Eventos adversos das vacinas para COVID-19 em crianças e adolescentes: sinopse baseada em evidências / Effectiveness of melatonin supplementation according to Cochrane systematic reviews

Contexto: O coronavírus da Síndrome Respiratória Aguda Grave (SARS-CoV-2) espalhou-se rapidamente em todo o mundo, a partir de dezembro de 2019. A vacinação tornou-se prioridade para a prevenção da doença, mas junto surgiu o temor de eventos adversos. Objetivo: Avaliar as evidências de possíveis eventos adversos das vacinas para COVID-19 em crianças e adolescentes. Material e Métodos: Trata-se de sinopse baseada em evidências. Procedeu-se à busca por estudos que associavam as vacinas para COVID-19 a eventos adversos a elas relacionados em três bases de dados: PubMed (1966-2024), Portal BVS (1982-2024) e Embase (1974-2024) e também no metabuscador de evidências TRIP DATABASE (2024). Foram utilizados os termos "COVID-19 Vaccines/adverse effects "[Mesh] Filters: Child: birth-18 years". Dois pesquisadores independentemente extraíram os dados e avaliaram a qualidade dos estudos para a síntese. O desfecho de análise envolveu a efetividade das vacinas para COVID-19 em crianças e adolescentes e a ocorrência de eventos adversos. Resultados: Foram encontradas 552 referências, seis estudos (3 revisões sistemáticas e 3 ensaios clínicos) foram incluídos (n = 13.642.718 participantes). Discussão: Há um número bastante razoável de estudos e amostragem sobre a vacinação para a COVID-19 em crianças e adolescentes. Esses estudos mostram efetividade e segurança das vacinas, sendo a ocorrência de eventos adversos mais associada a efeitos locais leves a moderados e um risco muito baixo de eventos adversos sistêmicos graves. Conclusões: Há evidência de efetividade das vacinas e baixo risco de complicações a elas associado, considerando-se que o risco-benefício justifica sua utilização em crianças e adolescentes nesse momento. Termos DeCS: Prática clínica baseada em evidências, vacina, COVID-19, eventos adversos, revisão.

Percepção dos profissionais de enfermagem sobre manejo de reação infusional a antineoplásicos: estudo qualitativo / Perception of nursing professionals on the management of infusion reactions to antineoplastics: qualitative study

Identificar a percepção dos profissionais de enfermagem sobre o manejo de reação infusional imediata a antineoplásicos. Método: Trata-se de um estudo descritivo de caráter exploratório com abordagem qualitativa realizado em um hospital no Rio Grande do Sul. Resultados: Todos os participantes afirmaram saber identificar uma reação infusional. Após a identificação da reação, nota-se que a maioria obedeceu a uma ordem de condutas a serem realizadas. Quanto aos cuidados para prevenção das reações infusionais, a maioria dos participantes mencionou a administração de medicamentos pré-quimioterápicos, como antialérgicos e antieméticos. Conclusão: Os achados demonstram que a maioria dos profissionais sabe reconhecer e manejar, porém há a necessidade de treinamentos e padronização das ações.(AU)

To identify the perception of nursing professionals about the management of immediate infusion reactions to antineoplastic drugs. Method: This is a descriptive, exploratory study with a qualitative approach carried out in a hospital in Rio Grande do Sul. Results: All the participants said they knew how to identify an infusion reaction. After identifying the reaction, it was noted that the majority followed an order of conduct to be carried out. As for precautions to prevent infusion reactions, most of the participants mentioned the administration of pre-chemotherapy drugs, such as anti-allergic and anti-emetic drugs. Conclusion: The findings show that most professionals know how to recognize and manage them, but there is a need for training and standardization of actions.(AU)

Identificar la percepción de los profesionales de enfermería sobre el manejo de las reacciones infusionales inmediatas a medicamentos antineoplásicos. Método: Se trata de un estudio descriptivo, exploratorio, con abordaje cualitativo, realizado en un hospital de Rio Grande do Sul. Resultados: Todos los participantes afirmaron saber identificar una reacción a la infusión. Después de identificar la reacción, la mayoría siguió un orden de conducta. En cuanto a las precauciones para prevenir las reacciones a la infusión, la mayoría de los participantes mencionó la administración de fármacos prequimioterápicos, como antialérgicos y antieméticos. Conclusión: Los hallazgos muestran que la mayoría de los profesionales saben reconocerlas y manejarlas, pero es necesaria la formación y la estandarización de actuaciones.(AU)

Fatores associados ao comprometimento da segurança do paciente na unidade de terapia intensiva / Factors associated with the commitment of patient safety in the intensive care unit / Factores asociados al compromiso de la seguridad del paciente en la unidad de cuidados intensivos

Objetivo: conhecer os fatores associados ao comprometimento da segurança do paciente. Método: trata-se de um artigo de revisão integrativa da literatura a partir das bases de dados Scientific Electrônic Library Online, PubMed e Literatura Latino-americana e do Caribe em Ciências da Saúde, realizada entre abril e maio de 2022. Resultados: foi visto os principais fatores que corroboram para o comprometimento da segurança, sendo a utilização inadequada dos equipamentos, falta de rotina e ausência de protocolo no setor. Foi detectado a problemática da carga exacerbada de trabalho. Conflitos na equipe também foi tido como um preditor para existência de evento adverso. E por fim, o quesito da subnotificação dos erros. Conclusão: é visto a necessidade da gestão reverter esses problemas, para que a assim a porcentagem de erros seja diminuída.

