Detección de eventos adversos en pacientes internados en clínica médica utilizando la herramienta Global Trigger Tool / Detection of adverse events in patients interned in medical clinic using the Global Trigger Tool

Resumen Introducción : El Global Trigger Tool (GTT) es una herramienta que identifica con precisión los eventos adversos, estos representan un problema relevante y prevenible en los hospitales. Métodos : Estudio de corte transversal basado en la revisión retrospectiva de historias clínicas aleatorizadas utilizando el GTT. Resultados : Se detectaron 161 eventos adversos (EA): 51 por cada 100 admisiones, 66 por cada 1000 días pa ciente y 30% de admisiones con EA. Los disparadores más frecuentes fueron del módulo cuidados, 25% com plicaciones asociadas al uso de procedimientos, 10% úlceras por presión y 9% infecciones asociadas a la atención. La presencia de EA tuvo asociación estadís ticamente significativa con estancia mayor a 5 días, y asociación moderada con edad y número de disparado res. En cuanto al daño, 78% de los pacientes presentaron eventos leves y 4% eventos fatales. En el análisis con cur vas ROC, los disparadores con mayor área bajo la curva fueron: complicación de procedimientos (0.70), úlceras por presión (0.61) y código de respuesta rápida (0.60). Discusión : Los eventos por 100 admisiones fueron superiores a la bibliografía pero no hubo diferencias en eventos por cada 1000 días paciente. Los casos fatales se produjeron por enfermedades infecciosas respiratorias en pacientes con comorbilidades, necesidad de sonda nasogástrica y deterioro cognitivo. Se destaca la escasa aplicación de la herramienta en hospitales públicos, y la implementación de análisis de disparadores con cur vas ROC. Conocer la frecuencia y el tipo de evento más frecuente permitirá implementar medidas que mejoren la seguridad de los pacientes.

Abstract Introduction : The Global Trigger Tool (GTT) is a tool that accurately identifies adverse events that represent a significant problem in hospitals. Methods : Cross-sectional study based on retrospec tive review of randomized medical records using the GTT tool. Results : A total of 161 adverse events (AEs) were detected: 51 events per 100 admissions, 66 per 1000 patient-days, and 30% of admissions with AEs. The most frequent triggers were from the care module, with 25% complications associated with the use of procedures, 10% pressure ulcers, and 9% care-associated infections. The presence of AEs had a statistically significant asso ciation with a stay of more than 5 days, and a moderate association with age and number of triggers. Regarding the damage, 78% of the patients presented mild events and 4% fatal events. The ROC curves analysis showed that the triggers with the greatest area under the curve were: procedural complication (0.70), pressure ulcers (0.61) and rapid response code (0.60). Discussion : The number of events per 100 admis sions was higher than that reported in the literature, but there were no differences in events per 1000 patient-days. Fatal cases were caused by respiratory infectious diseases in patients with comorbidities, nasogastric tube needs and cognitive decline. The study highlights the scarce use of the tool in public hospitals and the implementation of trigger analysis with ROC curves. Knowing the frequency and the most frequent type of event will allow the implementation of measures that improve patient safety.

Relación entre las variantes genéticas UGT y HLA y eventos adversos asociados al uso de lamotrigina. Revisión sistemática

Introducción: La lamotrigina (LTG) es un fármaco antiepiléptico aromático, en los humanos se usa principalmente en el campo de la neurología y psiquiatría. Existen eventos adversos (EA), secundarios al uso de anticonvulsivantes, por ejemplo, la necrólisis epidérmica tóxica (NET), y el síndrome de Steven Johnson (SSJ), su incidencia está estimada en 1 de 1000 a 10000 exposiciones con una mortalidad mayor al 35 %. Objetivo: Describir la relación entre la presentación de eventos adversos y los polimorfismos de la UGT y HLA en pacientes que usaron lamotrigina. Metodología: Se realizó una revisión sistemática de la literatura, incluyendo una búsqueda en las bases de datos, con estudios del tipo ensayos clínicos controlados aleatorizados y estudios observacionales de cohortes, casos y controles. Resultados: La búsqueda inicial encontró un total de 96 artículos, de los cuales luego de aplicar los criterios de inclusión y exclusión quedaron 8. Conclusiones: Al momento del desarrollo de este estudio, no hay suficiente evidencia que relacione como factor de causalidad las variantes de las HLA y UGT con la predicción de los eventos adversos (EA), con el uso de lamotrigina. Además, es importante decir que en Colombia no tenemos estudios, y que no conocemos estas variantes genéticas por lo tanto la extrapolación no se puede realizar, llevando a recomendar que se deben hacer estudios en población colombiana con las variantes planteadas como posibles relacionadas con los EA a lamotrigina.

