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

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

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

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

Side effects of chronic systemic glucocorticoid therapy: what dermatologists should know

Abstract In dermatologists' clinical practice, the use of systemic glucocorticoids is recurrent for the management of different comorbidities that require chronic immunosuppression. The prescription of this medication requires caution and basic clinical knowledge due to the several adverse effects inherent to the treatment. However, different doubts may arise or inappropriate conduct may be adopted due to the lack of objective and specific guidelines for the screening, prophylaxis and management of complications from chronic corticosteroid therapy. Considering this problem, the authors carried out a narrative review of the literature to gather up-to-date data on adverse effects secondary to the chronic use of systemic glucocorticoids. The broad approach to this topic made it possible to review the pathophysiology and risk factors for these complications, as well as to develop updated orientation that can be used as a learning tool and quick reference for dermatologists during their clinical practice with glucocorticoids.

Mortality and years of life lost related to adverse drug events in Brazil

ABSTRACT OBJECTIVE To assess regional and national mortality and years of life lost (YLL) related to adverse drug events in Brazil. METHODS This is an ecological study in which death records from 2009 to 2018 from the Mortality Information System were analyzed. Codes from the International Classification of Diseases 10th revision (ICD-10) that indicated drugs as the cause of death were identified. The number of deaths and the YLL due to adverse drug events were obtained. Crude, age- and gender-specific, and age-adjusted mortality rates and YLL rates per 100,000 inhabitants were formed by year, age group, gender, and Brazilian Federative Unit. Rate ratios were calculated by comparing rates from 2009 to 2018. A joinpoint regression model was applied for temporal analysis. RESULTS For the selected ICD-10 codes, a total of 95,231 deaths and 2,843,413 YLL were recorded. Mortality rates from adverse drug events increased by a mean of 2.5% per year, and YLL rates increased by 3.7%. Increases in rates were observed in almost all age groups for both genders. Variations in rates were found between Federative Units, with the highest age-adjusted mortality and YLL rates occurring in the Distrito Federal. CONCLUSIONS The numbers and rates of deaths and YLL increased during the study period, and variations in rates of deaths and YLL were observed between Brazilian Federative Units. Information on multiple causes of death from death certificates can be useful for quantifying adverse drug events and analyzing them geographically, by age and by gender.

A novel agent for myeloma causing toxic keratopathy, belantamab mafodotin: a case report and literature review / Belantamabe-mafodotina, um novo agente para mieloma, causando ceratopatia tóxica: relato de caso e revisão da literatura

ABSTRACT A 60-year-old-male with refractory relapsed multiple myeloma presented with redness, pain, foreign body sensation, and blurred vision in both eyes that gradually increased after his third belantamab mafotodin infusion. Biomicroscopy revealed bilateral microcyst-like epithelial changes and epithelial crystal-like deposits, whereas in vivo confocal microscopy revealed intraepithelial and subepithelial hyperreflective deposits in corneal epithelium. Belantamab mafodotin therapy was discontinued for seven weeks due to corneal toxicity, which cleared progressively. We aim to demonstrate belantamab mafodotin-related corneal toxicity that may be detected using slit lamp and in vivo confocal biomicroscopy.

RESUMO Um homem de 60 anos, diagnosticado com mieloma múltiplo recidivante refratário, apresentou vermelhidão, dor, sensação de corpo estranho e visão turva em ambos os olhos, aumentando gradualmente após sua terceira infusão de belantamabe mafodotina. À biomicroscopia, foram observadas alterações epiteliais bilaterais semelhantes a microcistos e depósitos epiteliais semelhantes a cristais. A microscopia confocal in vivo revelou depósitos hiper-refletivos intraepiteliais e subepiteliais na córnea. Devido à toxicidade corneana, a terapia com belantamabe mafodotina foi interrompida por sete semanas e a toxicidade foi gradualmente resolvida. Nosso objetivo é demonstrar os achados à biomicroscopia confocal in vivo e à lâmpada de fenda da toxicidade corneana relacionada ao belantamabe mafodotina.

ERG and OCT abnormalities in retinoblastoma after melphalan intravitreous injection / Anormalidades do ERG e OCT em um caso de retinoblastoma após injeção intravítrea de melfalan

ABSTRACT The authors report full-field electroretinogram and optical coherence tomography findings of intravitreal melphalan retinal toxicity. An 18-month-old girl with unilateral group D retinoblastoma was evaluated with light-adapted 3 full-field electroretinogram protocol and optical coherence tomography (I-Stand optical coherence tomography, Optovue) after treatment with intravitreal melphalan for active vitreous seeds. After the third injection, the child developed retinal pigment epithelial changes near the injection site. The photopic response of the full-field electroretinogram standard flash cones showed a decrease in amplitude responses of waves a and b in the affected eye compared to the contralateral eye. Optical coherence tomography showed loss of photoreceptors and outer nuclear layers in the affected eye. Melphalan toxicity is dose-dependent, and despite its treatment benefits, it can affect vision. Our case shows an updated, in-depth retinal toxicity assessment of intravitreal melphalan in the human retina with optical coherence tomography and its correlation with electroretinogram changes.

