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)

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.

Safety Evaluation of Tianzhi Granules in Treating Mild-to-moderate Vascular Dementia / 中国实验方剂学杂志

ObjectiveTo systematically evaluate the safety of Tianzhi granules used in the treatment of mild-to-moderate vascular dementia. MethodA randomized， double-blind， double-simulated， positive drug/placebo parallel controlled multi-center phase Ⅳ clinical trial and an open multi-center phase Ⅳ clinical trial of Tianzhi granules in the treatment of mild-to-moderate vascular dementia were conducted. Safety data of 1 492 patients were included and analyzed according to inclusion and exclusion criteria. The main evaluation measures were the incidence rate of adverse events/adverse reactions， laboratory indicators， vital signs， and electrocardiogram （ECG） results. ResultA total of six adverse events possibly related to the test drug occurred in 520 patients of the double-blind trial， and the symptoms were all mild and recovered. The incidence of adverse events was not statistically different among Tianzhi granules， donepezil， and placebo groups. Nine adverse events possibly related to the test drug were observed in 972 patients of the open trial， and the symptoms were mild and recovered. Laboratory tests （blood routine， urine routine， liver function， kidney function， and coagulation） and vital signs were compared before treatment （baseline） and after treatment of 12 and 24 weeks， respectively. There was no statistical significance in the main indicators before and after treatment. In the double-blinded trial， there was no significant difference in safety indicators between different groups before and after treatment. The most frequent adverse reaction was gastrointestinal discomfort， with an incidence rate of 6.64‰. ConclusionAdverse reactions occasionally occur in patients using Tianzhi granules， and it is safe to use Tianzhi granules to treat mild-to-moderate vascular dementia clinically.

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.

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.

Reacciones adversas a múltiples antibióticos / Adverse drug reactions to multiple antibiotics

Resumen La información sobre reacciones adversas es fundamental para conocer la seguridad real de los medicamentos comercializados. Existen casos de pacientes con síndrome de intolerancia a múl tiples drogas, una entidad poco reportada, la que puede presentarse cuando en un mismo paciente ocurren reacciones adversas a más de dos medicamentos no relacionados farmacológicamente. Se describe el caso de una mujer con diagnóstico de endocarditis por Staphylococcus aureus multisensible, que cursó con reacciones adversas a cinco antibióticos estructuralmente no relacionados y con mecanismos de acción diferentes, en dos internaciones consecutivas. Las reacciones fueron secundarias a cefazolina (tricitopenia), vancomicina (injuria renal), daptomicina (elevación de creatina fosfoquinasa) y linezolid (hepatotoxicidad) en la primera internación, y a cotrimoxazol (plaquetopenia) en la segunda. En todos los casos se observó daño transitorio en diferentes sistemas de órganos. Finalmente, se otorgó alta hospitalaria con clindamicina sin nuevas intercurrencias hasta finalizar tratamiento. Este caso podría corresponder al síndrome antes mencionado o a una entidad aún no caracterizada.

Abstract Adverse reaction reporting is essential to understand the actual safety of marketed medicines. There are cases of patients with multidrug intolerance syndrome, an under-reported entity, which can occur when adverse reactions to more than two pharmacologically unrelated drugs occur in the same patient. We describe the case of a woman diagnosed with multisensitive Staphylococcus aureus endocarditis who experienced adverse reactions to five structurally unrelated antibiotics with different mechanisms of action in two consecutive hospitalisations. The reactions were secondary to cefazolin (tricytopenia), vancomycin (renal injury), daptomycin (elevated creatine phosphokinase) and linezolid (hepatotoxicity) in the first hospitalization, and to cotrimoxazole (thrombocytopenia) in the second. Transient damage to different organ systems was observed in all cases. Finally, hospital discharge was granted with clindamycin without further intercurrences until treatment was completed. This case could cor respond to the aforementioned syndrome or to an as yet uncharacterized entity.

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.

