Ischaemic Priapism: A Complication of Self-Administered Hyaluronic Acid Gel as an Injectable Filler for Penile Augmentation

Background: Injectable hyaluronic acid (HA) gel has emerged as a widely used soft tissue filler for surgeries. In penile reconstructivesurgery, HA gel has been employed for penile or glans augmentation in selected patients diagnosed with micropenis.This augmentation technique involves injecting the gel into submucosal tissue and increasing the size of the penis for approximately1 year. A few studies have investigated the possible complications correlated with medically assisted penile injections ofHA gel. However, no previous reports have shown the complications of self-administered HA injection. This case report aims topresent the first documented case of ischaemic priapism as a complication of self-administered HA injection.Case Presentation: We present the case of a 43-year-old male who self-administered a 20 mL injection of HA into the dorsal sideof his penis. The injected material probably reached the corpora cavernosa, leading to priapism within a few hours. However,the patient did not seek medical attention until 72 h later. The first two initial conservative attempts of blood drainage wereunsuccessful because the gel had obstructed vein drainage, causing the penis to remain in a state of priapism. The final treatmentapproach involved shunting, high enoxaparin doses and oral Effortil administration.Conclusions: While complications from medically assisted HA injections have been documented, this case report sheds light onthe complications arising from self-administered penile injections. Priapism is a severe medical condition that requires immediatetreatment to avoid potentially serious long-term consequences. Healthcare providers and patients must acknowledge itssymptoms and its appropriate course of treatment, especially in the context of penile medical injections. (AU)

Patrones y resultados del cambio de anticoagulantes orales directos en la fibrilación auricular no valvular: experiencia en la práctica clínica en España / Patterns and outcomes of switching direct oral anticoagulants in non-valvular atrial fibrillation: A real-world experience from Spain

Objetivos El objetivo consistía en evaluar un programa de gestión de anticoagulantes orales directos (ACOD) en pacientes con fibrilación auricular no valvular (FANV) según sus perfiles, idoneidad de la dosis, patrones de cambio de tratamiento, efectividad y seguridad Se trató de un estudio observacional, prospectivo y longitudinal en una cohorte de pacientes atendidos en la práctica clínica cotidiana en un hospital regional español con un plan de seguimiento de 3 años para pacientes que iniciaron el tratamiento con dabigatrán, rivaroxabán o apixabán entre enero de 2012 y diciembre de 2016. Métodos Se analizaron 490 episodios de tratamiento (apixabán 2,5mg, 9,4%; apixabán 5mg, 21,4%; dabigatrán 75mg, 0,6%; dabigatrán 110mg, 12,4%; dabigatrán 150mg, 19,8%; rivaroxabán 15mg, 17,8%; rivaroxabán 20mg, 18,6%) en 445 pacientes. En el 13,6% de los pacientes tratados con dabigatrán, el 9,7% de los tratados con rivaroxabán y el 3,9% de los tratados con apixabán se cambió a otros ACOD o se modificó la dosis. Resultados El ACOD al que se cambió con mayor frecuencia fue el apixabán. Los motivos más frecuentes para cambiar de tratamiento fueron toxicidad (23,8%), hemorragia (21,4%) y deterioro renal (16,7%). En el 23,8% de los episodios se constató una inadecuación de la dosis. Las tasas de ictus y accidentes isquémicos transitorios (AIT) fueron de 1,64 y 0,54 eventos/100 años/paciente, respectivamente, mientras que las de hemorragias importantes, no importantes, pero clínicamente relevantes (NICR) e intracraneales fueron de 2,4, 5 y 0,5 eventos/100 años/paciente, respectivamente. Las hemorragias digestivas y genitourinarias fueron el tipo más frecuente de eventos hemorrágicos. En el análisis multifactorial, el ictus previo y la edad fueron factores predictivos independientes de ictus/AIT. El uso concomitante de antiagregantes plaquetarios, el sexo masculino y la edad fueron factores predictivos independientes de eventos hemorrágicos (AU)

