patients with schizophrenia (SZ), little is currently known about the relationship between inflammation, cognition, and sex in SZ. The current study aimed to explore the association between peripheral inflammation and cognitive impairment in SZ as a function of sex. The sample included 132 clinically stable patients with SZ, of whom 82 were males (62.1%) and 50 females (37.9%). Sociodemographic data were collected, an accurate assessment was performed using the Positive and Negative Syndrome (PANSS), Clinical Assessment Interview for Negative Symptoms (CAINS), and Calgary Depression (CDS) scales, and the MATRICS Consensus Cognitive Battery (MCCB), and CRP levels were tested. A Pearson correlation and multiple regression analyses, including potential confounding factors, were performed. We found an inverse association between CRP levels and performance on visual learning (r = - 0.386, p = 0.006) domain in female patients only, whereas no correlations were found in males. The regression model for women retained age (ß = - 0.319, p = 0.017), the CAINS-MAP score (ß = - 0.247, p = 0.070), and the CRP (ß = - 0.321, p = 0.013) as predictors of visual learning. Our results suggest the possible existence of sex-specific modulation of the association between systemic inflammation and the cognitive features of the illness.

Glutamine and New Pharmacological Targets to Treat Suicidal Ideation.

Glutamate is the major excitatory neurotransmitter in the central nervous system, and it is linked with the amino acid glutamine through a metabolic relationship of enzymatic compound interconversion and transportation, also known as the glutamate-glutamine cycle.A growing body of evidence suggests involvement of the glutamatergic neurotransmitter system in suicidal behaviours. The initial evidence comes from the pathophysiology of neuropsychiatric disorders, as disruptions in glutamate neurotransmission have been found underlying pathology in multiple suicide-related psychiatric conditions such as major depressive disorder, schizophrenia, post-traumatic stress disorder, and bipolar disorder.Existing data from experimental animal models and human in vivo studies also demonstrate that glutamate plays a key role in suicide-related personality traits including aggression and impulsive aggression.Further studies on glutamate system dysfunction underlying suicidal behaviours have focused on the different steps of the glutamate-glutamine cycle: an inflammation-mediated reduction of glutamine synthetase activity has been found in depressed suicide attempters, phosphate-activated glutaminase genes are reduced in suicide completers, and gene expression abnormalities in NMDA receptors have also been discovered in suicide victims.Evidence of a role of the glutamate-glutamine cycle in suicidal behaviours unveils new targets for anti-suicide interventions. Lithium's mechanism to reduce the risk of suicide in people with mood disorders may be related to its ability to increase glutamine synthetase, whereas novel NMDA antagonists such as ketamine [or its S(+) enantiomer esketamine] have already demonstrated positive results in reducing suicidal ideation.

Evaluation of Anti-Cytotoxic and Anti-Genotoxic Effects of Nigella sativa through a Micronucleus Test in BALB/c Mice.

Nigella sativa (N. sativa) is a medicinal plant used for its therapeutic pharmacological effects such as anti-inflammatory, antioxidant, anticancer, antidiabetic, and immunomodulation. This study explored the anti-cytotoxic and anti-genotoxic effect of N. sativa through a micronucleus test (MNT) of BALB/c mice peripheral blood. Using 6-to-8-week-old healthy male BALB/c mice, four groups were formed: (1) Control (sterile water), single-dose 2 mg/kg/intraperitoneal (i.p); (2) N. sativa oil, 500 mg/kg/24 h/7 days/i.p; (3) Cisplatin (CP), single-dose 2 mg/kg/subcutaneous (s.c); (4) N. sativa + CP with their respective dosage. When evaluating polychromatic erythrocytes (PCE), a biomarker of cytotoxicity, the group treated with N. sativa + CP experienced an increase in the frequency of PCE, which demonstrated the recovery of bone marrow and modulation of cell proliferation. The analysis of micronucleated polychromatic erythrocytes (MNPCE), an acute genotoxicity biomarker, showed similar frequency of MNPCE within the groups except in CP, but, in the N. sativa + CP group, the frequency of MNPCE decreased and then regulated. Finally, the frequency of micronucleated erythrocytes (MNE), a biomarker of genotoxicity, the supplementation of N. sativa oil did not induce genotoxic damage in this model. Thus, we conclude that N. sativa has both cytoprotective, genoprotective effects and modulates cell proliferation in BALB/c mice.