Introduction: Lamotrigine (LTG) is an aromatic antiepileptic drug, mainly used in humans in the field of neurology and psychiatry. There are secondary adverse events (AEs) related to the use of anticonvulsants, for example, toxic epidermal necrolysis (TEN) and Steven Johnson syndrome (SJS). Their incidence is estimated at 1 in 1,000 to 10,000 exposures with a mortality greater than 35%. Objective: To describe the relationship between the presentation of adverse events and UGT and HLA polymorphisms in patients who used lamotrigine. Methodology: A systematic review of the literature was carried out, including a database search, with studies such as randomized controlled clinical trials and observational cohort and case-control studies. Results: The initial search found a total of 96 articles. After applying the inclusion and exclusion criteria, only 8 were considered. Conclusions: At the time of the development of this study, there was not enough evidence to relate HLA and UGT variants as a causal factor to predict adverse events (AEs) due to the use of lamotrigine. Furthermore, it is important to say that in Colombia there are no studies, and that we do not know these genetic variants, therefore it is not possible to extrapolate it. Thus the recommendation is that studies should be carried out in the Colombian population using variants proposed as possibly relating AEs. to lamotrigine.

Signal mining and analysis of adverse drug event signals of darolutamide / 中国药房

OBJECTIVE To explore and analyze the adverse drug event （ADE） signals of darolutamide and provide a reference for its clinical safe use. METHODS ADEs related to darotamide were collected based on the US FDA adverse event reporting system （FAERS） database from the third quarter of 2019 to the third quarter of 2022. Data mining and analysis were conducted by the report odds ratio （ROR） and proportional reporting ratio （PRR） methods. RESULTS A total of 565 ADE reports related to darolutamide were extracted， 356 ADE reports about darolutamide as the primary suspected drug were included， 38 ADE signals with darolutamide as the primary suspected drug were excavated， involving 15 system organ class （SOC）， mainly concentrated in patients over 65 years old. The SOC of darotamide ADE signal mainly focused on various examinations， systemic diseases and various reactions at the administration site， benign/malignant tumors or those with unknown nature （including cystic and polypoid）， kidney and urinary system diseases. A total of 13 ADE signals not mentioned in the instructions included increased prostate-specific antigen， dysphagia， cognitive impairment， erectile dysfunction， rhabdomyolysis， gynecomastia and decreased platelet count， etc. CONCLUSIONS When using darolutamide， in addition to ADE in the drug instruction， we should pay close attention to potential ADE， such as increased prostate-specific antigen， rhabdomyolysis， gynecomastia and decreased platelet count， so as to avoid drug withdrawal or organ damage caused by ADE.

Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system / 中国药房

OBJECTIVE To provide reference for the clinically safe application of acalabrutinib by mining and analyzing the risk signals of adverse drug events （ADE）. METHODS The acalabrutinib-induced ADE reports were extracted from the U.S. FDA adverse event reporting system using the OpenVigil 2.1 platform from November 1， 2017 to March 31， 2023. The reporting odds ratio （ROR） method and composite criteria method from the Medicines and Healthcare Products Regulatory Agency （MHRA） were used for detection of ADE signals. RESULTS There were 7 869 ADE reports of acalabrutinib as the primary suspect drug and 142 ADE positive signals were detected from them， involving 20 system organ classes， which was generally consistent with the ADE recorded in the drug instruction of acalabrutinib， mainly involving general disorders and administration site conditions， various inspection， blood and lymphatic system disorders， various neurological disorders and cardiac disorders. In addition， this study identified several new potential ADE signals that were not mentioned in the drug instruction， including sudden cardiac death， pulmonary toxicity， tumor lysis syndrome， pleural effusion， dyspepsia， gastroesophageal reflux disease， bone pain， decreased blood pressure， and abnormal blood sodium， etc. CONCLUSIONS When using acalabrutinib， in addition to paying attention to the ADE recorded in its instructions， the risk of serious ADE that may lead to death， such as sudden cardiac death and pulmonary toxicity， should also be evaluated to avoid or reduce the occurrence of ADE as much as possible.

