La enseñanza de la Radiología en otros estudios universitarios / The teaching of Radiology in other university studies

Tras la implantación del Espacio Europeo de Formación Superior, los contenidos del Área de Radiología y Medicina Física que se impartían tradicionalmente en la Licenciatura de Medicina se han incorporado también a los nuevos grados de Odontología, Enfermería, Fisioterapia, Podología y, en menor medida, Farmacia, Terapia Ocupacional, Logopedia, e Ingeniería Biomédica. En su conjunto, los conceptos básicos de radiología y protección radiológica se imparten en Murcia en 5 grados diferentes con un total de 52,5 créditos ECTS, participando en la formación de 1219 alumnos cada curso académico. Esta incorporación en los nuevos grados ha triplicado el número de asignaturas en las que se imparte docencia pregrado, y duplicado tanto el número de créditos ECTS como el número de alumnos de pregrado a los que dirige su labor de formación. Así, ante la posible creación de nuevos grados universitarios en un futuro próximo (Imagen para el Diagnóstico y Técnico en Radioterapia) sería necesaria la implicación de un mayor número de profesionales acreditados, de diferentes especialidades, y que optimicen los recursos docentes (bibliografía, material docente, casos clínicos, etc.) para su utilidad en las diferentes asignaturas que comparten contenidos similares.(AU)

After the implementation of the European Space for Higher Education, the contents of the Radiology and Physical Medicine Area that were taught in the Medicine Degree have also been incorporated into the new degrees of Dentistry, Nursing, Physiotherapy, Podiatry, and, to a lesser extent, Pharmacy, Occupational Therapy, Logopedia, and Biomedical Engineering As a whole, the basic concepts of radiology and radiological protection are taught in Murcia in 5 different degrees with a total of 52.5 ECTS credits, participating in the training of 1,219 students each academic year. This incorporation in the new degrees has tripled the number of subjects in which undergraduate teaching is taught, and doubled both the number of ECTS credits and the number of undergraduate students to whom it directs its training work. Thus, given the possible creation of new university degrees in the near future (Diagnostic Imaging and Radiotherapy Technicians), it would be necessary to involve a greater number of accredited professionals, from different specialties, and to optimize teaching resources (bibliography, material teacher, clinical cases, etc.) for its usefulness in the different subjects that share similar contents.(AU)

The teaching of Radiology in other university studies.

After the implementation of the European Space for Higher Education, the contents of the Radiology and Physical Medicine Area that were taught in the Medicine Degree have also been incorporated into the new degrees of Dentistry, Nursing, Physiotherapy, Podiatry, and, to a lesser extent, Pharmacy, Occupational Therapy, Logopedia, and Biomedical Engineering As a whole, the basic concepts of radiology and radiological protection are taught in Murcia in 5 different degrees with a total of 52.5 ECTS credits, participating in the training of 1219 students each academic year. This incorporation in the new degrees has tripled the number of subjects in which undergraduate teaching is taught, and doubled both the number of ECTS credits and the number of undergraduate students to whom it directs its training work. Thus, given the possible creation of new university degrees in the near future (Diagnostic Imaging and Radiotherapy Technicians), it would be necessary to involve a greater number of accredited professionals, from different specialties, and to optimize teaching resources (bibliography, material teacher, clinical cases, etc.,) for its usefulness in the different subjects that share similar contents.

Healthcare contacts with self-harm during COVID-19: An e-cohort whole-population-based study using individual-level linked routine electronic health records in Wales, UK, 2016-March 2021.

