RESUMO
BACKGROUND: Reports regarding the causative drugs of drug-induced cutaneous adverse reactions in China are indistinct, such that different regions have reported the spectrum of drugs differs substantially in different clinical conditions. OBJECTIVE: To explore the causative drugs that led to cutaneous reactions. METHODS: Adverse drug reaction reports from central China were collected and divided into cutaneous adverse reactions and severe cutaneous adverse reactions groups. Cases were reviewed retrospectively for causative drugs. RESULTS: The male:female ratio was equal in both cutaneous adverse reactions and severe cutaneous adverse reactions. In cutaneous adverse reactions (n=482), the highest incidence happened between 51 and 60 years of age and the top three causative drugs were antibiotics (48%), Chinese medicine (16%), and allopurinol (9%). In severe cutaneous adverse reactions (n=126), the highest incidence happened between 41 and 50 years of age and the top three causative drugs were sedative-hypnotics and antiepileptics (39%), antibiotics (22%), and allopurinol (15%). Carbamazepine was the most frequently used single-drug (16/18) in sedative-hypnotics and antiepileptics. ß-lactams were the most frequently used antibiotics that induced both cutaneous adverse reactions and severe cutaneous adverse reactions. STUDY LIMITATIONS: The small sample size, retrospective design, collection of cutaneous adverse reactions and severe cutaneous adverse reactions at different time frames and locations, and exclusion of patients taking more than five medications are limitations of the study. CONCLUSIONS: Gender does not affect cutaneous adverse reactions and severe cutaneous adverse reactions. The top three drugs to induce cutaneous adverse reactions are antibiotics, Chinese medicine, and allopurinol, while those that triggered severe cutaneous adverse reactions are sedative-hypnotics and antiepileptics, antibiotics, and allopurinol. Carbamazepine is the most frequent single drug that induces severe cutaneous adverse reactions. ß-lactams are the most frequently used antibiotics that induce both cutaneous adverse reactions and severe cutaneous adverse reactions.
Assuntos
Toxidermias/epidemiologia , Toxidermias/etiologia , Adolescente , Adulto , Distribuição por Idade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/efeitos adversos , Anticonvulsivantes/efeitos adversos , Criança , Pré-Escolar , China/epidemiologia , Humanos , Hipnóticos e Sedativos/efeitos adversos , Incidência , Lactente , Pessoa de Meia-Idade , Estudos Retrospectivos , Distribuição por Sexo , Adulto JovemRESUMO
Abstract Background: Reports regarding the causative drugs of drug-induced cutaneous adverse reactions in China are indistinct, such that different regions have reported the spectrum of drugs differs substantially in different clinical conditions. Objective: To explore the causative drugs that led to cutaneous reactions. Methods: Adverse drug reaction reports from central China were collected and divided into cutaneous adverse reactions and severe cutaneous adverse reactions groups. Cases were reviewed retrospectively for causative drugs. Results: The male:female ratio was equal in both cutaneous adverse reactions and severe cutaneous adverse reactions. In cutaneous adverse reactions (n = 482), the highest incidence happened between 51 and 60 years of age and the top three causative drugs were antibiotics (48%), Chinese medicine (16%), and allopurinol (9%). In severe cutaneous adverse reactions (n = 126), the highest incidence happened between 41 and 50 years of age and the top three causative drugs were sedative-hypnotics and antiepileptics (39%), antibiotics (22%), and allopurinol (15%). Carbamazepine was the most frequently used single-drug (16/18) in sedative-hypnotics and antiepileptics. β-lactams were the most frequently used antibiotics that induced both cutaneous adverse reactions and severe cutaneous adverse reactions. Study limitations: The small sample size, retrospective design, collection of cutaneous adverse reactions and severe cutaneous adverse reactions at different time frames and locations, and exclusion of patients taking more than five medications are limitations of the study. Conclusions: Gender does not affect cutaneous adverse reactions and severe cutaneous adverse reactions. The top three drugs to induce cutaneous adverse reactions are antibiotics, Chinese medicine, and allopurinol, while those that triggered severe cutaneous adverse reactions are sedative-hypnotics and antiepileptics, antibiotics, and allopurinol. Carbamazepine is the most frequent single drug that induces severe cutaneous adverse reactions. β-lactams are the most frequently used antibiotics that induce both cutaneous adverse reactions and severe cutaneous adverse reactions.
Assuntos
Humanos , Lactente , Pré-Escolar , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Adulto Jovem , Toxidermias/etiologia , Toxidermias/epidemiologia , China/epidemiologia , Incidência , Estudos Retrospectivos , Fatores Etários , Distribuição por Sexo , Distribuição por Idade , Hipnóticos e Sedativos/efeitos adversos , Antibacterianos/efeitos adversos , Anticonvulsivantes/efeitos adversosRESUMO
INTRODUCCIÓN: La eritrodermia es un síndrome inflamatorio cutáneo infrecuente caracterizado por compromiso eritematoso generalizado y descamación, de más del 90% de superficie cutánea total. OBJETIVO: Caracterizar clínica e histopatológicamente a los pacientes con eritrodermia en un hospital universitario chileno. METODOLOGÍA: Estudio retrospectivo, realizado en el Hospital Clínico Universidad de Chile, basado en revisión de fichas clínicas e informes histopatológicos de pacientes con eritrodermia, entre 2005 y 2018. Se evaluó edad, sexo y variables clínicas (co-morbilidades, síntomas, días de evolución, ingreso hospitalario, informe histopatológico, diagnóstico y evolución). RESULTADOS: Total de 28 pacientes, 18 hombres (64%), edad promedio 59 años. Causa más frecuente de eritrodermia fue dermatosis pre-exis-tentes, con 15 casos (54%), que incluyen: psoriasis 9 (32%), dermatitis de contacto 3 (11%), PRP 2 (7%), dermatitis atópica 1 (4%). A estas le siguen: reacción adversa medicamentosa 6 (21%), idiopática 6 (21%) y Síndrome de Sezary 1 (4%). CONCLUSIÓN: El presente estudio corresponde a la primera serie de eritrodermias realizada en Chile. Destacan las dermatosis preexistentes como la principal causa, lo que se correlaciona con la literatura.