Aims The aim is to evaluate a management program for direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation (NVAF) patients according to their profiles, appropriateness of dosing, patterns of crossover, effectiveness and safety. This is an observational and longitudinal prospective study in a cohort of patients attended in daily clinical practice in a regional hospital in Spain with 3-year a follow-up plan for patients initiating dabigatran, rivaroxaban or apixaban between Jan/2012 and Dec/2016. Methods We analyzed 490 episodes of treatment (apixaban 2.5, 9.4%; apixaban 5, 21.4%; dabigatran 75, 0.6%; dabigatran 110, 12.4%; dabigatran 150, 19.8%; rivaroxaban 15, 17.8% and rivaroxaban 20, 18.6%) in 445 patients. 13.6% of patients on dabigatran, 9.7% on rivaroxaban, and 3.9% on apixaban switched to other DOACs or changed dosing. Results Apixaban was the most frequent DOAC switched to. The most frequent reasons for switching were toxicity (23.8%), bleeding (21.4%) and renal deterioration (16.7%). Inappropriateness of dose was found in 23.8% of episodes. Rates of stroke/transient ischemic attack (TIA) were 1.64/0.54 events/100 patients-years, while rates of major, clinically relevant non-major (CRNM) bleeding and intracranial bleeding were 2.4, 5, and 0.5 events/100 patients-years. Gastrointestinal and genitourinary bleeding were the most common type of bleeding events (BE). On multivariable analysis, prior stroke and age were independent predictors of stroke/TIA. Concurrent platelet inhibitors, male gender and age were independent predictors of BE. Conclusion This study complements the scant data available on the use of DOACs in NVAF patients in Spain, confirming a good safety and effectiveness profil (AU)

Effects of Cefixime on Immune Functions and Inflammatory Factors in Children with Urinary Tract Infection and Targeted Nursing Strategies

Objective: This study aims to explore the effects of cefixime on immune functions and inflammatory factors in children with urinary tract infection and to investigate its nursing strategies. Methods: A total of 161 children with urinary tract infection who were diagnosed in our hospital from November 2019 to November 2021 were selected. All children were treated with cefixime and received targeted nursing strategies. The indices of immune functions and the levels of inflammatory factors were compared before and after the treatment. The satisfaction degree of children’s family members, recurrence rate and incidence of adverse reactions were measured. Results: The levels of CD3+, CD4+ and CD4+/CD8+ in children after the treatment were significantly higher but the CD8+ level was significantly lower than those before the treatment (p < 0.001). The levels of C-reactive protein, tumour necrosis factor-α and interleukin-6 after the treatment were lower than those before the treatment (p < 0.001). The average score of nursing satisfaction of children’s family members was (84.53 ± 13.65) points, with the total satisfaction degree of 90.68% (146/161). Within 6 months after the treatment, only six children had urinary tract infection again and the recurrence rate was 3.73% (6/161). During the treatment, seven children had adverse reactions to the drug, with an incidence rate of 4.35% (7/161). Conclusions: Cefixime can improve the immune function of children with urinary tract infection and reduce the levels of inflammatory factors. The implementation of targeted nursing strategies can improve clinical satisfaction and reduce the recurrence rate of the disease and thus can be helpful to establish a comprehensive and efficient clinical program for children with urinary tract infection (AU)

Adverse drug events related to extemporaneous compounding medicines / Eventos adversos a medicamentos relacionados a adequações posológicas

In the present study, we investigated the causality between adverse drug events and extemporaneous compounding from spontaneous reports generated by a healthy team in a medium-complexity public hospital in São Paulo state, Brazil. An observational cross-sectional study was conducted between August/2017 to July/2018. All adverse drug events spontaneous reports, which mentioned extemporaneous compounding, were evaluated. The selected variables were patient’s clinical history, pharmacotherapy, adverse drug reactions, medication error and type of extemporaneous compounding. Causality assessment between the adverse drug reaction and extemporaneous compounding was performed by World Health Organization – Uppsala Monitoring Center algorithm and medication error analysis was performed by the National Council for Coordination of Reporting and Prevention of Medication Errors algorithm. 3,211 spontaneous reports were evaluated. Only 144 (4.5%) reports mentioned extemporaneous compounding, being 110 eligible for analysis. The causality assessment showed that in 27 (24%) reports the adverse drug reaction and medication error identified were possibly related to extemporaneous compounding, with an underreporting index of 0.87. From these 27 reports, 3 adverse drug reactions were classified as “probable” and 23 as “possible” whereas 4 medication error were classified as “error, harm: category E”. Although extemporaneous compounding is a common practice in hospitals, only a small portion of the reports included it. Future studies may investigate the use of extemporaneous compounding as a trigger tool for adverse drug reactions since this study shows that one out of four reports that mentioned it leads to patient harm. (AU)

