Abstinencia a corto plazo y seguridad de citisina. Un estudio multicéntrico y observacional en España / [Short-term withdrawal and safety of cytisine. A multicenter and observational study in Spain]

Introducción y objetivos. Citisina es un fármaco empleado para la cesación tabáquica recientemente comercializado en nuestro país. El objetivo de este estudio es analizar la abstinencia a corto plazo y la seguridad en la práctica clínica diaria en población sana y con comorbilidades. Material y métodos . Estudio observacional, descriptivo y multicéntrico realizado en un centro de saludde Atención Primaria y dos Unidades de Tabaquismo de hospitales de tercer nivel. Se realiza una búsqueda en la base de datos de Tabaquismo para identificar pacientes fumadores tratados con citisina. Se analizan las características basales de los fumadores, la abstinencia mantenida al mes y a los 3 meses, así como el porcentaje de eventos adversos y el tipo de los mismos. Resultados. Un 81,5% de los pacientes se mantienen sin fumar durante el primer mes desde el inicio del tratamiento y un 61% a los 3 meses. En los pacientes con comorbilidades significativas, los porcentajes de abstinencia al mes y a los 3 meses son los siguientes: en EPOC 73% y 56,6% respectivamente, en enfermedad cardiovascular 63,5% y 42,1%, en enfermedad psiquiátrica 71% y 57,1%, y en neoplasias 66% y 55%. Solo un 7,7% presentaban efectos adversos al fármaco. Conclusiones. Citisina es una opción terapéutica efectiva a corto plazo y segura. (AU)

Introduction and objectives. Cytisine is a drug used for smoking cessation recently marketed in our country. The aim of this study is to analyze short-term abstinence and safety in daily clinical practice in healthy population and with comorbidities. Material and methods. Observational, descriptive and multicenter study carried out in a primary care health center and two smoking cessation units of third level hospitals. A search was performed in the Smoking database to identify smoking patients treated with cytisine. We analyzed the baseline characteristics of the smokers, the abstinence maintained at 1 and 3 months, as well as the percentage of adverse events and their type. Results. 81.5% of patients remained smoke-free during the first month after starting treatment and 61% at 3 months. In patients with significant comorbidities, the abstinence percentages at 1 month and 3 months were as follows: In COPD 73% and 56.6% respectively, in cardiovascular disease 63.5% and 42.1%, in psychiatric disease 71% and 57.1% and in neoplasms 66% and 55%. Only 7.7% presented adverse effects to the drug. Conclusions. Cytisine is an effective short-term and safe therapeutic option. (AU)

Análisis de las fases del rescate acuático como elemento discriminativo del rendimiento / Analysis of the phases of lifesaving as a discriminative element of performance

Purpose: The aim of this study was to analyze the different phases of a water rescue, their influence in the whole lifesavingand if lifeguards could be differentiated according to their abilities during a water rescue.Methods: A cross-sectional study was carried out to analyze the different phases and lifeguard’sabilities of a simulated water rescue of 100 m. Thirty-fourprofessional lifeguards performed the test and the time was recorded for the first phase (swimming to the victim), the second phase (towing back the victim) and the third phase (extracting the victim). A discriminant analysis was conducted in order to classifylifeguards in two groups (high or medium level of abilities during the water rescue) and the times were compared on each phase.Results: The time during the second and the third phase classify correctly the lifeguards according to their level of abilities. Lifeguards with higher level of abilities performed the water rescue significantly faster, specifically during the second (p < 0.001, ES =1.38, large) and the third phase (p =0.002, ES = 1.09, medium), but no differences were found in the first part of the water rescue (p > 0.05). Conclusion: The time of a simulated water rescue seems to bea good method to classify lifeguards according to their abilities. These findings could allow rescue teams to know the skills of their lifeguards and design strategiesin order to decrease risks and enhance lifesaving (AU)

Objetivo: Analizar las diferentes fases del rescate para conocer su influencia sobre el resultado final y categorizar a los socorristas de acuerdo a su competencia acuática.Métodos: Se realizó un estudio cruzado simulando un rescate a 100 metros con 34 socorristas, analizando las tres fases del rescate: nado hacia la víctima, traslado a tierra y extracción. Se realizó un análisis discriminante para clasificar a los socorristas según el tiempo de rescate.Resultados: La segunda y la tercera fase clasificó correctamente a los socorristas de acuerdo al tiempo empleado. La mayor competencia fue determinada especialmente en la segunda fase del salvamento (p<0,001, TE=1,38, grande) y en menor medida de la tercera fase (p=0,002, TE=1,09, mediano).Conclusión: El tiempo empleado en la segunda fase parece ser un buen método para clasificar la competencia de los socorristas durante el rescate. Estos hallazgos proporcionan información relevante para el entrenamiento y organización de equipos de rescate (AU)