INTRODUCTION: Erythroderma is an infrequent cutaneous inflammatory disorder characterized by generalized erythematous compromise and desquamation, of more than 90% of total cutaneous surface. OBJECTIVE: Clinical and histopathological cha-racterization of patients with erythroderma in a Chilean university hospital. METHODOLOGY: Retrospective study, performed at the University of Chile Clinical Hospital, based on review of clinical records and histopatho-logical reports of patients with erythroderma, between 2005 and 2018. Age, sex and clinical variables were evaluated (co-morbidities, symp-toms, days of evolution, hospital admission, histopathological report, diagnosis and evolu-tion). RESULTS: A total of 28 patients, 18 were men (64%), average age 59 years. Most frequent cause of erythroderma was pre-existing dermatosis, with 13 cases (52%), which included: psoriasis 9 (32%), contact dermatitis 3 (11%), PRP 2 (7%), atopic dermatitis 1 (4%). These are followed by adverse drug eruption 6 (21%), idiopathic 6 (21%) and Sezary syndrome 1 (4%). CONCLUSION: The present study corresponds to the first series of erythrodermas performed in Chile. The pre-existing dermatoses were the main cause of erythroderma, which coincides with other reports.
Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Adulto Jovem , Dermatite Esfoliativa/etiologia , Dermatite Esfoliativa/patologia , Dermatite Esfoliativa/epidemiologia , Psoríase/complicações , Psoríase/epidemiologia , Evolução Clínica , Chile , Estudos Transversais , Estudos Retrospectivos , Toxidermias/complicações , Toxidermias/epidemiologia , Dermatite Atópica/complicações , Dermatite Atópica/epidemiologia , Dermatite de Contato/complicações , Dermatite de Contato/epidemiologiaRESUMO
BACKGROUND: Renal transplant recipients (RTR), which are an increasing population, frequently suffer from post-transplant dermatological complications. Despite the well-established role of dermatologists in the outpatient care of these patients, no previous studies were found concerning dermatology consultations for hospitalized RTR. OBJECTIVES: To investigate the epidemiology of dermatological conditions presented by RTR during hospitalization and assess the impact of dermatology consultations performed in the hospital setting. METHODS: Dermatology consultations requested for RTR admitted at a kidney transplantation referral hospital in Brazil over 36 consecutive months were retrospectively included. RESULTS: 176 consultations were included. Infectious dermatoses prevailed (52.3%), followed by inflammatory diseases (14.2%), neoplasms (12.5%) and drug reactions (8.5%). Diagnostic agreement between requesting and consulting teams was 38.1%. Most consultations were motivated by common dermatological conditions, unrelated to admission diagnosis. There were some differences in comparison to previous studies including general inpatients, such as: larger proportion of infectious dermatoses and neoplasms, smaller proportion of inflammatory diseases, higher percentage of patients submitted to skin biopsy, smaller proportion of consultations managed with a single visit and higher probability of a systemic treatment being recommended in this population. CONCLUSION: Hospitalized RTR present distinct dermatological epidemiology and higher level of complexity, when compared to studies including general inpatients. Dermatology interventions during hospitalization may be beneficial in the multidisciplinary care of these patients, either contributing to the investigation of systemic conditions or providing relief for cutaneous comorbidities.