RESUMO Os autores relatam os achados de eletrorretinograma de campo total e tomografia de coerência óptica (OCT) da toxicidade retiniana ao melfalan intravítreo. Menina de 18 meses com retinoblastoma foi avaliada com fases fotópicas do eletrorretinograma de campo total e tomografia de coerência óptica após o tratamento com melfalan intravítreo. Após a terceira injeção, a criança desenvolveu alterações do epitélio pigmentar da retina próximo ao local da injeção. A resposta fotópica do eletrorretinograma de campo total mostrou diminuição da amplitude das respostas das ondas a e b no olho afetado comparado com o olho sadio. A tomografia de coerência óptica mostrou alterações significativas nas camadas retinianas externas no olho comprometido. A toxicidade do melfalan é dose dependente e, apesar dos benefícios terapêuticos, podem causar alterações retinianas significativas. Este caso demonstra uma avaliação atual e aprofundada da toxicidade retiniana do melfalan intravítreo na retina humana através da tomografia de coerência óptica e sua correlação com as alterações no eletrorretinograma.

When the fever will not stop, stop the pills! A case report

ABSTRACT Neuroleptic malignant syndrome (NMS) is a neurologic emergency potentially fatal. This rare side effect is most commonly associated with first-generation antipsychotics and less frequently with atypical or second-generation antipsychotics. The diagnosis relies on both clinical and laboratory criteria, with other organic and psychiatric conditions being ruled out. CASE REPORT: A 39-year-old female patient, who is institutionalized and completely dependent, has a medical history of recurrent urinary infections and colonization by carbapenem-resistant Klebsiella pneumoniae. Her regular medication regimen included sertraline, valproic acid, quetiapine, risperidone, lorazepam, diazepam, haloperidol, baclofen, and fentanyl. The patient began experiencing dyspnea. Upon physical examination, she exhibited hypotension and a diminished vesicular murmur at the right base during pulmonary auscultation. Initially, after hospitalization, she developed high febrile peaks associated with hemodynamic instability, prompting the initiation of antibiotic treatment. Despite this, her fever persisted without an increase in blood inflammatory parameters, and she developed purulent sputum, necessitating antibiotherapy escalation. The seventh day of hospitalization showed no improvement in symptoms, suggesting NNMS as a differential diagnosis. All antipsychotic and sedative drugs, as well as antibiotherapy, were discontinued, after which the patient showed significant clinical improvement. CONCLUSION: Antipsychotic agents are commonly employed to manage behavioral changes linked to various disorders. However, their severe side effects necessitate a high degree of vigilance, the cessation of all medications, and the implementation of supportive care measures. A prompt and accurate diagnosis of NMS is crucial to alleviating the severe, prolonged morbidity and potential mortality associated with this syndrome.

Eventos adversos pós-vacina contra o papilomavírus humano em adolescentes: revisão sistemática da literatura / Adverse events following human papillomavirus vaccine in adolescents: systematic review of the literature / Eventos adversos tras la vacuna contra el virus del papiloma humano en adolescentes: revisión sistemática de la literatura

Objetivo: O objetivo desse estudo foi investigar a ocorrência de Eventos Supostamente Atribuídos a Vacinação e/ou Imunização associados à vacina Papilomavírus Humano entre adolescentes de ambos os sexos. Métodos:Trata-se de uma revisão sistemática, realizada segundo os preceitos do Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Resultados: Inicialmente, foram identificados 11.016 artigos e, após a remoção de duplicidades, restaram 6.824. Destes, 59 foram selecionados para leitura na íntegra. Ao final, nove estudos compuseram a amostra. Os resultados indicam que a maioria dos Eventos Supostamente Atribuídos a Vacinação e/ou Imunização foram leves e moderados, prevalecendo eventos no local da injeção, como a dor e edema. Os Eventos Supostamente Atribuídos a Vacinação e/ou Imunização sistêmicos mais frequentes foram a febre, cefaleia, fadiga e tontura. Conclusão: A vacina contra o Papilomavírus Humano para os adolescentes é segura, reforçando-se sua importância como estratégia para diminuir as taxas de incidência dos cânceres associados ao Papilomavírus Humano.

Objective: The objective of this study was to investigate the occurrence of Events Supposedly Attributable to Vaccination and/or Immunization associated with the Human Papillomavirus vaccine among adolescents of both sexes. Methods: This is a systematic review carried out according to the principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Results: Initially, 11,016 articles were identified, of which 6,824 remained after removing duplicates, and 59 of these were selected for full reading. The sample comprised nine studies. The results indicate that most Events Supposedly Attributable to Vaccination and/or Immunization were mild and moderate, and events at the injection site, such as pain and edema, prevailed. The most common systemic Events Supposedly Attributable to Vaccination and/or Immunization were fever, headache, fatigue and dizziness. Conclusion: The Human Papillomavirus vaccine for adolescents is safe, reinforcing its importance as a strategy to reduce the incidence rates of Human Papillomavirus associated cancers

