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Article in English | LILACS | ID: biblio-1353078

ABSTRACT

Códigos da Classificação Internacional de Doenças como Rastreadores de Eventos Adversos a MedicamentosARTIGO DE REVISÃOJosé Romério Rabelo Melo1,2 , Elisabeth Carmen Duarte,3 Silvia Maria de Freitas4 , Eduardo Gabriel Pinheiro5 , Eudiana Vale Francelino6,7 , Paulo Sergio Dourado Arrais7 Introdução: Os Eventos Adversos a Medicamentos-EAM representam riscos à saúde e sua subnotificação representa um desafio para a saúde pública. A busca ativa de casos suspeitos de EAM nos bancos de dados de saúde utilizando a Classificação Internacional de Doenças-CID é uma das estratégias que pode reduzir as subnotificações desses eventos. Objetivo: O objetivo desse estudo é identificar os códigos da CID mais usados como rastreadores de EAM e avaliar a sua concordância entre os pesquisadores. Métodos: Foi realizada uma revisão sistemática da literatura utilizando as bases de dados PubMed, Scopus, Web of Science, MEDLINE e LILACS com os descritores "Classificação Internacional de Doenças", "CID-10", "Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos", "Envenenamento", "Erros de Medicação". Os artigos incluídos tiveram seus códigos CID identificados, comparados e sua qualidade avaliada. A análise de concordância dos códigos foi feita usando o modelo de ensaios de Bernoulli, testes de proporções binomial exata e a técnica de false discovery rate para analisar as hipóteses postas. A análise estatística foi feita com o software R. O estudo está registrado no PROSPERO sob n.º CRD42019120694. Resultados: Foram identificados 5.167 artigos e após os critérios de seleção, 33 foram incluídos nessa revisão. Foram identificados 1.105 códigos da CID. O coeficiente de prevalência dos EAM variou entre 0,18% e 18,4% em internações hospitalares e a taxa de mortalidade variou entre 0,12 a 45,9 óbitos por 100 mil óbitos. Somente 195 (17,7%) códigos tiveram alta concordância entre os pesquisadores. Muitos códigos CID utilizados para detectar EAM possuem baixa concordância entre os pesquisadores e produziram diferentes taxas do evento. Conclusão: Os códigos rastreadores de EAM identificados representam um método simples e eficiente para captação de eventos adversos em grandes bancos de dados em saúde, contribuindo na redução da subnotificação nos tradicionais sistemas de notificações de EAM.Palavras-chave: Informática médica, Farmacoepidemiologia, Segurança do paciente, Classificação internacional de doenças, Efeitos colaterais e reações adversas relacionadas a medicamentos. (AU)


International Classification of Diseases Codes as screeners for Adverse Drug EventsREVIEW ARTICLEJosé Romério Rabelo Melo1,2 , Elisabeth Carmen Duarte,3 Silvia Maria de Freitas4 , Eduardo Gabriel Pinheiro5 , Eudiana Vale Francelino6,7 , Paulo Sergio Dourado Arrais7 1. Agência Nacional de Vigilância Sanitária/Gerência Geral de Inspeção e Fiscalização, Brasília, (DF), Brasil2. Universidade Federal do Ceará-UFC. Programa de Pós-Graduação de Ciências Farmacêuticas, Fortaleza, (CE), Brasil3. Universidade de Brasília-UnB. Faculdade de Medicina. Núcleo de Medicina Tropical, (DF), Brasil4. Universidade Federal do Ceará-UFC. Departamento de Estatística e Matemática Aplicada. Fortaleza, (CE), Brasil5. Instituto de Matemática, Estatística e Computação Científica (IMECC). Programa de Pós-Graduação em Estatística, UNICAMP. Campinas, (SP), Brasil6. Universidade Federal do Ceará-UFC. Faculdade de Farmácia, Odontologia e Enfermagem. Grupo de Prevenção ao Uso Indevido de Medicamentos-GPUIM. Departamento de Farmácia, Fortaleza, (CE), Brasil7. Universidade Federal do Ceará-UFC. Faculdade de Farmácia, Odontologia e Enfermagem. Departamento de Farmácia, Fortaleza, (CE), Brasilhttps://doi.org/10.11606/issn.2176-7262.rmrp.2021.178993Introduction: Adverse drug events (ADEs) represent health risks and their underreporting represents a challenge to public health. The active search for suspected cases of ADE in health databases using the International Classification of Diseases-CID is one of the strategies that can reduce underreporting of these events. Objective: The aim of this study is to identify the ICD codes most commonly used as tracers of ADE and to assess their concordance among researchers. Methods: A systematic literature review was conducted using the PubMed, Scopus, Web of Science, MEDLINE and LILACS databases with the descriptors "International Classification of Diseases", "ICD-10", "Drug-Related Side Effects and Adverse Reactions", "Poisoning", "Medication Errors". The included articles had their ICD codes identified, compared and their quality assessed. The analysis of concordance of the codes was done using Bernoulli's test model, exact binomial proportions tests and the false discovery rate technique to analyze the hypotheses posed. Statistical analysis was done using R software. The study is registered in PROSPERO under CRD42019120694. Results: A total of 5,167 articles were identified and after the selection criteria, 33 were included in this review. A total of 1,105 ICD codes were identified. The prevalence coefficient of ADEs ranged from 0.18% to 18.4% in hospital admissions and the mortality rate ranged from 0.12 to 45.9 deaths per 100,000 deaths. Only 195 (17.7%) codes had high concordance among researchers. Many ICD codes used to detect ADEs have low inter-rater concordance and produced different event rates. Conclusion: The identified ADE tracking codes represent a simple and efficient method for capturing adverse events in large healthcare databases, contributing to the reduction of underreporting in traditional ADE reporting systems. (AU)


Subject(s)
Medical Informatics , International Classification of Diseases , Health Strategies , Pharmacoepidemiology , Health Risk , Delivery of Health Care , Drug-Related Side Effects and Adverse Reactions , Patient Safety
2.
Rev. cuba. hematol. inmunol. hemoter ; 37(3): e1445, 2021. tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1341399

ABSTRACT

Introducción: Durante el tratamiento de inducción de la leucemia linfoide aguda en niños no siempre se identifican las reacciones adversas a medicamentos. Objetivo: Describir los eventos adversos y las reacciones adversas a medicamentos durante el tratamiento de inducción de la leucemia linfoide aguda, en niños tratados en el Instituto de Hematología e Inmunología de Cuba, durante 2012-2017. Método: Estudio observacional, descriptivo, transversal, de series de casos en farmacovigilancia, se utilizó la farmacovigilancia activa. Variables: sexo, edad, grupo pronóstico, semana de tratamiento, tipo de evento adverso, sistema de órgano afectado, severidad e imputabilidad. La información se obtuvo del registro nacional del protocolo ALLIC-BFM 2009 y las historias clínicas. Resultados: Se incluyeron 69 niños, 55,1 por ciento (38 casos) fueron masculinos, 56,5 por ciento (39 niños) tenía entre uno y seis años. El 52,2 por ciento (36 pacientes) pertenecían al grupo pronóstico intermedio. Se registraron 471 eventos adversos. El 50,5 por ciento (238/471) ocurrió en la primera semana de tratamiento. Los más frecuentes: anemia (17,8 por ciento; 84/471), neutropenia (16,1 por ciento; 76/471) y trombocitopenia (15,9 por ciento; 75/471). Los sistemas de órganos más afectados: hemolinfopoyético (57,54 por ciento; 271/471) y gastrointestinal (15,71 por ciento; 74/471). El 93,2 por ciento (439/471) se clasificó en reacciones adversas posibles. Según gravedad el 72,4 por ciento (330/456) fueron moderadas y el 27,4 por ciento (125/456) graves. Conclusiones: Todos los casos presentaron eventos adversos, predominaron las alteraciones hematológicas y los eventos reportados para fármacos incluidos en la quimioterapia. Se identificaron reacciones adversas clasificadas como posibles, con predominio de las moderadas y graves(AU)