Assuntos
Pacientes Internados/estatística & dados numéricos , Transplante de Rim , Complicações Pós-Operatórias/epidemiologia , Encaminhamento e Consulta , Dermatopatias/epidemiologia , Adulto , Idoso , Brasil/epidemiologia , Toxidermias/epidemiologia , Feminino , Hospitais Universitários , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Encaminhamento e Consulta/estatística & dados numéricos , Estudos Retrospectivos , Dermatopatias/etiologia , Dermatopatias Infecciosas/epidemiologia , Neoplasias Cutâneas/epidemiologiaRESUMO
STUDY OBJECTIVE: To evaluate the safety and tolerability of immunosuppressive drugs used in a planned randomized conversion from a calcineurin inhibitor, tacrolimus, to a mammalian target of rapamycin inhibitor, sirolimus, in de novo kidney transplant recipients. DESIGN: Prospective safety analysis of data from a prospective, randomized, open-label, controlled study. PATIENTS: A total of 119 adult kidney transplant recipients who received tacrolimus (TAC), mycophenolate sodium (MPS), and prednisone between February 2008 and May 2010; after 3 months of this regimen, 60 of these patients were randomized to conversion from TAC to sirolimus (SRL/MPS group), and 59 patients continued with the TAC regimen (TAC/MPS group). MEASUREMENTS AND MAIN RESULTS: Both groups were followed for 24 months after transplantation for immunosuppressive regimen-associated and time-dependent occurrences of adverse events (AEs) and serious adverse events (SAEs). Before conversion from TAC to SRL, the cumulative incidence of AEs was 98%; 25% were SAEs. Gastrointestinal AEs (66%) and infections (58%) were the most frequent AEs. The incidences of TAC and MPS dose reductions due to AEs were 1.7% and 12%, respectively. After conversion, no significant differences were noted in the SRL/MPS group versus the TAC/MPS group in the cumulative incidences of AEs (100% vs. 98%) and SAEs (27% vs. 30%). The most common AEs were gastrointestinal (70% vs. 54%, p=0.23) and infection (77% vs. 73%, p=0.79) in the SRL/MPS versus TAC/MPS groups. The incidence of aphthous ulcer (28% vs. 0%, p=< 0.01), sinusitis (10% vs. 0%, p=0.01), dermatitis (15% vs. 3%, p=0.03), and dyslipidemia (35% vs. 14%, p=0.02) were higher in the SRL/MPS group compared with the TAC/MPS group. Cox proportion regression analysis showed a higher relative risk for gastrointestinal (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2-3.01, p<0.05) and skin and subcutaneous tissue (HR 2.5, 95% CI 1.1-4.1, p<0.05) AEs in the SRL/MPS group compared with the TAC/MPS group. AE-related dose reductions occurred in 18.3% of patients receiving SRL and 3.3% of patients receiving TAC. MPS dose reductions due to AEs occurred in 11.7% of patients receiving SRL and 13.6% of patients receiving TAC. CONCLUSION: SRL/MPS treatment was associated with a time-dependent higher incidence of gastrointestinal and skin and subcutaneous tissue AEs, which occurred mainly during the first 6 months after conversion from TAC/MPS. Although the treatments with SRL or TAC after 3 months of transplantation showed different safety profiles, both regimens demonstrated adequate tolerability, with low rates of early discontinuation related to AEs.
Assuntos
Toxidermias/epidemiologia , Gastroenteropatias/induzido quimicamente , Imunossupressores/efeitos adversos , Transplante de Rim/efeitos adversos , Sirolimo/efeitos adversos , Tela Subcutânea/efeitos dos fármacos , Serina-Treonina Quinases TOR/antagonistas & inibidores , Adulto , Brasil/epidemiologia , Inibidores de Calcineurina/efeitos adversos , Inibidores de Calcineurina/uso terapêutico , Toxidermias/imunologia , Toxidermias/fisiopatologia , Monitoramento de Medicamentos , Quimioterapia Combinada/efeitos adversos , Feminino , Gastroenteropatias/epidemiologia , Gastroenteropatias/imunologia , Gastroenteropatias/fisiopatologia , Humanos , Imunossupressores/uso terapêutico , Incidência , Falência Renal Crônica/imunologia , Falência Renal Crônica/metabolismo , Falência Renal Crônica/cirurgia , Masculino , Pessoa de Meia-Idade , Ácido Micofenólico/efeitos adversos , Ácido Micofenólico/uso terapêutico , Prednisona/efeitos adversos , Prednisona/uso terapêutico , Índice de Gravidade de Doença , Sirolimo/uso terapêutico , Tela Subcutânea/imunologia , Serina-Treonina Quinases TOR/metabolismo , Tacrolimo/efeitos adversos , Tacrolimo/uso terapêuticoRESUMO
BACKGROUND/OBJECTIVES: Maculo-papular drug exanthema (MPE) is the most common type of cutaneous adverse drug reaction (CAR). Exanthematous macules and papules may also be the initial presentation of severe CAR (SCAR). We aimed to identify characteristics associated with the diagnosis of SCAR in CAR-hospitalised patients. METHODS: This cross-sectional study was performed in a tertiary hospital in Chile. All CAR patients who were initially evaluated for exanthematous macules and papules were assessed for clinical, laboratory and pathological variables and these were contrasted with MPE or SCAR diagnosis at discharge. RESULTS: We enrolled 86 patients, of whom 25 (29%) had an at-discharge diagnosis of SCAR. SCAR patients were younger and the latency (time from starting drug to development of first skin lesions) was longer than in MPE patients: 43.6 ± 18.7 years versus 54.0 ± 21.8 years (P = 0.039) and 14 days; range 1 to 35, versus 7 days; range 1 to 45 (P = 0.001). The presence of cutaneous pain (OR 7.4 95% CI 1.3-41), mucosal involvement (OR 9.5 CI 95% 2.6- 34.5) and anticonvulsant use (OR 6.11 95% CI 1.91-19.53) were significantly associated with SCAR at discharge. Antibiotics use was significantly associated with MPE diagnosis (OR 2.8 95% CI 1.1-7.6). These six variables together explain 45% of the risk of having SCAR (R2 = 0.449). None of the early laboratory or pathological variables was associated with SCAR. CONCLUSIONS: In hospitalised patients assessed for exanthematous macules and papules, the evaluation of these clinical features may aid in the early identification of SCAR cases.