Objective: to know the factors associated with compromised patient safety. Method: this is an integrative literature review article based on the Scientific Electronic Library Online, PubMed and Latin American and Caribbean Literature in Health Sciences databases, carried out between April and May 2022. Results: it was seen the main factors that corroborate for the compromise of safety, being the inadequate use of equipment, lack of routine and lack of protocol in the sector. The problem of exacerbated workload was detected. Conflicts in the team was also considered a predictor for the existence of an adverse event. And finally, the issue of underreporting of errors. Conclusion: the need for management to reverse these problems is seen, so that the percentage of errors is reduced.

Objetivos:conocer los factores asociados a la seguridad del paciente comprometida. Método: este es un artículo de revisión integradora de la literatura basado en las bases de datos Scientific Electronic Library Online, PubMed y Latin American and Caribbean Literature in Health Sciences, realizado entre abril y mayo de 2022. Resultados: se vieron los principales factores que corroboran para el compromiso de seguridad, siendo el uso inadecuado de equipos, falta de rutina y falta de protocolo en el sector. Se detectó el problema de la sobrecarga de trabajo. Los conflictos en el equipo también fueron considerados predictores de la existencia de un evento adverso. Y por último, el tema del subregistro de errores. Conclusión: se ve la necesidad de que la gestión revierta estos problemas, de modo que se reduzca el porcentaje de errores.

Sistemas de notificación de eventos adversos como estrategia para la cultura de calidad y seguridad del paciente / Adverse event reporting systems as a strategy for a culture of quality and patient safety

Introducción: el objetivo de los Sistemas de Notificación de Eventos Adversos, Eventos Centinela y Cuasifallas, es conocer la frecuencia con la que se presentan y generar las estrategias para su disminución y la no repetición de dichos eventos. Se debe informar al personal de salud involucrado en los procesos de atención, principalmente a quienes tienen contacto directo con los pacientes. Desarrollo: se realizó una revisión bibliográfica conceptual y de investigación sobre los sistemas de notificación de eventos adversos. La búsqueda y selección de artículos publicados de 2016 a 2021, fue en la base de datos PubMed y el índice de revistas de acceso abierto Medigraphic, mediante los siguientes criterios de búsqueda en español e inglés: sistemas de notificación, evento adverso, evento centinela, sistema VENCER, Instituto Mexicano del Seguro Social, Secretaría de Salud; así como el uso del operador booleano AND: Notificatión AND adverse event, notification system AND sentinel event, adverse event AND quality plan. Se obtuvo un aproximado de 194 resultados, de los cuales se seleccionaron los artículos que se apegaban al objetivo de esta revisión. Conclusiones: con la presente revisión bibliográfica se muestra que la notificación de los eventos adversos por parte del personal de la salud involucrados en los procesos de atención, adquiere especial relevancia cuando ésta es proporcional a la adquisición de luna cultura de calidad y seguridad en la atención de los pacientes... (AU)

Abstract Introduction: The objective of the Notification Systems for Adverse Events, Sentinel Events and Near Failures is to know the frequency with which they occur and to generate strategies for their reduction and non-repetition of said events. Health personnel involved in the care processes should be informed, mainly those who have direct contact with patients. Development: A conceptual and research literature review on adverse event reporting systems was carried out. The search and selection of articles published from 2016 to 2021 was in the PubMed database and the Medigraphic open access journal index, using the following search criteria in Spanish and English: notification systems, adverse event, sentinel event, VENCER system, Mexican Institute of Social Security, Ministry of Health, as well as the use of the boolean operator AND: Notification AND adverse event, notification system AND sentinel event, adverse event AND quality plan. An approximate of 194 results were obtained, from which the articles that met the objective of this review were selected. Conclusions: This bibliographic review shows that the notification of adverse events by health personnel involved in care processes acquires special relevance when it is proportional to the acquisition of a culture of quality and safety in care. from the patients.

Nursing evaluation of pediatric preoperative anxiety: a qualitative study / Avaliação de enfermagem da ansiedade pré-operatória pediátrica: um estudo qualitativo? / Evaluación enfermera de la ansiedad prequirúrgica pediátrica: estudio cualitativo

Abstract Objective: to explore and describe how perioperative nurses assess and interpret the child's behavior before entering the operating room, identifying the strategies they use to reduce anxiety and the proposals for improvements. Method: descriptive qualitative study using semi-structured interviews and participant observation of daily routines. Thematic analysis of data. This study follows the recommended criteria for publication of articles of the qualitative methodology Consolidated Criteria for Reporting Qualitative Research. Results: four topics emerged from the data: a) assessment of anxiety or close communication with the child and their family; b) evaluating what was observed; c) managing anxiety and d) improving the assessment or proposals for improvements in daily practice. Conclusion: nurses assess anxiety in their daily practice through observation using their clinical judgment. The nurse's experience is decisive for the appropriate assessment of the preoperative anxiety in child. Insufficient time between waiting and entering the operating room, lack of information from child and their parents about the surgical procedure, and parental anxiety make it difficult to assess and properly manage anxiety.

Resumo Objetivo: explorar e descrever como as enfermeiras perioperatórias avaliam e interpretam o comportamento da criança antes de entrar na sala de cirurgia, identificando as estratégias que utilizam para minimizar a ansiedade e as propostas de melhoria. Método: estudo qualitativo descritivo utilizando entrevistas semiestruturadas e observação participante das rotinas diárias. Análise temática dos dados. O estudo segue os critérios recomendados para publicação de artigos da metodologia qualitativa Consolidated Criteria for Reporting Qualitative Research. Resultados: quatro temas emergiram dos dados: a) avaliação da ansiedade ou comunicação próxima com a criança e sua família; b) analisando o que foi observado; c) controlando a ansiedade e d) melhorando a avaliação ou propostas de melhoria na prática diária. Conclusão: as enfermeiras avaliam a ansiedade em sua prática diária por meio da observação e usando julgamento clínico. A experiência da enfermeira é decisiva na avaliação adequada da ansiedade pré-operatória da criança. A falta de tempo entre a espera e o momento de entrar na sala de cirurgia, a escassez de informação que a criança e os pais têm sobre o processo cirúrgico e a ansiedade dos pais, dificultam a avaliação e o controle adequado da ansiedade.