No presente estudo, foi investigada a causalidade entre eventos adversos a medicamentos (EAM) e adequações posológicas (AP) a partir de notificações espontâneas geradas pela equipe de saúde de um hospital público de média complexidade no estado de São Paulo, Brasil. Foi conduzido um estudo observacional transversal entre agosto/ 2017 a julho/ 2018. Todas as notificações de EAM, que mencionavam AP, foram avaliadas. As variáveis selecionadas foram história clínica do paciente, farmacoterapia, reações adversas a medicamentos, erro de medicação e a técnica de manipulação extemporânea. A avaliação da causalidade entre a EAM e a AP foi realizada pelo algoritmo da Organização Mundial da Saúde – Centro de Monitoramento de Uppsala e a análise do erro de medicação foi realizada pelo algoritmo do Conselho Nacional para Coordenação de Notificação e Prevenção de Erros de Medicação. Foram avaliadas 3.211 notificações espontâneas. Apenas 144 (4,5%) notificações mencionaram AP, sendo 110 elegíveis para análise. A avaliação de causalidade mostrou que em 27 (24%) notificações, a reação adversa ao medicamento e o erro de medicação identificados estavam possivelmente relacionados à AP, com um índice de subnotificação de 0,87. Destas 27 notificações, 03 reações adversas a medicamentos foram classificadas como “prováveis” e 23 como “possíveis”, e 04 erros de medicação, classificados “erro com dano: categoria E”. Embora as AP seja uma prática comum em hospitais, são escassas as notificações que as descrevem. Estudos futuros podem investigar o uso de AP como uma ferramenta para rastrear EAM, porque observamos que um em cada quatro notificações com relato de AP estava relacionado a EAM. (AU)

Epidemia de escabiosis: los nuevos retos de una enfermedad ancestral / Epidemic Scabies: New Treatment Challenges in an Ancient Disease

La escabiosis es una de las enfermedades transmisibles más prevalentes en el mundo, actualmente en auge en nuestro entorno. Existen diferentes causas que explican la problemática de esta epidemia: una incorrecta aplicación o pauta del tratamiento; la disminución de la sensibilidad o la resistencia al tratamiento tópico y las carencias en el conocimiento del parásito y su transmisibilidad. Por este motivo es necesario un nuevo enfoque en el tratamiento de esta enfermedad que contemple los problemas y la evidencia actual. Si hay una persistencia de la clínica tras un correcto tratamiento es importante corroborar el fracaso terapéutico y estandarizar la actitud. Por último, ante un caso recalcitrante cabría plantear la posibilidad de priorizar el tratamiento oral, aumentar su dosis, realizar tratamientos combinados o plantear su uso fuera de ficha técnica en poblaciones especiales. La aparición de nuevos tratamientos, como el spinosad o, sobre todo, la moxidectina, aportan esperanza en el control de esta enfermedad (AU)

Scabies, which is among the most prevalent diseases worldwide, is becoming more frequent in Spain. The problems of this epidemic can be explained by several factors: improper application or prescription of treatments, resistance or reduced sensitivity to topical treatments, and poor understanding of the parasite and contagion. We require a new evidence-based approach to therapy that takes these problems into consideration. If symptoms persist after proper treatment, it is important to identify the reason for failure and standardize our approach. In refractory cases, the prescriber should prioritize oral medication, indicate a higher dose, combine treatments, or evaluate the use of off-label treatments in certain populations. The availability of new medications —such as spinosad or, especially, moxidectin— offer hope for bringing this disease under control (AU)

[Translated article] Epidemic Scabies: New Treatment Challenges in an Ancient Disease / Epidemia de escabiosis: los nuevos retos de una enfermedad ancestral

Scabies, which is among the most prevalent diseases worldwide, is becoming more frequent in Spain. The problems of this epidemic can be explained by several factors: improper application or prescription of treatments, resistance or reduced sensitivity to topical treatments, and poor understanding of the parasite and contagion. We require a new evidence-based approach to therapy that takes these problems into consideration. If symptoms persist after proper treatment, it is important to identify the reason for failure and standardize our approach. In refractory cases, the prescriber should prioritize oral medication, indicate a higher dose, combine treatments, or evaluate the use of off-label treatments in certain populations. The availability of new medications —such as spinosad or, especially, moxidectin— offer hope for bringing this disease under control (AU)

La escabiosis es una de las enfermedades transmisibles más prevalentes en el mundo, actualmente en auge en nuestro entorno. Existen diferentes causas que explican la problemática de esta epidemia: una incorrecta aplicación o pauta del tratamiento; la disminución de la sensibilidad o la resistencia al tratamiento tópico y las carencias en el conocimiento del parásito y su transmisibilidad. Por este motivo es necesario un nuevo enfoque en el tratamiento de esta enfermedad que contemple los problemas y la evidencia actual. Si hay una persistencia de la clínica tras un correcto tratamiento es importante corroborar el fracaso terapéutico y estandarizar la actitud. Por último, ante un caso recalcitrante cabría plantear la posibilidad de priorizar el tratamiento oral, aumentar su dosis, realizar tratamientos combinados o plantear su uso fuera de ficha técnica en poblaciones especiales. La aparición de nuevos tratamientos, como el spinosad o, sobre todo, la moxidectina, aportan esperanza en el control de esta enfermedad (AU)