Factores de riesgo en la Bulimia Nerviosa (BN): elementos claves de seguridad en el cuidado de la salud. Una revisión de la literatura / Bulimia nervosa risk factors (BN): key elements of health care security. A review of the literature

Resumen Se realizó una revisión de literatura con el objetivo de identificar los factores de riesgo de la BN, utiles para que el equipo de salud proteja la seguridad de sus intervenciones y atención a las personas que padecen este trastorno en el ciclo de vida adolescente y joven. Se hizo una búsqueda en bases de datos y repositorios, con uso de términos libres como: BN, adolescente, factor de riesgo, trastorno de conducta alimentaria, en español e inglés, combinados con operadores boleanos (AND, OR, NOT) y de posición (WTH y NEAR). Se incluyeron 72 documentos tras la selección por criterios de inclusión, se hizo depuración de ellos según sus datos bibliográficos, objetivo, tipo de estudio, resultados y conclusión. Los resultados muestran que hay aún factores biológicos por rastrear y analizar, dentro de los sociodemográficos, la edad de afectación principalmente reportada es la adolescencia y adultez joven, no hubo diferencias por raza o nivel socioeconómico. Factores comportamentales como preocupación por la imagen corporal, dietas y ejercicio son documentados. Desde el área psicosocial, la disfuncionalidad individual y los antecedentes de trastornos psicológicos, la familia y el entorno cultural condicionan para que el cuerpo logre su delgadez. La conclusión general sugiere que la seguridad de la atención en la BN está en explorar los antecedentes individuales, biológicos, psicológicos y comportamentales; reconocer dinámicas familiares y la influencia del entorno social. Asimismo, es útil, el trabajo interdisciplinar e integración de red de apoyo familiar para lograr atención segura en la BN.

Abstract Review of literature aimed at recognizing risk factors of BN, useful for the health team to protect the safety of their interventions and care for people suffering from this disorder in the adolescent and young life cycle. It consists of a narrative review, carried out by means of search in databases and repositories, with use of free terms such as: BN, adolescent, risk factor, food behavior disorders, in Spanish and English, combined with bolean operators (AND, OR, NOT) and position (WTH and NEAR). Seventy-two sources were incorporated, documents were selected by inclusion criteria, review according to bibliographic data, objective, type of study, results, and conclusion. The results show that there are still biological factors to be traced and analyzed, within the sociodemographic the age of involvement is adolescence and youth, it does not have differences by race or socioeconomic level. Behavioral factors such as concern for body image, diets and exercise are documented. From the psychosocial area, individual dysfunction and backgrounds of psychological disorders, the family and the cultural environment influence to achieve the thinness of the body. The general conclusion suggests that the safety of care in the BN lies in exploring the individual, biological, psychological and behavioral backgrounds, recognizing family dynamics and the influence of the social environment. It is useful, interdisciplinary work and integration of family support network to achieve safe health care in the BN.

Hepatotoxicidad inducida por clozapina: reporte de caso y revisión breve de la literatura

Introducción: Los antipsicóticos son medicamentos que pueden producir elevaciones transitorias de las enzimas hepáticas. La clozapina es un antipsicótico atípico usado en el tratamiento de la esquizofrenia refractaria a los antipsicóticos convencionales y existe evidencia que puede producir elevaciones de las transaminasas hepáticas, expresión de dafño hepático con patrón hepatocelular. Métodos: Reporte de caso y revisión no sistemática de la literatura relevante. Presentación del caso: Una mujer de 39 años con diagnóstico de esquizofrenia paranoide acudió a un servicio de urgencias de un hospital general por náuseas, vómitos e ictericia que apareció tras el inicio de clozapina. No hubo mejoría clínica de la paciente durante la hospitalización, que falleció a los 44 días de su ingreso. Revisión de la literatura: La clozapina puede elevar las cifras de función hepática de manera transitoria y asintomática. Hay criterios clínicos para recomendar la suspensión de este antipsicótico. Conclusiones: Este caso es el tercero en la literatura que registra un desenlace fatal tras un cuadro de hepatotoxicidad inducido por clozapina. © 2021 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España, S.L.U. Todos los derechos reservados.

Introduction: Antipsychotics are drugs that can produce transient elevations of hepatic enzymes. Clozapine is an atypical antipsychotic used in treatment-resistant schizophrenia and there is evidence that it can produce elevations of hepatic transaminases, expression of liver damage in a hepatocellular pattern. Methods: Case report and non-systematic review of the relevant literature. Case presentation: A 39-year-old woman with a diagnosis of paranoid schizophrenia attended the emergency department of a general hospital for nausea, vomiting and jaundice that appeared after the initiation of clozapine. There was no clinical improvement during hospitalization, and death occurred after 44 days. Literature review: Clozapine can increase the liver enzyme levels transiently and asymptomatically; however, there are clinical criteria that recommend the withdrawal of the antipsychotic. Conclusions: This is the third case reported in the literature of a fatal outcome of clozapine-induced hepatotoxicity.