INTRODUCTION: Reduced rates of help seeking by those who self-harmed during the COVID-19 pandemic have been reported. OBJECTIVES: To understand changes in healthcare service contacts for self-harm during the COVID-19 pandemic across primary, emergency and secondary care. METHODS: This retrospective cohort study used routine electronic healthcare data for Wales, United Kingdom, from 2016 to March 14, 2021. Population-based data from primary care, emergency departments and hospital admissions were linked at individual-level. All Welsh residents aged ≥10 years over the study period were included in the study. Primary, emergency and secondary care contacts with self-harm at any time between 2016 and March 14, 2021 were identified. Outcomes were counts, incidence, prevalence and proportion of self-harm contacts relative to all contacts in each and all settings, as well as the proportion of people contacting one or more settings with self-harm. Weekly trends were modelled using generalised estimated equations, with differences between 2020 (to March 2021) and comparison years 2016-2018 (to March 2017-2019) quantified using difference in differences, from which mean rate of odds ratios (µROR) across years was reported. RESULTS: The study included 3,552,210 individuals over the study period. Self-harm contacts reduced across services in March and December 2020 compared to previous years. Primary care contacts with self-harm reduced disproportionately compared to non-self-harm contacts (µROR = 0.7, p<0.05), while their proportion increased in emergency departments during April 2020 (µROR = 1.3, p<0.05 in 2/3 comparison years) and hospital admissions during April-May 2020 (µROR = 1.2, p<0.05 in 2/3 comparison years). Despite this, those who self-harmed in April 2020 were more likely to be seen in primary care than other settings compared to previous years (µROR = 1.2, p<0.05). A lower proportion of those with self-harm contacts in emergency departments were subsequently admitted to hospital in December 2020 compared to previous years (µROR = 0.5, p<0.05). CONCLUSIONS: These findings suggest that those who self-harmed during the COVID-19 pandemic may have been less likely to seek help, and those who did so faced more stringent criteria for admission. Communications encouraging those who self-harm to seek help during pandemics may be beneficial. However, this needs to be supported by maintained provision of mental health services.

Enseñando en la universidad a gestionar las emociones y a establecer el vínculo terapéutico con el paciente / University teaching in how to manage emotions and establish a therapeutic bond with the patient

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Conocimiento de la estimulación prenatal en los programas de educación maternal en Atención Primaria por parte de las mujeres gestantes / Pregnant women's knowledge of prenatal stimulation in educational programs for pregnant women in primary care

Objetivo: Estudiar el grado de conocimiento sobre la estimulación prenatal y los beneficios que se obtienen de esta en mujeres embarazadas de dos Centros de Salud de Talavera de la Reina (Toledo). Diseño del estudio: Estudio observacional transversal. Emplazamiento: Centros de Salud urbanos de Talavera de la Reina, Toledo. (C.S. La Solana y C.S. La Algodonera). Participantes: 26 mujeres gestantes (edad media de 30,92 años y 7,23 meses de gestación). Mediciones principales: Mediante muestreo consecutivo se seleccionaron gestantes del programa de preparación al parto que respondieron un cuestionario elaborado 'ad hoc' acerca del conocimiento y beneficios de la estimulación prenatal o intrauterina. También se recogieron variables sociodemográficas. Resultados: El 53,8 % (IC 95 %: 33,3-73,4) de las mujeres gestantes no había escuchado hablar de la estimulación prenatal ni conoce de la importancia de esta. Un 96,2 % (IC 95 %: 80,3-99,9) de las madres gestantes no sabe de la existencia de ningún centro especializado o centro de salud en el que se realice esta práctica. Al 76,9 % (IC 95 %: 56,3-91) de las mujeres gestantes no le han explicado lo que es la estimulación prenatal ni los beneficios, sin embargo el 96,2 % (IC 95 %: 80,3-99,9) de embarazadas cree que la estimulación prenatal ofrece beneficios a su futuro hijo/a. Conclusiones: Existe un alto porcentaje de mujeres que desconoce lo que es la estimulación prenatal, su importancia y los centros donde esta se realiza, así como una falta de información por parte de las matronas sobre la estimulación prenatal y sus beneficios (AU)