Assuntos
Antibacterianos/efeitos adversos , Anticonvulsivantes/efeitos adversos , Toxidermias/fisiopatologia , Exantema/fisiopatologia , Síndrome de Stevens-Johnson/fisiopatologia , Adulto , Distribuição por Idade , Idoso , Antibacterianos/uso terapêutico , Anticonvulsivantes/uso terapêutico , Chile/epidemiologia , Estudos Transversais , Progressão da Doença , Toxidermias/epidemiologia , Toxidermias/etiologia , Exantema/induzido quimicamente , Exantema/epidemiologia , Feminino , Humanos , Incidência , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Estudos Retrospectivos , Índice de Gravidade de Doença , Distribuição por Sexo , Síndrome de Stevens-Johnson/etiologia , Centros de Atenção TerciáriaAssuntos
Hanseníase/epidemiologia , Adulto , Idoso , Toxidermias/epidemiologia , Toxidermias/etiologia , Quimioterapia Combinada , Feminino , Humanos , Hansenostáticos/efeitos adversos , Hansenostáticos/uso terapêutico , Hanseníase/tratamento farmacológico , Masculino , México/epidemiologia , Pessoa de Meia-Idade , Morbidade/tendências , Estudos Retrospectivos , Determinantes Sociais da Saúde , Resultado do TratamentoAssuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Hanseníase/epidemiologia , Estudos Retrospectivos , Morbidade/tendências , Resultado do Tratamento , Toxidermias/etiologia , Toxidermias/epidemiologia , Quimioterapia Combinada , Determinantes Sociais da Saúde , Hansenostáticos/efeitos adversos , Hansenostáticos/uso terapêutico , Hanseníase/tratamento farmacológico , México/epidemiologiaRESUMO
Las reacciones adversas a medicamentos (RAM) se encuentranen forma habitual en la práctica clínica, representando hasta el2% del total de consultas dermatológicas. Dentro de las RAM reportadas,hasta el 30% corresponderían a RAM mucocutáneas(RAM- MC). El Programa de Farmacovigilancia se implementó enChile el año 1995. Desde el año 2011 se encuentra normado,siendo de carácter obligatorio la notificación al Subdepartamentode Farmacovigilancia del Instituto de Salud Pública (ISP). El objetivode este trabajo es describir retrospectivamente las notificacionesde sospechas de RAM- MC realizadas al ISP durante el año2013. Se obtuvo un total de 113 notificaciones, la mayoría de ellasen mujeres (59,3%). Las RAM- MC más frecuentemente notificadasfueron erupción eritematosa (47,8%), hiperpigmentación dela piel (23,9%), síndrome de Stevens Johnson (8,8%) y anafilaxia(8,8%). Los fármacos involucrados con mayor frecuencia fueronlos quimioterapéuticos (28,3%), antibióticos (19,5%), otros (15%)y anticonvulsivantes (8%).
Adverse drug reactions (ADRs) are seen routinely in clinicalpractice, representing up to 2% of dermatology consultations.Among the reported ADRS, up to 30% correspond to mucocutaneousADRS-MC. The Pharmacovigilance Programmewas implemented in Chile in 1995. Since 2011 it notificationis mandatory to the Subdepartment of Pharmacovigilance ofthe Public Health Institute (ISP). The aim of this study is todescribe retrospectively the reports of suspected ADRS-MCmade to the ISP during 2013. A total of 113 notifications wereobtained, most of them in women (59.3%). The RAM-MC morefrequently reported were erythematous rash (47.8%), skin hyperpigmentation(23.9%), Stevens Johnson syndrome (8.8%)and anaphylaxis (8.8%).The drugs most often involved were chemotherapeutics(28.3%), antibiotics (19.5%), others (15%) and anticonvulsants(8%).
Assuntos
Masculino , Feminino , Humanos , Adolescente , Adulto , Lactente , Pré-Escolar , Criança , Adulto Jovem , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Toxidermias/epidemiologia , Dermatopatias/epidemiologia , Notificação de Doenças , Estudos Retrospectivos , Distribuição por Idade e Sexo , Farmacovigilância , Chile/epidemiologiaRESUMO
This study describes the adverse drug reactions (ADRs) and their incidence in patients with rheumatoid arthritis who were treated in the Colombian health system. A retrospective cohort study was conducted using information from all patients who were diagnosed with rheumatoid arthritis and attended specialized health care centers in the cities of Bogotá, Cali, Manizales, Medellin, and Pereira between 1 December 2009 and 30 August 2013. The ADRs were obtained from medical records and the pharmacovigilance system registry and sorted by frequency and affected tissue according to World Health Organization Adverse Reaction Terminology (WHO-ART). A total of 949 reports of ADRs were obtained from 419 patients (32.8 ADRs per 100 patient-years); these patients were from a cohort of 1 364 patients being treated for rheumatoid arthritis and followed up for an average of 23.8 months (± 12.9). The cohort was mostly female (366, 87.4%) and had a mean age of 52.7 years (± 13.1). The highest numbers of ADRs were reported following the use of tocilizumab, rituximab, and infliximab (28.8, 23.1, and 13.3 reports per 100 patient-years respectively). The most frequently reported ADRs were elevated transaminase levels and dyspepsia. Overall, 87.7% of ADRs were classified as type A, 36.6% as mild, 40.7% as moderate, and 22.7% as severe. As a result, 73.2% of patients who experienced an ADR stopped taking their drugs. The occurrence of ADRs in patients treated for rheumatoid arthritis is common, especially in those associated with the use of biotechnologically produced anti-rheumatic drugs. This outcome should be studied in future research and monitoring is needed to reduce the risks in these patients.