Objetivo: El objetivo de este estudio fue investigar la ocurrencia de Eventos Supuestamente Atribuibles a la Vacunación o Inmunización asociados a la Vacuna contra el Virus del Papiloma Humano entre adolescentes de ambos sexos. Métodos: Se trata de una revisión sistemática realizada según la declaración Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Resultados:Se identificaron 11.016 artículos y, tras eliminar duplicados, quedaron 6.824. De ellos, 59 fueron seleccionados para lectura completa. La muestra estuvo compuesta por nueve estudios. Los resultados indican que la mayoría de los Eventos Supuestamente Atribuibles a la Vacunación o Inmunización fueron leves y moderados, prevaleciendo los eventos en el lugar de la inyección, como dolor y edema. Los Eventos Supuestamente Atribuibles a la Vacunación o Inmunización sistémicos más comunes fueron fiebre, dolor de cabeza, fatiga y mareos. Conclusión: La vacuna contra el Virus del Papiloma Humano para adolescentes es segura, lo que refuerza su importancia como estrategia para reducir las tasas de incidencia de cánceres asociados al Virus del Papiloma Humano.

Managerial Decision-Making of Nurses in Hospitals: creation and validation of a simulation scenario / Tomada de Decisão Gerencial do Enfermeiro da Área Hospitalar: construção e validação de cenário de simulação / Toma de Decisiones Gerenciales del Enfermero en el Área Hospitalaria: construcción y validación de un escenario de simulación

Abstract Objective: to build and validate a clinical simulation scenario on hospital nurse managerial decision-making competence for undergraduate nursing students. Method: a descriptive and methodological study was carried out in a higher education institution, with the participation of 10 judges and five players. To do so, the conceptual simulation model proposed by Jeffries and standards of the International Nursing Association for Clinical Simulation and Learning were used to prepare the scenario and the checklist. Results: the scenario was called "Managerial decision-making of nurses in the face of adverse events in a hospital". The scenario script and checklist were built for validation. The checklist was face- and content-validated. Afterward, judges used the checklist to validate the scenario, which, in its final version, was composed of Prebriefing (seven items), Scenario in Action (18 items) and Debriefing (seven items). Conclusion: the scenario proved to be a teaching strategy that anticipates the reality of future nurses, bringing them the self-confidence to perform their activities and helping them to act critically and reflectively during decision-making processes.

Resumo Objetivo: construir e validar um cenário de simulação clínica sobre a competência tomada de decisão gerencial do enfermeiro hospitalar para estudantes de graduação em enfermagem. Método: estudo descritivo e metodológico realizado em uma instituição de ensino superior, com a participação de 10 juízes e cinco atores. Utilizou-se o modelo conceitual de simulação proposto por Jeffries e guias padronizadas da International Nursing Association for Clinical Simulation in Learning para a elaboração do cenário e do checklist. Resultados: o cenário ficou denominado como "Tomada de decisão gerencial do enfermeiro diante de eventos adversos no contexto hospitalar". Construiu-se o script do cenário e o checklist para a sua validação. Realizou-se validação de face e conteúdo do checklist. Posteriormente, juízes de posse do checklist, validaram o cenário que, em sua versão final, ficou composto por Prebriefing (sete itens), Cenário em Ação (18 itens) e Debriefing (sete itens). Conclusão: o cenário mostrou-se uma estratégia de ensino capaz de antecipar a realidade do futuro enfermeiro, trazendo autoconfiança na execução de suas atividades, contribuindo para agir de forma crítica e reflexiva durante o processo de tomada de decisão.

Resumen Objetivo: construir y validar un escenario de simulación clínica sobre la competencia en la toma de decisiones gerenciales del enfermero hospitalario para estudiantes del grado en enfermería. Método: estudio descriptivo y metodológico realizado en una institución de educación superior, con la participación de 10 jueces y cinco actores. Se utilizó el modelo conceptual de simulación propuesto por Jeffries y guías estandarizadas de la International Nursing Association for Clinical Simulation in Learning para la elaboración del escenario y del checklist. Resultados: el escenario se denominó "Toma de decisiones gerenciales del enfermero ante eventos adversos en el contexto hospitalario". Se construyó el script del escenario y el checklist para su validación. Se realizó la validez aparente y el contenido del checklist. Posteriormente, los jueces en posesión del checklist, validaron el escenario que, en su versión final, quedó compuesto por Prebriefing (siete ítems), Escenario en Acción (18 ítems) y Debriefing (siete ítems). Conclusión: el escenario demostró ser una estrategia de enseñanza capaz de anticipar la realidad del futuro enfermero, trayendo autoconfianza en la ejecución de sus actividades, contribuyendo para actuar de forma crítica y reflexiva durante el proceso de toma de decisiones.

Um raro caso de vasculite leucocitoclástica induzida por oxacilina / A rare case of oxacillin-induced leukocytoclastic vasculitis

