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.

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.

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.

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)

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).

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.

Metemoglobinemia como efeito adverso do tratamento para hanseníase: relato de caso / Methemoglobinemia as an adverse effect of the treatment for leprosy: case report / Metahemoglobinemia como efecto adverso del tratamiento de la lepra: informe de caso

Introdução: O tratamento da hanseníase consiste em um regime de poliquimioterapia com as seguintes drogas: Rifampicina, Dapsona e Clofazimina. Entre os efeitos colaterais, a metemoglobinemia decorre do uso da Dapsona e requer atenção especial, pois enseja a necessidade de suspensão da medicação e, em casos graves, de internação hospitalar. Trata-se de uma complicação rara, na qual ocorre uma anomalia da hemoglobina, que impossibilita a captação e a liberação de oxigênio. É provocada pela ação da Dapsona, quando administrada em quantidade e em duração além das recomendadas. Destacam-se como sinais e sintomas a presença de cianose, baixa saturação de oxigênio e dispneia aos esforços, embora a PaO2 esteja de acordo com os valores de referência. O diagnóstico da metemoglobinemia é realizado pela co-oximetria. Pacientes com cianose ou sintomas de hipoxemia, com PaO2 suficientemente alta, apresentam elevada suspeição. Apresentação do caso: Apresenta-se um caso de metemoglobinemia identificado na Atenção Primária à Saúde (APS) durante um tratamento de hanseníase, que exigiu condução minuciosa, culminando na suspensão da poliquimioterapia, com resolução do evento adverso. Conclusão: O acompanhamento clínico rigoroso pela APS durante o tratamento da hanseníase possibilita o reconhecimento precoce de eventuais efeitos adversos da poliquimioterapia, bem como a adoção das devidas medidas.

Introduction: Leprosy treatment consists of a multidrug therapy regimen with the following drugs: Rifampicin, Dapsone, and Clofazimine. Among the side effects, methemoglobinemia results from the use of Dapsone and requires special attention, as it leads to the need to discontinue the medication and, in severe cases, hospitalization. It is a rare complication, on which there is hemoglobin anomaly, which makes it impossible to capture and release oxygen. It is caused by the action of Dapsone when administered in doses and duration beyond the recommended ones. The presence of cyanosis, low oxygen saturation, and dyspnea on exertion stand out as signs and symptoms, although the PaO2 is within the reference values. The diagnosis of methemoglobinemia is performed by co-oximetry. Patients with cyanosis or symptoms of hypoxemia, with sufficiently high PaO2, are highly suspicious. Case presentation: A case of methemoglobinemia identified in Primary Health Care (PHC) during a treatment for leprosy is presented, which required meticulous management, culminating in the suspension of multidrug therapy, with resolution of the adverse event. Conclusions: The strict clinical follow-up by the PHC during the treatment of leprosy allows the early recognition of possible adverse effects of multidrug therapy as well as the adoption of the necessary measures.

Introducción: El tratamiento de la lepra consiste en un régimen de poliquimioterapia con los siguientes fármacos: Rifampicina, Dapsona y Clofazimina. Entre los efectos secundarios, la metahemoglobinemia resulta del uso de Dapsona y requiere atención especial, ya que conlleva la necesidad de suspender la medicación y, en casos graves, la hospitalización. Es una complicación rara, en la que existe una anomalía de la hemoglobina, que imposibilita la captación y liberación de oxígeno. Es provocada por la acción de la Dapsona, cuando se administra en cantidad y duración superiores a las recomendadas. Los signos y síntomas son cianosis, baja saturación de oxígeno y disnea a mínimos esfuerzos, aunque la PaO2 está dentro de los valores de referencia. El diagnóstico de metahemoglobinemia se realiza por cooximetría. Los pacientes con cianosis o síntomas de hipoxemia, con PaO2 suficientemente elevada, presentan alta sospecha. Presentación del caso: Se presenta un caso de metahemoglobinemia identificado en Atención Primaria de Salud (APS) durante un tratamiento por lepra, que requirió una conducta exhaustiva, culminando con la suspensión de la poliquimioterapia con resolución del evento adverso. Conclusiones: El estricto acompañamiento clínico por parte de la APS durante el tratamiento de la lepra permite el reconocimiento precoz de los posibles efectos adversos decurrentes de la poliquimioterapia, así como la adopción de las medidas necesarias.