Objective: Study the level of knowledge about prenatal stimulation and its benefits of pregnant women in two primary health care centres in Talavera de la Reina (Toledo). Study Design: Observational cross-sectional study. Location: Primary health care urban centres in Talavera de la Reina, Toledo (CHC La Solana and CHC La Algodonera). Participants: 26 pregnant women with an average age of 30.92. Gestational age was 7.23 months. Main measurements: Consecutive sampling of pregnant women attending the preparation for childbirth program, who answered a questionnaire prepared 'ad hoc' about knowledge and benefits of prenatal or intrauterine stimulation. Socio-demographic variables were also collected. Results: 53.8% (CI 95%: 33.3-73.4) of pregnant women had not heard about prenatal stimulation and do not know its importance. 96.2% (CI 95%: 80.3-99.9) of pregnant mothers do not know any specialized centre or health care centre in which this practice is carried out. 76.9% (CI 95%: 56.3-91) of pregnant women have not been told about prenatal stimulation or its benefits. However, 96.2% (CI 95%: 80.3-99.9) of pregnant women believe that prenatal stimulation offers benefits to their unborn children. Conclusions: There is a high percentage of women who are ignorant of what prenatal stimulation is, its importance and the centres where it is carried out, as well as a lack of explanation of prenatal stimulation and its benefits by midwives (AU)

Mental disorder prevalence and associated risk factors in three prisons of Spain.

AIMS: To determine the lifetime and monthly prevalence of people with mental disorders and its association with sociodemographic factors and criminal risk in three Spanish prisons (Ocaña, Madrid I, II and VI). METHOD: Cross-sectional epidemiological study of a sample of 184 inmates. Socio-demographic and criminal data were collected by an ad hoc interview. Mental disorders were assessed with the clinical version of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Axis I Disorders (SCID-I). RESULTS: Life prevalence of mental disorders was 90.2%. The most common mental disorders and substance abuse or dependence was 72.3%, followed by mood disorder (38.5%) and psychotic disorders (34.2%). Moreover, the prevalence of any mental disorder in the last month was 52.2%. The main psychotic disorder (20.7%) was followed by substance abuse or dependence (18.5%), and mood disorder state (13%). A socio-demographic profile as a risk for each disorder was found. DISCUSSION: The prevalence of people with mental disorders is very high in Spanish prisons, and is associated with a distinct demographic profile. It is essential to continue researching this reality, translating the results into therapeutic and preventive action adapted to the status of inmates to reduce social inequalities in this high priority public health situation.

La adhesión terapéutica desde la vinculación emocional. La técnica U / No disponible

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Molecular analysis of community-acquired methicillin-susceptible and resistant Staphylococcus aureus isolates recovered from bacteraemic and osteomyelitis infections in children from Tunisia.

Thirty-six children (27 boys, nine girls) that fulfilled CDC criteria for community-acquired infections were diagnosed with bacteraemia and/or osteomyelitis caused by Staphylococcus aureus during an 18-month period (2006-2008). Antibiotic susceptibility was determined by an agar dilution method. SCCmec type, carriage of pvl genes, agr type and spa-typing were determined using specific PCR protocols. Clonal relatedness was examined by pulsed field gel electrophoresis-SmaI and mutilocus sequence typing techniques. From the 36 isolates, eight (22%) corresponded to methicillin-resistant Staphylococcus aureus (MRSA) -t044/042-CC80/CC5-IVc-pvl(+) -agrIII/II. The highest genetic diversity was observed among the 28 community-acquired methicillin-susceptible S. aureus (CA-MSSA) isolates: 22 spa-variants that also grouped by multilocus sequence typing in CC1, CC5, CC6, CC8, CC30, CC80, CC97 and the singletons ST464, ST1467, ST1468 and ST1469. The pvl genes were detected in all eight CA-MRSA isolates and in eight CA-MSSA isolates (28%), being significantly more frequent among isolates causing osteoarticular infection (11 of 12, 92%) than in the bacteraemic isolates (six of 24, 25%). Based on patients' age, three groups were considered: newborns, infants and children. Bacteraemia was diagnosed in all newborns and infants, whereas in 42% of the children group osteomyelitis was the unique presentation. In most cases, the portal of entry was either the skin or unknown. In general, favourable outcome was observed, except in four cases-three of whom had severe complications and one died. In summary, we analysed the epidemiological and genetic background of community-acquired staphylococcal strains causing bacteraemic and/or osteomyelitis infections in children from Tunisia, describing three new sequence types and one novel spa type.

