Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines.

TRIAL DESIGN: An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. METHODS: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. INCLUSION CRITERIA: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)- classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 µg doses (two complete guidelines). The objective of this study was to provide Health workers-staff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix® dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking. RESULTS: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate 0.5 ml doses of Fendrix®, administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first dose of Fendrix®. 57.14% (12 out 21) had a positive response to second dose of Fendrix®. 22.22% (2 out 9) had a positive response to third dose of Fendrix and 42.96% (3 out 7) had a positive response to last dose of Fendrix®. Overall, 94.02% (64 out 67) of participants had a positive response to Fendrix®. No serious adverse event occurred. CONCLUSIONS: The use of Fendrix®, is a viable vaccine alternative for NHS workers classified as "non-responders". Revaccination of healthy non-responders with Fendrix®, resulted in very high proportions of responders without adverse events. TRIAL REGISTRATION: The trial was registered in the Spanish National Trial Register (REEC), ClinicalTrials.gov and inclusion has been stopped (identifier NCT03410953; EudraCT-number 2016-004991-23). FUNDING: GRS 1360/A/16: Call for aid for the financing of research projects in biomedicine, health management and socio-health care to be developed in the centres of the Regional Health Management of Autonomous Community of Castile-Leon. In addition, this work has been supported by the Spanish Platform for Clinical Research and Clinical Trials, SCReN (Spanish Clinical Research Network), funded by the Subdirectorate General for Research Evaluation and Promotion of the Carlos III Health Institute (ISCIII), through the project PT13/0002/0039 and project PT17/0017/0023 integrated in the State Plan for R&D&I 2013-2016 and co-financed by and the European Regional Development Fund (ERDF).

Factors that determine the loss of control when reducing therapy by steps in the treatment of moderate-severe asthma in standard clinical practice: A multicentre Spanish study. / Factores que condicionan la pérdida de control al reducir escalones terapéuticos en el tratamiento del asma moderada-grave en la práctica clínica habitual: estudio español multicéntrico.

BACKGROUND: Although the clinical practice guidelines recommend continuous adjustment of asthma treatment and reducing the maintenance drugs when achieving control (step-down), there are few studies of standard clinical practice aimed at collecting information on the factors that determine step-down failure. OBJECTIVE: To determine the factors that determine step-down failure in standard clinical practice of patients with moderate-severe asthma controlled by a combination of inhaled glucocorticoids and long-acting beta agonists. METHODS: A multicentre retrospective study included 374 patients with moderate-severe asthma controlled with inhaled glucocorticoids and long-acting beta agonists for whom the physician indicated a step-down in 2016. RESULTS: The step-down failed in 41.7% of the patients. The following factors were related to failure: greater patient age (P=.006), presence of at least 2 comorbidities (P=.016), greater severity level (severe persistent vs. moderate persistent) (P<.001), greater age at diagnosis (>40 years) (P=.045), the higher the therapeutic step before (P=.003) and after the change (P<.001), the shorter the time of improvement/control prior to the change (P=.019), lower FEV1 (P=.001) and a poorer Asthma Control Test score or Asthma Control Questionnaire score before the step-down (P<.001). The logistic regression analysis showed a higher probability of step-down failure in the more elderly patients (OR, 0.983; 95% CI 0.969-0.997) and those with severe asthma compared to those with moderate asthma (OR, 0.537; 95% CI 0.292-0.985), as well as an increased probability of success if the patients had the disease controlled for more than 6 months (OR, 2.253; 95% CI 1.235-4.112). CONCLUSION: In standard clinical practice conditions, step-down fails in a high percentage of patients, and the suggestion is to indicate step-down when the patient has had more than 6 months of disease control.