Recomendaciones para el tratamiento oral de pacientes adultos con enfermedad de Gaucher tipo 1 / Recommendations for oral treatment for adult patients with type 1 Gaucher disease

Revisión de la evidencia científica sobre el tratamiento oral de pacientes adultos con enfermedad de Gaucher tipo 1 (EG1), con formato de guía clínica, según la normativa Agree II. Se describen las principales diferencias entre los 2 tratamientos orales disponibles actualmente para el tratamiento de esta entidad (miglustat y eliglustat).En esta revisión se recuerda que los criterios para iniciar el tratamiento oral en los pacientes con EG1 deben valorarse de forma individualizada. Si bien miglustat y eliglustat son inhibidores de la enzima glucosilceramida sintetasa, los 2 presentan diferentes mecanismos de acción y propiedades farmacológicas y nunca se deben considerar como equivalentes. Miglustat está indicado en pacientes con EG1 no grave que no pueden recibir otro tratamiento de primera línea, mientras que eliglustat está indicado en pacientes con EG1 con cualquier gravedad, en primera línea y sin necesidad de estabilización previa con tratamiento de reemplazo enzimático. Es importante enfatizar que para iniciar tratamiento con eliglustat debemos conocer el fenotipo metabólico CYP2D6 y que su asociación con fármacos metabolizados a través de los citocromos CYP2D6 y CYP3A4 –o bien que utilicen la glucoproteína P– se debe evaluar individualmente. Durante el embarazo se debe evitar el uso de eliglustat, pudiéndose emplear únicamente el tratamiento de reemplazo enzimático. A diferencia de miglustat, cuyos efectos adversos han limitado su utilización, eliglustat no solo ha demostrado una eficacia similar a la del tratamiento de reemplazo enzimático, sino que ha demostrado mejoría en la calidad de vida de los pacientes EG1. (AU)

This work is a review of the scientific evidence on the oral treatment of adult patients with Gaucher disease type 1 (GD1) with a clinical guideline format according to the Agree II regulations. It describes the main differences between the 2 oral treatments currently available for treating this disease (miglustat and eliglustat).This review reminds us that the criteria for starting oral treatment in patients with GD1 must be assessed individually. Although miglustat and eliglustat are both glucosylceramide synthase enzyme inhibitors, they have different mechanisms of action and pharmacological properties and should never be considered equivalent. Miglustat is indicated in patients with non-severe GD1 who cannot receive other first-line treatments, while eliglustat is indicated as first-line treatment for patients with GD1 of any severity without the need for prior stabilization with enzyme replacement therapy. It is important to emphasize that in order to start treatment with eliglustat, we must know the CYP2D6 metabolic phenotype and its association with drugs metabolized through the CYP2D6 and CYP3A4 cytochromes –or alternatively those that use P-Glycoprotein– must be evaluated on an individual basis. During pregnancy, the use of eliglustat should be avoided; only enzyme replacement therapy can be used. Unlike miglustat, whose adverse effects have limited its use, eliglustat has not only demonstrated similar efficacy to enzyme replacement therapy but has also been shown to improve the quality of life of patients with GD1. (AU)

Severity of gastrointestinal bleeding is similar between patients receiving direct oral anticoagulants or vitamin K antagonists

Background: gastrointestinal bleeding (GIB) is a commonadverse event related to anticoagulation therapy. However,evidence comparing the severity, etiology and outcome ofGIB in patients taking direct oral anticoagulants (DOAC) vs.vitamin K antagonists (VKA) is scarce.Aim: to evaluate the severity, etiology and outcomes of GIBin patients under DOACs compared to VKA.Methods: patients under oral anticoagulant therapy admitted to the emergency department with acute GIB wereprospectively recruited from July 2016 to January 2018 ata tertiary referral hospital. Demographic and clinical out comes were obtained from medical records. GIB severitywas classified as mild, major, or severe according to theclinical presentation and type of support needed. Etiologyand location of bleeding, number of packed red blood cells(PRBC) transfused, and length of hospital stay were recorded until discharge or in-hospital death.Results: a total of 208 patients with acute GIB under oralanticoagulant treatment were recruited: 119 patients wereon VKA and 89 patients on DOAC, with similar characteristics. Thirty-one patients had severe GIB; 134 had major and43 had mild GIB, with no differences in severity, numberof PRBC, and length of hospital stay between the groups.Peptic disease was the most frequent etiology of GIB inpatients on VKA (20.2 % vs. 13.6 %, p = 0.20). Diverticularbleeding was the most frequent adverse event in patientson DOAC (14.3 % vs. 24.8 %, p = 0.056).Conclusions: severity and clinical outcomes of GIB aresimilar between patients on DOAC and patients on VKA,regardless of GIB etiology. (AU)