Ingeniería tisular del tejido óseo. Diseño y desarrollo de materiales híbridos biológicamente activos basados en vitrocerámicas para sustitución ósea / Bone tissue engineering. Design and development of biologically active vitroceramic-based hybrid materials to be used as bone substitutes

Objetivo: Describir el desarrollo y caracterización de un material vitrocerámico y la respuesta inicial de células madre mesenquimales adultas (MSC-A) aisladas de la medula ósea. Material y metodología: El material se obtuvo por calentamiento de un vidrio 55SiO2-41CaO-4P2O5 (mol/%) por el método sol-gel. Las células se aislaron por aspirados directos de cresta ilíaca de pacientes adultos jóvenes. Se estudió el grado de adherencia, proliferación y diferenciación a osteoblastos de las MSC-A sembradas sobre el material. La diferenciación celular se evaluó mediante la producción de osteocalcina y la pérdida del marcador mesenquimal CD90. La proliferación celular sobre el sustrato se realizó mediante el ensayo de reducción de sales de tetrazolio. El material sembrado se implantó en un defecto crítico realizado en fémur de conejo para valorar su capacidad osteorregeneradora, y se observó mediante TAC. Resultados: Las MSC-A se adhirieron, expandieron, proliferaron y produjeron matriz extracelular mineralizada sobre el material durante el tiempo en cultivo, al mismo tiempo que mostraron fenotipo osteoblástico, e incrementaron la producción de osteocalcina y la pérdida de expresión de CD90. El material se reabsorbió parcialmente al final del estudio. Conclusión: El material es citocompatible, osteoconductor, bioactivo, con capacidad de promover la diferenciación de MSC-A a osteoblastos y la neoformación ósea después de su implantación en asociación con MSC-A; es una matriz adecuada para la regeneración del tejido óseo (AU)

Purpose: To describe the development and characterization of a vitroceramic material as well as the initial response of adult mesenchymal stem (MSCs-A) isolated from bone marrow. Material and methodology: The material was obtained by heating glass with composition in mol% 55SiO2-41CaO-4P2O5 by a sol gel method. Cells were isolated from direct iliac crest aspirates from young adult patients. An analysis was performed of the degree of adhesion, proliferation and osteoblastic differentiation of MSCs-A seeded onto the material. Cell differentiation was evaluated through the production of osteocalcin and the loss of the CD90 mesenchymal marker. Cell proliferation on the substrate was performed using the tetrazolium salt reduction method. The seeded material was implanted in a critical defect caused in a rabbit femur in order to determine its osteogenerating capacity; CT observations were carried out. Results: MSCs-A se bound to the material, expanded, proliferated and produced mineralized extracellular matrix on the material during the culture period. At the same time, they showed an osteoblastic phenotype, increasing osteocalcin production and losing CD90 expression. The material was partially resorbed at the end of the study. Conclusion: The material is cytocompatible, osteoconductive, bioactive and has a capacity to promote osteoblastic differentiation of MSCs-A as well as new bone formation following its implantation in association with MSCs-A; an appropriate matrix for bone tissue regeneration (AU)

Contribución de un programa de calidad asistencial al desarrollo de un Instituto de Gestión Clínica del Aparato Locomotor / Contribution of a Healthcare Quality Program to the Development of an Institute for the Clinical Management of the Musculoskeletal System