Evaluación de los comparadores empleados en los estudios pivotales de nuevos medicamentos e indicaciones / Assessment of comparators used in pivotal studies of new medicines and indications

Objetivo: En algunos casos, los estudios pivotales para aprobar nuevos medicamentos no emplean el comparador más adecuado. El objetivo es cuantificar este problema analizando los Informes de Posicionamiento Terapéutico (IPT) publicados por el Ministerio de Sanidad español.Métodos: El comparador se clasificó en seis categorías según la adecuación del tratamiento, es decir, si coincidía con el estándar de tratamiento al ser autorizado: A-“inicialmente adecuado”, B-“sin comparador por causa ética”, C-“sin comparador excluyendo los clasificados en B”, D-“inadecuado” y E-“parcialmente subóptimo” (cuando era estándar solo para parte de los pacientes).La variable principal fue la proporción de nuevos fármacos/indicaciones con comparación suficiente (categorías A, B y C) o deficiente (el resto). La información sobre comparadores y tratamiento estándar se extrajo del IPT. Resultados: Se analizaron aleatoriamente 186 IPT con nuevos medicamentos/indicaciones, publicados entre 2013 y 2022. La comparación se consideró suficiente en un 73,7% (IC95 66,9-79,5) de los casos. El 26,3% restante (IC95 20,5-33,1) presentaba comparaciones deficientes en el ensayo pivotal, ya fuera por comparador inadecuado (11,3%), parcialmente subóptimo (5,4%) o ausencia de un estudio comparativo (9,7%). No hubo diferencias en relación con el año de aprobación.Conclusiones: Aproximadamente uno de cada cuatro nuevos medicamentos o indicaciones carece de una comparación suficiente en el momento de empezar a ser utilizado en la práctica clínica. La proporción no mejora a lo largo de los últimos 10 años. Las agencias reguladoras deben ser más exigentes en la selección del comparador para los ensayos clínicos pivotales, por cuestiones éticas y sanitarias. (AU)

Objective: Pivotal studies to approve new medicines often do not use the most appropriate comparator. The objective is to quantify this problem by analysing the Therapeutic Positioning Reports (IPT for its acronym in Spanish) published by the Spanish Health Ministry.Methods: The comparator was classified into six categories, based on the appropriateness of the treatment, i.e. whether it matched the standard of treatment when authorised: A-«initially adequate» (at the start of the study), B-«no comparator for ethical reasons», C-«no comparator -excluding B-«, D-«inadequate» and E-«partially suboptimal» (when it was standard for part of the included patients but not for all of them).The primary endpoint was the proportion of new drugs/indications with sufficient (categories A, B and C) or poor comparator (the rest). Information on comparators and standard treatment was extracted from the IPT. Results: We randomly analysed 186 IPTs with new drugs or indications, published between 2013 and March 2022. Comparability was assessed as sufficient in 73.7% (95%CI 66.9-79.5) of cases. The remaining 26.3% (95%CI 20.5-33.1) had poor comparisons in the pivotal trial, either due to inadequate comparator (11.3%), partially suboptimal (5.4%) or absence of a comparative study excluding ethical justification (9.7%). Conclusions: Approximately one in four new medicines or indications lacks sufficient comparability at the time of entry into clinical practice. The proportion has not improved over the last 10 years. Regulatory agencies need to be more stringent in comparator selection for pivotal clinical trials, for ethical and health reasons. (AU)

Cerebral Phospho-Tau Acts Synergistically with Soluble Aß42 Leading to Mild Cognitive Impairment in AAV-AD Rats.