Reacciones adversas medicamentosas en ancianos de Matanzas, Cuba 2014-2019 / Adverse drug reactions in the elderly of Matanzas, Cuba 2014-2019

Resumen Objetivo: Caracterizar las sospechas de reacciones adversas a medicamentos que se presentaron en los adultos mayores en Matanzas, en el periodo 2014 al 2019. Materiales y Método: Estudio de serie de casos en Farmacovigilancia (FV). Se revisó la base de datos de reportes de sospecha de reacciones adversas a los medicamentos de la Unidad Coordinadora Provincial de Farmacovigilancia, entre 2014 y 2019. Resultados: Se evaluaron un total de 1926 reportes de reacciones adversas por medicamentos en ancianos, representaron el 24,3 % del total. Predominaron las mujeres (56,7 %) y el grupo de edad entre 60 y 69 años (51,4%). Prevaleció la erupción cutánea (13,4 %). Los antimicrobianos y los antiinflamatorios no esteroideos, fueron los que se asociaron más con las RAM en piel, así como del sistema digestivo. La tos estuvo relacionada con el captopril. Predominaron las reacciones adversas por medicamentos de baja frecuencia (55,2%), moderadas (83,8%) y las probables (77,1%) según imputabilidad. Conclusiones: El perfil de seguridad en ancianos en la provincia de Matanzas muestra un predominio de reacciones adversas frecuentes, moderadas y probables en mujeres con edades entre 60 a 69 años. Los antimicrobianos, los inhibidores de la enzima convertidora de angiotensina y los antiinflamatorios no esteroideos fueron los fármacos más notificados por los médicos y farmacéuticos produciendo síntomas a nivel del sistema digestivo y la piel.

Abstract Objective: To characterize suspected adverse drug reactions that occurred in older adults in Matanzas, from 2014 to 2019. Materials and methods: Pharmacovigilance (FV) case series study. The database of reports of suspected adverse drug reactions of the Provincial Pharmacovigilance Coordinating Unit, between 2014 and 2019, was reviewed. Results: A total of 1926 reports of adverse drug reactions in the elderly were evaluated, representing 24, 3% of the total. Women (56.7%) and the age group between 60 and 69 years (51.4%) predominated. Skin rash prevailed (13.4%). Antimicrobials and non-steroidal anti-inflammatory drugs were the ones most associated with ADRs in the skin, as well as in the digestive system. Cough was related to captopril. Adverse drug reactions of low frequency (55.2%), moderate (83.8%) and probable (77.1%) prevailed according to immutability. Conclusions: The safety profile in the elderly in the province of Matanzas shows a predominance of frequent, moderate and probable adverse reactions in women aged between 60 and 69 years. Antimicrobials, angiotensin-converting enzyme inhibitors and non- steroidal anti-inflammatory drugs were the drugs most reported by doctors and pharmacists, producing symptoms at the level of the digestive system and the skin.

Effect of double dose plateletpheresis on target yield and donor platelet recovery

Abstract Introduction The demand for apheresis platelets has increased in the recent past and the shrinking donor pool has shifted the trend to collection of double-dose or higher yield of platelets. Objective The present study aimed to determine the effect of double-dose plateletpheresis on the target yield and donor platelet recovery. Methods The study was conducted on 100 healthy plateletpheresis donors, 50 of whom were in the study group, which underwent double-dose plateletpheresis (DDP), and 50 of whom were in the control group for single-donor plateletpheresis. Pre- and post-procedure samples of donors were subjected to a complete blood count. The DDP product was sampled for platelet yield and then split into two parts. Platelet yield, collection efficiency, collection rate, recruitment factor and donor platelet loss were calculated. Results The mean platelet yield in the SDP was 4.09 ± 1.15 × 1011 and in the DDP, 5.93 ± 1.04 × 1011. There was a significant correlation between the pre-donation platelet count and platelet yield. The total of platelets processed for the SDP were 5.42 ± 1.08 × 1011 and for the DDP, 7.94 ± 0.77 × 1011. The collection efficiency was 71.93 ± 25.14% in the SDP and 72.94 ± 16.28% in the DDP, while the collection rates were 0.78 × 1011 and 0.94 × 1011 per minute, respectively. The average recruitment factor observed was 0.98 in the SDP, while it was 0.99 in the DDP. The mean platelet loss observed in the SDP was 35.55 ± 8.53% and in the DDP, 37.76 ± 8.65%. Conclusion The double-dose plateletpheresis supplements the platelet inventory in developing countries where the apheresis donor pool is limited. It is prudent to ensure stringent donor selection criteria for donors donating high-yield platelet products, thus enhancing donor safety and retention.