En el año 1999 se constituye en el Hospital Clínic de Barcelona, el Instituto del Aparato Locomotor (ICAL), agrupación organizativa de los Servicios de Cirugía Ortopédica y Traumatología, Reumatología y Rehabilitación. Al mismo tiempo, y con el objetivo de asegurar la calidad de este proceso de cambio, se diseñó un programa de calidad específico, en el que se definían objetivos de mejora a conseguir en un año natural y se monitorizaban una serie de indicadores de calidad, tanto técnica como percibida. Los resultados de estos últimos 5 años nos indican que se ha observado unamejora en la mayoría de indicadores (exceptuando los relativos a las infecciones quirúrgicas y las altas voluntarias), contribuyendo a la consolidación y el reconocimiento de este proyecto innovador en el Instituto de Gestión Asistencial de las Enfermedades del Aparato Locomotor, que sitúa al enfermo en el epicentro de la organización y a los médicos como auténticos gestores del mismo

In 1999, the Institute for the Musculoskeletal System (ICAL) was established in Barcelona’s Hospital Clínic as an institution entrusted with the organization of the orthopedic and trauma surgery, rheumatology and rehabilitation services offered by theHospital. At the same time, with a view to making sure that the change was as smooth as possible, a specific quality assurance scheme was implemented, whereby a series of improvements were identified as necessary, which had to be made within one calendar year, and a series of both technical and perceived quality indicators were identified for monitoring.The results obtained in the last five years show that there has been an improvement in most of the indicators (except those related to surgical infections and voluntary discharges), contributing to the strengthening and the prestige of this innovative Institute devoted to the management of musculoskeletal conditions,which makes the patient the focus of the healthcare effort and the physician the mainstay of clinical management

Safety and immunogenicity of a combined hepatitis B virus-Haemophilus influenzae type B vaccine comprising a synthetic antigen in healthy adults.

The combined HB-Hib vaccine candidate Hebervac HB-Hib (CIGB, La Habana), comprising recombinant HBsAg and tetanus toxoid conjugate synthetic PRP antigens has shown to be highly immunogenic in animal models. A phase I open, controlled, randomized clinical trial was carried out to assess the safety and immunogenicity profile of this bivalent vaccine in 25 healthy adults who were positive for antibody to HBsAg (anti-HBs). The trial was performed according to Good Clinical Practices and Guidelines. Volunteers were randomly allocated to receive the combined vaccine or simultaneous administration of HB vaccine Heberbiovac-HB and Hib vaccine QuimiHib (CIGB, La Habana). All individuals were intramuscularly immunized with a unique dose of 10 microg HBsAg plus 10 microg conjugated synthetic PRP. Adverse events were actively recorded after vaccine administration. Total anti-HBs and IgG anti-PRP antibody titers were evaluated using commercial ELISA kits at baseline and 30 days post-vaccination. The combined vaccine candidate was safe and well tolerated. The most common adverse reactions were local pain, febricula, fever and local erythema. These reactions were all mild in intensity and resolved without medical treatment. Adverse events were mostly reported during the first 6-72 hours post-vaccination. There were no serious adverse events during the study. No severe or unexpected events were either recorded during the trial. The combined vaccine elicited an anti-HBs and anti-PRP booster response in 100% of subjects at day 30 of the immunization schedule. Anti-HBs and anti-PRP antibody levels had at least a two-fold increase compared to baseline sera. Even more, anti-HBs antibody titer showed a four-fold increase in 100% of volunteers in the study group. The results indicate that the combined HB-Hib vaccine produces increased antibody levels in healthy adults who have previously been exposed to these two antigens. To our knowledge, this is the first demonstration of safety and immunogenicity for a combined vaccine comprising recombinant HBV and synthetic Hib antigens. The present results support phase I-II clinical trial in the target population, two months old healthy infants.

Spanish dental hygienist attitudes to dental radiological protection: assessment of a 1-day pilot course.

OBJECTIVES: To determine hygienists' knowledge of and attitudes to X-ray equipment and film processing, and to assess both after a 1-day course. STUDY POPULATION: One-hundred and four dental hygienists from the south-east of Spain attending a 1-day course in oral radiology. METHODOLOGY: A questionnaire comprising different sections related with socio-demographic items, X-ray equipment and the processing of dental films was answered before and after a 1-day pilot course on radiation protection. RESULTS: The response rate was 89.42% (n = 93). Of the participants 94.6% were women, with a mean age of 29.52 (SD 6.861) and 7.20 years of professional experience (SD 5.089). The level of knowledge before the course was 48.28%, which increased to 85.62% after the course (P < 0.001). CONCLUSIONS: The prescribed standard was reached by <23.65% of those attending the course at the beginning. Although attending the course led to a considerable improvement, it did not always result in a high level of knowledge of basic radiation equipment and processing.