Focusing on the rational application of 0.1% CsA cationic emulsion in ocular surface inflammatory disorder / 中华实验眼科杂志

Ocular surface inflammatory disorder (OSID) is a chronic ocular disease caused by systemic disorders or involving the local immune system.OSID induces persistent inflammatory reaction in the ocular adnexal connective tissues which in turn give rise to tear hypertonicity and ocular surface epithelial damage, leading to dry eye formation or progression.Common immune-related ocular surface diseases include vernal keratoconjunctivitis, Sj?gren syndrome, graft versus host disease, dry eye and immune-related corneal disease, all of which can significantly impact the visual function and quality of life of patients.Current treatments including the use of artificial tears and glucocorticoid eye drops are not always effective and have the risk of adverse events.Cyclosporine A (CsA) is a commonly utilized immunosuppressant that has a strong immunomodulatory effect, but its clinical application is somewhat limited due to the low permeability of its current ophthalmic dosage form.The development of CsA ophthalmic agents has changed the treatment strategy for OSID.The development of 0.1% CsA cationic emulsion has significantly improved the efficacy and safety of topical CsA treatment, which is worth the attention.In order to rationally apply 0.1% CsA cationic emulsion to OSID, ophthalmologists should fully understand the immune-related pathogenesis of each OSID and comprehend the curative effect, indication, application methods and adverse events of topical CsA treatment.

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.

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.

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.

Dietary exposure level of to perfluorinated compounds and its relationship with perinatal adverse events in pregnant women in Xuhui District of Shanghai / 环境与职业医学

Background Perfluorinated compounds (PFCs) are persistent organic pollutants. Dietary exposure to PFCs among pregnant women may lead to elevated risks of adverse events during pregnancy and postpartum depression. Objective To estimate potential risk of dietary exposure to PFCs among pregnant women in Xuhui District, Shanghai, and the relationship between dietary PFCs exposure and risks of adverse events during pregnancy and postpartum depression. Methods This study was a small cohort study which recruited women residing in Xuhui District from July 2017 to September 2018. All information was collected through questionnaires by trained investigators. Basic information and dietary information were collected at the time of inclusion, where the dietary information was obtained through the Food Frequency Questionnaire (FFQ). A follow-up visit was conducted within 42 d after delivery to collect the occurrence of adverse events during pregnancy and postpartum depression. According to the results of dietary survey, sampling and PFCs level testing were conducted on commercially available staple foods, poultry and livestock meat, aquatic products, vegetables, milk and dairy products, eggs, etc. The food sampling points covered all subdistricts in Xuhui District, including farmers' markets, supermarkets, convenience stores, and shops. Daily exposure level and hazard ratio (HR) of PFCs per capita were calculated according to the dietary survey and laboratory testing. Logistic regression was used to estimate the relationship between PFCs exposure and the risks of adverse events during pregnancy and postpartum depression. The levels of PFCs exposure were further divided into 4 groups according to interquartile range, and OR and Ptrend value were calculated respectively. Results A total of 345 pregnant women were recruited in this study, whose average age was (29.61±4.92) years. Among them, 26.37% subjects reported at least one adverse event during pregnancy, and 30.14% subjects reported an Edinburgh Postnatal Depression Scale (EPDS) score ≥12. A total of 132 food samples were collected and tested, and PFCs were positive mainly in milk and dairy products, poultry meat, livestock meat, eggs, fresh water products, and sea water products. The PFCs positive rate in fresh water products was the highest, reaching 100%. The average concentration of PFCs in the positive samples was 0.018-2.10 μg·kg−1. The HR of PFCs was 4.44. A higher risk of postpartum depression was found along with a higher perfluorooctane sulfonate (PFOS) exposure level (Ptrend=0.02). Conclusion Dietary PFCs exposure may pose a health risk to pregnant women. The study findings suggest that decreasing the intake of freshwater products might help reduce the risk of PFCs exposure among pregnant women in Xuhui district, Shanghai.