Efficacy and safety of ticagrelor combined with atorvastatin in the treatment of acute cerebral infarction / 中国医师进修杂志

Objective:To investigate the efficacy and adverse reactions of ticagrelor combined with atorvastatin in the treatment of acute cerebral infarction (ACI).Methods:A total of 80 patients with ACI who were diagnosed and treated in Anhui Suixi County Hospital from October 2021 to October 2022 were selected retrospectively and randomly divided into the control group and observation group, each group with 40 cases. The patients in the control group were treated with routine basic treatment and atorvastatin for ACI. The patients in the observation group was treated with ticagrelor on the basis of the control group. The clinical efficacy, neurological function, daily living ability, platelet function (platelet count, platelet inhibition rate), inflammatory factors including high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and adverse reactions of the two groups were compared.Results:The total effective rate of the observation group was higher than that of the control group: 92.50%(37/40) vs. 72.50% (29/40), there was statistical differences ( P<0.05). After treatment, the score of National Institute of Health Stroke Scale of the observation group was lower than that of the control group: (9.37 ± 2.91) points vs. (14.20 ± 3.39) points, and the score of Barthel index scale (BI) was higher than that of the control group: (72.26 ± 13.27) points vs. (58.93 ± 9.43) points, there were statistical differences ( P<0.05). After treatment, the platelet count and platelet adenosine diphosphate (ADP) inhibition rate of the observation group were higher than those of the control group: (284.65 ± 41.58) × 10 9/L vs. (210.46 ± 36.12) × 10 9/L, (79.43 ± 16.42)% vs. (62.40 ± 13.95)%, there were statistical differences ( P<0.05). After treatment, the serum hs-CRP and IL-6 levels of the observation group were lower than those of the control group: (11.64 ± 2.96) mg/L vs. (19.75 ± 4.57) mg/L, (4.26 ± 0.93) ng/L vs. (8.95 ± 1.83) ng/L, there were statistical differences ( P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups after treatment ( P>0.05). Conclusions:Ticagrelor combined with atorvastatin has a better therapeutic effect on ACI, which can effectively improve the neurological deficit and the ability of self-care.

Clinical study of Peiyuan Kangai Decoction combined with acupuncture in the treatment of advanced liver cancer with qi deficiency and blood stasis syndrome / 国际中医中药杂志