Introduction: During the induction treatment of acute lymphoid leukemia in children, adverse drug reactions are not always identified. Aims: Describe the demographic and clinical characteristics of children with acute lymphoid leukemia who receive induction treatment at the Institute of Hematology and Immunology between 2012-2017. Characterize adverse events that occur during induction treatment. Describe adverse drug reactions during induction. Methods: Observational, descriptive, cross-sectional study of case series in pharmacovigilance, used active pharmacovigilance. Variables: sex, age, prognosis group, week of treatment, type of adverse event, organ system affected, severity and imputability. The information was obtained from the national register of the ALLIC-BFM 2009 protocol and the medical records. Results: 69 children were included, 55.1 percent belonged to the male sex, 56.5 percent were between one and six years old. 52.2 percent (36 children) belonged to the intermediate prognosis group. 471 events were recorded. 50.5 percent occurred in the first week of treatment. The most frequent: anemia (17.8 percent), neutropenia (16.1 percent) and thrombocytopenia (15.9 percent). The most affected organ systems: hemolinfopoietic (57.5 percent) and gastrointestinal (15.7 percent). According to the severity, 72.4 percent were moderate and 27.4 percent severe. Conclusions: The whole presented adverse events, hematological alterations and reported events for drugs included in chemotherapy predominated. Adverse reactions classified as possible were identified, moderate and severe predominated(AU)


Subject(s)
Humans , Infant , Child, Preschool , Child , Drug-Related Side Effects and Adverse Reactions , Precursor Cell Lymphoblastic Leukemia-Lymphoma/therapy , Remission Induction/methods , Epidemiology, Descriptive , Cross-Sectional Studies
3.
SOBECC ; 26(3): 181-188, 30-09-2021.
Article in Portuguese | LILACS, BDENF | ID: biblio-1343229

ABSTRACT

Objetivos: Descrever níveis residuais aceitáveis de óxido de etileno em dispositivos médicos, analisar processos de aeração recomendados e compará-los com a regulação brasileira. Método: Revisão integrativa da literatura, com descritores específicos, sem restrição de ano de publicação. Busca dos dados entre outubro e novembro de 2019, que resultou em 34 estudos incluídos no estudo. Resultados: A regulação brasileira vigente está desatualizada em relação à classificação de produtos, à determinação de valores de resíduos tóxicos de óxido de etileno em dispositivos médicos e aos processos recomendados para a aeração desses produtos, podendo contribuir para riscos de eventos adversos para pacientes usuários de dispositivos inadequadamente aerados, e, consequentemente, urge sua atualização. Conclusão: As lacunas desse marco regulatório beneficiam indiretamente as empresas que terceirizam a esterilização a óxido de etileno ao omitir controles essenciais para a segurança do paciente exposto a possíveis resíduos tóxicos de óxido de etileno, favorecer práticas inseguras de esterilização de produtos para saúde, além de dificultar o controle de serviço de saúde pelas vigilâncias sanitárias do país.


Objectives: To describe acceptable residual levels of ethylene oxide in medical devices, analyze recommended aesther processes and compare them with the Brazilian regulation. Method: Integrative literature review, with specific descriptors, without year of publication restriction. Data search between October and November 2019, which resulted in 34 studies included in the study. Results: Current Brazilian regulation is outdated in relation to product classification, the determination of waste values ethylene oxide toxic in medical devices and the recommended processes for the aecization of these products, and may contribute to risks of adverse events for patients users of inappropriately aenated devices, and consequently urge their update. Conclusion: The shortcomings of this regulatory framework indirectly benefit companies that outsource ethylene oxide sterilization by omitting essential controls for safety of the patient exposed to possible toxic residues of ethylene oxide, unsafe practices of sterilization of health products, in addition to hindering the control of health service by the country's health surveillance.


Objetivos: Describir los niveles residuales aceptables de óxido de etileno (OE) en dispositivos médicos, analizar los procesos de aireación recomendados y compararlos con la normativa brasileña. Método: revisión integrativa de la literatura, con descriptores específicos, sin restricción de año de publicación. Búsqueda de datos entre octubre y noviembre de 2019, que resultó en 34 estudios incluidos en el estudio. Resultados: La normativa brasileña actual está desactualizada en cuanto a la clasificación de productos, determinación y valores de residuos tóxicos de OE en dispositivos médicos y procesos recomendados para la aireación de estos productos, lo que puede contribuir al riesgo de eventos adversos para los pacientes que utilizan una aireación inadecuada de dispositivos y, en consecuencia, se necesita urgentemente una actualización. Conclusión: Las brechas en este marco regulatorio benefician indirectamente a las empresas que externalizan la esterilización a OE, al omitir controles esenciales para la seguridad de los pacientes expuestos a posibles residuos tóxicos de OE, favoreciendo prácticas inseguras de esterilización de productos sanitarios, además de dificultar el control de servicio de salud por la Vigilancia Sanitaria del país.


Subject(s)
Humans , Aeration , Drug-Related Side Effects and Adverse Reactions , Ethylene Oxide , Toxic Wastes , Sterilization , Patient Safety
4.
Rev. bras. anal. clin ; 53(2): 143-147, 20210630. tab
Article in Portuguese | LILACS | ID: biblio-1348874

ABSTRACT

Em março de 2020 a Organização Mundial da Saúde (OMS) declarou o início de uma pandemia devastadora causada pelo vírus SARS-CoV-2. Desde então, evidências científicas acumuladas mostram que gestantes e puérperas configuram grupos de risco para complicações obstétricas, hospitalizações, mortes maternas, prematuridade e óbitos fetais, diferente dos resultados publicados no início da pandemia. Estudos preliminares já evidenciam que a vacinação nas gestantes e puérperas é benéfica e segura para o trinômio mãe-feto-lactente. Os imunizantes atualmente disponibilizados pelo Programa Nacional de Imunizações (PNI) são funcionalmente inativados, não contendo nenhum componente vivo em suas formulações, semelhantes às outras vacinas já utilizadas no calendário de vacinação das gestantes. Além disso, nos estudos experimentais em animais não foi identificado nenhum efeito teratogênico. O Plano Nacional de Operacionalização da Vacinação da Covid-19, na sua 8ª edição, contempla a vacinação para as gestantes e puérperas acima de 18 anos com e sem comorbidades. Após a vacinação em grande escala realizada em vários países com imunizantes vetoriais não replicantes (Oxford /AstraZeneca/Fiocruz e Johnson & Johnson), observou-se eventos adversos raríssimos e graves da síndrome de trombose com trombocitopenia (TTS). Atendendo à solicitação da ANVISA, o Plano Nacional de Imunizações suspendeu temporariamente a vacinação das gestantes e puérperas com vacinas que utilizem essa plataforma, após um caso notificado com uma gestante, na cidade do Rio de Janeiro que resultou em óbito materno e fetal, com possível associação de causalidade.