Revisión de los diferentes tipos de rellenos periorales y sus aplicaciones en odontología / Review of the different types of perioral fillers and their odontological applications

La aplicación de materiales de relleno como alternativa a las intervenciones quirúrgicas estéticas con el fin de corregir defectos faciales en la piel tales como arrugas o imperfecciones, es una práctica que cada vez es más demandada por los pacientes en el día a día en la consulta. Existen distintos materiales capaces de devolver a la piel ese volumen perdido con los años. Estos, se clasifican en función de su composición y de su duración. El ácido hialurónico es el material de relleno más empleado por los odontólogos al gozar de un gran éxito por ser efectivo y versátil además es un producto seguro, ya que sus posibles complicaciones son mínimas

The application of filling materials as an alternative to aesthetic surgical interventions, in order to correct facial defects in the skin, such as wrinkles or imperfections, is a practice that is increasingly demanded by patients on a day-to-day basis in the practice.There are several materials capable of returning the skin that volume lost over the years. These are classified according to their duration and duration.Hyaluronic acid is the most used filling material for dentists to enjoy great success because it is effective and versatile, it is also a safe product since it is possible to have minimal problems

Reacciones adversas asociadas a la vacuna del meningococo B (4CMenB) en adultos en situaciones especiales / Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations

Objetivo: Conocer el perfil de seguridad de la vacuna del meningococo B (4CMenB) en adultos en situaciones especiales. Método: Estudio prospectivo de seguridad de fase IV. Se aplicaron criterios de inclusión y ciertas condiciones de vacunación. Se recogieron las reacciones adversas descritas en la ficha técnica. La evaluación de las reaccio nes adversas se realizó a las 24 horas de la vacunación ("solicitadas") y durante los siete primeros días ("no solicitadas"). Resultados: Se incluyeron 72 pacientes (54,2% hombres; media de edad 52,5 años; 81,9% asplenia anatómica). La frecuencia de fiebre > 38 ºC en las primeras 24 horas fue mayor de la observada en la ficha técnica para el grupo de adultos (12,5% versus no conocida). Más del 75% de los pacientes refirió dolor local en las primeras horas [media de la puntuación de la Escala Visual Analógica 3,22 (IC95%: 2,67-3,76) en la primera dosis y 3,23 (IC95%: 2,69-3,78) en la segunda dosis]. No hubo diferencias estadísticamente significativas. El 97,22% registró síntomas hasta los siete días postvacunación. Conclusiones: 4CMenB muestra un buen perfil de seguridad en adultos en situaciones especiales. La frecuencia de fiebre > 38 ºC es mayor que la esperada. El dolor local es la reacción adversa más frecuentemente registrada, pero la intensidad es baja. Estos resultados invitan a una revisión de la situación de cara a sugerir una posible modificación de la ficha técnica

Objective: To know the safety profile of the 4CMenB vaccine in adults in special situations. Method: Security prospective study of phase IV. Inclusion criteria and some vaccination conditions were applied. The adverse reactions described in the data sheet were collected. The adverse reactions evaluation was performed 24 hours after vaccination ("requested") and during the first seven days ("not requested"). Results: 72 patients were included (54.2% men, mean age 52.5 years, 81.9% anatomic asplenia). The frequency of fever > 38 ºC in the first 24 hours of vaccination was higher than the observed in the summary of product characteristics for the group of adults (12.5% vs. not known). More than 75% of the patients reported local pain in the first hours [average of the Analog Visual Scale score 3.22 (95% CI: 2.67-3.76) in the 1st dose and 3.23 (95% CI: 2.69-3.78) in the 2nd dose]. There were no statistically significant differences. 97.22% registered symptoms until 7 days after vaccination. Conclusions: 4CMenB shows a good safety profile in adults in special situations. The frequency of fever > 38 ºC is higher than expected. Local pain is the most frequently recorded adverse reactions, but the intensity is low. These results suggest a review of the situation in order to suggest a possible modification of the summary of product characteristics of the vaccine

Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations.