Proyecto "KAIRÓS": monitorización ambulatoria de la presión arterial en farmacia comunitaria. Control y seguimiento de la presión arterial en pacientes hipertensos ancianos tratados / 'KAIRÓS' project: ambulatory monitoring of blood pressure in community pharmacies. Monitoring and follow-up of blood pressure in hypertensive elderly patients under treatment

Objetivos: Conocer, mediante la monitorización ambulatoria de la presión arterial (MAPA) en farmacia comunitaria (FC), el grado de control de la presión arterial (PA) del paciente hipertenso anciano. Identificación del perfil circadiano. Identificación de hipertensión clínica aislada (HCA) e hipertensión enmascarada no controlada (HENC). Métodos: Muestreo consecutivo de los pacientes hipertensos ancianos con tratamiento farmacológico antihipertensivo atendidos en dos FC. Se realizó medida aislada de presión arterial en farmacia comunitaria (MAFC) y MAPA durante un mínimo de 29h a cada paciente. Se envió informe al médico para su valoración. Resultados: 219 pacientes (47,9% mujeres, edad media 71,5±5,4 años). El grado de control con medida con MAFC (74 pacientes) es del 34% y con MAPA (99 pacientes) es del 45%. La prevalencia de patrón circadiano dipper fue del 29,7%. 21 pacientes hipertensos controlados con MAFC (<140/90) (9,6%) tuvieron cifras de PA≥130/80 en MAPA 24h y/o ≥135/85 en MAPA actividad y/o ≥120/70 MAPA nocturna, considerándose pacientes con hipertensión enmascarada no controlada (HENC). 46 pacientes hipertensos no controlados en MAFC (≥140/90) (21%) tuvieron cifras de PA<130/80 en MAPA 24h y <135/85 en MAPA actividad y <120/70 MAPA nocturna, considerándose pacientes con hipertensión clínica aislada (HCA). Conclusiones: El grado de control de la PA de pacientes hipertensos ancianos es mayor cuando se analiza mediante MAPA. Su perfil circadiano es mayoritariamente non dipper. La realización de MAPA en FC permite identificar la HCA y la HENC. La medida islada de PA es insuficiente para optimizar el control de la HTA en estos pacientes

Objectives: Learning, through ambulatory blood pressure monitoring (AMBP) in community pharmacies (CP), the level of blood pressure (BP) monitoring in hypertensive elderly patients. Identification of circadian profile. Identification of isolated clinical hypertension (ICH) and hidden uncontrolled hypertension (HUH). Methods: Consecutive sampling of hypertensive elderly patients with antihypertensive drug treatment attended to at two CPs. Isolated measuring of blood pressure in a community pharmacy (IMCP) and AMBP were conducted over at least 29 hours in each patient. The report was sent to the doctor for evaluation. Results: 219 patients (47.9% females, aged 71.5±5.4 years on average). The level of control with IMCP measurement (74 patients) is 34% and with AMBP (99 patients) is 45%. The prevalence of the dipper circadian rhythm was 29.7%. 21 hypertensive patients controlled with IMCP (<140/90) (9.6%) had BP values of≥130/80 in AMBP 24h, and/or ≥135/85 in AMBP activity and/or ≥120/70 night time AMBP, considering patients with hidden uncontrolled hypertension (HUH). 46 hypertensive uncontrolled patients in IMCP (≥140/90) (21%) had BP values of<130/80 in AMBP 24h and <135/85 in AMBP activity and <120/70 night time AMBP, considering patients with isolated clinical hypertension (ICH). Conclusions: The level of BP control of hypertensive elderly patients is higher when measured with AMBP. Its circadian profile is mostly non dipper. AMBP measurement in CPs allows identification of ICH and HUH. Isolated BP measurements are not sufficient to optimize HBP control in these patients

Algunas consideraciones sobre el infarto cerebral desde otra óptica / Remarks on cerebral infarct from another point of view

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Análisis de recursos asistenciales para el ictus en España en 2012: ¿beneficios de la Estrategia del Ictus del Sistema Nacional de Salud? / Analysis of stroke care resources in Spain in 2012: Have we benefitted from the Spanish Health System’s stroke care strategy?