BACKGROUND: Alzheimer's disease (AD) is a continuum of events beginning with an increase in brain soluble Aß42 followed by the appearance of hyperphosphorylated tau (P-tau, asymptomatic stage). Mild Cognitive Impairment (MCI) then appears (prodromal stage). However, the individual contribution of these two soluble proteins in the onset of the first cognitive symptoms remains unclear. OBJECTIVES: We sought to understand the specific impact of p-tau on the development of MCI in the AAV-AD rat model, a model of late-onset Alzheimer's disease (LOAD) predementia. METHODS: We specifically reduced the phosphorylation level of tau while leaving Aß42 levels unchanged using a DYRK1A protein kinase inhibitor, Leucettine L41, in an adeno-associated virus-based Alzheimer's disease (AAV-AD) rat model. Leucettine L41 was administered by intraperitoneal injection at 20 mg/kg per day in AAV-AD rats from 9 (late asymptomatic phase) to 10 (prodromal phase) months of age. RESULTS: Decreased soluble forms of P-tau induced by chronic administration of Leucettine L41 did not change soluble Aß42 levels but prevented MCI onset in 10-month-old AAV-AD rats. CONCLUSIONS: The present study argues that P-tau is required to induce the development of MCI. Consistent with our previous findings that soluble Aß42 is also required for MCI onset, the data obtained in the AAV-AD rat model confirm that the transition from the asymptomatic to the prodromal stage may be caused by the combined presence of both soluble brain forms of Aß42 and p-tau, suggesting that the development of MCI may be the consequence of their synergistic action.

Efficacy of early use of remdesivir: a systematic review of subgroup analysis.

OBJECTIVE: A possible benefit has been suggested for early treatment of severe coronavirus disease 2019 (COVID-19) with remdesivir. The efficacy of this drug is controversial and could significantly influence the efficiency in healthcare systems. The objective is the methodological interpretation of subgroup analyzes according to starting of remdesivir treatment with respect to symptom onset of COVID-19. METHODS: A search in Pubmed® database was performed. Randomized clinical trials (RCTs) with subgroup analysis regarding early and late use of remdesivir were selected. All endpoints were assessed using two methodologies. First methodology considered statistical interaction, pre-specification, biological plausibility, and consistency of results. Second methodology was a validated tool with preliminary questions to discard subset analysis without relevant minimum conditions, and a checklist with recommendations for applicability. RESULTS: A total of 54 results were found and five RCTs were selected. According first methodology, consistent heterogeneity was only found in time to clinical improvement and better clinical status score at day 15 for patients with severe COVID-19 and <7 days of symptoms. About second methodology, these results about early use of remdesivir may be applied to clinical practice with caution. CONCLUSIONS: We developed a systematic search and application of an established methodology for interpretation of subgroup analysis about early use of remdesivir. Results in severe COVID-19 suggested that early use of remdesivir provides a greater benefit in <7 days of symptoms for time to clinical improvement and better clinical status score at day 15. Future studies could use 7-day cut-off of symptoms to evaluate remdesivir.

Management of anticoagulation in pregnant women with venous thromboembolism: An international survey of clinical practice.

INTRODUCTION: Venous thromboembolism (VTE) is an important cause of maternal morbidity and mortality. During pregnancy, VTE is treated with low-molecular-weight-heparin (LMWH). Studies assessing the optimal duration and peripartum management of therapeutic anticoagulation are lacking. This survey aimed to assess clinician practices for the management of anticoagulation in pregnant women with acute VTE. METHODS: An electronic survey consisting of clinical scenarios addressing anticoagulation management for VTE in pregnancy was created. The target sample was clinicians likely to be involved in the management of pregnant women with acute VTE. The survey completion rate and proportion of individuals selecting a response were determined. RESULTS: 96 respondents completed the survey including general internists (56.3%), hematologists (21.9%), and obstetricians (6.3%). In the management of a VTE in first or second trimester, most respondents preferred therapeutic LMWH until 6 weeks postpartum. In the first and second trimester, 48.0% and 37.5% of respondents, respectively, opted to reduce the dose of anticoagulation after 3 or 6 months. 29.2% of physicians opted for bridging with intravenous heparin around delivery when treating a VTE in the third trimester. 73.0% perceived an increased risk of clinically relevant non-major bleeding associated with the use of therapeutic anticoagulation in the peripartum and postpartum periods. CONCLUSIONS: The survey highlights a wide variability of practice in the management of therapeutic anticoagulation in pregnancy. Larger scale studies with relevant clinical outcomes including thrombosis and bleeding risks are needed to inform clinical practice.

Organizing pneumonia.

Organizing pneumonia is a nonspecific pathologic pattern of response to lung damage. It can be idiopathic, or it can occur secondary to various medical processes, most commonly infections, connective tissue disease, and pharmacological toxicity. Although there is no strict definition of the pattern of organising pneumonia as in other idiopathic interstitial pneumonias, the characteristic pattern of this disease could be considered to include patchy consolidations and ground-glass opacities in the peribronchial and subpleural areas of both lungs. Moreover, studies of the course of the disease show that these lesions respond to treatment with corticoids, migrate with or without treatment, and tend to recur when treatment is decreased or withdrawn. Other manifestations of organising pneumonia include nodules of different sizes and shapes, solitary masses, nodules with the reverse halo sign, a perilobular pattern, and parenchymal bands.