OBJECTIVE: To know the safety profile of the 4CMenB vaccine in adults in special situations. METHOD: Security prospective study of phase IV. Inclusion criteria and some  vaccination conditions were applied. The adverse reactions described in the data  sheet were collected. The adverse reactions evaluation was performed 24 hours  after vaccination ("requested") and during the first seven days ("not  requested"). RESULTS: 72 patients were included (54.2% men, mean age 52.5 years, 81.9%  anatomic asplenia). The frequency of fever > 38 ºC in the first 24 hours of  vaccination was higher than the observed in the summary of product characteristics for the group of adults (12.5% vs. not known). More than 75% of the patients reported local pain in the first hours [average of the Analog Visual Scale score 3.22 (95% CI: 2.67-3.76) in the first dose and 3.23 (95% CI: 2.69-3.78) in the second dose]. There were no statistically significant differences. 97.22% registered symptoms until 7 days  after vaccination. CONCLUSIONS: 4CMenB® shows a good safety profile in adults in special situations. The frequency of fever > 38 ºC is higher than expected. Local  pain is the most frequently recorded adverse reactions, but the intensity is low.  These results suggest a review of the situation in order to suggest a possible  modification of the summary of product characteristics of the vaccine.

Objetivo: Conocer el perfil de seguridad de la vacuna del meningococo B  (4CMenB) en adultos en situaciones especiales.Método: Estudio prospectivo de seguridad de fase IV. Se aplicaron criterios de  inclusión y ciertas condiciones de vacunación. Se recogieron las reacciones adversas descritas en la ficha técnica. La evaluación de las reacciones adversas se realizó a las 24 horas de la vacunación ("solicitadas") y  durante los siete primeros días ("no solicitadas").Resultados: Se incluyeron 72 pacientes (54,2% hombres; media de edad 52,5  años; 81,9% asplenia anatómica). La frecuencia de fiebre > 38 ºC en las  primeras 24 horas fue mayor de la observada en la ficha técnica para el grupo  de adultos (12,5% versus no conocida). Más del 75% de los pacientes refirió  dolor local en las primeras horas [media de la puntuación de la Escala Visual  Analógica 3,22 (IC95%: 2,67-3,76) en la primera dosis y 3,23 (IC95%: 2,69- 3,78) en la segunda dosis]. No hubo diferencias estadísticamente significativas.  El 97,22% registró síntomas hasta los siete días postvacunación.Conclusiones: 4CMenB® muestra un buen perfil de seguridad en adultos en  situaciones especiales. La frecuencia de fiebre > 38 ºC es mayor que la  esperada. El dolor local es la reacción adversa más frecuentemente registrada,  pero la intensidad es baja. Estos resultados invitan a una revisión de la situación  de cara a sugerir una posible modificación de la ficha técnica.

Insulin glargine affects the expression of Igf-1r, Insr, and Igf-1 genes in colon and liver of diabetic rats.

OBJECTIVES: The mitogenic effect of the analogous insulin glargine is currently under debate since several clinical studies have raised the possibility that insulin glargine treatment has a carcinogenic potential in different tissues. This study aimed to evaluate the Igf-1r, Insr, and Igf-1 gene expression in colon and liver of streptozotocin-induced diabetic rats in response to insulin glargine, neutral protamine Hagedorn (NPH) insulin, and metformin treatments. MATERIALS AND METHODS: Male Wistar rats were induced during one week with streptozotocin to develop Type 2 Diabetes (T2D) and then randomly distributed into four groups. T2D rats included in the first group received insulin glargine, the second group received NPH insulin, the third group received metformin; finally, untreated T2D rats were included as the control group. All groups were treated for seven days; after the treatment, tissue samples of liver and colon were obtained. Quantitative PCR (qPCR) was performed to analyze the Igf-1r, Insr and Igf-1 gene expression in each tissue sample. RESULTS: The liver tissue showed overexpression of the Insr and Igf-1r genes (P>0.001) in rats treated with insulin glargine in comparison with the control group. Similar results were observed for the Insr gene (P>0.011) in colonic tissue of rats treated with insulin glargine. CONCLUSION: These observations demonstrate that insulin glargine promote an excess of insulin and IGF-1 receptors in STZ-induced diabetic rats, which could overstimulate the mitogenic signaling pathways.