A vasculite leucocitoclástica é uma patologia cujos mecanismos estão associados ao processo de inflamação vascular. Estima-se que até 24% dos casos de vasculite estão relacionados ao uso de fármacos, sendo os antimicrobianos beta-lactâmicos um dos grupos farmacológicos comumente associados a este desfecho adverso. A oxacilina, uma penicilina semissintética, possui um anel beta-lactâmico que confere atividade biológica e está associada com maior frequência a relatos de vasculite leucocitoclástica. No entanto, casos semelhantes relacionados a esse antimicrobiano são raros, sendo identificados apenas três casos na literatura. Diante desse contexto, relatamos um quarto caso de vasculite leucocitoclástica em um homem de 56 anos, em tratamento com oxacilina, que desenvolveu a vasculite no 3º dia de uso do antimicrobiano. Além da suspensão da oxacilina, ele foi tratado com 125 mg/dia de metilprednisolona endovenosa por sete dias, seguido de 20 mg/dia de prednisona oral por quatro dias, resultan-do em remissão satisfatória das lesões cutâneas e ausência de novos desfechos adversos. Este caso corrobora a possível relação causal entre o uso de oxacilina e o desenvolvimento da vasculite leucocitoclástica, apesar de sua ocorrência ser rara. A resposta favorável às intervenções terapêuticas, incluindo a suspensão da oxacilina e o uso de corticosteroides, destaca a eficácia dessas abordagens no tratamento dessa complicação (AU).

Leukocytoclastic vasculitis is a pathology whose mechanisms are associated with the process of vascular inflammation. It is estimated that up to 24% of the cases of vasculitis are drug-related, with beta-lactam antimicrobials be-ing one of the pharmacological groups commonly associated with this adverse outcome. Oxacillin, a semisynthetic penicillin, has a beta-lactam ring that confers biological activity and is most frequently associated with reports of leukocytoclastic vasculitis. However, similar cases related to this antimicrobial are rare, with only three cases identified in the literature. Against this background, we report a fourth case of leukocytoclastic vasculitis in a 56-year-old man, on oxacillin treatment, who developed the vasculitis on the 3rd day of antimicrobial use. In addition to oxacillin suspension, he was treated with 125 mg/day of intravenous methylprednisolone for seven days, followed by 20 mg/day of oral prednisone for four days, resulting in satisfactory remission of the skin lesions and no new adverse outcomes. This case provides further evidence supporting the potential causal relationship between the use of oxacillin and the development of leukocytoclastic vasculitis, albeit a rare occurrence. The positive response to therapeutic interventions, such as oxacillin suspension and corticosteroid treatment, underscores the effectiveness of these approaches in addressing this complication (AU),

Predicción de toxicidad de la quimioterapia y radioterapia en el paciente oncológico quirúrgico

Fundamento la toxicidad asociada a los tratamientos de quimioterapia y radioterapia eleva la morbilidad y la mortalidad en los pacientes oncológicos. Objetivo diseñar un modelo predictivo de toxicidad de la quimioterapia y la radioterapia en el paciente oncológico quirúrgico. Métodos estudio analítico, de casos y controles, en pacientes oncológicos quirúrgicos que cumplieron los criterios de inclusión para la predicción de toxicidad preoperatoria, en el periodo enero a diciembre de 2022, en el Hospital Provincial Docente Oncológico María Curie, de Camagüey. Mediante el paquete estadístico Statistical Package for the Social Sciences, se seleccionó una muestra aleatoria de 334 pacientes, 197 sin toxicidad (grupo control) y 137 con toxicidad (grupo de estudio). Se realizó estimación de predictores de toxicidad mediante regresión logística binaria. Se seleccionó el modelo de mejor ajuste. Resultados el modelo en el paso tres predice un porcentaje global de 83,5 % con respecto a los valores observados. La sensibilidad resultó ser de 81,8; y la especificidad, 84,8. El modelo presentó buen poder discriminativo. Las variables en la ecuación fueron: hipertensión arterial, fracción de eyección del ventrículo izquierdo y anemia. La comparación de la predicción con la realidad, mediante curva Receiver Operating Characteristic determinó un área bajo la curva de 0,901. Conclusión se obtuvo una función de regresión logística que permitió la estimación de la probabilidad de toxicidad en pacientes oncológicos quirúrgicos electivos, la cual proporcionó una herramienta para su predicción desde el preoperatorio.

Foundation the toxicity associated with chemotherapy and radiotherapy treatments increases morbidity and mortality in cancer patients. Objective to design a predictive model of chemotherapy and radiotherapy toxicity in surgical cancer patients. Methods analytical, case-control study, in surgical oncology patients who met the inclusion criteria for the prediction of preoperative toxicity, from January to December 2022, at the María Curie Provincial Teaching Oncology Hospital in Camagüey. Using the Statistical Package for the Social Sciences, a random sample of 334 patients was selected, 197 without toxicity (control group) and 137 with toxicity (study group). Toxicity predictors were estimated using binary logistic regression. The model with the best fit was selected. Results the model in step three predicts an overall percentage of 83.5% with respect to the observed values. The sensitivity turned out to be 81.8; and the specificity, 84.8. The model presented good discriminative power. The variables in the equation were: arterial hypertension, left ventricular ejection fraction, and anemia. The comparison of the prediction with reality, using the Receiver Operating Characteristic curve, determined an area under the curve of 0.901. Conclusion a logistic regression function was obtained that allowed the estimation of the toxicity probability elective surgical cancer patients, which provided a tool for its prediction from the preoperative period.