Complicaciones hemorrágicas de la nefrolitotomía percutánea: valor del tratamiento endovascular precoz / Hemorrhagic complicationes after percutaneous nephrolithotomy: The importance of an early endovascular management

Introducción y objetivos: La hemorragia secundaria a la fístula arteriovenosa (FAV) o al pseudoaneurisma (PA) es una complicación poco frecuente de la nefrolitotomía percutánea (NLPC). El objetivo de este estudio es evaluar las complicaciones hemorrágicas (CH) tras la NLPC y los resultados del tratamiento endovascular.Materiales y métodosEntre mayo de 2009 y diciembre de 2019 se realizaron en nuestro centro 1.335 NLPC por litiasis renal. Analizamos la incidencia de CH tempranas y tardías, el tratamiento administrado, la necesidad de embolización posterior y los datos clínicos y analíticos de los pacientes.ResultadosUn total de 59 (4,4%) pacientes presentaron CH, y todos fueron tratados con arteriografía y embolización selectiva (AES) para controlar el sangrado. Se observó hematoma perirrenal en 38 pacientes (64%).En cuanto a los hallazgos angiográficos, hubo 32 (54%) PA, 8 (14%) FAV, 4 (7%) extravasaciones por laceración vascular y 15 (25%) PA combinadas con FAV. En un caso, fueron necesarios 3 procedimientos para controlar la hemorragia. En 30 pacientes (51%) no se requirió transfusión de sangre, mientras que en 29 (49%) se transfundió una media de 1,3 unidades. La mediana de seguimiento fue de 24±21 meses.El intervalo de tiempo medio entre la NLPC y la AES fue de 7,3±4,9 días. Un total de 24 (41%) pacientes reingresaron tras el alta debido a una CH tardía que requería AES. La demora entre el reingreso y la AES fue de 4,8±4,6horas de media.ConclusiónLas CH tempranas y tardías tras la NLPC pueden ser mayores. El tratamiento con AES tras la detección precoz es un método efectivo y mínimamente invasivo que evita múltiples transfusiones de sangre, en muchos casos insuficientes. (AU)

Introduction and objectives: Hemorrhage due to arteriovenous fistula (AVF) or pseudoaneurysm (PA) is a rare complication after percutaneous nephrolithotomy (PCNL). The objective of this study is to evaluate hemorrhagic complications (HC) after PCNL and the results of their endovascular treatment.Materials and methodsBetween May 2009 and December 2019, 1335 PCNL were performed in our center for kidney stone disease. We analyzed the incidence of early and late HC, their management, the need for subsequent embolization, as well as clinical and analytical data of these patients.ResultsA total of 59 (4.4%) patients presented HC. Bleeding was managed with arteriography and selective embolization (ASE). Perirenal hematoma was seen in 38 patients (64%).Regarding angiographic findings, there were 32 (54%) PA, 8 (14%) AVF, 4 (7%) extravasations due to vascular laceration and 15 (25%) PA combined with AVF. In one case, 3 procedures were required to control the bleeding. In 30 patients (51%) blood transfusions were not necessary, while in 29 (49%), a mean of 1.3 units were transfused. Median follow-up was 24±21 months.Mean time interval between PCNL and ASE was 7.3±4.9 days. A total of 24 (41%) patients were readmitted after discharge due to late HC requiring ASE. Delay between readmission and ASE was 4.8±4.6hours in average.ConclusionEarly and late HC after PCNL can be severe. Rapid identification and treatment with ASE is an effective and minimally invasive and avoids multiple blood transfusions which in many cases constitute an insufficient treatment. (AU)

Hemorrhagic complicationes after percutaneous nephrolithotomy: The importance of an early endovascular management.