Recidiva de vasculitis en trasplante renal tratada con rituximab / The recurrence of the vasculitis in the renal transplant treatment with rituximab

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[Acute renal failure in the transretinoic syndrome]. / Insuficiencia renal aguda en el síndrome de ácido-transretinoico.

UNLABELLED: The all-trans retinoic acid (ATRA) is the treatment of first line of acute promyelocytic leukemia (APL). ATRA is usually well tolerated, but a few major side effects can be observed, ATRA syndrome (RAS) being the most important of them, potentially fatal. The manifestations of this Syndrome are fever, weight gain, pulmonary infiltrates, pleural or pericardial effusions, hypotension, liver dysfunction and renal failure. MATERIAL AND METHODS: We studied to the 29 patients diagnosed in (January of 2002 - December of 2004) of acute promyelocytic leukemia (APL), which were treated with ATRA, all received the 45 dose of mg/m(2)/d . The diagnosis of the leukemia was made by citomorphologist analysis. The criterion of renal insufficiency, it was an increase of the creatinina superior to 20% of the basal level. The definition of the transretinoico acid Syndrome was based on the clinical criteria of Frankel. RESULTS: Fourteen patients presented the Transretinoico Syndrome (48.3%), 11 of which (37.9%) died. The fundamental differences between the patients with or without ATRA were: fever (14 vs. 9, p=0,017), gain of weight (14 vs 0, p=0,000), pleural effusion (14 vs 2, p=0.000), pulmonary infiltrates (13 vs 1, p=0,000), cardiac failure (12 versus 2, p=0,000), respiratory distress (12 versus 4, p=0,003), presence of renal failure (10 vs 4, p=0,02), necessity of substitute renal treatment (6 vs 0, p=0,006) and arterial hypotension (12 vs. 3, p=0,001). The acute renal failure appeared in 10 of the 14 patients with SAR (71.4%), to 12+/-5 (1-25) days of the beginning of the treatment and their duration it was of 14+/-5 (1-46) days. Six (60%) needed substitute renal treatment and 5 (50%) died. Of the patients who survived, only a patient continues in dialysis. In both patient in that renal biopsy was made, the study showed signs of cortical necrosis. CONCLUSIONS: The appearance of acute renal failure in the course of the SAR is frequent, being observed deterioration of the renal function that needs substitute renal treatment in more than half the cases. The association of RAS with renal failure entails the high mortality (50%). The diagnosis and the precocious restoration of suitable the preventive measures and therapeutic are very important to avoid in possible the this serious complication of the treatment with ATRA.

Insuficiencia renal aguda en el síndrome de ácido-transretinoico / Acute renal failure in the transretinoic syndrome