Manejo das irregularidades menstruais secundárias ao uso de contraceptivos ­ análise das recomendações atuais / Management of menstrual irregularities secondary to contraceptive use ­ analysis of current recommendations

As irregularidades menstruais representam uma série de desordens na quantida- de, duração, frequência ou regularidade do sangramento uterino. Entre suas cau- sas destaca-se o sangramento secundário ao uso de anticoncepcionais, uma razão frequente de descontinuidade dos contraceptivos, podendo aumentar as taxas de gestações não planejadas. Boa parte dos contraceptivos pode levar a mudanças no padrão de sangramento uterino, e a abordagem inicial do sangramentos irregula- res inclui a avaliação de outras possíveis causas, o reforço do uso correto da medi- cação, a tranquilização da paciente quanto à benignidade do quadro e à tendência a melhora com a continuidade do uso. Os anti-inflamatórios podem ser usados como estratégia inicial, e, não havendo resposta satisfatória, há alternativas espe- cíficas para cada método. Este trabalho visa identificar as recomendações atuais sobre o manejo do sangramento anormal decorrente de contraceptivos, por meio de revisão narrativa de estudos publicados sobre o tema nos últimos vinte anos.

Abnormal uterine bleeding represents a series of disorders in the amount, du- ration, frequency and or regularity of uterine bleeding. Among its causes, uterine bleeding secondary to the use of contraceptives stands out as a frequent reason for contraceptive discontinuity, which could lead to unplanned pregnancies. Most contraceptives can cause changes in the pattern of uterine bleeding, and the ini- tial approach of the abnormal bleeding includes assessing other possible cau- ses, reinforcing the correct use of medication, and reassuring the patient about the benignity of the condition and the tendency to improve with the continuity of the treatment. Anti-inflammatory drugs can be used as an initial strategy, and, if there is no satisfactory answer, there are specific alternatives for each contracep- tive method. This work aims to identify them current recommendations on the management of abnormal bleeding resulting from contraceptives use, through a narrative review of studies published on the subject in the last twenty years.

EGFR inhibitors: clinical aspects, risk factors and biomarkers for acneiform eruptions and other mucosal and cutaneous adverse effects

Abstract The frequency of the use of drugs that act on the epidermal growth factor receptor (EGFR) is increasing, with the consequent onset of cutaneous toxicity, specifically acneiform eruption. The authors extensively review the topic, focusing on describing how these drugs can affect the skin and its appendages, that is, the pathophysiology that encompasses the cutaneous toxicity related to the use of EGFR inhibitors. In addition, it was possible to list the risk factors that may be associated with adverse effects of these drugs. Based on this recent knowledge, the authors expect to aid in the management of patients who are more vulnerable to toxicity, reduce morbidities, and improve the quality of life of patients undergoing treatment with EGFR inhibitors. Other issues related to the toxicity of EGFR inhibitors, such as the clinical aspects of the acneiform eruption grades, and other different types of cutaneous and mucosal reactions, are also included in the article.

Safety and effectiveness of adding fentanyl or sufentanil to spinal anesthesia: systematic review and meta-analysis of randomized controlled trials

Abstract Introduction Spinal infusions of either fentanyl or sufentanil have been reported in international reports, articles, and scientific events worldwide. This study aimed to determine whether intrathecal fentanyl or sufentanil offers safety in mortality and perioperative adverse events. Methods MEDLINE (via PubMed), EMBASE, CENTRAL (Cochrane library databases), gray literature, hand-searching, and clinicaltrials.gov were systematically searched. Randomized controlled trials with no language, data, or status restrictions were included, comparing the effectiveness and safety of adding spinal lipophilic opioid to local anesthetics (LAs). Data were pooled using the random-effects models or fixed-effect models based on heterogeneity. Results The initial search retrieved 4469 records; 3241 records were eligible, and 3152 articles were excluded after reading titles and abstracts, with a high agreement rate (98.6%). After reading the full texts, 76 articles remained. Spinal fentanyl and sufentanil significantly reduced postoperative pain and opioid consumption, increased analgesia and pruritus. Fentanyl, but not sufentanil, significantly reduced both postoperative nausea and vomiting, and postoperative shivering; compared to LAs alone. The analyzed studies did not report any case of in-hospital mortality related to spinal lipophilic opioids. The rate of respiratory depression was 0.7% and 0.8% when spinal fentanyl or sufentanil was added and when it was not, respectively. Episodes of respiratory depression were rare, uneventful, occurred intraoperatively, and were easily manageable. Conclusion There is moderate to high quality certainty that there is evidence regarding the safety and effectiveness of adding lipophilic opioids to LAs in spinal anesthesia.

Adverse effects of cannabinoid use: what is the safety paradigm? / Efeitos adversos do uso dos canabinoides: qual o paradigma de segurança?

ABSTRACT BACKGROUND AND OBJECTIVES: Interest in the use of marijuana (Cannabis sativa) for medicinal purposes has increased exponentially in recent decades, and the plant and its derivatives are becoming more frequently found in prescriptions for patients with chronic pain. All prescription drugs and illicit substances have adverse effects, even those from plants, fruits, and flowers, as has been well established with the use of tobacco, alcohol, and opium. Marijuana is no exception. The purpose of this study was to review and synthesize the evidence related to the adverse effects promoted by plant-derived cannabinoids, and the implications for the safety of using these substances in pain patients. CONTENTS: A narrative review was conducted based on articles published in scientific journals indexed in Pubmed and Scielo between the years 2000 and 2022. CONCLUSION: The evidence is still contradictory and weak on many aspects of adverse effects and clearly there is a need for further research and advances towards a more detailed elucidation of these effects for both non-medical and medical cannabis use. Screening and monitoring of such use, identifying situations of vulnerability to mental illness and dependence, with careful surveillance for adverse effects, is critical.