INTRODUCTION AND OBJECTIVES: Hemorrhage due to arteriovenous fistula (AVF) or pseudoaneurysm (PA) is a rare complication after percutaneous nephrolithotomy (PCNL). The objective of this study is to evaluate hemorrhagic complications (HC) after PCNL and the results of their endovascular treatment. MATERIALS AND METHODS: Between May 2009 and December 2019, 1335 PCNL were performed in our center for kidney stone disease. We analyzed the incidence of early and late HC, their management, the need for subsequent embolization, as well as clinical and analytical data of these patients. RESULTS: A total of 59 (4.4%) patients presented HC. Bleeding was managed with arteriography and selective embolization (ASE). Perirenal hematoma was seen in 38 patients (64%). Regarding angiographic findings, there were 32 (54%) PA, 8 (14%) AVF, 4 (7%) extravasations due to vascular laceration and 15 (25%) PA combined with AVF. In one case, 3 procedures were required to control the bleeding. In 30 patients (51%) blood transfusions were not necessary, while in 29 (49%), a mean of 1.3 units were transfused. Median follow-up was 24 ±â€¯21 months. Mean time interval between PCNL and ASE was 7.3 ±â€¯4.9 days. A total of 24 (41%) patients were readmitted after discharge due to late HC requiring ASE. Delay between readmission and ASE was 4.8 ±â€¯4.6 h in average. CONCLUSION: Early and late HC after PCNL can be severe. Rapid identification and treatment with ASE is an effective and minimally invasive and avoids multiple blood transfusions which in many cases constitute an insufficient treatment.

Hemorrhagic complicationes after percutaneous nephrolithotomy: The importance of an early endovascular management. / Complicaciones hemorrágicas de la nefrolitotomía percutánea: valor del tratamiento endovascular precoz.

INTRODUCTION AND OBJECTIVES: Hemorrhage due to arteriovenous fistula (AVF) or pseudoaneurysm (PA) is a rare complication after percutaneous nephrolithotomy (PCNL). The objective of this study is to evaluate hemorrhagic complications (HC) after PCNL and the results of their endovascular treatment. MATERIALS AND METHODS: Between May 2009 and December 2019, 1335 PCNL were performed in our center for kidney stone disease. We analyzed the incidence of early and late HC, their management, the need for subsequent embolization, as well as clinical and analytical data of these patients. RESULTS: A total of 59 (4.4%) patients presented HC. Bleeding was managed with arteriography and selective embolization (ASE). Perirenal hematoma was seen in 38 patients (64%). Regarding angiographic findings, there were 32 (54%) PA, 8 (14%) AVF, 4 (7%) extravasations due to vascular laceration and 15 (25%) PA combined with AVF. In one case, 3 procedures were required to control the bleeding. In 30 patients (51%) blood transfusions were not necessary, while in 29 (49%), a mean of 1.3 units were transfused. Median follow-up was 24±21 months. Mean time interval between PCNL and ASE was 7.3±4.9 days. A total of 24 (41%) patients were readmitted after discharge due to late HC requiring ASE. Delay between readmission and ASE was 4.8±4.6hours in average. CONCLUSION: Early and late HC after PCNL can be severe. Rapid identification and treatment with ASE is an effective and minimally invasive and avoids multiple blood transfusions which in many cases constitute an insufficient treatment.

Posterior pelvic tilt evolution in patients undergoing total hip arthroplasty. A minimum 5-years follow-up clinico-radiological study. / Evolución de la inclinación pélvica a lo largo del tiempo en pacientes intervenidos de prótesis total de cadera. Estudio clínico-radiológico con un seguimiento mínimo de cinco años.

BACKGROUND AND OBJECTIVE: Pelvic tilt influences the relative position between total hip arthroplasty (THA) components. Changes in lumbar spine over time may affect clinical and radiological outcomes of THA during follow-up. We assessed the evolution of pelvic tilt and cup position after THA for a minimum follow-up of five years and the possible appearance of complications. MATERIAL AND METHODS: This retrospective study includes 48 patients operated between 2008 and 2012. Clinical data, complication and radiological analysis included sacro-femoral-pubic and acetabular abduction angles on the anteroposterior pelvic view; and cup anteversion angle on the lateral cross-table hip view according to Woo and Morrey. All assessments were done pre-operatively and at 6 weeks, one, two and five years post-operatively. RESULTS: Mean sacro-femoral-pubic decreased from 60.6∘ preoperatively to 58.8∘ at five years (p > .05), more in females (from 63.3 to 59.3) than males (58.7 to 58.3). Acetabular abduction increased from 47.3 at six-week postoperatively to 48.2 at five years (p > .05) and acetabular anteversion varied from 24.3∘ to 36.1∘ (p < .04). There were four dislocations: one late recurrent dislocation which required cup revision. CONCLUSION: Despite the sacro-femoral-pubic angle tendency to decrease and anteversion tendency to increase after five years, larger studies with longer follow-up are needed to confirm the potential increasing in long term complications.