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.

ADE signal mining and analysis of axitinib based on FAERS database / 中国药房

OBJECTIVE To provide references for the clinical safe use of axitinib. METHODS Adverse drug event （ADE） data for axitinib were collected from the US FDA Adverse Event Reporting System （FAERS） database from the first quarter of 2012 to the fourth quarter of 2022. The data were mined and analyzed by utilizing the ratio-of-reporting-ratio （ROR） method and comprehensive standard method of the United Kingdom’s Medicines and Healthcare Products Regulatory Agency （MHRA） of proportional imbalance measurement. RESULTS A total of 13 962 reports of axitinib-related ADEs were obtained， with patients’ age concentrated in 65-85 years （43.25%）， gender predominantly male （65.23%）， country of reporting predominantly US （60.01%）， and serious ADE outcomes mostly hospitalization or prolonged hospitalization （31.51%）. A total of 172 ADE risk signals were detected， involving 18 system and organ classifications （SOC）， mainly systemic diseases and various reactions at the site of administration （3 749 cases， 30.84%） and gastrointestinal system diseases （2 067 cases， 17.00%）. ADE risk signals that occurred more frequently were generally consistent with the drug instruction， such as diarrhea， fatigue， and hypertension； new ADE risk signals requiring clinical attention were death， immune-mediated nephritis， and PT signals contained in the SOC of various benign， malignant， and tumors of undetermined nature （including cysts and polyps）. CONCLUSIONS For ADEs that occur frequently with axitinib and are already contained in the drug instruction （e.g. hypertension， diarrhea）， they should be adequately evaluated before administration， especially for patients with combined use of immune checkpoint inhibitors and patients with underlying hypertension； for ADEs with stronger signals and newer ADEs （e. g. death， disease progression， tumor progression）， the patient’s disease progression should be closely monitored during the treatment period for potentially fatal ADEs； for its rare ADEs （e. g.immune-mediated nephritis， scrotal ulcer， non-infectious encephalitis）， clinical validation should be further strengthened.

Risk signal mining of ixazomib based on the database of FAERS / 中国药房

OBJECTIVE To explore the risk signal of ixazomib and provide a reference for clinically rational drug use. METHODS The Open Vigil 2.1 online tool was used to extract the data of adverse drug events （ADE） reported by the database of FDA adverse event reporting system （FAERS） from the launch of ixazomib in America （November 20th， 2015） to the latest update of the Open Vigil website （March 31st， 2023）. The data were mined by using the proportional reporting ratio （PRR） and Bayesian confidence propagation neural network （BCPNN） of the proportional imbalance method. The signals were coded by system organ class （SOC） and preferred term （PT） according to MedDRA v25.1. RESULTS A total of 13 841 ADE reports with ixazomib as the “primary subject” were extracted， involving slightly more male patients （49.53%）， and most of them were 65 years old and above （72.48%）； the reports came from 57 countries/regions， mainly America （52.90%）. A total of 186 positive signals were excavated， with 51 high-intensity， 99 medium-intensity， and 36 low-intensity signals， involving 19 SOCs. The top 50 PT in frequency and signal intensity of PRR included neuropathy peripheral （414 cases， high-intensity signal）， platelet count decreased （379 cases， high-intensity signal）， thrombocytopenia （360 cases， high-intensity signal）， cytopenia （75 cases， high-intensity signal） and neurological symptoms （41 cases， high-intensity signal）. SOC involved included nervous system disorders， investigations， and blood and lymphatic system disorders. ADE occurred most frequently in gastrointestinal diseases （2 588 cases）， including diarrhea （1 077 cases， high-intensity signal）， nausea （737 cases， medium-intensity signal）， vomiting （459 cases， medium-intensity signal）， constipation （275 cases， medium-intensity signal）， and so on. The positive signals of infections and infestations contained the largest number of PTs， and most of them were not recorded in the drug instruction， including 12 high-intensity signals （1 030 cases） and 30 medium-intensity signals （627 cases）， which were mainly distributed in lung infection， upper respiratory infection， gastrointestinal infection， sepsis， herpes zoster and so on. The signals of cardiac amyloidosis （7 cases， high-intensity signal） and acute coronary syndrome （14 cases， high-intensity signal） of cardiac disorders and renal dysfunction （91 cases， medium-intensity signal） of renal and urinary disorders were all strong and had not been recorded in the drug instruction. CONCLUSIONS In addition to routine attention to the common ADE of ixazomib in gastrointestinal diseases，nervous system disorders and blood and lymphatic system disorders， clinical attention should also be paid to various infections that may occur during the treatment of patients， and the occurrence of cardiovascular toxicity and renal dysfunction should be monitored.