Introducción: La Estrategia del Ictus del Sistema Nacional de Salud (EISNS) fue un documento de consenso entre las distintas administraciones y sociedades científicas que se desarrolló con el objetivo de mejorar la calidad del proceso asistencial y garantizar la equidad territorial. Nuestro objetivo fue analizar los recursos asistenciales existentes y si se había cumplido el objetivo de la EISNS. Material y métodos: La encuesta sobre los recursos disponibles se realizó por un comité de neurólogos de cada una de las comunidades autónomas (CC.AA), los cuales también realizaron la encuesta de 2008. Los ítems incluidos fueron el número de Unidades de Ictus (UI), su dotación (monitorización, neurólogo 24 h/7 días, ratio enfermería, protocolos), ratio cama UI/100.000 habitantes, recursos diagnósticos (ecografía cardíaca y arterial cerebral, neuroimagen avanzada), realización de trombolisis intravenosa, intervencionismo neurovascular (INV), cirugía del infarto maligno de la arteria cerebral media (ACM) y disponibilidad de la telemedicina. Resultados: Se incluyeron datos de 136 hospitales. Existen 45 UI distribuidas de un modo desigual. La relación cama de UI por habitantes y comunidad autónoma osciló entre 1/74.000 a 1/1.037.000 habitantes, cumpliendo el objetivo solo Cantabria y Navarra. Se realizaron por neurólogos 3.237 trombolisis intravenosas en 83 hospitales, con un porcentaje respecto del total de ictus isquémico entre el 0,3 y el 33,7%. Los hospitales sin UI tenían una disponibilidad variable de recursos. Se realiza INV en todas las CC.AA salvo La Rioja, la disponibilidad del INV 24 h/7 días solo existe en 17 ciudades. Hay 46 centros con cirugía del infarto maligno de la ACM y 5 con telemedicina. Conclusión: La asistencia al ictus ha mejorado en cuanto al incremento de hospitales participantes, la mayor aplicación de trombolisis intravenosa y procedimientos endovasculares, también en la cirugía del infarto maligno de la ACM, pero con insuficiente implantación de UI y de la telemedicina. La disponibilidad de recursos diagnósticos es buena en la mayoría de las UI, e irregular en el resto de hospitales. Las distintas CC.AA deben avanzar para garantizar el mejor tratamiento y equidad territorial, y así conseguir el objetivo de la EISNS

Introduction: The Spanish Health System’s stroke care strategy (EISNS) is a consensus statement that was drawn up by various government bodies and scientific societies with the aim of improving quality throughout the care process and ensuring equality among regions. Our objective is to analyse existing healthcare resources and establish whether they have met EISNS targets. Material and methods: The survey on available resources was conducted by a committee of neurologists representing each of Spain’s regions; the same committee also conducted the survey of 2008. The items included were the number of stroke units (SU), their resources (monitoring, neurologists on call 24 h/7d, nurse ratio, protocols), SU bed ratio/100 000 inhabitants, diagnostic resources (cardiac and cerebral arterial ultrasound, advanced neuroimaging), performing iv thrombolysis, neurovascular interventional radiology (neuro VIR), surgery for malignant middle cerebral artery (MCA) infarctions and telemedicine availability. Results: We included data from 136 hospitals and found 45 Stroke Units distributed unequally among regions. The ratio of SU beds to residents ranged from 1/74,000 to 1/1,037,000 inhabitants; only the regions of Cantabria and Navarre met the target. Neurologists performed 3,237 intravenous thrombolysis procedures in 83 hospitals; thrombolysis procedures compared to the total of ischaemic strokes yielded percentages ranging from 0.3 to 33.7%. Hospitals without SUs showed varying levels of available resources. Neuro VIR is performed in every region except La Rioja, and VIR is only available on a 24 h/7 d basis in 17 cities. Surgery for malignant MCA infarction is performed in 46 hospitals, and 5 have telemedicine. Conclusion: Stroke care has improved in terms of numbers of participating hospitals, the increased use of intravenous thrombolysis and endovascular procedures, and surgery for malignant MCA infarction. Implementation of SUs and telemedicine remain insufficient. The availability of diagnostic resources is good in most SUs and irregular in other hospitals. Regional governments should strive to ensure better care and territorial equality, which would achieve the EISNS objectives