Los hallazgos oculares relacionados con el uso de bisfosfonatos orales / The ocular findings related to oral bisphosphonate use

Objetivo Nuestro objetivo fue investigar los hallazgos de afectación ocular en pacientes femeninas con osteoporosis que usaban bisfosfonato oral (BP). Métodos Se incluyó en el estudio a un total de 51 pacientes con osteoporosis, de 50 a 75 años, que utilizaron BP oral durante al menos un año para el grupo de estudio y a 64 pacientes sin osteoporosis de la misma edad para el grupo de control, todas del sexo femenino. Se anotaron el tipo de BP y el tiempo de exposición. Se evaluaron los resultados del examen oftálmico de las pacientes que recibieron BP oral por osteoporosis y de las controles. Resultados La duración media del uso de BP fue de 3,96 años. Se detectó que 4de 51 pacientes fueron diagnosticadas con disfunción de la glándula de Meibomio (7,8%), 7de 102 ojos tenían margen palpebral eritematoso, irregular, engrosado o telangiectasia alrededor de los orificios glandulares. No hubo hallazgos patológicos en el examen del fondo de ojo. El valor medio de las medidas del brote (ph/ms) fue de 7,90±7,96 en el grupo de estudio y de 5,02±0,81 en el grupo de control. Cuando se compararon los valores medios, hubo una diferencia significativa entre los 2grupos (p=0,001). Se encontró una diferencia significativa en el valor medio de las mediciones del flare entre las pacientes que usaban alendronato e ibandronato y las del grupo de control (p=0,001; p=0,005, respectivamente). Conclusión Nuestro estudio mostró que el flare de la cámara anterior asociado con la inflamación crónica del ojo se puede observar con mayor frecuencia en pacientes que usan alendronato e ibandronato por vía oral en comparación con aquellos que no lo hacen. Además, se puede decir que BP oral puede provocar efectos secundarios oculares similares a los de la BP intravascular (AU)

Objective We aimed to investigate ocular involvement findings in female osteoporosis patients using oral bisphosphonate (BP). Methods A total of 51 female osteoporosis patients aged 50-75 years using oral BP for at least one year for the study group and 64 age-matched non-osteoporosis female patients for the control group were included in the study. The BP type and exposure time were noted. The ophthalmic examination findings and measurements of the flare of the patients who received oral BP due to osteoporosis and the controls were evaluated. Results The mean duration of BP use was 3.96 years. In the study group, it was detected 4of 51 patients were diagnosed with meibomian gland dysfunction (MGD) (7.8%), 7of 102 eyes had erythematous, irregular, thickened lid margin or telangiectasia around the glandular orifices. There were no pathological findings on fondus examination. The mean value of measurements of the flare (ph/ms) was 7.90±7.96 in the study group, and 5.02±0.81 in the control group. When the mean values were compared, there was a significant difference between the 2groups (P=0.001). A significant difference was found in the mean value of measurements of the flare between the patients using alendronate, and ibandronate with the control group (P=0.001; P=0.005, respectively). Conclusion Our study showed that the flare in the anterior chamber associated with chronic ocular inflammation can be seen higher rate in patients using oral alendronate, and ibandronate compared to those who do not. Morever it can be said that oral BPs may cause similar ocular side effects like as intravascular BPs (AU)

Gender differences in antithrombotic treatment in patients with atrial fibrillation from Spain versus the rest of Western Europe. GLORIA-AF Program

Background and objective:Thromboembolic risk is higher in women than men with non-valvular atrial fibrillation (NVAF). Published data indicate variability in antithrombotic use by gender and region. We analyzed gender-specific antithrombotic treatment patterns in Spain and rest of Western Europe (rWE) in patients with NVAF.Methods:GLORIA-AF (Phase III) is a global, prospective, observational study which enrolled newly diagnosed NVAF patients with CHA2DS2-VAScs≥1 (2014–2016). Analyses were performed comparing antithrombotic treatments by gender in Spain and rWE.Results:This analysis included 1163 and 7972 patients from Spain and rWE, respectively. Stroke risk was higher in women than men in both Spain and rWE. While in rWE, bleeding risk and antithrombotic treatment pattern were similar between genders, in Spain bleeding risk in women was lower and more females compared to men received OACs (95.0% versus 92.4%, d=−0.1078, respectively). Fewer Spanish patients received direct oral anticoagulants (DOACs) (women 32.1%, men 25.3%) than vitamin-K-antagonists (VKAs) (women 63.0%, men 67.1%) vs. rWE patients. In Spain women received more DOACs compared to men (56.0% versus 44.0%).Conclusions:OAC rates were higher in Spain as compared to rWE. More women received OACs in Spain, while in rWE no difference by gender was observed. DOACs in rWE are the most prescribed OAC while in Spain, due to prescription barriers, its use remains low for both genders and VKAs are preferred. Spanish women received more DOACs compared to men. (NCT01468701). (AU)