In march 2020, the World Health Organization announced the onset of a devastating pandemic caused by the SARS-CoV-2 virus. Since then, accumulated scientific evidence have been showing that pregnant and postpartum women are at risk groups for obstetric complications, hospitalizations, maternal deaths, prematurity and fetal deaths, unlike the results obtained at the beginning of the pandemic. Preliminary studies have already shown that vaccination in pregnant women is beneficial and safe for the mother-fetus/infant trinomial. Covid-19 vaccines currently available on the National Program Immunization (PNI) don´t contain any live component in their formulations and they are similar to other inactivated vaccines that have been already used safely in the vaccination schedule of pregnant women. Furthermore, experimental studies in animals did not identify any teratogenic effects so far. The 8th edition of Covid-19 National Plan for the Operationalization of Vaccination, advise to perform Covid-19 vaccination in pregnant and postpartum women over 18 years of age with comorbidities. However, some states are following their own guidelines, and to recommend immunizing even those without comorbidities. After large-scale vaccination carried out in several countries with non-replicating vector immunizing agents (Oxford / AstraZeneca / Fiocruz and Johnson & Johnson), very rare and serious adverse events of thrombocytopenic thrombocytosis (TT) were observed. In response to ANVISA's request, the PNI temporarily suspended the vaccination of pregnant and postpartum women with vaccines that use this platform, after a case reported with a pregnant woman in the city of Rio de Janeiro that resulted in maternal and fetal death, with a possible association with the Oxford / AstraZeneca / Fiocruz vaccine. Additionally, the PNI interrupted the vaccination of pregnant and postpartum women without comorbidities or risk factors for infection with any immunizing agent using this immunizing.


Subject(s)
Humans , Female , Pregnant Women , Postpartum Period , Drug-Related Side Effects and Adverse Reactions , COVID-19 Vaccines , Infant
5.
Medicina (B.Aires) ; 81(2): 208-213, June 2021. graf
Article in Spanish | LILACS | ID: biblio-1287272

ABSTRACT

Resumen El manejo de las reacciones adversas inducidas por los inhibidores del punto de control inmunitario (IPCI) en cáncer, demanda un trabajo multidisciplinario. Revisamos las causas y el curso clínico de las consultas e internaciones debidas a reacciones adversas de los IPCI entre septiembre de 2015 y julio de 2019 en el Instituto Alexander Fleming. Se registraron los datos demográficos, diagnóstico oncológico, reacción adversa y su grado, requerimiento de internación, tratamiento, mortalidad y evaluación de la reexposición. Se registraron 124 reacciones adversas por IPCI en 89 pacientes. Sesenta y ocho recibían monoterapia y 21 terapia combinada. Las manifestaciones cutáneas fueron las más frecuentes, seguidas de las generales, endocrinas (con mayor frecuencia hipotiroidismo), colitis, neumonitis, neurológicas y hepatitis. Fueron graves (grado ≥ 3), 26 toxicidades en 25 pacientes. Se internaron 15, y 6 de ellos requirieron terapia intensiva. Un caso fue fatal. Recibieron glucocorticoides 34 (12 de ellos por vía intravenosa). Un paciente recibió micofenolato y uno inmuno globulina endovenosa. En 20 se discontinuó el tratamiento. Ocho se reexpusieron y uno de ellos debió suspender definitivamente. Se presenta en esta serie de casos nuestra experiencia con el diagnóstico y tratamiento de las reacciones adversas de una familia de drogas cuya utilización ha crecido en los últimos años.


Abstract The management of patients with immune-related adverse events (irAEs) frequently demands a multidisciplinary approach. We reviewed the causes and clinical course of medical visits and admissions at the Instituto Alexander Fleming due to irAEs between September 2015 and July 2019. Demographic data, diagnosis, toxicity and its severity, requirement of admission, treatment, mortality, and evaluation of the re-administration of immunotherapy were collected. We found 124 irAEs in 89 patients. Sixty-eight of them received monotherapy (76.4%) and 21 (23.6%) combination of drugs. Cutaneous manifestations were the most frequent cause of irAEs, followed by general manifestations, endocrine dysfunctions (hypothyroidism the most frequent), colitis, pneumonitis, neurologic dis orders, and hepatitis. In 26 adverse events (in 25 patients), severity grade was ≥ 3. Fifteen were admitted and 6 required ICU admission. One patient died. Thirty-four received glucocorticoids, 12 of them by intravenous route. One patient received mycophenolate and one IVIG. In 20, the treatment was discontinued; 8 were re-exposed, with definitive discontinuation in one patient. In this case series we report our experience in the diagnosis and management of adverse reactions related to a family of drugs whose use has grown in recent years.


Subject(s)
Humans , Drug-Related Side Effects and Adverse Reactions , Neoplasms/drug therapy , Nervous System Diseases , Immune Checkpoint Inhibitors , Immunologic Factors/therapeutic use , Immunotherapy
6.
Arch. argent. pediatr ; 119(3): e247-e251, Junio 2021. ilus
Article in Spanish | LILACS, BINACIS | ID: biblio-1248216

ABSTRACT

La reacción a drogas con eosinofilia y síntomas sistémicos es una reacción adversa cutánea rara, potencialmente grave. Puede presentar fiebre, erupción cutánea polimorfa, edema facial y/o linfoadenopatías. La reactivación del virus herpes humano tipo 6 se asocia a un curso más grave y/o prolongado.Un lactante de 22 meses en tratamiento con fenobarbital presentó lesiones eritematopapulares, fiebre, leucocitosis, proteína C reactiva elevada y alteración de pruebas hepáticas. Se realizó biopsia de piel compatible con reacción adversa a drogas. Se trató con corticoides sistémicos e inmunoglobulina intravenosa sin respuesta. La reacción en cadena de la polimerasa para virus herpes humano tipo 6 resultó positiva. Se inició ciclosporina más prednisona, con buena respuesta. Existe poca evidencia del uso de ciclosporina en adultos, cuando los corticoides sistémicos son inefectivos. Este es el primer reporte pediátrico Podría ser una alternativa efectiva o un complemento de los corticosteroides sistémicos cuando no responde a tratamientos convencionales.


Drug reaction with eosinophilia and systemic symptoms is a rare and potentially serious skin adverse reaction, with fever, polymorphous skin rash, facial edema, and/or lymphadenopathy. Reactivation of human herpes virus type 6 has been associated with a more severe and/or prolonged course. A 22-month-old infant under phenobarbital treatment developed erythematous-papular lesions, fever, leukocytosis, elevated C-reactive protein, and abnormal liver tests. The skin biopsy was compatible with an adverse drug reaction. Treatment with systemic corticosteroids and intravenous immunoglobulin had no response. Polymerase chain reaction for human herpesvirus type 6 was positive, and cyclosporine plus prednisone was started with a good response. There is little evidence for the use of cyclosporine in adults when systemic corticosteroids are ineffective. This is the first report of pediatric drug reaction with eosinophilia and systemic symptoms treated with cyclosporine, which could be an effective alternative or an adjunct to systemic corticosteroid therapy unresponsive to conventional treatments.