Acute abducens nerve palsy with acute disseminated encephalomyelitis-like presentation following COVID-19 vaccination

We report two adult cases of abducens nerve palsy presenting immediately (within weeks) after they received the first dose of Covishield vaccination. Magnetic resonance imaging (MRI) of the brain obtained after the onset of diplopia demonstrated demyelinating changes. The patients had associated systemic symptoms. Post-vaccination demyelination typically known as acute disseminated encephalomyelitis (ADEM) associated with several vaccines is more common in children. Although the mechanism of the nerve palsy remains unclear, it is suspected to be related to the post-vaccine neuroinflammatory syndrome. Cranial nerve palsies and ADEM-like presentations may represent part of the neurologic spectrum following COVID-vaccination in adults, and ophthalmologists should be aware of these sequelae. Although cases of sixth nerve palsy following COVID vaccination are already reported, associated MRI changes have not been reported from India.

COVID-19 vaccination in children: a public health priority

Abstract Objective: Covid-19 had a direct impact on children's health. The aim of this review was to analyze epidemiological and clinical data, the consequences of the pandemic, and vaccination aspects in this group. Sources of data: The searches were carried out from January 2020 to November 2022, in the MEDLINE databases (PubMed) and publications of the Brazilian Ministry of Health and the Brazilian Society of Pediatrics. Summary of findings: Covid-19 has a mild presentation in most children; however, the infection can progress to the severe form and, in some cases, to MIS-C. The prevalence of the so-called long Covid in children was 25.24%. Moreover, several indirect impacts occurred on the health of children and adolescents. Vaccination played a crucial role in enabling the reduction of severe disease and mortality rates. Children and adolescents, as a special population, were excluded from the initial clinical trials and, therefore, vaccination was introduced later in this group. Despite its importance, there have been difficulties in the efficient implementation of vaccination in the pediatric population. The CoronaVac vaccines are authorized in Brazil for children over three years of age and the pediatric presentations of the Pfizer vaccine have shown significant effectiveness and safety. Conclusions: Covid-19 in the pediatric age group was responsible for the illness and deaths of a significant number of children. For successful immunization, major barriers have to be overcome. Real-world data on the safety and efficacy of several pediatric vaccines is emphasized, and the authors need a uniform message about the importance of immunization for all children.

Complete atrioventricular block secondary to the BBIBP-CorV vaccine The report of a rare adverse event; the first description in Colombia

Introduction: cardiovascular complications due to COVID-19 infection are very frequent. However, these complications are rarely reported as a vaccine reaction. Case presentation: a female patient with no significant cardiovascular history developed functional class deterioration 14 days after her third dose of the BBIBP-CorV vaccine, along with three syncopal episodes. She was seen at a primary care level and an electrocardiogram was ordered which showed Mobitz 2 atrioventricular block which progressed to a complete block. Molecular tests for COVID-19 infection were negative, as were immunological studies for collagen disease, Chagas, and viral myocarditis. A transthoracic echocardiogram showed no regional kinetic disturbances, and the ejection fraction was preserved at 60%. Cardiac magnetic resonance imaging showed edema in the T2-STIR sequences, and subepicardial enhancement in the medial distal lateral region was compatible with acute myocarditis. The patient required a permanent pacemaker. Discussion: electrical or mechanical dysfunction secondary to a COVID-19 vaccine is anecdotal, with few reports in the literature. In a review of both the 2021 European Society of Cardiology and the 2018 American Heart Association Guidelines on cardiac pacing and cardiac resynchronization therapy, no recommendation was found for these types of events associated with COVID-19 or following vaccination. An international network should be created to report these events and thus determine general management guidelines. For now, the recommendations must be individualized for these patients. (Acta Med Colomb 2022; 48. DOI:https://doi.org/10.36104/amc.2023.2602).

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)

Safety profile of CoviShield (ChAdOx1nCoV-19) vaccine among healthcare workers in a tertiary care hospital