RESUMO JUSTIFICATIVA E OBJETIVOS: O interesse na utilização da maconha (Cannabis sativa) com fins medicinais aumentou de forma exponencial nas últimas décadas e a planta e seus derivados vêm se tornando mais frequentemente encontrados nas prescrições médicas de pacientes com dor crônica. Todos os fármacos prescritos e substâncias ilícitas têm efeitos adversos, mesmo aquelas provenientes de plantas, frutas e flores, como já ficou bem estabelecido com o uso do tabaco, álcool e ópio. A maconha não é exceção. O objetivo deste estudo foi revisar e sintetizar as evidências relacionadas aos efeitos adversos promovidos pelos canabinoides derivados da planta, e às implicações sobre a segurança do uso destas substâncias em pacientes com dor. CONTEÚDO: Foi realizada uma revisão narrativa baseada em artigos publicados em revistas científicas indexadas no Pubmed e Scielo, entre os anos de 2000 e 2022. CONCLUSÃO: As evidências ainda são contraditórias e frágeis em relação a muitos aspectos dos efeitos adversos e claramente há a necessidade de mais pesquisas e avanços para uma elucidação mais detalhada destes efeitos tanto para o uso não medicinal quanto médico de cannabis. É fundamental uma triagem e monitoramento desse uso, identificando situações de vulnerabilidade a doenças mentais e dependência, com cuidadosa vigilância de efeitos adversos.

Immune checkpoint inhibitor-induced endocrinopathies: a possible indicator of improved survival

ABSTRACT Objective: To evaluate the association between the patients' characteristics and the development of endocrine toxicity and to assess the association between endocrine-related adverse effects (ERAE) development and mortality. Subjects and methods: A retrospective observational study was conducted in 98 patients submitted to immunotherapy in our centre since its introduction in 2015 until March 2021. We excluded patients for which data regarding the corticotroph axis evaluation was missing. We used linear and logistic regression models to address our aims. Results: We observed a significant negative association between ERAE development and death (OR 0.32; p = 0.028). We detected no associations between ERAE and the following characteristics: age at immune checkpoint inhibitors (ICI) initiation, sex, diabetes mellitus, medical history, immunotherapy duration and ICI type. Conclusion: The development of an ERAE may be associated with a better overall survival rate in advanced oncologic disease, supporting the role of an unleashed immune system response to malignant cells.

Vigilancia de los eventos adversos a la vacunación en Camagüey (2018)

Objetivo: Evaluar la vigilancia de los eventos adversos a la vacunación en Camagüey en 2018. Métodos: Investigación en servicios y sistemas de salud de tipo operacional, con diseño evaluativo, que abarcó desde el 1ro. de enero hasta el 31 de diciembre de 2018. La población de estudio quedó constituida por 355 trabajadores (149 médicos de la familia, 161 enfermeras de familia, 16 enfermeras vacunadoras y 29 gerentes del programa de vacunación). La información se obtuvo mediante observación, revisión documental y entrevistas. Para evaluar los componentes: estructura, procesos y resultados, se definieron diferentes criterios, indicadores y estándares. Resultados: La estructura se evaluó como definida. El 90,9 % de los indicadores relacionados con cobertura y capacitación de los recursos humanos obtuvo la puntuación máxima, y en los recursos materiales, solo en el 81,2 % de los vacunatorios se disponía del conjunto de modelos necesario para el trabajo y control. Los atributos de sensibilidad, simplicidad, flexibilidad, aceptabilidad, integralidad, oportunidad y capacidad de autorespuesta, se evaluaron satisfactoriamente (70 % o más del estándar propuesto); la sensibilidad alcanzó solo el 34,2 %. Se obtuvo una tasa de 150 eventos adversos por 105dosis aplicadas, pero sin eventos graves, y los resultados se consideraron útiles. Conclusiones: El sistema de vigilancia de eventos adversos a la vacunación en Camagüey cumplió con los estándares establecidos para la confiabilidad del programa de vacunación y la toma de decisiones: una estructura bien definida, procesos con buen funcionamiento y resultados muy útiles.

Objective: To evaluate the surveillance for adverse events to vaccination in Camagüey in 2018. Methods: Operational research in health services and systems, with an evaluative design, which covered from January 1 to December 31, 2018. The study population comprised 355 workers (149 family physicians, 161 family nurses, 16 nurse vaccinators, and 29 vaccination program managers). Information was obtained through observation, documentary review, and interviews. Different criteria, indicators, and standards were established for evaluating the structure, process and outcome components. Results: The structure was evaluated as defined. The maximum score was obtained in 90.9% of the indicators related to coverage and training of human resources. Regarding material resources, only 81.2% of the vaccination centers had the necessary set of templates to carry out the work and control. The attributes of sensitivity, simplicity, flexibility, acceptability, comprehensiveness, timeliness, and self-response capacity were evaluated satisfactorily (70% or more of the proposed standard); sensitivity reached only 34.2%. A rate of 150 adverse events per 105doses applied was obtained; severe events were not evidenced, and the results were considered useful. Conclusions: The surveillance system for adverse events to vaccination in Camagüey met the standards established for the reliability of the vaccination program and decision-making: a well-defined structure, well-functioning processes, and very useful outcomes.