Subject(s)
Humans , Male , Infant , Herpesvirus 6, Human , Drug Hypersensitivity Syndrome/diagnosis , Cyclosporine/therapeutic use , Adrenal Cortex Hormones/therapeutic use , Drug-Related Side Effects and Adverse Reactions , Eosinophilia , Drug Hypersensitivity Syndrome/complications , Drug Hypersensitivity Syndrome/therapy
7.
Arch. argent. pediatr ; 119(3): e234-e238, Junio 2021. tab, ilus
Article in Spanish | LILACS, BINACIS | ID: biblio-1248142

ABSTRACT

El síndrome de sensibilidad a fármacos con eosinofilia y síntomas sistémicos o síndrome de DRESS según sus siglas en inglés (drug reaction with eosinophilia and systemic symptoms) se encuentra entre las reacciones medicamentosas cutáneas graves. Este consiste en una tríada clínica que incluye fiebre, exantema y compromiso sistémico, acompañado de eosinofilia y/o linfocitos atípicos.Se presenta el caso de una paciente de sexo femenino con fibrosis quística, de 18 meses de edad, quien desarrolló esta patología durante un tratamiento con trimetoprima-sulfametoxazol para erradicar Staphylococcus aureus meticilino resistente en esputo. Los pacientes con fibrosis quística reciben múltiples esquemas antibióticos según bacteriología en secreciones respiratorias para evitar el deterioro de la función pulmonar y colonización por gérmenes resistentes. Es menester conocer y sospechar este síndrome, debido al riesgo incrementado de hipersensibilidad a drogas en fibrosis quística, pronóstico ominoso y su elevada morbimortalidad


Drug reaction with eosinophilia and systemic symptoms or DRESS syndrome is among severe cutaneous drug reactions. This constitutes a clinical triad that includes fever, skin rash and systemic compromise, accompanied by eosinophilia and/or atypical lymphocytes.We present the case of an 18-month-old female patient with cystic fibrosis, who develops this pathology during a trimethoprim-sulfamethoxazole cycle as an eradicating treatment of methicillin-resistant Staphylococcus aureus in bronchial secretions. Cystic fibrosis patients receive multiple antibiotic regimens according to bacteriology in sputum, to avoid impairment in their lung function and colonization by resistant germs. Due to the increased risk of drug hypersensitivity in cystic fibrosis, an ominous prognosis and high morbidity and mortality, knowledge and a high index of suspicion of this syndrome are necessary


Subject(s)
Humans , Female , Infant , Cystic Fibrosis , Drug Hypersensitivity Syndrome/diagnosis , Staphylococcus aureus , Trimethoprim, Sulfamethoxazole Drug Combination/adverse effects , Drug-Related Side Effects and Adverse Reactions , Eosinophilia/diagnosis , Drug Hypersensitivity Syndrome/complications
8.
Arch. argent. pediatr ; 119(3): 192-197, Junio 2021. tab
Article in English, Spanish | LILACS, BINACIS | ID: biblio-1222951

ABSTRACT

Introducción. La inmunoglobulina G endovenosa (IGEV) es un medicamento hemoderivado de inmunoglobulina G polivalente y policlonal. Posee un amplio espectro de indicaciones como inmunomodulador o como terapia de reemplazo. Asimismo, si bien se considera un tratamiento seguro, la incidencia de reacciones adversas reportadas en la literatura varía del 1 % al 81 %. Este trabajo tuvo como objetivo evaluar la utilización de IGEV y describir los acontecimientos adversos por la medicación en un hospital pediátrico de alta complejidad.Población y métodos. Se realizó un estudio de farmacoepidemiología, observacional y prospectivo. Se evaluaron pacientes que recibieron IGEV durante 7 meses, en 6 áreas de un hospital pediátrico de alta complejidad de la Ciudad Autónoma de Buenos Aires. La unidad de análisis fue cada infusión de IGEV, y la principal variable de estudio fue la presencia de reacciones adversas.Resultados. Se analizaron 305 infusiones en 111 pacientes. El 81,6 % de las indicaciones fueron de tipo supletorio. La dosis máxima utilizada fue 1 g/kg. En el 99,6 % de las infusiones, se indicó algún tipo de premedicación; la difenhidramina fue la droga más utilizada, aunque con diferentes posologías. Se registraron 12 reacciones adversas (el 3,9 % de las infusiones), tres de las cuales se consideraron graves: dos meningitis asépticas y una crisis comicial. Todas se resolvieron ad integrum.Conclusiones. La tasa de reacciones adversas de la IGEV en nuestro medio fue baja, con mayoría de reacciones leves e inmediatas y evolución favorable en todos los pacientes.


Introduction. Intravenous immunoglobulin G (IVIG) is a blood product from polyvalent and polyclonal immunoglobulin G. It covers a broad range of indications as immunomodulator or replacement therapy. In addition, although it is considered a safe therapy, the incidence of adverse reactions reported in the bibliography ranges from 1 % to 81 %. The objective of this study was to assess IVIG use and describe related adverse events in a tertiary care children's hospital.Population and methods. This was a pharmacoepidemiological, observational, and prospective study. Patients receiving IVIG for 7 months in 6 areas of a tertiary care children's hospital in the Autonomous City of Buenos Aires were assessed. The analysis unit was each IVIG infusion, and the main variable was the presence of adverse reactions.Results. A total of 305 infusions in 111 patients were analyzed. In 81.6 % of cases, the indication was for replacement. The maximum dose was 1 g/kg. In 99.6 % of infusions, some type of premedication was indicated; diphenhydramine was the most common drug, with varying dosages. A total of 12 adverse reactions (3.9 % of infusions) were recorded; 3 were severe: aseptic meningitis (2 cases) and seizures (1 case). All resolved to normal.Conclusions. The rate of IVIG adverse reactions in our setting was low; most reactions were mild and immediate and resolved favorably in all patients


Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Adolescent , Immunoglobulin G/adverse effects , Pharmacovigilance , Immunoglobulin G/administration & dosage , Immunoglobulin G/therapeutic use , Prospective Studies , Immunoglobulins, Intravenous , Pharmacoepidemiology , Drug-Related Side Effects and Adverse Reactions
9.
Rev. cuba. pediatr ; 93(2): e1148, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1280374

ABSTRACT

Introducción: El derrame pleural paraneumónico es la enfermedad pleural más frecuente de la infancia, el 40-60 por ciento de los casos se presenta como complicación de neumonía adquirida en la comunidad. Ante la aparición de líquido pleural viscoso, con fibrina o tabiques, la fibrinólisis intrapleural aporta beneficios en la resolución de esta grave afección. Objetivo: Describir la evolución clínica e imagenológica de tres niños graves con derrame pleural paraneumónico complicado complejo y empiema. Presentación de casos: Pacientes ingresados en la Unidad de Terapia Intensiva del Hospital Pediátrico Provincial "Dr. Eduardo Agramonte Piña" con el diagnóstico de neumonía adquirida en la comunidad complicada con derrame pleural paraneumónico complicado complejo, tratados con estreptoquinasa recombinante por vía intrapleural; la primera paciente presentó crecimiento de Pseudomona en el cultivo de líquido pleural, patógeno no habitual en las infecciones respiratorias agudas procedentes de la comunidad. El segundo caso, se recibió complicada con shock séptico y el tercer paciente con ecografía torácica que mostró derrame pleural multitabicado, con grandes bolsones y gruesos tabiques. Los tres casos evolucionaron satisfactoriamente, sin necesidad de tratamiento quirúrgico, ni aparición de reacciones adversas atribuibles al fibrinolítico. Conclusiones: La administración intrapleural de la estreptoquinasa recombinante en niños graves con derrame pleural paraneumónico complicado complejo y empiema, resulta un método eficaz y seguro en la evacuación del foco séptico pleural, lo que favorece el control de la infección, sin aparición de complicaciones. Los casos presentados tuvieron evolución satisfactoria y en ninguno se produjo evento adverso relacionado con la administración de la estreptoquinasa recombinante intrapleural(AU)