Background: Coronavirus 2019 was declared as a pandemic by the World Health Organization in March 2020. Bereft of specific treatment for the disease, vaccinations and COVID appropriate behavior have come to be the main approaches to combat the pandemic. A number of vaccines have been approved after clearing clinical trials. Hence, it is essential to evaluate the safety profile of each vaccine for ensuring optimum health of the general population. This study was conducted to evaluate the adverse events following CoviShield vaccination in a tertiary care center. Aims and Objectives: The aim of the study was to describe the pattern of adverse effects, treatment given, and comorbidities seen in healthcare workers (HCW) who reported to the adverse drug reaction (ADR) monitoring center in the department of pharmacology Government T.D. Medical College, Alappuzha, following CoviShield vaccination from January 2021 to October 2021. Materials and Methods: A retrospective and descriptive study was carried out at Department of Pharmacology, GTDMCA involving all HCW who reported side effects following CoviShield vaccination in the ADR monitoring centre (AMC) in the Department of Pharmacology, GTDMCA from January 2021 to Oct 2021. Results: Out of 620 HCWs who reported adverse event following vaccination, majority (45%) were from the age group 21–30 years. About 83% of HCWs who reported adverse effect were women. Majority of the respondents (96%) experienced the adverse effects within 24 h. About 88% of respondents experienced these adverse effects after the initial dose alone. Commonly encountered adverse effects were fever (57%), headache (43%), myalgia (38%) etc. Hypertension (7%) was the most common comorbidity seen. Majority of the beneficiaries (70%) took paracetamol for the treatment of the adverse effect. Conclusion: Majority of the vaccinated HCWs experienced minor and self-limiting adverse event following immunization (AEFI) with Chimpanzee Adenovirus Oxford novel CoronaVirus-19. No serious AEFI were reported to the AMC. Despite the record speed at which the vaccine has been developed, it has shown to have a good safety profile considering the millions of doses that have been administered.

Rastreamento da hipersensibilidade metálica pelos profissionais e estudantes de saúde na prática clínico-cirúrgica / Seguimiento de la hipersensibilidad metálica por profesionales y estudiantes de salud en la práctica clínico-quirúrgica / Screening of metallic hypersensitivity by health professionals and students in clinical-surgical practice

Objetivo: investigar o rastreamento da hipersensibilidade metálica realizada pelos profissionais e estudantes de saúde durante a prática clínico-cirúrgico. Método: estudo exploratório-descritivo realizado com 228 profissionais e estudantes da área da saúde, por meio de questionário eletrônico semiestruturado, aplicado durante abril e maio de 2021, analisado por meio da estatística descritiva e da frequência de palavras. Resultados: 11,0% dos participantes realizaram a investigação sobre a hipersensibilidade metálica. 67,1% declararam que muito provavelmente poderiam incluir essa temática durante a triagem em seus atendimentos. Falta de conhecimento sobre alergia a metais e causas multifatoriais durante a prática clínico-cirúrgica foram citadas como barreiras para a implementação do rastreamento da hipersensibilidade metálica. Conclusão: pouco se evidencia o rastreamento da hipersensibilidade metálica em pacientes durante a prática clínico-cirúrgica dos profissionais e estudantes de saúde.

Objetivo: investigar el rastreo de la hipersensibilidad metálica realizada por los profesionales y estudiantes de salud durante la práctica clínico-quirúrgica. Método: estudio exploratorio-descriptivo realizado con 228 profesionales y estudiantes del área de la salud, por medio de cuestionario electrónico semiestructurado, aplicado durante abril y mayo de 2021, analizado por medio de la estadística descriptiva y de la frecuencia de palabras. Resultados: 11,0% de los participantes realizaron la investigación sobre la hipersensibilidad metálica. El 67,1% declaró que muy probablemente podrían incluir esa temática durante la selección en sus atenciones. La falta de conocimientos sobre la alergia a los metales y las causas multifactoriales durante la práctica clínico-quirúrgica se citaron como barreras para la implementación del seguimiento de la hipersensibilidad metálica. Conclusión: poco se evidencia el rastreo de la hipersensibilidad metálica en pacientes durante la práctica clínico-quirúrgica de los profesionales y estudiantes de salud.

Objective to investigate the screening of metallic hypersensitivity performed by health professionals and students during clinical-surgical practice. Method: an exploratory-descriptive study conducted with 228 health professionals and students, through a semi-structured electronic questionnaire, applied during April and May 2021, analyzed through descriptive statistics and the frequency of words. Results: 11.0% of participants conducted research on metallic hypersensitivity. 67.1% stated that they could very likely include this theme during screening in their care. Lack of knowledge about metal allergy and multifactorial causes during clinical-surgical practice were cited as barriers to the implementation of metallic hypersensitivity screening. Conclusion: there is little evidence of metallic hypersensitivity screening in patients during the clinical-surgical practice of health professionals and students.