Resumen Objetivo: explorar y describir cómo las enfermeras perioperatorias evalúan e interpretan el comportamiento del niño antes de entrar a quirófano, identificando las estrategias que utilizan para minimizar la ansiedad y las propuestas de mejora. Método: estudio cualitativo descriptivo mediante entrevistas semiestructuradas y observación participante de las rutinas diarias. Análisis temático de los datos. El estudio sigue las recomendaciones de criterios para la publicación de artículos de metodología cualitativa Consolidated Criteria for Reporting Qualitative Research. Resultados: cuatro temas surgieron de los datos: a) evaluación de la ansiedad o comunicación estrecha con el niño y su familia; b) valorando lo observado; c) manejando la ansiedad y d) mejorando la evaluación o propuestas de mejora para la práctica diaria. Conclusión: enfermeras evalúan la ansiedad en su práctica diaria de forma observacional utilizando el juicio clínico. La experiencia de la enfermera es determinante en la adecuada evaluación de la ansiedad prequirúrgica del niño. La falta de tiempo entre la espera y el momento de entrar a quirófano, la mala información que tiene el niño y los padres sobre el proceso quirúrgico y la ansiedad de los padres dificultan la evaluación y el manejo correcto de la ansiedad.

Atención farmacéutica en pacientes con inmunodeficiencia adquirida y/o tuberculosis en el área ambulatoria de un hospital pediátrico / Pharmacovigilance in patients with acquired immunodeficiency and/or tuberculosis in the outpatient area of a pediatric hospital

La Atención farmacéutica (AF) ayuda a los pacientes a alcanzar objetivos terapéuticos reduciendo los problemas relacionados al medicamento (PRM). Objetivos: analizar los PRM en la práctica de la AF a pacientes con inmunodeficiencia adquirida (IDA) y/o tuberculosis (TBC) y evaluar su impacto. Método: estudio, descriptivo, observacional, en el área ambulatoria de Farmacia. Se incluyeron pacientes con IDA y/o TBC con: inicio de tratamiento, polifarmacia, reinternaciones frecuentes, regular/mala adherencia, reacciones adversas a medicamentos (RAM) previas y/o comorbilidades. Se entrevistaron pacientes o cuidadores y se registraron PRM, errores, grados de adherencia y conocimiento farmacoterapéutico, retiro oportuno de medicamentos y parámetros clínicos. Se registró la intervención farmacéutica y entregó material educativo. Se repitieron las mediciones en una segunda entrevista. Resultados: Se estudiaron 54 pacientes (28 con IDA y 26 con TBC). Se realizaron 93 intervenciones (29.9% dirigidas al prescriptor, 27.8% a otros profesionales) y se detectaron 8 RAM y 53 errores (28 IDA y 25 TBC), el principal PRM fue la mala/regular adherencia con bajo porcentaje de conocimiento farmacoterapéutico completo. Después de la AF, en IDA el grado de adherencia tuvo una mejora estadísticamente significativa (p= 0.012), también fue significativa la mejora en el retiro oportuno de la medicación (28.6% a 71.4% p=0.005 IDA). Se obtuvieron resultados favorables de carga viral (CV) en 72% pacientes con IDA y aumento de peso en 92% pacientes con TBC, aunque no fueron estadísticamente significativos. Conclusiones: mediante AF se mejoró la adherencia y la comunicación en pacientes pediátricos con IDA y/o TBC (AU)

Pharmacovigilance (PV) helps patients achieve therapeutic goals by reducing drug-related problems (DRP). Objectives: to analyze DRPs in the practice of PV in patients with acquired immunodeficiency (AIDS) and/or tuberculosis (TB) and to evaluate its impact. Methods: A descriptive, observational study was conducted in the outpatient pharmacy area. Patients with AIDS and/or TB with: treatment initiation, polypharmacy, frequent readmissions, regular/poor adherence, previous adverse drug reactions (ADR) and/or comorbidities were included. Patients or caregivers were interviewed, and DRP, errors, adherence and pharmacotherapeutic knowledge, timely drug withdrawal, and clinical parameters were recorded. The pharmaceutical intervention was recorded and educational material was delivered. Measurements were repeated in a second interview. Results: We studied 54 patients (28 with AIDS and 26 with TB). Ninety-three interventions were performed (29.9% addressed to the drug prescriber, 27.8% to other professionals) and 8 ADRs and 53 errors were detected (28 AIDS and 25 TB). The main DRP was poor/regular adherence together with a low level of complete pharmacotherapeutic knowledge. After PV, in patients with AIDS the degree of adherence statistically significantly improved (p= 0.012). The improvement in timely medication withdrawal was also significant (28.6% vs. 71.4% p=0.005 AID). Favorable viral load results were obtained in 72% of patients with AIDS and weight gain in 92% of patients with TB, although they were not statistically significant. Conclusions: PV improved adherence and communication in pediatric patients with AIDS and/or TB (AU)

Efecto de los fármacos en la prolongación del QT y la aparición de muerte súbita en la COVID-19 / Effect of Drugs on QT Prolongation and Sudden Death in COVID-19