Objective:To evaluate the efficacy of Peiyuan Kangai Decoction combined with acupuncture in the treatment of advanced liver cancer with qi deficiency and blood stasis syndrome.Methods:Randomized controlled trial. From May 2019 to May 2021, 162 advanced liver cancer patients with qi deficiency and blood stasis syndrome in Shizhong District Cancer Hospital of Leshan were randomly divided into three groups by random drawing method, with 54 in each group. All patients were given FOLFOX4 chemotherapy regimen. Based on the chemotherapy, the 1st control group was given Peiyuan Kangai Decoction, and the 2nd control group was given acupuncture therapy, and the combined group was given decoction and acupuncture therapy. All three groups were treated for 6 weeks. Traditional Chinese Medicine syndrome score was performed before and after treatment, Piper fatigue scale was used to evaluate the fatigue degree of patients. Vimentin (VIM), Golgi transmembrane glycoprotein 73 (GP73) and chemokine ligand 1 (CXCL1) were determined by ELISA. The adverse reactions during treatment were observed and the clinical efficacy was evaluated.Results:The combined group showed the response rate was 61.11% (33/54), the disease control rate was 72.22% (39/54), the 1st control group showed the response rate was 40.74% (22/54), the disease control rate was 53.70% (29/54), and the 2nd control group showed the response rate was 38.89% (21/54), and the disease control rate was 51.85% (28/54). The response rate and disease control rate of the combined group were significantly higher than either the control group 1 and 2 ( χ2 values were 6.59, 5.68, respectively, and P values were 0.037, 0.043, respectively). After treatment, the scores of liver swelling and pain, fatigue and shortness of breath, anorexia, sallow and emaciation in the combined group were significantly lower than those in the control group 1 and the control group 2 ( F values were 13.90, 15.69, 13.20, 10.55, respectively, P<0.01); the scores of emotions, feeling, behavior and cognition were significantly lower than those in the control group 1 and control group 2 ( F values were 49.55, 27.42, 19.69, 20.55, respectively, P<0.01). After treatment, the levels of serum VIM [(52.54±6.69) ng/L vs. (61.29±7.89) ng/L, (65.11±7.92) ng/L, F=39.63], GP73 [(19.72±3.90) ng/L vs. (24.42±4.23) ng/L, (25.12±4.76) ng/L, F=25.05], CXCL1 [(3.12±0.72) ng/L vs. (4.85±0.95) ng/L, (4.98±0.91) ng/L, F=77.67] in the combined group were significantly lower than those in the control group 1 and the control group 2 ( P<0.01). During the treatment, the incidence of toxic and side effects in the combined group was 18.52% (10/54), the control group 1 was 27.78% (15/54), and the control group 2 was 24.07% (13/54). There was no statistically significant difference in the incidence of toxic and side effects among the three groups ( χ2=1.31, P=0.520). Conclusion:On the basis of FOLFOX4 chemotherapy, combined therapy with Peiyuan Kangai Decoction and acupuncture treatment can improve the symptoms and fatigue of patients with advanced liver cancer, reduce the levels of serum VIM, GP-73, CXCL1, improve the efficacy safely.

Analyzing and monitoring real-world clinical safety of ensartinib for the treatment of patients with ALK-positive non-small cell lung cancer / 国际肿瘤学杂志

Objective:To evaluate the safety of ensartinib in the treatment of anaplastic lymphoma kinase (ALK) -positive non-small cell lung cancer (NSCLC) in the real-world clinical setting.Methods:Clinical data of 2 221 patients with ALK-positive locally advanced or metastatic NSCLC who received ensartinib treatment (225 mg/d) from December 16, 2020 to December 16, 2021 were collected and analyzed to assess drug adverse reactions in all population including elderly patients (≥ 65 years old) .Results:Among the total 2 221 patients, 511 patients (23.01%) experienced adverse events, including 8 patients (0.36%) who experienced serious adverse events. Adverse events led to dose modification in 67 patients (3.02%) and discontinuation in 18 patients (0.81%). The common adverse events were rash (407/2 221, 18.33%), pruritus (41/2 221, 1.85%), constipation (41/2 221, 1.85%), and facial edema (31/2 221, 1.40%). Thirty-six patients (1.62%) experienced ≥grade 3 adverse events. After symptomatic treatment of 511 patients with adverse reactions, 50 patients (9.78%) were healed, 271 patients (53.03%) were improved, 120 patients (23.48%) were persisted, and 70 patients (13.71%) were unknown due to loss of follow-up or other reasons. Forty-three patients (1.94%) reported 57 unintended adverse reactions. Among the 599 elderly patients, 116 patients (19.37%) experienced adverse events, including 1 patient (0.17%) who experienced serious adverse events. Adverse events led to dose modification in 25 patients (4.17%) and discontinuation in 5 patients (0.83%). The common adverse events of elderly patients were rash (88/599, 14.69%), constipation (14/599, 2.34%), facial edema (12/599, 2.00%), and pruritus (10/599, 1.67%). Twelve patients (2.00%) experienced ≥grade 3 adverse events. Among the 116 elderly patients with adverse reactions following the symptomatic treatment, 11 patients (9.48%) were healed, 58 patients (50.00%) were improved, 28 patients (24.13%) were persisted, and 19 patients (16.39%) were unknown due to loss of follow-up or other reasons. During the treatment, 1 patient (0.05%) experienced grade 2 interstitial lung disease, and no patient died due to adverse events.Conclusion:Ensartinib has a favorable safety profile in the real-world populations, with the most frequent adverse events being rash, mostly mild, and low incidence of ≥grade 3 adverse events. Overall, adverse reactions were tolerable and manageable.