Introduction: Parapneumonic pleural effusion is the most common pleural disease in childhood; 40-60 percent of cases occur as a complication of community-acquired pneumonia. Given the onset of viscous pleural fluid, with fibrin or septums, intra-pleural fibrinolysis provides benefits to solve this serious condition. Objective: Describe the clinical and imaging evolution of three seriously ill children with complex complicated parapneumonic pleural effusion and empyema. Case presentation: Patients admitted to the Intensive Therapy Unit of "Dr. Eduardo Agramonte Piña" Provincial Pediatric Hospital with the diagnosis of pneumonia acquired in the community worsen with complex complicated parapneumonic pleural effusion, and treated in the intrapleural way with recombinant streptokinase. The first patient showed growth of Pseudomona in the culture of pleural fluid, a pathogen which is not common in acute respiratory infections from the community. The second case was complicated with septic shock; and the third patient had a chest ultrasound that showed multi-sited pleural effusion, with large bags and thick septums. All three cases evolved satisfactorily, without needing surgical treatment, or having adverse reactions attributable to fibrinolytic ones. Conclusions: Intrapleural administration of recombinant streptokinase in seriously ill children with complex complicated parapneumonic pleural effusion and empyema is an effective and safe method in the evacuation of pleural septic focus, which favors infection control, without complications. The cases presented had satisfactory evolution and none of them occurred adversely related to the administration of intrapleural recombinant streptokinase(AU)


Subject(s)
Humans , Female , Infant , Child, Preschool , Pleural Effusion , Pneumonia , Respiratory Tract Infections , Infection Control , Growth , Drug-Related Side Effects and Adverse Reactions
10.
Rev. cuba. med ; 60(2): e1507, tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1280344

ABSTRACT

Introducción: Los adultos mayores generalmente presentan diferentes patologías, lo que implica un alto consumo de medicamentos, con lo cual, este grupo poblacional constituye uno de los que mayor cantidad de errores pueden cometer en el uso de fármacos. Objetivo: Evaluar el comportamiento del consumo de fármacos en una población perteneciente a la tercera edad. Métodos: Se realizó un estudio descriptivo de corte transversal en un consultorio médico del municipio Arroyo Naranjo de La Habana en el período entre octubre de 2018 y mayo de 2019. La población estuvo conformada por 365 pacientes geriátricos con diagnóstico de enfermedad crónica no transmisible (ECNT). Se realizó un muestreo al azar para un total de 67 pacientes seleccionados. Las variables analizadas fueron: edad, sexo, ECNT asociada y medicamentos consumidos. Los datos fueron obtenidos mediante revisión de historias clínicas y entrevistas realizadas. Se realizó un análisis porcentual para determinar prevalencia en cada variable analizada. Resultados: Los medicamentos que más destacaron en la muestra fueron los antihipertensivos e hipoglucemiantes. El consumo de medicamentos fue superior en los pacientes de 75 años en adelante y fundamentalmente en las mujeres. Los hombres, por su parte, constituyeron los más irresponsables en la adherencia al tratamiento. Conclusiones: Existió correspondencia entre los tratamientos y las patologías en la mayoría de los casos con excepción de algunos pacientes en los que la relación beneficio-riesgo del tratamiento no se cumplió totalmente. Sin embargo, de manera global, se considera que no existe un adecuado uso de los medicamentos en la muestra(AU)


Introduction: Aged adults generally have different pathologies, which implies high consumption of drugs, with which, this population group is one of those that can make the higher number of errors when using medication drugs. Objective: To evaluate the behavior of drug use in an elderly population. Methods: A descriptive cross-sectional study was carried out in a medical office in Arroyo Naranjo municipality, Havana, from October 2018 to May 2019. 365 geriatric patients made up the population they had diagnosis of chronic non-communicable disease (NCD). A random sampling was carried out for a total of 67 selected patients. The variables analyzed were age, sex, associated NCD, and medications used. The data were obtained by studying medical records and interviews. A percentage analysis was carried out to determine prevalence in each variable analyzed. Results: The drugs that stood out the most in the sample were antihypertensive and hypoglycemic drugs. The consumption of drugs was higher in patients aging 75 years and older and mainly in women. Men were the most irresponsible in adherence to treatment. Conclusions: There was correspondence between the treatments and the pathologies in most cases with the exception of some patients in whom the benefit-risk ratio of the treatment was not fully met. However, generally, it is considered that there is no adequate use of the drugs in the sample(AU)


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Aged , Drug Therapy/methods , Drug-Related Side Effects and Adverse Reactions/epidemiology , Epidemiology, Descriptive , Cross-Sectional Studies
11.
Online braz. j. nurs. (Online) ; 20: e20216500, 05 maio 2021. ilus
Article in English, Spanish, Portuguese | LILACS, BDENF | ID: biblio-1248393

ABSTRACT

OBJETIVO: Mapear as práticas de segurança do paciente realizadas em pacientes oncológicos paliativos em uso de morfina para o controle da dor. MÉTODO: Revisão de escopo para responder à pergunta: Quais as evidências sobre as práticas de segurança do paciente realizadas em pacientes oncológicos paliativos que fazem uso de morfina para o controle da dor? A busca será realizada nas bases de dados MEDLINE, LILACS, Scopus, Embase, Web of Science, Cochrane e CINAHL e literatura cinzenta. Após a busca, todos as citações serão agrupadas no software Rayyan e as duplicatas removidas. Os títulos e resumos serão selecionados por dois revisores independentes. O texto completo das citações selecionadas será avaliado em detalhes em relação aos critérios de inclusão por dois revisores independentes. Os dados extraídos serão apresentados em um diagrama ou forma tabular de maneira que se alinhe com o objetivo desta revisão de escopo, e um resumo narrativo será fornecido


OBJECTIVE: To map the patient safety practices performed in palliative cancer patients using morphine for pain control. METHOD: A scoping review to answer the following question: What is the evidence on the patient safety practices performed in palliative cancer patients using morphine for pain control? The search will be carried out in the MEDLINE, LILACS, Scopus, Embase, Web of Science, Cochrane and CINAHL databases, as well as in the gray literature. After the search, all citations will be grouped in the Rayyan software and the duplicates will be removed. Titles and abstracts will be selected by two independent reviewers. The full text of the selected citations will be evaluated in detail in relation to the inclusion criteria by two independent reviewers. The extracted data will be presented in diagram or table formats so that it aligns with the objective of this scoping review, and a narrative abstract will be provided.