Antecedentes y objetivo:El riesgo tromboembólico es mayor en mujeres que en varones con fibrilación auricular no valvular (FANV). Existen diferencias en el uso de anticoagulantes (ACO) según sexo y zona geográfica. Se estudiaron los patrones de anticoagulación por sexo en España y el resto de Europa Occidental (rEO) en pacientes con FANV.Métodos:GLORIA-AF es un estudio observacional prospectivo (fase III) que incluyó a pacientes con diagnóstico reciente de FANV y CHA2DS2-VASc>1 (2014-2016). Se analizó la prescripción de anticoagulantes por sexo en España y el rEO.Resultados:Se incluyó a 1.163 pacientes de España y 7.972 del rEO. El riesgo de ictus fue superior en mujeres tanto en España como en el rEO. El riesgo de hemorragia y el tratamiento antitrombótico fueron similares en ambos sexos en el rEO; en España, el riesgo de hemorragia fue menor en mujeres y estas recibieron más ACO que los varones (95,0% vs. 92,4%, d=–0,1078). En España, menos pacientes recibieron ACO directos (ACOD) (mujeres 32,1%, varones 25,3%) vs. antagonistas de la vitamina K (AVK) (mujeres 63,0%, varones 67,1%), y las mujeres recibieron más ACOD que los varones (56,0% vs. 44,0%).Conclusiones:En España se emplearon más ACO que en el rEO y más mujeres fueron tratadas con ACO, mientras que en el rEO no hubo diferencias por sexo. En el rEO, los ACOD se emplearon más. En España, los ACOD se emplean menos por restricciones de prescripción y se emplean más los AVK. Las mujeres españolas reciben más ACOD que los varones. (NCT01468701). (AU)

Documento de consenso de la Sociedad Española de Patología Digestiva y de la Sociedad Española de Trombosis y Hemostasia sobre hemorragia digestiva masiva no varicosa y anticoagulantes orales de acción directa / Consensus document of the Spanish Society of Digestives Diseases and the Spanish Society of Thrombosis and Haemostasis on massive nonvariceal gastrointestinal bleeding and direct-acting oral anticoagulants

Introducción: la experiencia y el conocimiento de la hemorragia digestiva masiva no varicosa durante el tratamiento con anticoagulantes orales de acción directa son limitados.Objetivos: proporcionar definiciones y recomendaciones basadas en evidencia.Métodos: documento de consenso elaborado por la Sociedad Española de Enfermedades Digestivas y la Sociedad Española de Trombosis y Hemostasia utilizando la metodología Delphi modificada. Se constituyó un panel de 24 gastroenterólogos con experiencia en hemorragia digestiva y se evaluó la construcción de consenso en tres rondas. Las recomendaciones finales se basan en una revisión sistemática de la literatura utilizando el sistema GRADE.Resultados: el acuerdo de los panelistas fue del 91,53 % para los 30 ítems como grupo, porcentaje que mejoró durante las rondas 2 y 3 para los ítems donde la experiencia clínica es menor. El desacuerdo explícito fue sólo del 1,25 %. Se estableció una definición de sangrado gastrointestinal masivo no varicoso en pacientes con anticoagulantes orales de acción directa y se desarrollaron recomendaciones para optimizar el manejo de esta condición.Conclusión: el abordaje de estos pacientes críticos debe ser multidisciplinario y protocolizado, optimizando las decisiones para la identificación temprana del cuadro y la estabilización del paciente de acuerdo con los principios de la reanimación con control de daños. Por tanto, se debe considerar la reversión inmediata de la anticoagulación, preferentemente con antídotos específicos (idarucizumab para dabigatrán y andexanet alfa para inhibidores directos del factor Xa); resucitación hemostática e identificación y manejo de puntos sangrantes. (AU)

Estudio multicéntrico sobre el tratamiento con N-acetilcisteína como antídoto en la intoxicación por paracetamol / N-acetylcysteine as an antidote for paracetamol poisoning: a multicenter study