Este estudio describe las reacciones adversas a medicamentos (RAM) y su incidencia en pacientes con artritis reumatoide y tratados en el sistema de salud colombiano. Se llevó a cabo un estudio retrospectivo de cohortes utilizando la información correspondiente a todos los pacientes con diagnóstico de artritis reumatoide que acudieron a centros especializados de atención de salud de las ciudades de Bogotá, Cali, Manizales, Medellín y Pereira entre el 1 de diciembre del 2009 y el 30 de agosto del 2013. Los casos de RAM se obtuvieron de las historias clínicas y del registro del sistema de farmacovigilancia, y se clasificaron por su frecuencia y el tejido afectado, según la Terminología de Reacciones Adversas de la Organización Mundial de la Salud (WHO-ART). Se obtuvo un total de 949 informes de RAM en 419 pacientes (32,8 RAM por 100 pacientes-año); estos pacientes correspondían a una cohorte de 1 364 pacientes tratados por artritis reumatoide y seguidos durante un promedio de 23,8 meses (± 12,9). La cohorte estaba compuesta principalmente por mujeres (366, 87,4%) y la media de edad era de 52,7 años (± 13,1). El mayor número de casos de RAM se notificó tras el uso de tocilizumab, rituximab e infliximab (28,8, 23,1 y 13,3 notificaciones por 100 pacientes-año, respectivamente). Las RAM notificadas con mayor frecuencia fueron la elevación de los niveles de transaminasas y la dispepsia. En términos generales, 87,7% de las RAM se clasificaron como de tipo A, 36,6% como leves, 40,7% como moderadas y 22,7% como graves. Como consecuencia, 73,2% de los pacientes que presentaron una RAM dejaron de tomar sus medicamentos. La aparición de RAM en pacientes tratados por artritis reumatoide es frecuente, especialmente cuando se utilizan fármacos antirreumáticos de producción biotecnológica. Estos resultados deben ser objeto de estudio en futuras investigaciones y señalan la necesidad de actividades de vigilancia para reducir los riesgos en estos pacientes.
Assuntos
Humanos , Masculino , Feminino , Pré-Escolar , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Adulto Jovem , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Antirreumáticos/uso terapêutico , Produtos Biológicos/efeitos adversos , Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/uso terapêutico , Colômbia/epidemiologia , Toxidermias/epidemiologia , Toxidermias/etiologia , Doença Hepática Induzida por Substâncias e Drogas/epidemiologia , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Seguimentos , Gastroenteropatias/induzido quimicamente , Gastroenteropatias/epidemiologia , Doenças Hematológicas/induzido quimicamente , Doenças Hematológicas/epidemiologia , Farmacovigilância , Doenças Retinianas/induzido quimicamente , Doenças Retinianas/epidemiologia , Estudos RetrospectivosRESUMO
Cutaneous reactions represent in many surveillance systems, the most frequent adverse events attributable to drugs. The spectrum of clinical manifestations is wide and virtually encompasses any known dermatological disease. The introduction of biological agents and so-called targeted therapies has further enlarged the number of reaction patterns especially linked with cytokine release or in balance. The frequency and clinical patterns of cutaneous reactions are influenced by drug use, prevalence of specific conditions (e.g., HIV infection) and pharmacogenetic traits of a population, and they may vary greatly among the different populations around the world. Studies of reaction rates in cohorts of hospitalized patients revealed incidence rates ranging from, 1 out 1000 to 2 out 100 of all hospitalized patients. For drugs such as aminopenicillines and sulfamides the incidence of skin reactions is in the order of 3-5 cases out of 100 exposed people. Although the majority of cutaneous reactions are mild and self-limiting, there are reactions such as Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) which are associated with significant morbidity and mortality. Surveillance systems routed on sound epidemiologic methodology, are needed to raise signals and to assess risks associated with specific reactions and drug exposures. Identification of risk factors for adverse reactions and appropriate genetic screening of groups at higher risk may improve the outcomes of skin reactions.
Assuntos
Toxidermias/epidemiologia , Estudos de Coortes , Comorbidade , Suscetibilidade a Doenças , Toxidermias/classificação , Toxidermias/diagnóstico , Toxidermias/prevenção & controle , Hipersensibilidade a Drogas/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Departamentos Hospitalares , Humanos , Incidência , Pacientes Internados , Masculino , México/epidemiologia , Terapia de Alvo Molecular/efeitos adversos , Farmacovigilância , Transtornos de Fotossensibilidade/induzido quimicamente , Transtornos de Fotossensibilidade/epidemiologia , Vigilância de Produtos Comercializados , Ensaios Clínicos Controlados Aleatórios como Assunto , República da Coreia/epidemiologia , Fatores de RiscoRESUMO
BACKGROUND: Everolimus is a mammalian target of rapamycin (mTOR) inhibitor approved for treatment of renal cell carcinoma, subependymal giant cell astrocytoma, breast cancer, and progressive neuroendocrine tumors of pancreatic origin. Its use may be hindered because of adverse events, including rash. The reported incidence and risk of a rash to everolimus varies widely and has not been closely investigated. Therefore, we conducted a systematic review and meta-analysis of the literature to determine the incidence and risk of developing a rash. METHODS: We searched PubMed and Web of Science databases and abstracts presented at the American Society of Clinical Oncology from 1998 to December 2011 using the keyword "everolimus" to identify relevant clinical trials. Eligible studies included prospective phase II and III clinical trials of cancer patients on 10 mg of everolimus daily with available data on incidence of rash. The summary incidence and relative risk (RR) of rash were calculated using either the random-effects or fixed-effects model, depending on the heterogeneity of the constituent studies. RESULTS: A total of 2242 patients with various malignancies from 13 clinical trials were included in the analysis. The summary incidences of all-grade and high-grade rash in patients on everolimus were 28.6% [95% confidence interval (CI), 20.8-38.0] and 1.0% (95% CI, 0.6-1.8), respectively. Everolimus was associated with a statistically significant increased risk of all-grade rash (RR=3.853, 95% CI, 2.470-6.013, P=0.000), but the RR for high-grade rash (RR=2.997, 95% CI, 0.633-14.185) was not statistically significant, with a P value of 0.166. CONCLUSIONS: Everolimus is associated with a significant risk of developing a rash. Management of rash to everolimus is critical to prevent dose modifications and decreased quality of life, both of which can negatively affect overall clinical outcomes.