OBJETIVO: Mapear las prácticas de seguridad del paciente realizadas en pacientes con cáncer paliativo que utilizan morfina para el control del dolor. MÉTODO: Revisión de alcance para responder a la pregunta: ¿Cuál es la evidencia sobre las prácticas de seguridad del paciente que se implementan en pacientes con cáncer paliativo que utilizan morfina para el control del dolor? La búsqueda se realizará en las bases de datos MEDLINE, LILACS, Scopus, Embase, Web of Science, Cochrane y CINAHL y literatura gris. Después de la búsqueda, todas las citas se agruparán en el software Rayyan y se eliminarán los duplicados. Los títulos y resúmenes serán seleccionados por dos revisores independientes. El texto completo de las citas seleccionadas será evaluado en detalle según los criterios de inclusión por dos revisores independientes. Los datos extraídos se presentarán en un diagrama o en forma de tabla para que se alineen con el objetivo de esta revisión de alcance, y se proporcionará un resumen narrativo.


Subject(s)
Humans , Patients , Pain Management , Patient Safety , Cancer Pain , Medical Oncology , Morphine , Palliative Care , Drug-Related Side Effects and Adverse Reactions
12.
Rev. enferm. neurol ; 20(1): 58-65, ene.-abr. 2021. tab
Article in Spanish | LILACS, BDENF | ID: biblio-1349249

ABSTRACT

Introducción: los errores en el proceso de administración de medicamentos (EPAM) corresponden a múltiples factores, como: la condición de vulnerabilidad del usuario, dinámica que se vive dentro de las propias unidades y confusión en la terapia farmacológica, entre otros. El mayor porcentaje de los EPAM se produce en la etapa de administración, por lo que el rol de enfermería es fundamental. Existen diversas estrategias destinadas a la prevención, con distintos niveles de complejidad, en términos de implementación. Objetivo: conocer las múltiples causas que llevan al personal de enfermería a realizar una mala praxis en el proceso de administración de medicamentos. Material y métodos: se realizó una revisión de literatura mediante la búsqueda de artículos científicos en las siguientes bases de datos: Cochrane, Embase, Medline y SciELO. Conclusión: es indispensable hacer conciencia de la responsabilidad en los profesionales de enfermería para cumplir con las normas en la administración de medicamentos, con los "10 correctos" y evitar riesgos innecesarios a los pacientes que pueden en algunos casos ocasionar consecuencias graves.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Medication Errors , Nursing Care , Drug Administration Routes , Drug-Related Side Effects and Adverse Reactions , Malpractice
13.
Rev. medica electron ; 43(2): 3222-3230, mar.-abr. 2021.
Article in Spanish | LILACS, CUMED | ID: biblio-1251939

ABSTRACT

RESUMEN La condición neurológica definida por la aparición de alteraciones en la percepción, usualmente interpretada como fenómenos extraños de metamorfosis y despersonalización, se reconoce como síndrome de Alicia en el país de las maravillas. Se presenta el caso de una paciente femenina de 9 años de edad, con el diagnóstico de síndrome de Alicia en el país de las maravillas secundario a medicación crónica con montelukast. El diagnóstico del síndrome psiquiátrico se realizó teniendo en consideración los antecedentes patológicos personales y el examen físico. El síndrome de Alicia en el país de las maravillas tiene un carácter benigno, sumamente infrecuente, y aunque su etiología no es del todo conocida, su aparición como reacción adversa a medicamentos es una opción que debe ser siempre considerada por el médico actuante (AU).


ABSTRACT The neurological condition defined by the appearance of alterations in perception usually interpreted as strange phenomena of metamorphosis and depersonalization is recognized as Alice in wonderland syndrome. The case of a 9-year-old female patient is presented, with the diagnosis of Alice in Wonderland syndrome secondary to chronic medication with montelukast. The diagnosis of the psychiatric syndrome was made taking into account personal pathological history and physical examination. Alice in Wonderland syndrome has a benign, extremely rare character and although its etiology is not fully known, its appearance, as an adverse reaction to medications, is an option that should always be considered by the acting physician (AU).


Subject(s)
Humans , Male , Female , Child , Drug-Related Side Effects and Adverse Reactions/complications , Alice in Wonderland Syndrome/chemically induced , Asthma/drug therapy , Case Reports , Child , Child Psychiatry/methods , Child Psychiatry/standards , Alice in Wonderland Syndrome/diagnosis , Alice in Wonderland Syndrome/etiology , Alice in Wonderland Syndrome/pathology , Alice in Wonderland Syndrome/psychology
14.
Rev. cuba. oftalmol ; 34(1): e1131, 2021. tab
Article in Spanish | LILACS, CUMED | ID: biblio-1289530

ABSTRACT

Objetivo: Evaluar la seguridad del HeberFERON( en el tratamiento del carcinoma basal palpebral. Métodos: Se realizó un estudio descriptivo en pacientes con carcinoma basal palpebral, a quienes se les aplicó HeberFERON( perilesional, de enero del año 2013 a enero de 2018. La muestra quedó constituida por 20 pacientes que cumplieron los criterios de inclusión. La dosis protocolizada fue de 3,5 x 106 UI, perilesional, dos veces a la semana por 5 semanas consecutivas. Las variables del estudio fueron: edad, sexo, color de la piel, localización del tumor, así como tipo y grado de evento adverso. Para todas las variables del estudio fueron calculadas las frecuencias absolutas y relativas. Resultados: La población estudiada con carcinoma basal palpebral mostró mayor frecuencia entre los 60 y 79 años de edad (80 por ciento) y las lesiones se presentaron fundamentalmente en el párpado inferior (60 (). El eritema palpebral y el dolor en el sitio de la inyección constituyeron los eventos adversos oculares más frecuentes (95,0 y 70,0 por ciento respectivamente) y se presentaron en el 95 por ciento de los pacientes investigados. Los eventos adversos sistémicos (fiebre, artralgia y la cefalea) prevalecieron en el 100 por ciento de los casos, en quienes el grado de severidad fue leve. Conclusiones: El HeberFERON( en el tratamiento del carcinoma basal palpebral es una buena alternativa no quirúrgica; es seguro y bien tolerado(AU)


Objective: Evaluate the safety of HeberFERON in the treatment of basal cell eyelid carcinoma. Methods: A descriptive study was conducted of patients with basal cell eyelid carcinoma undergoing perilesional HeberFERON therapy from January 2013 to January 2018. The sample was composed of 20 patients meeting the inclusion criteria. The protocol dose was 3.5 x 106 UI perilesional twice a week for five consecutive weeks. The variables analyzed were age, sex, skin color and tumor location, as well as adverse event type and degree. Absolute and relative frequencies were estimated for all the study variables. Results: The prevailing age group in the study basal cell eyelid carcinoma population was 60-79 years (80 percent). The most common lesion site was the lower eyelid (60 percent). Eyelid erythema and injection site pain were the most frequent ocular adverse events (95.0 percent and 70.0 percent, respectively), presenting in 95 percent of the study subjects. Systemic adverse events (fever, arthralgia and headache) prevailed in 100 percent of the cases studied, among whom the degree of severity was mild. Conclusions: HeberFERON is a good non-surgical alternative for basal cell eyelid carcinoma. It is safe and well tolerated(AU)


Subject(s)
Humans , Middle Aged , Aged , Carcinoma, Basal Cell/drug therapy , Interferons/therapeutic use , Eyelid Neoplasms/therapy , Epidemiology, Descriptive , Drug-Related Side Effects and Adverse Reactions
15.
Med. U.P.B ; 40(1): 55-64, 03/03/2021. tab
Article in Spanish | LILACS, COLNAL | ID: biblio-1177499

ABSTRACT

Las reacciones adversas a medicamentos son una de las principales causas de muerte en el mundo, producen muchos ingresos hospitalarios y aumentan los costos de atención. Dentro de los medicamentos que más se asocian con estas reacciones están los antibióticos y de estos los más comunes son los betalactámicos, ampliamente utilizados en las instituciones de salud. Las manifestaciones más frecuentes de las reacciones adversas a betalactámicos son alérgicas, dermatológicas, gastrointestinales, renales, hepáticas y neurológicas. Se realiza una revisión general de las reacciones adversas de estos medicamentos, se mencionan los distintos antibióticos betalactámicos con su clasificación y espectro de acción y más precisamente se explican las distintas reacciones adversas por uso de betalactámicos según el sistema comprometido.