Effect of the area under the curve of carboplatin dosage on therapeutic efficacy and safety in Chinese patients with epithelial ovarian cancer / 西安交通大学学报(医学版)

【Objective】 To retrospectively analyze the average carboplatin dosage and calculate the area under the curve (AUC) using the Calvert formula in first-line chemotherapy in patients with epithelial ovarian cancer in The First Affiliated Hospital of Xi’an Jiaotong University so as to evaluate the effect of the AUC difference in the Chinese population on therapeutic efficacy and safety. 【Methods】 We enrolled patients who underwent first-line chemotherapy with paclitaxel and carboplatin 3-week regimen in our hospital from January 1, 2012 to January 1, 2022. According to the median of AUC, the patients were divided into high-dose group and low-dose group. The overall response rate (ORR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and the incidence of adverse events (AEs) were compared. 【Results】 A total of 153 patients were enrolled in this study and the median AUC of carboplatin was 3.981 (range 2.314-5.446). Only 10.46% patients (16/153) had an AUC above 5. There were 77 patients with the AUC0.05). The ORR in the low-dose group and the high-dose group was 59.74% and 57.89%, respectively, and the DCR was 87.01% and 85.53%, respectively. The median PFS of the two groups was 14 and 15.5 months, respectively, and the median OS was 50 and 55 months, respectively. None of the above outcomes were statistically different between the two groups (P>0.05). The two groups showed significant differences in the incidence of anemia, neutropenia, and thrombocytopenia (P<0.05). The incidence of nausea and vomiting, grade 1-2 diarrhea or constipation, and grade 1-2 fever showed significant differences (P<0.05). In addition, the incidence of dose limiting toxicity (DLT), including grade 4 thrombocytopenia and febrile neutropenia (FN), was significantly increased in the high-dose group (P<0.05). 【Conclusion】 Compared with the recommended AUC 5-6 of carboplatin abroad, the actual carboplatin dosage in the first-line chemotherapy for patients with epithelial ovarian cancer was generally insufficient in our hospital. There was no difference in therapeutic efficacy between the patients with AUC<4 and AUC≥4. However, considering the increased risk of some AEs and DLT in the high-dose group, it is not recommended to increase the carboplatin AUC blindly.

Analysis on Legal Relationship Based on a Typical Case of Medical Device Clinical Trial / 中国医学伦理学

Guaranteeing the rights and safety of subjects is an important responsibility of all participants in the medical devices clinical trial, including medical institutions, sponsors and researchers. The legal disputes caused by serious adverse events in the clinical trial of medical devices are characterized by complex legal relationships, great difficulty in handling, and many points of dispute. Based on a typical case of medical device clinical trials, this paper discussed the litigation subject qualification, the treatment of contract breach and tort in medical device clinical trial, analyzed the responsibility of different subjects, and provided constructive suggestions on the risk management of medical device clinical trial.

Blood transfusion adverse event management system: construction and application / 中国输血杂志

【Objective】 To establish a blood transfusion adverse event management system and apply it to adverse events management, so as to enhance the ability to identify and process reports as well as prevent adverse events. 【Methods】 According to the errors during the whole process of blood transfusion, the management information system of blood transfusion adverse events was established, and the data of adverse transfusion reactions and adverse transfusion events from 2020 to 2022 were collected according to the system requirements. The system monitoring data and statistical analysis were used to analyze the causes of errors in each link of blood transfusion, sort the incidence of each department, focus on supervising the departments with high frequency of adverse events, and propose effective rectification. 【Results】 The management system counted 51 cases of adverse reactions. The incidence of adverse reactions of plasma (43.1 %, 22/51) was higher than that of red blood cells (39.2 %, 20/51), and the number of allergic reactions was slightly higher than that of febrile non-hemolytic transfusion reaction. Among the 628 cases of adverse transfusion events, blood transport, inbound and storage (TS-A) errors accounted for the highest proportion of 46.2% (290/628), 20.9% (131/628) in post-transfusion disposal and evaluation (TS-G) and 15.8% (99/628) in pre-transfusion evaluation and transfusion application (TS-B). TS-A12 accounted for 63.8 % (185/290) in TS-A errors, which was mainly due to plasma leakage caused by extrusion during transport and the expiration of red blood cells caused by insufficient blood inventory management. TS-B errors mainly focus on the failure to fully assess the bleeding tendency of patients before surgical system surgery, resulting in no or insufficient preoperative blood preparation. Most of the TS-G errors were unqualified medical record. 【Conclusion】 Blood transfusion adverse event management system can help to identify and prevent the occurrence or recurrence of adverse events, formulate targeted rectification and preventive measures, and improve the haemovigilance ability.