Introducción: Las evidencias científicas han demostrado que durante el período pandémico por la COVID-19 ha existido un incremento de la incidencia de muerte súbita cardiovascular, proporcional al incremento de los casos y a la letalidad por la enfermedad. Objetivos: Compilar información sobre los fármacos empleados en el tratamiento de la COVID-19 y sus posibles efectos en la prolongación del intervalo QT y la aparición de muerte súbita. Métodos: Se realizó una búsqueda de información a partir de las bases de datos PubMed, Medline y SciELO, en los idiomas español e inglés en el período de enero de 2020 a enero de 2023. Resultados: Los hallazgos más recientes sugieren que los factores relacionados con el tratamiento médico del paciente para sus enfermedades cardiovasculares previas, el empleo concomitante de drogas para otras comorbilidades, el ensayo de nuevas drogas que se investigan en la actualidad para el tratamiento de la enfermedad y el uso inadecuado de fármacos en complicaciones graves por la COVID-19, pueden ocasionar prolongación del intervalo QT y arritmias ventriculares tipo torsades de pointes, lo que puede conllevar a la aparición de muerte súbita. Conclusiones: Ha sido demostrado el efecto deletéreo de los fármacos en el tratamiento de la COVID-19 y sus posibles asociaciones a la terapéutica del paciente, en la prolongación del tiempo de repolarización ventricular cardíaca, cuya traducción eléctrica es un intervalo QT prolongado y su contribución a la génesis de arritmias malignas potencialmente fatales capaces de desencadenar un paro cardíaco y evolucionar a la muerte súbita(AU)

Scientific evidence has shown an increase in the incidence of sudden cardiovascular death during the COVID-19 pandemic period. This has been proportional to the increase in cases and mortality from the disease. Direct and indirect injury to the myocardium and vascular system allow to partially explain the statistics. Among the factors related to the medical treatment of the patient for previous cardiovascular diseases, it is the concomitant use of drugs for other comorbidities. The trial of new drugs for the treatment of this condition and the inappropriate use of drugs in serious complications from COVID-19 are currently being investigated. These can cause QT prolongation and torsades de pointes ventricular arrhythmias, which can lead to sudden death. Monitoring the QT interval is recommended, before and during treatment, in patients who come to the emergency room with a clinical condition suggestive of COVID-19. Additionally, modifiable factors favoring its prolongation should be evaluated. Decision-making in the application of therapeutic protocols in patients with COVID-19 with prolonged QTc at baseline, or with increased QTc after starting treatment, must go through the analysis of the risk/benefit ratio defined by a multi- and interdisciplinary team(AU)

Fatores Associados aos Triggers e Eventos Adversos em Pediatria / Factors Associated with Triggers and Adverse Events in Pediatrics

Introdução: A ocorrência frequente de eventos adversos durante a internação hospitalar demanda meios proativos de gerenciamento de riscos, incluindo a verificação de rastreadores/triggers. Objetivo: verificar os fatores associados aos triggers e eventos adversos na internação pediátrica. Material e Métodos: Pesquisa transversal embasada na metodologia do Institute for Healthcare Improvement (IHI), por meio da aplicação do Paediatric Trigger Tool (PTT) a uma amostra (n=194) de prontuários de pacientes pediátricos de um hospital do Centro-Oeste do Brasil. Foi realizada análise estatística descritiva, inferencial e regressão de Poisson. Resultados: Mais da metade (n=107; 55,15%) dos pacientes apresentou pelo menos um trigger na internação. Foram identificados 204 triggers/gatilhos, com maior ocorrência de queda de hemoglobina/hematócrito (9,80%), queda de saturação de oxigênio (9,80%) e aumento de marcadores de funções renais (9,20%). Do total de gatilhos, 64 (31,37%) eventos adversos foram confirmados, os quais foram classificados majoritariamente como dano temporário com necessidade de suporte ao paciente (65,62%). O tempo de internação (p-valor=0,004) e o caráter da internação (p-valor<0,001) foram variáveis associadas à ocorrência de triggers. Caráter de internação e admissões provenientes de outras instituições foram preditores na ocorrência de triggers e eventos adversos. Discussão: O estudo encontrou 31,37% dos triggers resultando em danos ao paciente, a detecção precoce é essencial na segurança do paciente pediátrico, internações prolongadas estão ligadas a infecções e eventos adversos, transferências de pacientes exigem medidas de segurança rigorosas e eficazes. Conclusões: internações prolongadas e crianças admitidas via transferência merecem atenção a triggers e/ou eventos adversos concretizados.

Introduction: The frequent occurrence of adverse events during hospital admission demands proactive means of risk management, including checking trackers/triggers. Objective: to verify the factors associated with triggers and adverse events in pediatric hospitalization. Material and Methods: Cross-sectional research based on the Institute for Healthcare Improvement (IHI) methodology, through the application of the Pediatric Trigger Tool (PTT) to a sample (n= 194) from medical records of pediatric patients from a hospital in the Center-West of Brazil. Descriptive, inferential statistical analysis and Poisson regression were performed. Results: More than half (n=107; 55.15%) of patients had at least one trigger upon admission. 204 triggers were identified, with the highest occurrence of a drop in hemoglobin/hematocrit (9.80%), a drop in oxygen saturation (9.80%) and an increase in kidney function markers (9.20%). Of the total triggers, 64 (31.37%) adverse events were confirmed, which were mostly classified as temporary damage requiring patient support (65.62%). The length of stay (p-value=0.004) and the nature of the hospitalization (p-value<0.001) were variables associated with the occurrence of triggers. Character of hospitalization and admissions from other institutions were predictors of the occurrence of triggers and adverse events. Discussion: The study found 31.37% of triggers resulting in harm to the patient, early detection is essential in pediatric patient safety, prolonged hospitalizations are linked to infections and adverse events, patient transfers require rigorous and effective safety measures. Conclusions: Prolonged hospitalizations and children admitted via transfer deserve attention to triggers and/or adverse events.