Adverse drug reactions are one of the leading causes of death in the world. They are also responsible for an increase in hospital admissions and higher care costs. Among the most associated drugs with these reactions are antibiotics and of these the most common are beta-lactams, which are widely used in health institutions. The most fre-quent manifestations of adverse reactions to beta-lactams are allergic, dermatological, gastrointestinal, renal, hepatic and neurological reactions. A general review of the adverse reactions to these drugs is carried out. Also, the different beta-lactam antibiotics are described along with their classification and spectrum of action, and an accurate explanation of the different adverse reactions due to the use of beta-lactams according to the compromised system is made.


As reações adversas a medicamentos são uma das principais causas de morte no mundo, resultam em muitas admissões hospitalares e aumentam os custos do atendimento. Entre os medicamentos que mais se associam a essas reações estão os antibióticos e, destes, os mais comuns são os beta-lactâmicos, amplamente utilizados em instituições de saúde. As manifestações mais frequentes de reações adversas aos beta-lactâmicos são alérgicas, dermatológicas, gastrointestinais, renais, hepáticas e neurológicas. Faz-se uma revisão geral das reações adversas desses medicamentos, são mencionados os diferentes antibióticos beta-lactâmicos com sua classificação e espectro de ação, e mais precisamente explicam as diferentes reações adversas devidas ao uso de beta-lactâmicos de acordo com o sistema comprometido


Subject(s)
Humans , Drug-Related Side Effects and Adverse Reactions , Pharmaceutical Preparations , Cause of Death , beta-Lactams , Anti-Bacterial Agents
16.
Article in Chinese | WPRIM | ID: wpr-879086

ABSTRACT

Methotrexate(MTX) is a commonly used antimetabolite, which can be used in the treatment of a variety of diseases. However, hepatotoxicity in the use of MTX severely limits its clinical use. Therefore, how to prevent and treat hepatotoxicity of MTX has become an urgent clinical problem. This paper summarizes and analyzes relevant literatures on the prevention and treatment of hepa-totoxicity caused by MTX with traditional Chinese medicines and natural medicines in recent years. MTX-induced hepatotoxicity mechanisms include folate pathway, oxidative stress damage and adenosine pathway, of which oxidative stress theory is the main research direction. A total of 14 kinds of traditional Chinese medicine and natural medicine extracts including white peony root, and 21 kinds of natural monomer compounds, including berberine, play an anti-MTX-induced hepatotoxic effect by resisting oxidative stress, inhibiting inflammation and regulating signal pathways. According to current studies on the prevention and treatment of hepatotoxicity induced by MTX with traditional Chinese medicines and natural medicines, there are insufficiencies, such as partial and superficial mechanism studies, inadequate combination of experimental research and clinical practice, non-standard experimental design and lack of application of advanced technologies and methods. This paper systematically reviewed the effects and mechanisms of traditional Chinese medicines and natural medicines against hepatotoxicity induced by MTX and defined current studies and deficiencies, in the expectation of proposing new study strategies and directions and providing scientific basis for rational clinical use of MTX and development of new drugs against MTX hepatotoxicity.


Subject(s)
Chemical and Drug Induced Liver Injury/prevention & control , Drug-Related Side Effects and Adverse Reactions , Humans , Liver/metabolism , Medicine, Chinese Traditional , Methotrexate/toxicity , Oxidative Stress
17.
Article in Chinese | WPRIM | ID: wpr-878975

ABSTRACT

Liver is the main place of drug metabolism. Mitochondria of hepatocytes are important targets of drug-induced liver injury. Mitochondrial autophagy could maintain the healthy operation of mitochondria in cells and the stable proliferation of cells. Therefore, the use of mitochondrial autophagy to remove damaged mitochondria is an important strategy of anti-drug-induced liver injury. Active ingredients that could enhance mitochondrial autophagy are contained in many traditional Chinese medicines, which could regulate the mitochondrial autophagy to alleviate relevant diseases. However, there are only a few reports on how to accurately and efficiently identify and evaluate such components targeting mitochondria from traditional Chinese medicine. Liquid chromatography-mass spectro-metry(LC-MS) combined with serum pharmacology in vivo can be used to accurately and efficiently find active ingredients of traditional Chinese medicine acting on mitochondrial targets. This paper reviewed the research ideas and methods of traditional Chinese medicine ingredients for increasing the hepatotoxicity of mitochondrial autophagy, in order to provide new ideas and methods for the study of active ingredients of traditional Chinese medicine targeting mitochondria.


Subject(s)
Chemical and Drug Induced Liver Injury , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal/toxicity , Humans , Medicine, Chinese Traditional , Mitochondria
18.
Article in Chinese | WPRIM | ID: wpr-878898

ABSTRACT

This study aimed to comprehensively analyze and compare the differences of different clinical study types currently published in the safety evaluation of Xuebijing Injection. Six databases, namely the Cochrane Library, PubMed, EMbase, CNKI, VIP and Wanfang database, were electronically retrieved to collect all types of studies on the safety of Xuebijing Injection, including randomized controlled trials, case-controlled studies, cohort studies, systematic reviews, and centralized monitoring studies of clinical safety(hospital), in order to comprehensively and objectively evaluate the safety of Xuebijing Injection, and analyze the differences of different research results. A total of 211 literatures were included, involving a total of 46 384 patients treated with Xuebijing Injection, and 423 adverse reactions(ADRs) occurred. They included 191 randomized controlled trials, 3 cohort studies, 15 systematic reviews, and 2 centralized monitoring studies of clinical safety(hospital), and the incidence of adverse reactions was 2.54%(common), 2.31%(common), 0.95%(occasionally), and 0.50%(occasionally). More than half of the 423 cases of ADRs occurred in skin and adnexal system(151 cases) and gastrointestinal system(65 cases), including such manifestations as rash, skin itching, nausea and vomiting, diarrhea. The degree of ADRs was mild. Randomized controlled trials showed that the incidence of ADR was the highest when Xuebijing Injection was used for malignant tumor and multiple organ failure. And the systematic evaluation showed that the incidence of ADR was the highest when Xuebijing Injection was used for spontaneous peritonitis of liver cirrhosis. In conclusion, different study types could lead to significant differences in the results of drug safety evaluation. Sample size, study type, and quality control are the main factors for biased results. Due to large sample size and high-quality, centralized monitoring studies become the better clinical safety evaluation model of drugs at present, and full life cycle management could more objectively reflect drug safety and guide clinical rational drug use.