Assuntos
Antineoplásicos/efeitos adversos , Toxidermias/epidemiologia , Toxidermias/etiologia , Sirolimo/análogos & derivados , Serina-Treonina Quinases TOR/antagonistas & inibidores , Antineoplásicos/administração & dosagem , Ensaios Clínicos como Assunto , Fatores de Confusão Epidemiológicos , Everolimo , Humanos , Incidência , Qualidade de Vida , Risco , Sirolimo/administração & dosagem , Sirolimo/efeitos adversosRESUMO
This study describes the adverse drug reactions (ADRs) and their incidence in patients with rheumatoid arthritis who were treated in the Colombian health system. A retrospective cohort study was conducted using information from all patients who were diagnosed with rheumatoid arthritis and attended specialized health care centers in the cities of Bogotá, Cali, Manizales, Medellin, and Pereira between 1 December 2009 and 30 August 2013. The ADRs were obtained from medical records and the pharmacovigilance system registry and sorted by frequency and affected tissue according to World Health Organization Adverse Reaction Terminology (WHO-ART). A total of 949 reports of ADRs were obtained from 419 patients (32.8 ADRs per 100 patient-years); these patients were from a cohort of 1,364 patients being treated for rheumatoid arthritis and followed up for an average of 23.8 months (± 12.9). The cohort was mostly female (366, 87.4%) and had a mean age of 52.7 years (± 13.1). The highest numbers of ADRs were reported following the use of tocilizumab, rituximab, and infliximab (28.8, 23.1, and 13.3 reports per 100 patient-years respectively). The most frequently reported ADRs were elevated transaminase levels and dyspepsia. Overall, 87.7% of ADRs were classified as type A, 36.6% as mild, 40.7% as moderate, and 22.7% as severe. As a result, 73.2% of patients who experienced an ADR stopped taking their drugs. The occurrence of ADRs in patients treated for rheumatoid arthritis is common, especially in those associated with the use of biotechnologically produced anti-rheumatic drugs. This outcome should be studied in future research and monitoring is needed to reduce the risks in these patients.
Assuntos
Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antirreumáticos/uso terapêutico , Produtos Biológicos/efeitos adversos , Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/uso terapêutico , Doença Hepática Induzida por Substâncias e Drogas/epidemiologia , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Criança , Pré-Escolar , Colômbia/epidemiologia , Toxidermias/epidemiologia , Toxidermias/etiologia , Feminino , Seguimentos , Gastroenteropatias/induzido quimicamente , Gastroenteropatias/epidemiologia , Doenças Hematológicas/induzido quimicamente , Doenças Hematológicas/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Farmacovigilância , Doenças Retinianas/induzido quimicamente , Doenças Retinianas/epidemiologia , Estudos Retrospectivos , Adulto JovemRESUMO
INTRODUCTION: Cutaneous manifestations in patients with acute leukemia (AL) cover a broad spectrum, including those due to leukemia per se, to chemotherapy and other drugs and those inherent to hospital care. MATERIAL AND METHODS: This is a cohort study in a tertiary hospital setting where the development of dermatoses was followed for 2 years in 22 patients with the diagnosis of AL. RESULTS: During the study, all patients developed some type of dermatosis, mostly due to chemotherapy.
Assuntos
Leucemia Mieloide Aguda/complicações , Leucemia-Linfoma Linfoblástico de Células Precursoras/complicações , Dermatopatias/epidemiologia , Adolescente , Adulto , Idoso , Alopecia/induzido quimicamente , Alopecia/epidemiologia , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Dermatite Alérgica de Contato/epidemiologia , Dermatite Alérgica de Contato/etiologia , Toxidermias/epidemiologia , Toxidermias/etiologia , Feminino , Seguimentos , Hospitais Especializados/estatística & dados numéricos , Humanos , Leucemia Mieloide Aguda/tratamento farmacológico , Leucemia Mieloide Aguda/patologia , Infiltração Leucêmica , Masculino , México/epidemiologia , Pessoa de Meia-Idade , Doenças da Unha/induzido quimicamente , Doenças da Unha/epidemiologia , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Leucemia-Linfoma Linfoblástico de Células Precursoras/patologia , Pele/patologia , Dermatopatias/etiologia , Dermatopatias Infecciosas/epidemiologia , Dermatopatias Infecciosas/etiologia , Adulto JovemRESUMO
Because the older group of the population is becoming more numerous, we see a high prevalence in drug adverse reactions among the elderly. Polypharmacy, which is the use of five or more medications, is one reason why this group has a greater risk of adverse drug reactions. Cutaneous adverse reactions to drugs are not always life threatening, but they can be an important factor for a poor quality of life among older patients. The potential benefits of appropriately prescribed medications are unquestionable, but the possibility of an adverse reaction must be recognized and prevented in older people so they can have a better quality of life.