Introducción: La frecuente aparición de eventos adversos durante el ingreso hospitalario exige medios proactivos de gestión de riesgos, incluida la verificación de rastreadores/disparadores. Objetivo: verificar los factores asociados a desencadenantes y eventos adversos en la hospitalización pediátrica, Material y Métodos: Investigación transversal basada en la metodología Institute for Healthcare Improvement (IHI), mediante la aplicación del Pediatric Trigger Tool (PTT) a una muestra (n= 194) de historias clínicas de pacientes pediátricos de un hospital del Centro-Oeste de Brasil. Se realizaron análisis estadísticos descriptivos, inferenciales y regresión de Poisson. Resultados: Más de la mitad (n=107; 55,15%) de los pacientes presentaron al menos un desencadenante al ingreso. Se identificaron 204 desencadenantes, con mayor incidencia de descenso de la hemoglobina/hematocrito (9,80%), descenso de la saturación de oxígeno (9,80%) y aumento de los marcadores de función renal (9,20%). Del total de desencadenantes, se confirmaron 64 (31,37%) eventos adversos, los cuales en su mayoría fueron clasificados como daños temporales que requirieron apoyo del paciente (65,62%). La duración de la estancia (p-valor=0,004) y la naturaleza de la hospitalización (p-valor<0,001) fueron variables asociadas con la aparición de desencadenantes. El carácter de la hospitalización y los ingresos de otras instituciones fueron predictores de la aparición de desencadenantes y eventos adversos. Discusión: El estudio encontró que el 31,37% de los desencadenantes resultan en daño al paciente, la detección temprana es esencial en la seguridad del paciente pediátrico, las hospitalizaciones prolongadas están vinculadas a infecciones y eventos adversos, los traslados de pacientes requieren medidas de seguridad rigurosas y efectivas. Conclusiones: Las hospitalizaciones prolongadas y los niños ingresados ​​vía traslado merecen atención a los desencadenantes y/o eventos adversos.

Múltiples reacciones adversas graves a fármacos en un paciente luego de la infección por COVID-19: informe de un caso / Drug-induced severe cutaneous adverse reactions in a patient after COVID-19 infection: case report

Durante la pandemia por COVID-19 se observaron diversas reacciones adversas a fármacos. Esto pudo haber estado relacionado con una mayor susceptibilidad inmunológica de los pacientes con SARS-CoV-2 a presentar este tipo de cuadros, así como también con la exposición a múltiples medicamentos utilizados en su tratamiento. Comunicamos el caso de un paciente con una infección respiratoria grave por COVID-19, que presentó 2 reacciones adversas graves a fármacos en un período corto de tiempo. (AU)

During the COVID-19 pandemic, various adverse drug reactions were observed. This could have been related to a greater immunological susceptibility of patients with SARS-CoV-2 to present this type of symptoms, as well as exposure to multiple drugs used in their treatment. We report the case of a patient with a severe respiratory infection due to COVID-19, who presented 2 serious adverse drug reactions associated with paracetamol in a short period of time. (AU)

Ocorrência de pneumotórax como evento adverso relacionado assistência à saúde / Ocorrência de pneumotórax como evento adverso relacionado assistência à saúde / Presence of pneumorax as an adverse event related to health care

Introdução: O acesso venoso central é definido como a colocação de um cateter com sua extremidade posicionada na veia cava ou no átrio direito, tendo diversas funções no manejo do paciente em estado crítico. Pneumotórax causado durante a inserção do cateter é um incidente que resulta em dano ao paciente, sendo assim considerado um evento adverso relacionado à assistência médica. Objetivo: Analisar a ocorrência de pneumotórax como evento adverso relacionado à assistência à saúde após a inserção de um cateter venoso central. Método: Trata-se de um estudo quantitativo, transversal e analítico. Depois de realizar o cálculo amostral para obtenção da amostra, pacientes submetidos à inserção de cateter venoso central na instituição pesquisada no período de abril até setembro de 2022 foram incluídos na pesquisa, a coleta de dados utilizou dados secundários. Resultados: Uma amostra de 103 pacientes foi obtido, dos quais 10 (9,7%) dos pacientes apresentaram pneumotórax relacionado à inserção de cateter venoso central. de pneumotórax. A ocorrência de pneumotórax e o fato de o profissional que inseriu o cateter ser residente. A ocorrência de pneumotórax teve associação significativa (p 0,03) levando ao aumento do tempo de internação. Conclusão: O os resultados encontrados demonstram uma significativa ocorrência do evento adverso relacionado à assistência à saúde pneumotórax, após a inserção do Cateter Venoso Central (CVC). Estratégias voltadas para a segurança do paciente são fundamentais e devem ser perseguidas constantemente.

Introduction: Central venous access is defined as the placement of a catheter with its end positioned in the superior vena cava or in the right atrium, having several functions in the management of the patient in critical condition. Pneumothorax caused during catheter insertion is an incident that results in harm to the patient, thus considered an adverse event related to health care. Objective: To analyze the occurrence of pneumothorax as adverse events related to health care after insertion of a central venous catheter. Method: This is a quantitative, cross-sectional, analytical study. After performing the sample calculation to obtain the sample, patients who underwent insertion of a central venous catheter at the researched institution from April to September 2022 were included in the research, data collection used secondary data. Results: A sample of 103 patients was obtained, of which 10 (9.7%) of the patients had pneumothorax related to the insertion of a central venous catheter. of pneumothorax. The occurrence of pneumothorax and the fact that the professional who inserted the catheter was a resident. The occurrence of pneumothorax had a significant association (p 0.03) leading to increased length of stay. Conclusion: The results found demonstrate a significant occurrence of the adverse event related to pneumothorax health care, after the insertion of the Central Venous Catheter (CVC). Strategies aimed at patient safety are fundamental and must be pursued constantly.(AU)