Subject(s)
Case-Control Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drugs, Chinese Herbal/adverse effects , Humans , Injections
19.
Rev. bras. cancerol ; 67(1): e-171188, 2021.
Article in Portuguese | LILACS | ID: biblio-1147737

ABSTRACT

Introdução: A enterocolite neutropênica (EN) consiste em ulceração ou necrose da mucosa do ceco, íleo terminal e cólon ascendente, sendo uma condição clínica ocasionada como evento adverso de medicamentos, principalmente em esquemas quimioterápicos. Por ser uma condição com alto índice de mortalidade, o presente relato tem como objetivo contribuir significativamente para discussões que envolvem a EN e a participação da equipe multiprofissional no desfecho clínico. Relato do caso: Paciente do sexo masculino, 75 anos, com diagnóstico de câncer de mama, evoluindo com EN após tratamento com quimioterapia adjuvante. A presença de comorbidades e a idade foram os principais fatores complicadores do quadro de tiflite. Por ser uma toxicidade importante e que pode levar à piora do quadro clínico do paciente com câncer, abordar esse tema é fundamental para um diagnóstico mais rápido, com possibilidade de medidas preventivas. Conclusão: Sendo assim, em virtude do notório aumento dos casos de EN, aponta-se como perspectiva a qualificação da equipe de saúde para a inserção de profissionais ainda mais especializados, capazes de contribuir e identificar os sinais e sintomas relacionados com toxicidades hematológicas, resultado de tratamentos quimioterápicos.


Introduction: Neutropenic enterocolitis (NE) consists of ulceration or necrosis of the mucosa of the cecum, terminal ileum, and ascending colon, being a clinical condition caused by an adverse drug event, mainly in chemotherapy regimens. As it is a high mortality rate condition, this report aims to contribute significantly to discussions involving NE and the participation of the multidisciplinary team in the clinical outcome. Case report: This is a 75-year-old male patient diagnosed with Breast Cancer, who developed EN after treatment with adjuvant chemotherapy. The presence of comorbidities and age were the main complicating factors in typhlitis. As it is an important toxicity and can lead to a worsening of the clinical condition of cancer patients, addressing this issue is essential for a faster diagnosis with the possibility of preventive measures. Conclusion: Therefore, in view of the notorious increase of cases of NE, the perspective of the qualification of the health team is pointed out, for the inclusion of even more specialized professionals capable of contributing and identifying the signs and symptoms related to hematological toxicities, result of chemotherapy treatments.


Introducción: La enterocolitis neutropénica (EN) consiste en la ulceración o necrosis de la mucosa del ciego, íleon terminal y colon ascendente, siendo una condición clínica causada por un evento adverso farmacológico, principalmente en regímenes de quimioterapia. Al tratarse de una afección con una alta tasa de mortalidad, este informe tiene como objetivo contribuir de manera significativa a las discusiones que involucran al EN y la participación del equipo multidisciplinario en el resultado clínico. Relato del caso: Paciente masculino, 75 años, diagnosticado de cáncer de mama, que desarrolló EN después del tratamiento con quimioterapia adyuvante. La presencia de comorbilidades y la edad fueron los principales factores de complicación en Tiflite. Como se trata de una toxicidad importante y puede conducir a un empeoramiento de la condición clínica de los pacientes con cáncer, abordar esta cuestión es fundamental para un diagnóstico más rápido con la posibilidad de medidas preventivas. Conclusión: Por tanto, ante el notable incremento de casos de EN, se apunta la perspectiva de la calificación del equipo de salud, para la inclusión de profesionales aún más especializados capaces de aportar e identificar los signos y síntomas relacionados con las toxicidades hematológicas, un resultado de los tratamientos de quimioterapia.


Subject(s)
Humans , Male , Aged , Breast Neoplasms, Male , Enterocolitis, Neutropenic/drug therapy , Patient Care Team , Chemotherapy, Adjuvant , Drug-Related Side Effects and Adverse Reactions
20.
Ciencia Tecnología y Salud ; 8(2): 220-231, 2021. il 27 c
Article in Spanish | LILACS-Express | LILACS, LIGCSA, DIGIUSAC | ID: biblio-1353228

ABSTRACT

El uso de inhibidores de calcineurina, en particular de tacrolimus como terapia inmunosupresora se ha generalizado a nivel mundial, permitiendo mejorar la tasa de sobrevida del injerto y la calidad de vida del paciente trasplantado. Con el acceso a los estudios de farmacogenética, los grupos de trasplante a nivel mundial se han visto motivados a realizar estudios genéticos que permitan interpretar la influencia de polimorfismos de genes como mTOR, PPP3CA, FK BP1A, FKBP2, y FOXP3, sin embargo, los más estudiados en la población trasplantada para optimizar la dosis de tacrolimus y ciclosporina son los polimorfismos del citocromo p450, CYP3A4 y CYP3A5.El objetivo de la presente revisión narrativa es examinar publicaciones recientes que estudien la relación entre el polimorfismo de CYP3A4/5 y el metabolismo de tacrolimus en pacientes trasplantados renales.Se revisó literatura reciente extraída de los sitios NCBI PubMed y PharmGKB.org en la que se hubiera investigado la influencia de los polimorfismos de CYP3A4/5 en el metabolismo de tacrolimus en trasplantados renales. Se identificó variaciones genéticas de CYP3A4/5 en pacientes trasplantados tratados con tacrolimus que permitirán a los médicos trasplantólogos dosificar de manera precisa el inmunosupresor. El uso de análisis farmacogenéticos permite determinar las variables genéticas del CYP3A4/5, y por lo tanto la toma de decisiones personalizadas en la dosis de inicio y de mantenimiento del inmunosupresor tacrolimus para alcanzar los niveles óptimos y con ello disminuir el riesgo de rechazo, de infecciones asociadas a inmunosupresión, y de toxicidad por el medicamento.


The use of the calcineurin inhibitor tacrolimus as immunosuppressive therapy, has become widespread world-wide, improving the graft's survival rate and the quality of life of the transplanted patient. With access to pharmacogenetic studies, transplant groups worldwide have been motivated to conduct genetic studies to inter-pret the influence of polymorphisms of genes such asmTOR, PPP3CA, FK BP1A, FKBP2, and FOXP3, however the most studied in the transplanted population to optimize the dose of tacrolimus and cyclosporine are those of cytochrome p450,CYP3A4 and CYP3A5. The objective of this narrative review is to examine recent publications studying the relationship betweenCYP3A4/5polymorphism, and tacrolimus metabolism in renal transplant patients. Literature extracted from the NCBI PubMed site and PharmGKB.org, from the past five years, which investigated the influence ofCYP3A4/5polymorphism on tacrolimus metabolism in renal transplants had been reviewed. Genetic variations ofCYP3A4/5 were identified in transplant patients treated with tacrolimus that will allow transplant physicians to dose the immunosuppressant accurately. The use of pharmacogenetic analyses makes it possible to determine the genetic polymorphisms ofCYP3A4/5, and therefore the decision-making cus-tomized at the starting and maintenance dose of the tacrolimus immunosuppressant to achieve optimal levels and thereby reduce the risk of rejection, immunosuppression-associated infections, and drug toxicity.


Subject(s)
Humans , Pharmacogenetics , Polymorphism, Genetic/genetics , Kidney Transplantation , Tacrolimus , Cytochrome P-450 CYP3A/drug effects , Immunosuppression/adverse effects , Cytochrome P-450 Enzyme System/genetics , Drug-Related Side Effects and Adverse Reactions , Prescription Drugs/toxicity , Calcineurin Inhibitors
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