Assuntos
Toxidermias/epidemiologia , Toxidermias/fisiopatologia , Polimedicação , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Toxidermias/prevenção & controle , Interações Medicamentosas , HumanosRESUMO
Adverse drug reactions (ADRs) are responsible for up to 10percent of hospital admissions worldwide; within them, that mucocutaneous reactions are the most common represented 30percent of the total. The aim of this study was to analyze 119 reports of ADRs recorded in the Pharmacy Department of University of Chile Clinical Hospital in the period 2004-2010 by gender, age, most frequent clinical presentations, drugs and health personnel linked to the notification. In addition, we tried to quantify the relative importance of mucocutaneous reactions in the total of reported ADRs. ADRs were more common in women (56.3percent). The average age was 52.84 years + / - 7.77, 52.07 + / - 10.6 for women and 53.84 + / - 13.43 for men without significant differences (p = 0.85). According to the clinical presentation, mucocutaneous reactions were the most frequent (31.1percent) followed by hematological (25.2percent). The drugs involved were chemotherapy (68.9percent), antibiotics (5.9percent) and NSAIDs, nonsteroidal anti-inflammatory drugs, (4.2percent). In health personnel linked to the notification, we found the association medical / pharmaceutical chemist was the most frequent (40.3percent), followed by a pharmaceutical chemist (33.6percent). In mucocutaneous ADRs we observed a mean age of 54.65 + / - 9.19 years and female predominance (62.2percent). According to the clinical dermatology, we observed a prevalence of skin rash (35.1percent), mucositis (21.6percent), facial erythema (16.2percent) and pruritus (16.2percent). The drugs involved were chemotherapy (78.4percent), antibiotics (8percent), antiretroviral therapy (5percent) and opioids (5percent). Finally, we found that according to time of onset, delayed reactions were the most frequent (43.2percent).
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Toxidermias/epidemiologia , Preparações Farmacêuticas/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Chile/epidemiologiaRESUMO
Introducción: Las Reacciones de Hipersensibilidad Medicomentosa (RHM) son un motivo de consulta muy común en Dermatología. Con el objetivo de implementar la farmacovigilancia dentro de la Sociedad Chilena de Dermatología (SOCHIDERM) se creó un Protocolo paro la notificación de RHM de tipo muco-cutáneo. Objetivo: Validar una propuesta de Protocolo de Farmacovigilancia de RHM de tipo mucocutáneo de la SOCHIDERM paro el uso de dermatólogos y médicos de nuestro país. Resultados: En nuestro estudio, la frecuencia de RHM fue 0,3% -0,5% del total de consultas ambulatorias y 5,2% 17,2% de las interconsultas a Dermatología. Los patrones más frecuentes fueron el urticarial, morbiliforme y la reacción medicamentosa fija. Los fármacos imputados con mayor frecuencia fueron los analgésicos/antiinflamatorios, los fármacos con acción en el sistema nervioso central, los antibióticos y los antihipertensivos. Discusión: Es importante tener un Protocolo de Farmacovigilancia. Esto nos permitirá obtener datos a nivel nacional. El desafío a corto plazo paro farmacovigilancia en SOCHIDERM es lograr notificar las RHM de tipo muco-cutáneo graves o con compromiso vital, que sean atendidas por dermatólogos en nuestro país, a través del Protocolo de Farmacovigilancia SOCHIDERM.
Introduction: Drug Hypersensitivity Reactions (DHR) are a common cause of consultation in dermatology. In order to implement fharmacovigilance in the Chilean Society of Dermatology (SOCHIDERM), we created a protocol for the notification of mucocutaneous DHR. Objective: To validate a SOCHIDERM mucocutaneous DHR pharmacovigilance protocol for dermatologists and physicians in our country. Results: In our study. DHR accounted for 0.3-0.5 % of all outpatient consultations, and 5,2-17,2% of interconsultations in dermatology. The most frequent patterns were urticarial, morbilliform and fixed drug reaction. The drugs most frequently involved were analgesics/anti-inflammatory drugs with action in the central nervous system, antibiotics and antihypertensives. Discussion: It is important to have a Pharmacovigilance Protocol since it will allow to obtain nationwide data. The short-term challenge for the SOCHIDERM pharmacovigilance is to notify serious or life-threatening mucocutaneous DHR that have been seen by dermatologists in our country, through this Protocol.
Assuntos
Humanos , Masculino , Adulto , Feminino , Pessoa de Meia-Idade , Hipersensibilidade a Drogas/epidemiologia , Preparações Farmacêuticas/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Distribuição por Idade e Sexo , Protocolos Clínicos , Chile/epidemiologia , Toxidermias/epidemiologia , Hospitais/estatística & dados numéricos , Instituições de Assistência Ambulatorial/estatística & dados numéricos , Estudos Multicêntricos como Assunto , Notificação de Doenças , Estudos RetrospectivosRESUMO
OBJECTIVE: Cutaneous reactions are among the most common adverse reactions to drugs. The purpose of this study is to examine the aetiology and outcome of cutaneous drug reactions among patients admitted to the Dermatology Ward at the University Hospital of the West Indies. SUBJECTS AND METHODS: This was a retrospective study looking at all patients who were admitted with a diagnosis of a cutaneous drug eruption from January 1, 1997 to December 31, 2005. Data included patient demographics, date of admission to hospital, duration of hospitalization and a detailed drug history including any previous episodes of drug sensitivity. All drugs reportedly ingested by the patients up to three months prior to their cutaneous reaction were documented and the period of time between drug ingestion and the appearance of skin lesions was also noted. Clinical diagnosis, co-morbidities, histopathological diagnosis, final outcome and all ensuing disabilities were noted. The data retrieved were collated and analyzed using SPSS 12.0. RESULTS: The results showed a female to male ratio of 2.2:1. The categories of drugs most commonly implicated were antimicrobials followed by anti-epileptic drugs and nonsteroidal anti-inflammatory drugs. The most common form of drug eruption requiring admission was the exanthematous drug eruption followed by erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome. CONCLUSION: In general, the causative agents identified and the types of drug eruptions were similar to those found in previous studies. However, the anti-epileptic drugs, phenytoin and carbamazepine, ranked among the most commonly implicated drugs which differ significantly from other studies.