Introducción: El acceso venoso central se define como la colocación de un catéter con su extremo posicionado en la vena cava superior o en la aurícula derecha, teniendo varias funciones en el manejo del paciente en estado crítico. El neumotórax causado durante la inserción del catéter es un incidente que resulta en daño para el paciente, por lo que se considera un evento adverso relacionado con la atención a la salud. Objetivo: Analizar la ocurrencia de neumotórax como eventos adversos relacionados con la atención a la salud después de la inserción de un catéter venoso central. Método: Se trata de un estudio cuantitativo, transversal, analítico. Después de realizar el cálculo de la muestra para la obtención de la muestra, se incluyeron en la investigación los pacientes que se sometieron a la inserción de un catéter venoso central en la institución investigada de abril a septiembre de 2022, la recolección de datos utilizó datos secundarios. Resultados: Se obtuvo una muestra de 103 pacientes, de los cuales 10 (9,7%) de los pacientes presentaron neumotórax relacionado con la inserción de un catéter venoso central. La ocurrencia de neumotórax y el hecho de que el profesional que insertó el catéter fuera residente. La ocurrencia de neumotórax tuvo una asociación significativa (p 0,03) que condujo a una mayor duración de la estancia. Conclusión: Los resultados encontrados demuestran una ocurrencia significativa del evento adverso relacionado con la atención de salud del neumotórax, después de la inserción del Catéter Venoso Central (CVC). Las estrategias dirigidas a la seguridad del paciente son fundamentales y deben ser seguidas constantemente.(AU)

Reações adversas medicamentosas em pacientes em quimioterapia e estratégias de intervenções / Adverse drug reactions in chemotherapy patients and intervention strategies / Reacciones adversas a medicamentos en pacientes quimioterápicos y estrategias de intervención

A quimioterapia do câncer pode ocasionar reações adversas medicamentosas (RAM), podendo resultar de interações medicamentosas (IM) e impactar na adesão. O presente estudo relatou as RAM apresentadas por pacientes em quimioterapia (QT) e propôs estratégias de intervenções. Este trabalho foi aprovado em comité de ética (5.160.503), sendo incluídos 23 pacientes em quimioterapia (oral- VO e/ou endovenosa- EV) e todos foram entrevistados. Recebiam apenas o QTEV, 20 pacientes e 2 QTEV e VO, a maioria em tratamento paliativo (50%), predomínio de estadiamento IV, sendo as doenças mais presentes de pâncreas (27,3%), estômago (22,7%) e mama (18,2%) e esquema mais usado foi Carboplatina + Paclitaxel. As principais comorbidades foram diabetes e hipertensão arterial. As interações medicamentosas foram classificadas em graves (45%), moderadas (55%) e intencional (75%), sendo necessário introdução de medicamentos de suporte (61%). Houve RAM de maior gravidade, neutropenia, sendo necessário a suspensão temporária, e de menor gravidade náuseas. Houve um óbito relacionado a evolução de doença e, talvez, o tratamento possa ter contribuído. Ao final, foram feitas as intervenções para cada caso e validado o formulário para a consulta farmacêutica a pacientes oncológicos.

Cancer chemotherapy can cause adverse drug reactions (ADRs), which can result from drug interactions (IM) and impact adherence. The present study reported the ADRs presented by patients undergoing chemotherapy (CT) and proposed intervention strategies. This work was approved by the ethics committee (5,160,503), and 23 patients on chemotherapy (oral-VO and/or intravenous-IV) were included and all were interviewed. Only received CTIV, 20 patients and 2 CTIV and VO, most in palliative treatment (50%), predominance of stage IV, being the most common diseases of pancreas (27.3%), stomach (22.7%) and breast (18.2%) and the most used regimen was Carboplatin + Paclitaxel. The main comorbidities were diabetes and arterial hypertension. Drug interactions were classified as severe (45%), moderate (55%) and intentional (75%), requiring the introduction of supportive drugs (61%). There were more severe ADRs, neutropenia, requiring temporary suspension, and less severe nausea. There was one death related to the evolution of the disease and, perhaps, the treatment may have contributed. At the end, interventions were made for each case and the form for the pharmaceutical consultation to cancer patients was validated.

La quimioterapia contra el cáncer puede causar reacciones adversas a los medicamentos (RAM), que pueden ser consecuencia de interacciones farmacológicas (IM) y repercutir en la adherencia. El presente estudio reportó las RAM presentadas por pacientes en quimioterapia (QT) y propuso estrategias de intervención. Este trabajo fue aprobado en comité de ética (5.160.503), se incluyeron 23 pacientes en quimioterapia (oral- VO y/o endovenosa-EV) y todos fueron entrevistados. Recibieron sólo QTEV, 20 pacientes y 2 QTEV y VO, la mayoría en tratamiento paliativo (50%), predominio de estadiaje IV, siendo las enfermedades más presentes las de páncreas (27,3%), estómago (22,7%) y mama (18,2%) y el esquema más utilizado fue Carboplatino + Paclitaxel. Las principales comorbilidades fueron la diabetes y la hipertensión arterial. Las interacciones farmacológicas se clasificaron como graves (45%), moderadas (55%) e intencionadas (75%), requiriendo la introducción de fármacos de apoyo (61%). La RAM más grave fue la neutropenia, que requirió la suspensión temporal, y la menos grave las náuseas. Hubo una muerte relacionada con la evolución de la enfermedad y, tal vez, el tratamiento pudo haber contribuido. Al final, se realizaron intervenciones para cada caso y se validó el formulario de consulta farmacéutica a pacientes oncológicos.