Medication Fall Risk Score e Evaluation Tools: Adaptação Transcultural para o uso no Brasil / Medication Fall Risk Score and Evaluation Tools: Cross-Cultural daptation for Use in Brazil

A queda é um problema potencial para todos os pacientes já que o risco aumenta no ambiente hospitalar, independente da instituição. Muitos fatores podem estar associados a queda, dentre eles o equilíbrio, que pode ser influenciado pelo uso de medicamentos. A aplicação de escala de avaliação para risco de quedas é uma das ferramentas mais empregadas no Brasil e no mundo, porém se faz necessário avaliar também os medicamentos em uso do paciente. Com o objetivo de realizar a adaptação transcultural e validação do Medication Falls Risk Score e da Evaluation Tools para a língua portuguesa do Brasil. Método: Estudo metodológico para a adaptação transcultural e validação das ferramentas Medication Falls Risk Score e Evaluation Tools, utilizando-se o protocolo de Beaton et al. e realizando a validação da praticabilidade de ambas as escalas. Os instrumentos obtiveram Índice de Validade de Conteúdo (IVC) médio de 0,99, sendo considerados válidos. A validação da praticabilidade de ambos os instrumentos teve resultados favoráveis, 65,2% dos participantes acharam a ferramenta de fácil aplicação, e o tempo médio gasto para a aplicação foi de 13 minutos e 30 segundos. Dentre as dificuldades encontradas, destaca-se a de reconhecer os medicamentos perante sua classe terapêutica, o que justifica a diferença entre o tempo de aplicação e acerto do teste aplicado. As ferramentas foram adaptadas transculturalmente para o português brasileiro, e apontaram uma excelente concordância e viabilidade de uso na prática nos cenários de atenção em saúde. A escala e as ferramentas aprovadas poderão servir como apoio para identificação, classificação e cuidado multiprofissional perante o risco de quedas de pacientes internados, sendo uma avaliação adicional a Morse Fall Scale - versão brasileira.

Falls are a potential problem for all patients, especially as the risk increases in the hospital environment, regardless of the institution. Many factors may be associated with falls, including balance, which may be influenced by the use of medication. The application of an assessment scale for the risk of falls is one of the most used tools in Brazil and in the world, but it is also necessary to evaluate the medications the patient is using. The objective of this study is to carry out the cross-cultural adaptation and validation of the Medication Falls Risk Score and the Evaluation Tools for the Brazilian Portuguese language. Method: Methodological study for the cross-cultural adaptation and validation of the Medication Falls Risk Score and Evaluation Tools, using the protocol by Beaton et al. and performing the validation of the feasibility of both scales. The instruments obtained an average Content Validity Index (CVI) of 0.99, being considered valid. The validation of the feasibility of both instruments had favorable results, 65.2% of the participants found the tool easy to apply, and the average time taken to apply it was 13 minutes and 30 seconds. Among the difficulties encountered, the difficulty of recognizing the drugs in terms of their therapeutic class stands out, which justifies the difference between the time of application and the accuracy of the applied test. The tools were cross-culturally adapted to Brazilian Portuguese and demonstrated excellent agreement and practicality in healthcare settings. The approved scale and tools may serve as support for the identification, classification, and multidisciplinary care regarding the risk of falls in hospitalized patients, with the Morse Fall Scale - Brazilian version being an additional assessment.

Medication package inserts do not present adequate information on potential risks for older adults in Brazil / Bulas de medicamentos não apresentam informações adequadas sobre potenciais riscos para idosos no Brasil

OBJECTIVE: To compare information on the risks of potentially inappropriate medications (PIMs) for older adults in the Beers criteria with data in the package inserts made available by the Brazilian Health Regulatory Agency. METHODS: This is an observational, cross-sectional study that compared information on the package inserts of 33 brand-name drugs in the Brazilian market with specific recommendations for older adults contemplated in the Beers criteria, categorizing them into: complete, incomplete, absent, or discrepant. RESULTS: Among the analyzed package inserts, 21.21% did not present a specific section dedicated to the use of these drugs by older adults and data were scattered throughout the text; 63.64% were classified as incomplete; 33.33% lacked data; and 3.03% had discrepant information. CONCLUSION: The analyzed package inserts presented incomplete data or lacked information characterizing the drugs as PIMs for older adults. This study demonstrated that some package inserts of drugs used in Brazil are not satisfactory, warranting higher caution in the medical community when prescribing these medications and guiding patients