El ácido transretinoico es el tratamiento de primera línea de la Leucemia Promielocítica Aguda. Habitualmente es bien tolerado, pero puede tener efectos secundarios, de los cuales el más grave es el Síndrome de Ácido Transretinoico, potencialmente fatal. Las manifestaciones de este Síndrome son fiebre, ganancia de peso, infiltrados pulmonares, derrame pleural o pericárdico, hipotensión, insuficiencia hepática e insuficiencia renal. Material y métodos: Se estudiaron 29 pacientes diagnosticados en los últimos 3 años (enero de 2002-diciembre de 2004) de Leucemia Promielocítica Aguda que fueron tratados con ácido transretinoico a dosis de 45 mg/m2/día. El diagnóstico de la leucemia se realizó por análisis citomorfológico. La insuficiencia renal aguda (IRA) se definió como un incremento de la creatinina superior al 20% del nivel basal y el Síndrome de Ácido Transretinoico (SAR) por los criterios de Frankel. Resultados: Catorce pacientes presentaron el Síndrome Transretinoico (48,3%), 11 de los cuales fallecieron (37,9%). Las diferencias fundamentales entre los pacientes con o sin ATRA fueron: fiebre (14 vs 9, p = 0,017), ganancia de peso (14 vs 0, p = 0,000), derrame pleural (14 vs 2, p = 0,000), presencia de infiltrados pulmonares (13 vs 1, p = 0,000), insuficiencia cardiaca (12 vs 2, p = 0,000), distress respiratorio (12 vs 4, p = 0,003), presencia de IRA (10 vs. 4, p=0,02), necesidad de tratamiento renal sustitutivo (6 vs 0, p = 0,006) e hipotensión arterial (12 vs 3, p = 0,001). La insuficiencia renal se produjo en 10 de los 14 pacientes con SAR (71,4%), a los 12 ± 5 (1-25) días del comienzo del tratamiento y su duración media fue de 14 ± 5 (1-46) días. Seis (60%) necesitaron tratamiento renal sustitutivo y 5 (50%) fallecieron. De los pacientes que sobrevivieron, sólo un paciente continúa en diálisis. En los dos pacientes en los que se realizó biopsia renal, el estudio histológico mostró signos de necrosis cortical. Conclusiones: La aparición de insuficiencia renal en el transcurso del SAR es frecuente, precisando tratamiento renal sustitutivo en más de la mitad de los casos. La asociación de SAR con IRA conlleva una alta mortalidad. El diagnóstico y la instauración precoz de las medidas preventivas y terapéuticas adecuadas son muy importantes para evitar en lo posible esta grave complicación del tratamiento con ATRA

The all-trans retinoic acid (ATRA) is the treatment of first line of acute promyelocytic leukemia (APL). ATRA is usually well tolerated, but a few major side effects can be observed, ATRA syndrome (RAS) being the most important of them, potentially fatal. The manifestations of this Syndrome are fever, weight gain, pulmonary infiltrates, pleural or pericardial effusions, hypotension, liver dysfunction and renal failure. Material and methods: We studied to the 29 patients diagnosed in (january of 2002-december of 2004) of acute promyelocytic leukemia (APL), which were treated with ATRA, all received the 45 dose of mg/m2/d. The diagnosis of the leukemia was made by citomorphologist analysis. The criterion of renal insufficiency, it was an increase of the creatinina superior to 20% of the basal level. The definition of the transretinoico acid Syndrome was based on the clinical criteria of Frankel. Results: Fourteen patients presented the Transretinoico Syndrome (48.3%), 11 of which (37.9%) died. The fundamental differences between the patients with or without ATRA were: fever (14 vs 9, p=0,017), gain of weight (14 vs 0, p = 0,000), pleural effusion (14 vs 2, p = 0.000), pulmonary infiltrates (13 vs 1, p = 0,000), cardiac failure (12 vs 2, p = 0,000), respiratory distress (12 vs 4, p = 0,003), presence of renal failure (10 vs 4, p = 0,02), necessity of substitute renal treatment (6 vs 0, p = 0,006) and arterial hypotension (12 vs 3, p = 0,001). The acute renal failure appeared in 10 of the 14 patients with SAR (71.4%), to 12 ± 5 (1-25) days of the beginning of the treatment and their duration it was of 14 ± 5 (1-46) days. Six (60%) needed substitute renal treatment and 5 (50%) died. Of the patients who survived, only a patient continues in dialysis. In both patient in that renal biopsy was made, the study showed signs of cortical necrosis. Conclusions: The appearance of acute renal failure in the course of the SAR is frequent, being observed deterioration of the renal function that needs substitute renal treatment in more than half the cases. The association of RAS with renal failure entails the high mortality (50%). The diagnosis and the precocious restoration of suitable the preventive measures and therapeutic are very important to avoid in possible the this serious complication of the treatment with ATRA

Phase I clinical trial in healthy adults of a nasal vaccine candidate containing recombinant hepatitis B surface and core antigens.