Objetivo. Conocer los aspectos clínicos relacionados con el tratamiento del antídoto N-acetilcisteína (NAC) en las intoxicaciones por paracetamol. Método. Estudio observacional y retrospectivo de los pacientes atendidos por intoxicación por paracetamol en cuatro servicios de urgencias durante 3 años (2017-2019). Se analizan variables epidemiológicas, clínicas y asistenciales, así como la idoneidad y seguridad en el empleo del tratamiento antidótico. Resultados. Se incluyeron 332 intoxicaciones: 260 casos (78%) tenían más de 16 años y 242 (73%) fueron mujeres. Doscientos sesenta y ocho intoxicaciones (81%) fueron de causa voluntaria y la semivida de eliminación se determinó en 20 ocasiones (6%). La descontaminación digestiva se indicó de forma incorrecta en 39 ocasiones (28%). Se inició tratamiento con antídoto en 195 casos (58,7%). En 282 casos (85%) no hubo ninguna clínica de gravedad. La correlación entre la dosis referida ingerida y la paracetamolemia en los casos de ingesta voluntaria (R2 = 0,23) fue más fuerte que en los casos de ingesta accidental (R2 = 0,007). Existieron diferencias estadísticamente significativas al relacionar los criterios de gravedad con la dosis referida ajustada al peso (p = 0,001) y el intervalo desde la ingesta y la primera asistencia médica (p = 0,008). Conclusiones. Existe variabilidad en aspectos fundamentales del tratamiento antidótico en las intoxicaciones por paracetamol, a pesar de estar claramente protocolizado su manejo.

Objective. To identify the most common problems related to use of N-acetylcysteine to reverse the toxic effects of paracetamol poisoning. Methods. Retrospective descriptive observational study of clinical records for patients treated for paracetamol poisoning in 4 emergency departments during 3 years (2017-2019). We analyzed epidemiologic, clinical, and care variables, especially those related to the suitability and safety of using N-acetylcysteine as an antidote. Results. We included 332 cases of poisoning of 260 patients (78%) were over the age of 16 years, and 242 (73%) were female. Two hundred sixty-eight poisonings (81%) were the result of voluntary intake. The elimination half-life was determined in 20 cases (6%). Gastrointestinal decontamination was incorrectly prescribed on 39 occasions (28%). Treatment with the antidote was begun in 195 cases (58.7%). No serious clinical signs or symptoms were present in 282 cases (85%). The correlation of paracetamol levels in urine was stronger with the amount of drug ingested voluntarily (R2 = 0.23) than with accidental intake (R2 = 0.007). Predefined severity criteria were significantly related to reported dose ingested per body weight (P = .001) and the interval between intake and first medical assistance (P = .008). Conclusions. Even though clear protocols are available to guide the use of antidote treatment in cases of paracetamol poisoning, variability in fundamental aspects of management is excessive.

Tratamiento de la escabiosis / Treatment of scabies

La escabiosis afecta a más de 200 millones de personas en el mundo, y ocasiona un importante impacto socioeconómico. El mecanismo de contagio es por contacto directo prolongado. El contagio por fómites es infrecuente, aunque puede ser importante en la sarna noruega. La terapia con permetrina tópica al 5% es recomendada como tratamiento de primera línea. Puede indicarse durante el embarazo y la lactancia, y parece ser segura en niños <2 meses. Sin embargo, últimamente se ha reportado una disminución de la efectividad de este fármaco. Otra alternativa en primera línea terapéutica es la ivermectina oral. Se puede administrar durante la lactancia, y estudios recientes sugieren que es segura en niños y lactantes pequeños. Diversas revisiones sistemáticas y metaanálisis han concluido que la ivermectina oral es tan efectiva y segura como la permetrina tópica. La administración terapéutica «en masa» de ivermectina oral es una excelente opción para el manejo de escabiosis en comunidades con alta prevalencia o de brotes en instituciones.

Scabies affects more than 200 million people around the world, and causes a significant socioeconomic impact. Prolonged skin-to-skin contact is the primary mode of transmission. Fomite-mediated transmission is uncommon, although it can be significant in crusted scabies. Topical therapy with permethrin 5% is recommended as first-line treatment. It can be indicated during pregnancy and lactation, and appears to be safe in children <2 months. However, a decrease in the effectiveness of this drug has recently been reported. Another first-line therapeutic alternative is oral ivermectin. It can be administered during lactation, and new evidence suggests that it is safe in children >15kg. Diverse systematic reviews and meta-analysis have concluded that oral ivermectin is as effective and safe as topical permethrin. Mass drug administration of oral ivermectin is an excellent option for the management of scabies in communities with high prevalence, or for scabies outbreaks in institutions.