Metrorragia disfuncional como primer síntoma de carcinoma de mama / Dysfunctional bleeding as the first symptom of breast carcinoma

Durante el periodo que denominamos perimenopausia en una mujer, con frecuencia se presentan alteraciones menstruales que consideramos dentro de la normalidad, no realizando estudios complementarios en la mayoría de las ocasiones y pautando tratamientos sintomáticos, si los precisa, hasta llegar el cese de la función ovárica. Presentamos un caso donde este tratamiento pautado tal vez intervino en el retraso diagnóstico del problema principal, el cáncer de mama lobulillar bilateral que, como primer síntoma, metastatizó en el endometrio provocando una metrorragia de difícil (AU)

During perimenopause, menstrual alterations are often considered within the normal range, and complementary studies are not usually performed. Symptomatic treatment is provided, if required, until cessation of ovarian function. We present the case of a woman in whom symptomatic treatment may have contributed to the delay in diagnosis of the main problem, bilateral lobular cancer, which presented as endometrial metastases, provoking difficult-to-control metrorrhagia (AU)

Analysis of stroke care resources in Spain in 2012: have we benefitted from the Spanish Health System's stroke care strategy?

INTRODUCTION: The Spanish Health System's stroke care strategy (EISNS) is a consensus statement that was drawn up by various government bodies and scientific societies with the aim of improving quality throughout the care process and ensuring equality among regions. Our objective is to analyse existing healthcare resources and establish whether they have met EISNS targets. MATERIAL AND METHODS: The survey on available resources was conducted by a committee of neurologists representing each of Spain's regions; the same committee also conducted the survey of 2008. The items included were the number of stroke units (SU), their resources (monitoring, neurologists on call 24h/7d, nurse ratio, protocols), SU bed ratio/100,000 inhabitants, diagnostic resources (cardiac and cerebral arterial ultrasound, advanced neuroimaging), performing iv thrombolysis, neurovascular interventional radiology (neuro VIR), surgery for malignant middle cerebral artery (MCA) infarctions and telemedicine availability. RESULTS: We included data from 136 hospitals and found 45 Stroke Units distributed unequally among regions. The ratio of SU beds to residents ranged from 1/74,000 to 1/1,037,000 inhabitants; only the regions of Cantabria and Navarre met the target. Neurologists performed 3,237 intravenous thrombolysis procedures in 83 hospitals; thrombolysis procedures compared to the total of ischaemic strokes yielded percentages ranging from 0.3 to 33.7%. Hospitals without SUs showed varying levels of available resources. Neuro VIR is performed in every region except La Rioja, and VIR is only available on a 24h/7 d basis in 17 cities. Surgery for malignant MCA infarction is performed in 46 hospitals, and 5 have telemedicine. CONCLUSION: Stroke care has improved in terms of numbers of participating hospitals, the increased use of intravenous thrombolysis and endovascular procedures, and surgery for malignant MCA infarction. Implementation of SUs and telemedicine remain insufficient. The availability of diagnostic resources is good in most SUs and irregular in other hospitals. Regional governments should strive to ensure better care and territorial equality, which would achieve the EISNS objectives.

Síndrome SUNCT secundario a dolicomegabasilar / SUNCT syndrome secondary to megadolichobasilar anomaly

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Tratamiento endoscópico con selladores biológicos de fístulas esofágicas residuales tras cirugía del síndrome de Boerhaave / Endoscopical treatment with biological glue of esophageal fistula after surgery in Boerhaave syndrome

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