Consideraciones de seguridad en la prescripción de medicamentos antiinflamatorios no esteroideos (AINEs), a través de una revisión de revisiones sistemáticas / Safety considerations during prescription of non-steroidal anti-inflammatory drugs (NSAIDs), through a review of systematic reviews

Los medicamentos antiinflamatorios no esteroideos (AI-NEs) se encuentran entre los medicamentos más consu-midos mundialmente. Esto hace necesario realizar unasíntesis amplia de la evidencia disponible sobre la pres-cripción segura y adecuada de AINEs en pacientes conenfermedad cardiovascular, enfermedad renal crónica,hipertensión, insuficiencia cardíaca o cirrosis hepáticay en población general. Para ello se ha realizado unarevisión de revisiones sistemáticas. El uso de AINEs seasoció a una probabilidad significativamente mayor dehepatotoxicidad y daño renal y un mayor riesgo de exa-cerbación de la insuficiencia cardíaca. Teniendo en cuen-ta el aumento del riesgo cardiovascular, hepático y renal,la prescripción de AINEs debe realizarse con cautela,considerando la duración del tratamiento y la situacióndel paciente. Por ello, se debe informar a los pacientessobre sus posibles consecuencias para la salud así comogarantizar un seguimiento adecuado de los mismos.(AU)

Non-steroidal anti-inflammatory drugs (NSAIDs) areamong the most widely used drugs worldwide. Thismakes it necessary to carry out a comprehensivesynthesis of the available evidence on the safe andadequate prescription of NSAIDs in patients with car-diovascular disease, chronic kidney disease, hyper-tension, heart failure or liver cirrhosis and in generalpopulation. For this, a review of systematic reviewswas carried out. The use of NSAIDs is associated witha significantly higher probability of hepatotoxicity andkidney damage, as well as increased risk of exacerba-tion of heart failure. Taking into account the increasedcardiovascular, liver and kidney risk, the prescription ofNSAIDs should be carried out with caution, consideringthe treatment duration and the patient’s situation. Forthis reason, patients should be informed about theirpossible health consequences as well as ensuring ade-quate monitoring of them.(AU)

Safety considerations during prescription of non-steroidal anti-inflammatory drugs (NSAIDs), through a review of systematic reviews.

Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used drugs worldwide. This makes it necessary to carry out a comprehensive synthesis of the available evidence on the safe and adequate prescription of NSAIDs in patients with cardiovascular disease, chronic kidney disease, hypertension, heart failure or liver cirrhosis and in general population. For this, a review of systematic reviews was carried out. Data extraction and analysis were performed independently by two reviewers and a narrative synthesis of the results was carried out. The use of NSAIDs is associated with a significantly higher probability of hepatotoxicity and kidney damage, as well as increased risk of exacerbation of heart failure. Taking into account the increased cardiovascular, liver and kidney risk, the prescription of NSAIDs should be carried out with caution, considering the treatment duration and the patient's situation. For this reason, patients should be informed about their possible health consequences as well as ensuring adequate monitoring of them.

Association between xerostomia, oral and general health, and obesity in adults. A cross-sectional pilot study.

BACKGROUND: The objective of this study was to analyse the association between oral and general health variables and obesity indicators with the sensation of dry mouth or xerostomia as evaluated on the Xerostomia Inventory (XI). MATERIAL AND METHODS: A total of 354 randomly selected subjects participated in this cross-sectional pilot study and completed an anonymous questionnaire. Anthropometric, clinical, and xerostomic variables were evaluated. Kruskal-Wallis, ANOVA and Bonferroni test were used for multiple comparisons. ROC curves and multinomial logistic regression were used to determine the (OR) risk of xerostomia. RESULTS: A total of 30.7 % of respondents reported xerostomia based on XI. The dry mouth question, the XI taken as a "gold standard", showed a diagnostic sensitivity of 70.37 %, and a specificity of 83.27 % (AUC=0.768, p<0.001). Logistical regression showed the highest xerostomia OR was associated to patients with bad self-perceived health, 6.31 (CI 95% 2.89-13.80, p<0.001). In the model adjusted for tooth mobility, bone or respiratory diseases, and the consumption of anxiolytics and antidepressants, the OR was 3.46 (CI 95% 1.47-8.18, p=0.005). CONCLUSIONS: a high prevalence of xerostomia was found in this cross-sectional pilot study, which was significantly more frequent in women, and increased with age. Xerostomia was associated to several systemic diseases, psychological conditions, and oral functional disorders such as tooth mobility. These preliminary results can serve as the basis for developing guidelines for the application of innovative measures designed to improve the quality of life of individuals with xerostomia.