Inmunoterapia oral con huevo en un hospital comarcal / Oral immunotherapy with egg in a regional hospital

Introducción y objetivos. La inmunoterapia oral (ITO) es una alternativa a la dieta de evitación en algunas alergias alimentarias. El objetivo de este trabajo es evaluar la eficacia y seguridad de la ITO con huevo en una consulta de alergia pediátrica. Material y métodos. Estudio observacional, longitudinal y retrospectivo de pacientes pediátricos con alergia al huevo persistente sometidos a ITO. Para la inducción se utilizó proteína de clara de huevo deshidratada administrada diariamente y con incrementos semanales hasta alcanzar una dosis de 4 gramos. Para la fase de mantenimiento se indicó una ingesta de al menos dos o tres huevos a la semana. Resultados. Se trataron 14 pacientes (6 niñas), de entre 5 y 13 años (mediana 5,5 años). Se consiguió desensibilización completa al final de la inducción en 11 pacientes (78,6%), que se mantuvo en todos ellos tras una mediana de tiempo de seguimiento de 29 meses. Durante la inducción los síntomas más frecuentes fueron: prurito orofaríngeo (9/14), dolor abdominal (7/14) y rinoconjuntivitis (6/14). Se emplearon antihistamínicos en 8 casos (57,1%) y ninguno precisó adrenalina. Entre los pacientes que consiguieron desensibilización se observó una tendencia al descenso de las IgE específicas, siendo estadísticamente significativo para las IgE a huevo completo (p = 0,047), clara de huevo (p = 0,031) y ovoalbúmina (p = 0,016). Conclusiones. La ITO con clara de huevo deshidratada resultó ser un tratamiento muy eficaz y bien tolerado en población pediátrica con alergia al huevo (AU)

Background and objective. Oral immunotherapy (OIT) is an alternative to strict avoidance for the management of some food allergies. The aim of this study is to assess the efficacy and safety of egg OIT in a paediatric allergy outpatient service. Methods. Retrospective, longitudinal observational study in children with persistent hen egg allergy who received egg OIT. For the build-up phase, dehydrated egg white was used daily. Updosing was performed weekly at the allergy unit, up to a final dose of 4 grams. Maintenance phase was carried out with a daily intake of one egg at least two or three times a week. Results. 14 patients (6 girls), whose ages ranged from 5 to 13 years (median 5.5 years) were treated with egg OIT. Eleven subject (78.6%) reached total desensitization, and all of them remained desensitized after a median follow-up time of 29 months. The most frequent adverse effects detected during the build-up phase were: oropharyngeal pruritus (9/14), abdominal pain (7/14), and rhinoconjuntivitis (6/14). Eight patients (57.1%) required oral antihistamines, and none received adrenaline. In those subjects that reached total desensitization, a trend to lower specific IgE levels was observed. That trends were statistically significand for whole egg (p = 0.047), egg white (p = 0.031), and ovalbumin (p = 0.016). Conclusions. Egg OIT was an effective and well tolerated treatment in children with egg allergY (AU)

Long-term outcome of omalizumab-assisted desensitisation to cow’s milk and eggs in patients refractory to conventional oral immunotherapy: real-life study

Background: Oral immunotherapy (OIT) is a promising approach to cow’s milk and egg aller-gies, but reactions are frequent and some patients cannot be desensitized. Objective: To evaluate long-term OIT outcomes with omalizumab (OMZ) in paediatric patients with severe egg and/or milk allergies.Methods: This retrospective real-life study analysed findings in children with Immunoglobulin E-mediated allergy to cow’s milk and/or hen eggs refractory to conventional OIT, who under-went OIT with OMZ in our department between 1 January 2010 and 31 December 2015. Results: In all, 41 patients were included (median age: 7 years; interquartile range [IQR]: 5.5–9.5); 26/41 (63.4%) underwent OIT for milk, 8/41 (19.5%) for egg and 7/41 (17.1%) for both. The median time between initiation of OMZ and OIT was 27 weeks (IQR: 22–33). Forty (97.56%) patients reached the maintenance phase (200 mL of cow’s milk and 30 mL of raw egg or 1 cooked egg) in a median time of 27 weeks (IQR: 18–37). The median total time with OMZ was 117 weeks (IQR: 88–144). During the OMZ period, 2.44% (1/41) of patients presented anaphy-laxis. After discontinuation of OMZ, 29.3% (12/41) presented anaphylaxis, 50% of them had a poor adherence to daily ingestion. One patient (2.44%) was diagnosed with eosinophilic esoph-agitis after 2 years of discontinuation of OMZ. Currently, after a median time of 9 years (IQR: 7–10) since the initiation of OMZ, 75.6% (31/41) are desensitized (27/31 without OMZ).Conclusions: Omalizumab allows desensitisation of children with severe allergies to cow’s milk and/or egg without developing severe reactions while receiving this treatment. However, dis-continuation of OMZ leads to severe allergic reactions, and hence must be monitored carefully.© 2022 Codon Publications. Published by Codon Publications (AU)