OBJETIVO: Comparar as informações sobre os riscos de medicamentos potencialmente inapropriados (MPIs) para idosos contidas nos critérios Beers com as informações presentes nas bulas para profissionais de saúde disponibilizadas pela Agência Nacional de Vigilância Sanitária no Brasil. METODOLOGIA: Estudo observacional e transversal que comparou informações das bulas para profissionais de saúde de 33 medicamentos de referência no mercado brasileiro com recomendações específicas para idosos contempladas nos critérios Beers e que foram categorizadas em: completas, incompletas, ausentes ou discrepantes. RESULTADOS: Dentre as bulas dos MPIs analisadas, 21,21% não apresentam seção específica destinada ao uso desses medicamentos por idosos, nas quais as informações estão dispersas pelo texto; 63,64% delas foram classificadas como incompletas; 33,33% tinham informações ausentes; e 3,03% com informações discrepantes. CONCLUSÃO: As bulas analisadas apresentaram dados incompletos ou não apresentam qualquer informação que caracterizasse o medicamento como MPI para idosos. Este estudo demonstra que algumas bulas de medicamentos utilizados no Brasil não estão satisfatórias, sugerindo maior cautela à comunidade médica na prescrição e na orientação aos seus pacientes

Clinical characteristics of patients with malignant tumors and immune checkpoint inhibitors related multisystem adverse events as well as therapeutic efficacy of immune checkpoint inhibitors: a retrospective study / 肿瘤研究与临床

Objective:To investigate the clinical characteristics of patients with malignant tumors and immune checkpoint inhibitors (ICI) related multisystem adverse events as well as therapeutic efficacy of ICI.Methods:The general data, immune-related adverse events (irAE) type, onset time, severity and ICI efficacy of patients with malignant tumors who developed irAE after receiving ICI in China-Japan Friendship Hospital between January 2019 and November 2021 were retrospectively analyzed. All patients were divided into multisystem irAE group and single system irAE group according to whether patients with more than 1 organ or system developed irAE for once. The occurrence of irAE was summarized, and the clinical characteristics of patients were compared. Progression-free survival analysis was not performed owing to the pause of immunotherapy caused by some irAE, so the efficacy of ICI was evaluated by using ICI treatment duration (TD).Results:A total of 47 patients with malignant tumors and irAE were included in this study, with 70 times of irAE in total. The median onset time was 90 d (35 d, 196 d). Among them, 12 patients (25.53%) developed multisystem irAE (32 times of irAE in total); the other 35 patients (74.47%) developed single system irAE (38 times of irAE in total). Cutaneous toxicity for 7 times, thyroid toxicity for 7 times and pulmonary toxicity for 5 times were the most frequent among multisystem irAE group; pulmonary toxicity for 13 times, thyroid toxicity for 12 times and cutaneous toxicity for 5 times were the most frequent among single system irAE group. There were no statistically significant differences in the proportion of patients stratified by age, gender, the combination of other treatments and different body mass between the two groups (all P > 0.05). The median follow-up time was 20 months (9-40 months). The median TD of ICI was 16.00 months (95% CI 3.62-31.22 months) in multisystem irAE group and 4.60 months (95% CI 4.12-11.30 months) in single system irAE group; TD in multisystem irAE group was longer than that in single system irAE group, and the difference was statistically significant ( HR = 0.413, 95% CI 0.202-0.844, P = 0.038). Conclusions:The efficacy of ICI in patients with malignant tumors and multisystem irAE is better than that in those with single system irAE. It suggests that the better efficacy of ICI may be associated with greater risk of irAE. There is no significant difference in the clinical features between multisystem irAE and single system irAE.

Effects of heat-sensitive moxibustion plus Chinese medication on the expression of serum inflammatory indicators and microRNAs in patients with multiple myeloma after chemotherapy / 针灸推拿医学（英文版）

Objective: To observe the effects of heat-sensitive moxibustion plus Chinese medication on serum inflammatory indicators, T-lymphocyte subsets, and serum microRNAs in patients with multiple myeloma after chemotherapy. Methods: Eighty-two patients with multiple myeloma who had terminated chemotherapy were divided into an observation group and a control group using the random number table method, with 41 cases in each group. The control group received symptomatic treatment of Western medicine plus oral Chinese medication Yi Shen Qiang Gu Tang (decoction for benefiting the kidney to strengthen bones), and the observation group received additional heat-sensitive moxibustion treatment. After the intervention, the following measures were observed, including clinical efficacy, symptom scores of traditional Chinese medicine (TCM), and tumor patient's quality of life (QOL) scores [including Karnofsky performance status (KPS) score, performance scale (PS) score, and tumor-specific QOL questionnaire score] alongside the serum inflammatory indicators [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and interleukin-6 (IL-6)], and the relative expression levels of T-lymphocyte subsets (CD3+, CD4+, and CD8+) and serum microRNA-302 (miR-302), microRNA-140-5p (miR-140-5p), and microRNA-125a (miR-125a). Results: After treatment, the total effective rate was 85.4％ in the observation group, higher than 68.3％ in the control group (P<0.05). The observation group was superior to the control group in improving the serum inflammatory factor levels, TCM symptom scores, tumor patient's QOL scores, and the relative expression levels of T-lymphocyte subsets and serum miR-302, miR-140-5p, and miR-125a, and the between-group differences were statistically significant (P<0.05). Conclusion: Heat-sensitive moxibustion plus Chinese medication can lower the serum inflammatory factor levels, strengthen immune function, mitigate TCM symptoms, enhance QOL, and raise the expression levels of serum miR-125a, miR-140-5p, and miR-302 in multiple myeloma patients after chemotherapy.