Surveillance of suspected adverse events following immunization in Chongchuan District from 2008 to 2022 / 预防医学

Objective @#To investigate the incidence of suspected adverse events following immunization(AEFI) in Chongchuan District, Nantong City, Jiangsu Province from 2008 to 2022, so as to provide insights into safety assessment of vaccines. @*Methods@#The data on AEFI surveillance in Chongchuan District from 2008 to 2022 were collected through the National Immunization Program Information Management System of China, including demographics, history of vaccination, laboratory tests, incidence of AEFI and clinical characteristics. The epidemiological, clinical characteristics and reported incidence of AEFI were analyzed in Chongchuan District from 2008 to 2022 using a descriptive epidemiological method. @*Results@#The reported incidence of AEFI in Chongchuan District from 2008 to 2022 appeared a tendency towards a decline (P<0.05), and the annual average reported incidence was 50.85/105. The incidence of AEFI associated with vaccines included in the national immunization program was significantly higher than that caused by vaccines that were not included in the national immunization program (74.67/105 vs. 20.35/105, P<0.05). General reaction was the predominant type of AEFI (1 937 cases, 44.21/105), and there were 274 cases with abnormal reactions (6.25/105) and 17 cases with coincident syndromes (0.39/105); however, no vaccine quality or vaccination accidents occurred. A high incidence rate was seen in AEFI associated with vaccines administered by subcutaneous (75.05/105) and intramuscular injection (47.40/105), and a low incidence rate was found in AEFI associated with vaccines administered orally (16.41/105). The five highest reported incidence rates of AEFI were found for the combined diphtheria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b vaccine (312.01/105), 7-valent pneumococcal polysaccharide-protein conjugate vaccine (292.14/105), inactivated Japanese encephalitis vaccine (248.37/105), Group ACYW135 meningococcal polysaccharide vaccine (240.67/105) and combined live vaccine for measles and rubella (229.31/105). The general reactions mainly included fever, redness and swelling and induration (1 878 cases, 96.95%), and abnormal reactions mainly included allergic skin rash (241 cases, 87.96%). In addition, 91.34% of AEFI occurred within 24 hours after vaccination, and 99.73% of cases with AEFI were cured during the 3-month follow-up.@*Conclusions@#The reported incidence of AEFI appeared a tendency towards a decline in Chongchuan District from 2008 to 2022. General reaction was the predominant type of AEFI, and all AEFI showed a good prognosis. The safety of vaccines was high in Chongchuan District from 2008 to 2022.

Surveillance of adverse events following immunization with combined attenuated live measles, mumps and rubella vaccines in Huzhou City from 2015 to 2021 / 预防医学

Objective@#To monitor the adverse events following immunization (AEFI) with combined attenuated live measles, mumps and rubella vaccines (MMR) in Huzhou City from 2015 to 2021, so as to provide insights into the implementation of the MMR immunization strategy.@*Methods@#All AEFI caused by MMR immunization in Huzhou City from 2015 to 2021 were captured from the AEFI Monitoring Information Management System of the Immunization Planning System of Chinese Disease Control and Prevention Information System, and the incidence, clinical features and epidemiological features of AEFI were analyzed descriptively.@*Results@#The reported incidence of AEFI caused by MMR immunization appeared a tendency towards a rise in Huzhou City from 2015 to 2021 (χ2trend=124.126, P<0.001). Totally 324 386 doses of MMR vaccines were immunized, and 317 cases with AEFI were reported, with an reported incidence rate of 9.77/104 doses. Following two-dose immunization, the reported incidence of AEFI caused by two-dose MMR immunization was significantly lower than by one-dose immunization (6.01/104 doses vs. 25.43/104 doses; χ2=113.692, P<0.001). The incidence rates of general reactions, abnormal reactions and coincidental events were 6.20/104 doses, 3.42/104 dose and 0.15/104 doses, respectively. Fever and allergic rash were predominant clinical manifestations of AEFI, and no vaccine quality accident, inoculation accident or psychogenic reaction were reported. There were 246 (77.60%) cases with AEFI within 24 hours following vaccination, and among children with AEFI, there were 173 boys (54.57%), and 200 children (63.09%) age ages of less than one year (63.09%). AEFI was reported in each quarter, and 99 cases (31.23%) were reported in the fourth quarter. The largest number of children with AEFI was reported in Wuxing District (78 cases, 24.61%).@*Conclusions@#The safety of MMR vaccination is high in Huzhou City. General reaction is the predominant AEFI, which mainly occurs within 24 hours following vaccination. Two-dose MMR vaccination does not increase the risk of AEFI.