Assessing the viability of recovered phosphorus from eutrophicated aquatic ecosystems as a liquid fertilizer.

One of the most important worldwide environmental challenges is the alteration of the biogeochemical cycle of phosphorus (P). P is globally exported from terrestrial to aquatic ecosystems, causing the eutrophication of the receiving waters. In this context, magnetic microparticles (MPs) have been recently proposed for trapping P in natural eutrophicated ecosystems, as well as in treated wastewaters. The main advantage of using MPs is that both P and MPs can be recovered from the treated water. Thus, the working hypothesis of the present study is that P can be desorbed from P-loaded MPs and recovered P can be later used as a fertilizer. To test this hypothesis, the best working conditions for desorbing P from P-loaded MPs were identified; then, an experiment with different plant nutrient solutions (neutralized solutions containing recovered P and an unfertilized control) was carried out with three different plant species: Ocimum basilicum L., Cucumis sativus L. and Cucumis melo L. Finally, germination, height, root and shoot biomass and P concentration in root and shoot were compared among treatments. Our results show that the best conditions for P desorption from P-loaded MPs occurred when using 0.1 M NH4OH and using H3PO4 for neutralizing pH. The greenhouse fertirrigation pot experiment showed that the neutralized solution containing desorbed P from P-loaded MPs can be used as a liquid fertilizer, since its combination with macro and microelements significantly increased plant height, growth rate, shoot and root biomass and shoot and root P concentration. As a result, MPs can be proposed to be used for counteracting the widespread and coupled problems of the exhaustion of the P reserves and the eutrophication of aquatic ecosystems.

Ceftaroline fosamil: clinical experience after 23-month prescription in a tertiary hospital.

OBJECTIVE: To determine the indications, success rate and adverse effects of ceftaroline fosamil treatment in a tertiary hospital. METHODS: In total, 84 cases from February 2018 to December 2019 were retrospectively analysed. No exclusion criteria were applied. RESULTS: Eighty-four patients, with a median age of 70 years, of which, 6.7% (56) were male, were treated with ceftaroline fosamil for a median of 14 days. Most indications were off-label, including 29 endocarditis (34.5%), 14 bacteraemia (16.6%), 5 Central nervous system (CNS) infections (6%) and 19 osteoarticular infections (22.6%). Staphylococcus aureus was the most frequently isolated microorganism, including 28 methicillin-sensitive S. aureus (MSSA; 33.3%) and 14 methicillin-resistant S. aureus (MRSA; 16.7%), followed by coagulase-negative Staphylococcus (23, 27.4%). The main reason for ceftaroline fosamil prescription was the failure of previous treatment (41.7% of cases). Treatment was successful in 60/84 patients (71.4%) and failed clinically or microbiologically in 14 (16.7%). Eight patients died for a reason not related to the infection and two were found to have a non-infectious condition. Twenty-two of thirty-five (62.8%) patients prescribed ceftaroline because of failure of previous treatment improved, including eight endocarditis and seven bacteraemia. Adverse effects were reported in five patients (5.9%) including neutropenia, thrombocytopenia, transaminases elevation and creatinine elevation; all except one were mild and all resolved after discontinuation of treatment. CONCLUSIONS: Ceftaroline fosamil is a well-tolerated cephalosporine, effective against multi- resistant gram-positive and many gram-negative microorganisms. Our experience suggests that it is effective as a rescue or first-line therapy in other indications than those currently approved.

The impact of pre-eclampsia definitions on the identification of adverse outcome risk in hypertensive pregnancy - analyses from the CHIPS trial (Control of Hypertension in Pregnancy Study).