Statin-related drug-induced liver injury / 中华肝脏病杂志

Statins are a kind of prescription drug that is widely used to treat hyperlipidemia, coronary artery disease, and other atherosclerotic diseases. A common side effect of statin use is a mild rise in liver aminotransferases, which occurs in less than 3% of patients. Statin-related liver injury is most commonly caused by atorvastatin and simvastatin, but severe liver injury is uncommon. Therefore, understanding and evaluating hepatotoxicity and weighing the benefits and risks is of great significance to better realize the protective effect of statins.

Genetic susceptibility to drug-induced liver injury / 中华肝脏病杂志

Drug-induced liver injury (DILI) risk prediction, diagnosis establishment, clinical management, and all other aspects are facing great challenges. Although the current understanding of its pathogenesis is still incomplete, research over the past 20 years has shown that genetic susceptibility may play an important role in the occurrence and development of DILI. In recent years, pharmacogenomics studies have further revealed the association between human leukocyte antigen (HLA) genes, some non-HLA genes, and hepatotoxicity from certain drugs. However, due to the lack of well-designed, prospective, large-sample cohort validation and low positive predictive values, there may still be some way to go before the current results can be truly translated into clinical practice for precise prediction and prevention of DILI risk.

Advances in clinical diagnosis and treatment of drug-induced liver injury in children / 中华肝脏病杂志

Drug-induced liver injury (DILI) is one of the most common adverse drug reactions that may seriously threaten the health of children and is receiving increasing clinical attention day by day. There is still no independent diagnosis and treatment guideline for DILI in children, but its clinical features are not completely similar to those in adults. This article reviews the epidemiology, clinical features, diagnosis, and treatment progress in order to provide a reference for the management of DILI in children.

Efficacy of decitabine combined with low dose chemotherapy on children with acute myeloid leukemia / 中华儿科杂志

Objective: To evaluate the efficacy of decitabine combined with low dose chemotherapy (LDC) in the treatment of high-risk, refractory and relapsed pediatric acute myeloid leukemia (AML). Methods: Clinical data of 19 AML children treated with decitabine combined with LDC in the Department of Hematology, Children's Hospital of Soochow University from April 2017 to November 2019 were analyzed retrospectively. The therapeutic response, adverse effects and survival status were analyzed,and the outcomes of patients were followed up. Results: Among 19 AML cases, there were 10 males and 9 females. Five cases were high-risk AML, 7 cases were refractory AML, and 7 cases were relapsed AML. After one course of decitabine+LDC treatment, 15 cases achieved complete remission, 3 cases got partial remission, and only 1 case didn't get remission. All patients received allogeneic hematopoietic stem cell transplantation as consolidation therapy. The follow-up time of all cases was 46 (37, 58) months, 14 children had survived. The cumulative three-year overall survival rate was (79±9) %, events free survival rates was (68±11) %, and recurrence free survival rate was (81±10) %. The most common adverse effects related to the induction treatment were cytopenia (19 cases) and infection (16 cases).There were no treatment-related death during the therapy. Conclusion: Decitabine combined with LDC is a safe and effective option for high-risk, refractory and relapsed AML children, which provides an opportunity for HSCT.

A Real-world Study on the Incidence and Outcome of Immune-related Adverse Events in Lung Cancer Patients / 中国肺癌杂志

BACKGROUND@#Immune-related adverse events (irAEs) are commonly occurred in patients treated with immune checkpoint inhibitors. However, evidence of irAEs derived from the Chinese population is relatively lacking. The aim of this study was to investigate the incidence and outcomes of irAEs in Chinese patients with lung cancer after receiving immune checkpoint inhibitors (ICIs).@*METHODS@#Clinical and follow-up data from lung cancer patients who received at least one time of ICIs from January 2018 to September 2021 at Huadong Hospital, Fudan University were included. Statistical descriptions and Kaplan-Meier method were used to analyze the overall incidence of irAEs, as well as the incidence and outcomes of each type of irAEs.@*RESULTS@#135 patients were included in the study. 106 patients (78.5%) presented at least one type of irAEs, and the median time to first irAEs onset was 28 d. Most irAEs occurred at early time after treatment, and most irAEs were mild-moderate and reversible. 57 patients (42.2%) died at the study cutoff. The mortality rate of severe irAEs was 12.6% (n=17), and among them 7 patients (41.2%) died of pneumonitis. The median progression-free survival (PFS) and overall survival (OS) time of the total population was 505 d (95%CI: 352-658) and 625 d (95%CI: 491-759), respectively. Patients who presented any irAEs achieved a longer PFS than those who did not (median PFS: 533 d vs 179 d, P=0.037, HR=0.57), while patients who presented skin toxicities achieved a longer OS than patients who did not (median OS: 797 d vs 469 d, P=0.006, HR=0.70).@*CONCLUSIONS@#In real-world settings, irAEs in lung cancer patients were commonly observed, with pneumonitis as the most common fatal irAEs. In addition, patients who presented any irAEs may tend to achieve a longer PFS.

Chinese guideline for diagnosis and management of drug-induced liver injury (2023 version) / 中华肝脏病杂志

Drug-induced liver injury (DILI) is an important adverse drug reaction that can lead to acute liver failure or even death in severe cases. Currently, the diagnosis of DILI still follows the strategy of exclusion. Therefore, a detailed history taking and a thorough and careful exclusion of other potential causes of liver injury is the key to correct diagnosis. This guideline was developed based on evidence-based medicine provided by the latest research advances and aims to provide professional guidance to clinicians on how to identify suspected DILI timely and standardize the diagnosis and management in clinical practice. Based on the clinical settings in China, the guideline also specifically focused on DILI in chronic liver disease, drug-induced viral hepatitis reactivation, common causing agents of DILI (herbal and dietary supplements, anti-tuberculosis drugs, anti-neoplastic drugs), and signal and assessment of DILI in clinical trials.