Surveillance of adverse events following immunization with human papillomavirus vaccines in Hangzhou City from 2017 to 2021 / 预防医学

Objective@#To investigate the incidence of adverse events following immunization (AEFI) of human papillomavirus (HPV) vaccines in Hangzhou City from 2017 to 2021, so as to provide insights into safety monitoring and evaluation for HPV vaccines.@*Methods@#The AEFI caused by immunization of bivalent (HPV2), quadrivalent (HPV4) and nonavalent HPV vaccines (HPV9) reported in Hangzhou City from 2017 to 2021 were captured from the AEFI Surveillance Module of Chinese Disease Control and Prevention Information System, and HPV vaccination data were captured from the Zhejiang Municipal Immunization Information Management System. The incidence, temporal distributions and clinical symptoms of AEFI were analyzed.@*Results@#Totally 922 310 doses of HPV vaccines were immunized in Hangzhou City from 2017 to 2021, and 232 cases with AEFI were reported, with an overall incidence rate of 25.15/105 doses. The reported incidence rates of AEFI caused by HPV2, HPV4 and HPV9 vaccination were 31.13/105 doses, 25.93/105 doses and 22.01/105 doses, respectively. General reactions and abnormal reactions were predominant AEFI, and the reported incidence rates of general reactions and abnormal reactions were 21.58/105 doses and 2.60/105 dose, respectively. AEFI predominantly occurred 0 to 1 day post-immunization (165 cases, 71.12%), and the main clinical symptoms included local swelling of injection sites, hard tubercle and fever, with reported incidence rates of 10.30/105 doses, 5.96/105 doses and 6.18/105 doses, respectively. @*Conclusions@#Low incidence of AEFI was reported following HPV vaccination in Hangzhou City from 2017 to 2021, and all AEFI were mild. The safety of HPV2, HPV4 and HPV9 remains high.

Developing process and term analysis of WFAS standard: General Requirements for the Risk Control in the Safe Use of Acupuncture / 中国针灸

In order to promote the application of WFAS standard, General Requirements for the Risk Control in the Safe Use of Acupuncture and the safe practice of acupuncture technology worldwide, the paper introduces the developing process and main contents of this standard, explains the developing purpose, scope, ideas, methods and basis, and analyzes the definition of the relevant terms. Through strictly complied with the development procedure of standard, the terms related to acupuncture risk in this standard are defined. The connotations of 5 special terms are clarified, i.e. "acupuncture risks" "adverse events of acupuncture" "adverse reactions of acupuncture" "acupuncture accidents" and "acupuncture negligence". The range, rank, control flow and source of risk, as well as the control measures are determined. The standard extracts the underlying common problems and basic requirement of the safe practice of acupuncture so as to lay a framework for the development of the relevant technical standards of acupuncture.

Mining and analysis for adverse drug event signals of liver failure in underage population based on the FAERS database / 中国药房

OBJECTIVE To conduct data mining on drugs causing liver failure in underage populations based on the FDA Adverse Event Reporting System （FAERS） database， so as to provide reference for clinical use of related drugs. METHODS The data on reported adverse drug event （ADE） of liver failure in this population （under 18 years old） from the first quarter of 2013 to the third quarter of 2022 were retrieved from the FAERS database for mining and analysis； they were divided into infants（≤1 year old）， young children（＞1-＜6 years old）， children（6-＜12 years old） and adolescents（12-＜18 years old） according to the age. The reporting odds ratio （ROR）， proportional reporting ratio and Bayesian confidence propagation neural network of the proportional imbalance method were used to screen ADE signals. RESULTS A total of 1 051 ADE reports of liver failure were collected from the underage population involving 60 drugs. The highest incidence was found in adolescents （410 cases， 39.01%）， followed by young children （297 cases， 28.26%）. The instructions of 14 drugs did not mention hepatobiliary system injury and liver failure risk， including 31 cases of levetiracetam （2.95%），18 cases of metronidazole （1.71%）， 16 cases of each of topiramate and methylprednisolone （1.52% each）， 12 cases of dexamethasone （1.14%）， 11 cases of tisagenlecleucel （1.05%）， 10 cases of each of ferrous sulfate， metformin and busulfan （0.95% each）， 9 cases of propofol （0.86%）， 8 cases of onasemnogene abeparvovec （0.76%）， 5 cases of each of diphenhydramine and omeprazole （0.48% each）， 4 cases of sebeliesterase α （0.38%）， totaling 165 cases， accounting for 15.70% of the total reported cases. Metformin was contrary to the known liver safety， and E-mail：libingchemical@163.com metronidazole and levetiracetam were new risk signals， which caused more serious clinical outcomes. CONCLUSIONS Fourteen new pharmacovigilance signals which cause liver failure in the underage population are found in this study； the liver function of patients should be closely monitored when using these drugs. Among those drugs， metformin neither undergoes liver metabolism nor has been reported in the relevant literature， and the liver-related ADE caused by metformin deserves further attention. The clinical outcomes caused by metronidazole and levetiracetam are relatively serious and need to be given sufficient attention.