BACKGROUND: The nasal vaccine candidate (NASVAC), comprising hepatitis B virus (HBV) surface (HBsAg) and core antigens (HBcAg), has been shown to be highly immunogenic in animal models. METHODS: A phase I double-blinded, placebo-controlled randomized clinical trial was carried out in 19 healthy male adults with no serologic markers of immunity/infection to HBV. This study was aimed at exploring the safety and immunogenic profile of nasal co-administration of both HBV recombinant antigens. The trial was performed according to Good Clinical Practice guidelines. Participants ranged in age from 18 to 45 years and were randomly allocated to receive a mixture of 50 microg HBsAg and 50 microg HBcAg or 0.9% physiologic saline solution, as a placebo, via nasal spray in a five-dose schedule at 0, 7, 15, 30, and 60 days. A total volume of 0.5 ml was administered in two dosages of 125 microl per nostril. Adverse events were actively recorded 1 h, 6 h, 12 h, 24 h, 48 h, 72 h, 7 days and 30 days after each dose. Anti-HBs and anti-HBc titers were evaluated using corresponding ELISA kits at days 30 and 90. RESULTS: The vaccine candidate was safe and well tolerated. Adverse reactions included sneezing (34.1%), rhinorrhea (12.2%), nasal stuffiness (9.8%), palate itching (9.8%), headache (9.8%), and general malaise (7.3%). These reactions were all self-limiting and mild in intensity. No severe or unexpected events were recorded during the trial. The vaccine elicited anti-HBc seroconversion in 100% of subjects as early as day 30 of the immunization schedule, while a seroprotective anti-HBs titer (>or=10 IU/l) was at a maximum at day 90 (75%). All subjects in the placebo group remained seronegative during the trial. CONCLUSION: The HBsAg-HBcAg vaccine candidate was safe, well tolerated and immunogenic in this phase I study in healthy adults. To our knowledge, this is the first demonstration of safety and immunogenicity for a nasal vaccine candidate comprising HBV antigens.

Transdermal transport of India ink by electromagnetic electroporation in Guinea pigs: an ultrastructural study.

Transdermic administration by electroporation has developed over recent years for applying drugs in a variety of pathological processes. However, mechanisms are still not finally settled. India ink was applied to the backs of guinea pigs and for the transdermic transport short, high-voltage pulses (TDES, Dencort Dell) were administrated. Punch biopsies (4 mm) immediately taken after 24, 48, 72, 96 and at 26 days were studied by light and electronic microscopy. The ultrastructural characteristics and image pigment particles were reported. Particles of India ink were observed in the stratum corneum and in the epidermic keratinocytes of samples studied immediately after treatment. Particles were also seen in the epidermic and folicular keratinocytes, and in the papillary and reticular dermis (among collagen fibers, vessel walls, and macrophages) in all the subsequent biopsies; but not in the controls, which were conducted with electromagnetic waves alone. No tissue alterations were observed. The efficacy and noninvasive nature of electroporation for the transdermic administration of macromolecules is confirmed.

A bioactive sol-gel glass implant for in vivo gentamicin release. Experimental model in Rabbit.

Biomaterial pieces with osteogenic properties, suitable for use in the treatment of bone defects, were synthesized. The materials, which avoid bone infections, are exclusively composed of gentamicin sulfate and bioactive SiO2-CaO-P2O5 sol-gel glass (synthesized previously), and were manufactured by means of uniaxial and isostatic pressure of the mixed components. After implanting the pieces into rabbit femur, we studied (1) antibiotic release, determining the concentration in proximal and distal bone, liver, kidney, and lung as a function of time, and (2) bone growth as a consequence of the glass reactivity in the biological environment. The results demonstrated that the implants are good carriers for local gentamicin release into the local osseous tissue, where they show excellent biocompatibility and bone integration. Moreover, these implants are able to promote bone growth during the resorption process.