OBJECTIVE: To examine the association between pre-eclampsia definition and pregnancy outcome. DESIGN: Secondary analysis of Control of Hypertension in Pregnancy Study (CHIPS) trial data. SETTING: International multicentre randomised controlled trial (RCT). POPULATION: In all, 987 women with non-severe non-proteinuric pregnancy hypertension. METHODS: We evaluated the association between pre-eclampsia definitions and adverse pregnancy outcomes, stratified by hypertension type and blood pressure control. MAIN OUTCOME MEASURES: Main CHIPS trial outcomes: primary (perinatal loss or high-level neonatal care for >48 hours), secondary (serious maternal complications), birthweight <10th centile, severe maternal hypertension, delivery at <34 or <37 weeks, and maternal hospitalisation before birth. RESULTS: Of 979/987 women with informative data, 280 (28.6%) progressed to pre-eclampsia defined restrictively by new proteinuria, and 471 (48.1%) to pre-eclampsia defined broadly as proteinuria or one/more maternal symptoms, signs or abnormal laboratory tests. The broad (versus restrictive) definition had significantly higher sensitivities (range 62-79% versus 36-50%), lower specificities (range 53-65% versus 72-82%), and similar or higher diagnostic odds ratios and 'true-positive' to 'false-positive' ratios. Stratified analyses showed similar results. Addition of available fetoplacental manifestations (stillbirth or birthweight <10th centile) to the broad pre-eclampsia definition improved sensitivity (74-87%). CONCLUSIONS: A broad (versus restrictive) pre-eclampsia definition better identifies women who develop adverse pregnancy outcomes. These findings should be replicated in a prospective study within routine healthcare to ensure that the anticipated increase in surveillance and intervention in a larger number of women with pre-eclampsia is associated with improved outcomes, reasonable costs and congruence with women's values. TWEETABLE ABSTRACT: A broad (versus restrictive) pre-eclampsia definition better identifies the risk of adverse pregnancy outcomes.

Mortality as a competition risk factor in the survival analysis of the results of the type of fixation of the total hip prosthesis in octogenarian patients. / Mortalidad como factor de riesgo de competencia en el análisis de supervivencia de los resultados del tipo de fijación de la prótesis total de cadera en pacientes octogenarios.

INTRODUCTION: Total hip replacement (THR) is challenging in octogenarians due to associated comorbidities and controversy regarding fixation type. We ask whether cemented THR is superior to uncemented THR in patients above the age of 80 years. MATERIAL AND METHODS: A total of 382 patients (441 hips) aged 80 years or older who underwent THR between 2004 and 2015 were analysed. A cemented THR was implanted in 196 hips (group 1), an uncemented THR with a grit-blasted stem in 121 (group 2), or with a porous-coated stem in 124 (group 3). Patients in group 1 had a higher mean age, more comorbidities and osteoporotic bone. Survival analysis was calculated using cumulative incidence function to account for the competing risk of death. RESULTS: Medical complications rate was similar. There were 3post-operative fractures: one in group 2 and 2in group 3. Competing risk analysis showed that the cumulative incidence of revision for any cause was 2.3 in group 1, 6.0 in group 2 and 4.1 in group 3 at 10years, and the cumulative incidence of revision for aseptic loosening was 1.2 in group 1, 3.7 in group 2 and 0 in group 3 at the same period. CONCLUSIONS: THR presents an acceptable number of adverse events for octogenarian patients. Despite uncemented fixation was satisfactory, the higher peri-prosthetic fracture rate worsens results in this group.

Expresiones y criterios mejorables en la redacción de informes de evaluación y posicionamiento terapéutico / Expressions and criteria that could be improved in the writing of reports for drug evaluation and therapeutic positioning

En la revisión de borradores de informes para evaluación y posicionamiento de nuevos fármacos en un entorno multidisciplinar, se observan determinados errores de expresión o criterio que se repiten con frecuencia. Principalmente, están relacionados con la consideración de “diferencias” o tendencias no significativas, abuso de la reducción relativa del riesgo, errores en la valoración de resultados por subgrupos sin calcular la interacción estadística, confusiones en la interpretación de las comparaciones indirectas, sobrevaloración de la relevancia clínica con variables subclínicas y afirmaciones sesgadas en el apartado de seguridad, entre otros. También se observa a menudo ambigüedad o inhibición en el posicionamiento, especialmente en situaciones de precariedad en la evidencia disponible. El presente trabajo expone de forma sintética tales errores, aclara algunos términos comunes y propone expresiones o criterios alternativos que se consideran preferibles, con el fin de ofrecer una evaluación para la toma de decisiones en beneficio de los pacientes. (AU)

In the review of reports for evaluation and positioning of new drugs in a multidisciplinary setting, some usual errors of expression or criteria are observed. Most of them are related to the consideration of «differences» or non-significant trends, abuse of the relative risk reduction, errors in the assessment of results by subgroups without calculating the statistical interaction, misinterpretation of indirect comparisons, excess in the assessment of clinical relevance with subclinical variables and biased statements in the safety section, among others. Ambiguity or inhibition in positioning is also often observed, especially in situations of precariousness in the available evidence. This work summarizes such errors, clarifies some common terms and proposes alternative expressions or criteria that are considered preferable, in order to offer evaluations for decision-making focused on the benefit of patients. (AU)