Efficacy and safety of bevacizumab combined with capecitabine in the treatment of advanced breast cancer / 国际肿瘤学杂志

Objective:To investigate the efficacy and safety of bevacizumab combined with capecitabine in the treatment of advanced breast cancer.Methods:Seventy-six patients with advanced breast cancer who were diagnosed in the Cancer Center of the People's Liberation Army Navy Anqing Hospital from August 2019 to May 2021 were selected. According to different treatment schemes, the patients were divided into the control group (using single drug capecitabine) and the test group (using bevacizumab combined with capecitabine), with 38 cases in each group. After 4 cycles of treatment, the clinical efficacy, progression-free survival (PFS), overall survival (OS) and adverse reactions were compared between the two groups, and the levels of vascular endothelial growth factor (VEGF) -121, VEGF-145, VEGF-165 and quality of life before and after treatment were compared.Results:The objective remission rate of the test group [57.89% (22/38) ] was higher than that of the control group [42.11% (16/38) ], but there was no statistically significant difference ( χ2=1.89, P=0.169) ; The disease control rate of the test group [81.58% (31/38) ] was better than that of the control group [55.26% (21/38) ], there was a statistically significant difference ( χ2=6.09, P=0.014). The median PFS of patients in the test group (6.3 months) was longer than that in the control group (4.2 months), there was a statistically significant difference ( χ2=0.48, P=0.003) ; The median OS of patients in the test group (14.8 months) was not significantly different from that in the control group (13.2 months) ( χ2=0.15, P=0.704). After treatment, the expression level of serum VEGF-121 [ (201.25±18.37) ng/L vs. (276.83±20.26) ng/L], VEGF-145 [ (102.24±12.16) ng/L vs. (170.39±15.28) ng/L], VEGF-165 [ (135.08±14.32) ng/L vs. (210.53±16.09) ng/L] in the test group was lower than that in the control group, there were statistically significant differences ( t=17.03, P<0.001; t=21.51, P<0.001; t=21.59, P<0.001). After treatment, patients in the test group were assessed according to 36-item Short-Form (SF-36) physiological function [ (80.18±13.96) score vs. (71.72±16.12) score], physiological function [ (67.19±30.62) score vs. (53.12±9.86) score], physical pain [ (70.01±17.97) score vs. (61.06±17.57) score], overall health [ (68.67±18.92) score vs. (57.96±20.97) score], vitality [ (78.39±19.37) score vs. (68.26±18.52) score], social function [ (82.24±19.73) score vs. (70.92±20.31) score], the scores of emotional function [ (73.81±28.86) score vs. (60.23±29.19) score] and mental health [ (76.19±12.82) score vs. (70.31±12.54) score] were higher than those of the control group, there were statistically significant differences ( t=2.45, P=0.017; t=2.03, P=0.046; t=2.19, P=0.031; t=2.34, P=0.022; t=2.33, P=0.023; t=2.46, P=0.016; t=2.04, P=0.045; t=2.02, P=0.047). The incidence of adverse reactions in the test group [18.42% (7/38) ] was lower than that in the control group [76.32% (29/38) ], there was a statistically significant difference ( χ2=25.54, P<0.001) . Conclusion:The combination of bevacizumab and capecitabine chemotherapy has a higher clinical effect on advanced breast cancer, which can significantly reduce the level of VEGF in patients, improve the quality of life of patients, with mild adverse reactions and high safety.

Management of Adverse Reactions to Contrast Media and the Involvement of the Pharmaceutical Department in Hospitals: a Questionnaire Survey / 医薬品情報学