Mining and analysis of adverse drug events signals of nilotinib based on FDA adverse event database / 中国药房

OBJECTIVE To provide a reference for safe drug use in clinic. METHODS ADE reports related to nilotinib from the first quarter of 2007 to the fourth quarter of 2022 were collected from the US FDA adverse event reporting system database. The reporting odds ratio （ROR） and proportional reporting ratio （PRR） of disproportionality measures were used to mine potential ADE signals，which were compared with drug instruction and related case report， and were screened and analyzed according to the designated medical events （DME） list formulated by the European Medicines Agency. RESULTS Totally 23 332 cases of ADE with nilotinib as the primary suspected drug were reported. A total of 359 positive signals were obtained，involving 24 system organ classes （SOC），mainly concentrated in various examinations，heart organ diseases，vascular and lymphatic diseases，all kinds of nervous system diseases，etc. Among them，ADEs such as vertebral artery stenosis，coronary artery stenosis，arterial disease，liver infection and the second primary malignant tumor were not mentioned in the instructions. Seven DMEs were detected，of which bone marrow failure，pulmonary hypertension and deafness were not mentioned in the drug instruction. CONCLUSIONS The common ADE signals of nilotinib excavated in this study are consistent with the instructions. In clinical use，special attention should be paid to DME not mentioned in the instructions such as bone marrow failure，pulmonary hypertension and deafness； cardiac function， blood glucose and blood lipid indexes should be monitored closely.

Safety of human papilloma virus vaccine based on Vaccine Adverse Event Reporting System from 2006 to 2021 / 中国生物制品学杂志

@#Objective To investigate the characteristics of distribution of adverse event(AE)associated with human papillomavirus(HPV)vaccine by analysis of data on AE collected from the Vaccine Adverse Event Reporting System(VAERS).Methods The data on AE reported in VAERS from January 1st,2006 to December 31st,2021 were analyzed and compared by using Pearson Chi-square test and Mann-Whitney U test.Results A total of 53 571 cases of AE were included in the study,in which the ratio of male to female was 0. 25∶1,and the median age of vaccinees was 15 years. A portion of 36. 1%of AE occurred after the first dose,while 90. 7% occurred within 3 d after vaccination. Both the gender ratios(χ~2=72. 570,P < 0. 001) and the median ages(Z = 4. 255,P < 0. 001)of vaccinees in non-serious and serious adverse event(SAE)showed significant difference. In terms of classification of SAE,hospitalization,prolonged hospitalization and disability were more common in females than in males,of which the percentages decreased with the increasing age. Among the AE,syncope was the most common clinical symptom. In the SAE,the highest proportion of deaths was caused by HPV2 vaccine,which was 19. 0%. The proportion of prolonged hospitalization caused by HPV4 vaccine was higher than that by HPV9vaccine. In general,HPV4 vaccine was more prone to cause SAE than HPV9 vaccine(χ~2=183. 267,P < 0. 001).Conclusion In all the AE,the largest proportion occurred in the age group of 9 ～ 17 years,followed by those in the groups of 18 ～ 26 and 27 ～ 45 years. Most of the AE occurred after the first dose. The clinical symptoms of AE caused by three vaccines were different. The analysis of distribution characteristics of AE may provide a reference for the study on clinical safety of HPV vaccine and optimization of vaccination.