Research progress on traditional Chinese medicine compounds combined with external therapy in treatment of hyperplasia of mammary glands / 中国中药杂志

Hyperplasia of mammary glands is a benign breast disease with disordered breast structure. Nowadays, the incidence rate of breast hyperplasia in women is increasing year by year, and the etiology is related to the imbalance of estrogen and progesterone in the body. The symptoms include breast pain, breast nodules, or nipple discharge, which can develop into breast cancer in the context of psychological pressure. Therefore, it is timely and effectively necessary for people to treat the symptoms. At present, traditional Chinese medicine(TCM) often treats breast hyperplasia by oral drug, external application, acupuncture, moxibustion, and massage, while western medicine often uses hormone therapy or surgery. TCM can regulate hormone levels to treat breast hyperplasia. Acupuncture, moxibustion, and other methods can stimulate acupoints to reduce breast lumps. However, since TCM is easy to produce hepatorenal toxicity after long-term use and simple external treatment is slow to take effect, rapid and effective treatment is difficult to be achieved. Although western medicine can inhibit the disease, it is easy to produce toxic and side effects if taken for a long time. In addition, surgery can only remove the focus and the recurrence rate is high. Some studies have found that the combination of oral and external use of TCM compounds has a significant effect, with mild toxic and side effects, few adverse reactions, and a low recurrence rate. Based on the relevant literature in recent years, this article reviewed the combination of oral and external treatment of TCM in the treatment of hyperplasia of mammary glands, discussed the effectiveness, clinical evaluation indexes, and mechanism, and pointed out the existing shortcomings to explore a comprehensive therapy worthy of clinical application.

Comparison of oxycodone and sufentanil in patient-controlled intravenous analgesia for postoperative patients: a meta-analysis of randomized controlled trials / 中华医学杂志(英文版)

BACKGROUND@#Managing acute postoperative pain is challenging for anesthesiologists, surgeons, and patients, leading to adverse events despite making significant progress. Patient-controlled intravenous analgesia (PCIA) is a recommended solution, where oxycodone has depicted unique advantages in recent years. However, controversy still exists in clinical practice and this study aimed to compare two drugs in PCIA.@*METHODS@#We performed a literature search in PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, Chinese National Knowledge Infrastructure, Wanfang, and VIP databases up to December 2020 to select specific randomized controlled trials (RCTs) comparing the efficacy of oxycodone with sufentanil in PCIA. The analgesic effect was the primary outcome and the secondary outcome included PCIA consumption, the Ramsay sedation scale, patients' satisfaction and side effects.@*RESULTS@#Fifteen RCTs were included in the meta-analysis. Compared with sufentanil, oxycodone showed lower Numerical Rating Scale scores (mean difference [MD] = -0.71, 95% confidence interval [CI]: -1.01 to -0.41; P < 0.001; I2 = 93%), demonstrated better relief from visceral pain (MD = -1.22, 95% CI: -1.58 to -0.85; P < 0.001; I2 = 90%), promoted a deeper sedative level as confirmed by the Ramsay Score (MD = 0.77, 95% CI: 0.35-1.19; P < 0.001; I2 = 97%), and resulted in fewer side effects (odds ratio [OR] = 0.46, 95% CI: 0.35-0.60; P < 0.001; I2 = 11%). There was no statistical difference in the degree of patients' satisfaction (OR = 1.13, 95% CI: 0.88-1.44; P = 0.33; I2 = 72%) and drug consumption (MD = -5.55, 95% CI: -14.18 to 3.08; P = 0.21; I2 = 93%).@*CONCLUSION@#Oxycodone improves postoperative analgesia and causes fewer adverse effects, and could be recommended for PCIA, especially after abdominal surgeries.@*REGISTRATION@#PROSPERO; https://www.crd.york.ac.uk/PROSPERO/; CRD42021229973.

Chinese multidisciplinary expert consensus on the management of adverse drug reactions associated with savolitinib / 中华肿瘤杂志

MET gene is a proto-oncogene, which encodes MET protein with tyrosine kinase activity. After binding to its ligand, hepatocyte growth factor, MET protein can induce MET dimerization and activate downstream signaling pathways, which plays a crucial role in tumor formation and metastasis. Savolitinib, as a specific tyrosine kinase inhibitor (TKI) targeting MET, selectively inhibits the phosphorylation of MET kinase with a significant inhibitory effect on tumors with MET abnormalities. Based on its significant efficacy shown in the registration studies, savolitinib was approved for marketing in China on June 22, 2021 for the treatment of advanced non-small cell lung cancer with MET 14 exon skipping mutations. In addition, many studies have shown that MET TKIs are equally effective in patients with advanced solid tumors with MET gene amplification or MET protein overexpression, and relevant registration clinical studies are ongoing. The most common adverse reactions during treatment with savolitinib include nausea, vomiting, peripheral edema, pyrexia, and hepatotoxicity. Based on two rounds of extensive nationwide investigations to guide clinicians, the consensus is compiled to use savolitinib rationally, prevent and treat various adverse reactions scientifically, and improve the clinical benefits and quality of life of patients. This consensus was prepared under the guidance of multidisciplinary experts, especially including the whole-process participation and valuable suggestions of experts in Traditional Chinese Medicine, thus reflecting the clinical treatment concept of integrated Chinese and western medicines.