Objective: Adverse reactions are sometimes induced by contrast media used for medical imaging and can be life-threatening. Thus, appropriate management is important for patient safety. The purpose of this study was to clarify the actual management of adverse reactions induced by contrast media in hospitals, the opportunities for intervention by hospital pharmacy departments and the attitudes of hospital pharmacists regarding the risk of adverse reactions.Methods: A self-administered questionnaire survey was conducted in the pharmacy departments of 16 hospitals (approximately 200 to 1,000 beds) located in the Tokyo metropolitan area of Japan. The survey asked about the presence or absence of internal rules or manuals regarding contrast media administration at each hospital, the management status of patients with risk factors for adverse reactions, the opportunities for interventions by pharmacists, and the opportunities for discussion regarding contrast media administration among pharmacists and other professionals.Results: Of the 16 hospitals, 10 responded to the questionnaires, and 7 of them had internal rules or manuals. These rules or manuals stipulated actions such as “do not administer contrast media” to patients with risk factor(s) for adverse reactions. For inpatients, there were opportunities for pharmacist interventions, such as drug management and guidance services and initial interviews upon hospital admission. However, for outpatients the opportunities for interventions were limited. At 5 of the 10 hospitals, pharmacists discussed contrast administration with physicians, radiologists, and other healthcare professionals.Conclusion: The present study reveal that many hospitals take great care in deciding on the administration of contrast media to patients at risk of adverse drug reactions. Our results indicate that the limited opportunities for “outpatient intervention" is an issue in the hospital pharmacy department's participation for proper use of contrast media.

Effect of intravitreal injection of anti-vascular endothelial growth factor agents on systemic concentration of vascular endothelial growth factor / 国际眼科杂志(Guoji Yanke Zazhi)

Chorioretinal disease has become a significant problem affecting human vision. Abnormal expression of vascular endothelial growth factor(VEGF)leads to increased fundus permeability and neovascularization. Vitreous injection of anti-VEGF agents can rapidly inhibit the level of VEGF in the eye and effectively control the development of the disease. At present, anti-VEGF agents are widely administered in ophthalmology. However, studies have shown that intravitreal anti-VEGF agents can reduce plasma VEGF concentration after entering the circulatory system, and the pointless off-target effects of drugs may lead to systemic adverse reactions. For elderly patients, patients with serious comorbidities, lactating women, premature infants and other special populations, attention should be paid to systemic VEGF inhibition after multiple injections. In this paper, in order to provide reference for clinical anti-VEGF therapy, the pharmacokinetics therapy, systemic adverse reactions, contralateral eye effects, and effects of anti-VEGF on breast milk and preterm infants were discussed, and the systemic effects of vitreous injection of anti-VEGF agents were reviewed.

Pharmacological Activities， Pharmacokinetics， and Adverse Reactions of Polyphyllin Ⅱ： A Review / 中国实验方剂学杂志

As a rare Chinese medicinal material， Paridis Rhizoma is mainly distributed in Yunnan， Guangxi， and Guizhou in southwestern China， with the effect of clearing heat and detoxifying， alleviating edema and relieving pain， cooling liver and tranquilizing mind. It is particularly effective for injuries from falls， fractures， contusions and strains， snake bites， cold wind-induced convulsion， and other diseases， which has been used for more than 2 000 years. According to modern research， polyphyllin Ⅱ， one of the main active components of Paridis Rhizoma， belongs to diosgenin in structure. It has the anti-tumor， anti-inflammatory， antiviral， antibacterial， immune-regulating， antioxidant， and multidrug resistance-reversing activities， showing good application prospect. Especially， the anti-tumor effect of polyphyllin Ⅱ has attracted wide attention， and the mechanism is inhibiting proliferation， migration， and invasion of tumor cells， inducing cell cycle arrest， apoptosis， and autophagy， suppressing angiogenesis， and modulating tumor microenvironment. However， the pharmacokinetic results show that polyphyllin Ⅱ has low bioavailability in vivo due to the low solubility， poor absorption， unsatisfactory distribution， and slow metabolism， which limit the clinical application. In recent years， there has been an explosion of research on the adverse reactions of polyphyllin Ⅱ， such as the strong hemolytic activity and obvious cytotoxicity to liver， kidney， myocardium and cardiovascular cells. Thus， papers were retrieved from "CNKI"， "VIP"， "Wanfang Data"， "PubMed"， "Web of Science"， and "Elsevier SD" with "Paris saponin Ⅱ"， "Polyphyllin Ⅱ" as the main keywords， and the pharmacological activities and mechanisms， pharmacokinetics， and adverse reactions were summarized. The findings are expected to serve as a reference for the in-depth research， development， and utilization of polyphyllin Ⅱ.