Las reacciones cutáneas se hallan entre las reacciones adversas más comunes frente a los medicamentos. El propósito de este estudio fue examinar la etiología y la evolución clínica de las reacciones cutáneas medicamentosas entre pacientes ingresados a la sala de dermatología en el Hospital Universitario de West Indies. MÉTODOS: Este es un estudio retrospectivo que pasa revista a todos los pacientes que fueron ingresados con diagnóstico de erupción cutánea desde el 1ero. de enero de 1997 al 31 de diciembre de 2005. RESULTADOS: Los resultados mostraron una proporción hembra-varón de 2.2:1. Las categorías de los medicamentos más frecuentemente implicados fueron los antimicrobianos, seguidos por los medicamentos antiepilépticos y los antiinflamatorios no esteroideos. La forma más común de erupción que requirió ingreso a causa de medicamentos, fue la erupción exantemática medicamentosa seguida por el eritema multiforme, la necrólisis epidérmica tóxica, y el síndrome de Stevens-Johnson. CONCLUSIÓN: En general, los agentes causativos identificados y los tipos de erupciones medicamentosas, fueron similares a los hallados en estudios previos. Sin embargo, los antiepilépticos conocidos como fenitoína y carbamazepina, estuvieron entre los medicamentos más comúnmente implicados, presentándose en tal sentido una diferencia significativa con los otros estudios.
Assuntos
Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Toxidermias/epidemiologia , Preparações Farmacêuticas/efeitos adversos , Síndrome de Stevens-Johnson , Anti-Infecciosos/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Anticonvulsivantes/efeitos adversos , Comorbidade , Dermatologia/estatística & dados numéricos , Toxidermias/etiologia , Eritema Multiforme/induzido quimicamente , Eritema Multiforme/epidemiologia , Departamentos Hospitalares/estatística & dados numéricos , Hospitais Universitários , Jamaica/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Síndrome de Stevens-Johnson/induzido quimicamente , Síndrome de Stevens-Johnson/epidemiologia , Resultado do TratamentoRESUMO
OBJECTIVE: Cutaneous reactions are among the most common adverse reactions to drugs. The purpose of this study is to examine the aetiology and outcome of cutaneous drug reactions among patients admitted to the Dermatology Ward at the University Hospital of the West Indies. SUBJECTS AND METHODS: This was a retrospective study looking at all patients who were admitted with a diagnosis of a cutaneous drug eruption from January 1, 1997 to December 31, 2005. Data included patient demographics, date of admission to hospital, duration of hospitalization and a detailed drug history including any previous episodes of drug sensitivity. All drugs reportedly ingested by the patients up to three months prior to their cutaneous reaction were documented and the period of time between drug ingestion and the appearance of skin lesions was also noted. Clinical diagnosis, co-morbidities, histopathological diagnosis, final outcome and all ensuing disabilities were noted. The data retrieved were collated and analyzed using SPSS 12.0. RESULTS: The results showed a female to male ratio of 2.2:1. The categories of drugs most commonly implicated were antimicrobials followed by anti-epileptic drugs and nonsteroidal anti-inflammatory drugs. The most common form of drug eruption requiring admission was the exanthematous drug eruption followed by erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome. CONCLUSION: In general, the causative agents identified and the types of drug eruptions were similar to those found in previous studies. However the anti-epileptic drugs, phenytoin and carbamazepine, ranked among the most commonly implicated drugs which differ significantly from other studies.
Assuntos
Toxidermias/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Infecciosos/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Anticonvulsivantes/efeitos adversos , Criança , Pré-Escolar , Comorbidade , Dermatologia/estatística & dados numéricos , Toxidermias/etiologia , Eritema Multiforme/induzido quimicamente , Eritema Multiforme/epidemiologia , Feminino , Departamentos Hospitalares/estatística & dados numéricos , Hospitais Universitários , Humanos , Jamaica/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Síndrome de Stevens-Johnson/induzido quimicamente , Síndrome de Stevens-Johnson/epidemiologia , Síndrome de Stevens-Johnson/etiologia , Resultado do Tratamento , Adulto JovemRESUMO
Las reacciones adversas medicamentosas mucocutáneas (RAMM) son una de las manifestaciones más frecuentes de reacción adversa a medicamentos. Su incidencia según datos internacionales alcanza un 2 por ciento a 3 por ciento en pacientes hospitalizados. Nosotros investigamos la incidencia de RAMM en el Servicio de Medicina Interna del Hospital Base de la ciudad de Los Ángeles. En el período junio-septiembre de 2006 se hospitalizaron 1.052 pacientes, diagnosticándose 3 casos de RAMM que representan un 0,3 por ciento. Se identificaron los fármacos atribuibles a las RAMM, correspondiendo a cloxacilina, toxoide tetánico y drogas antituberculosas; éstas se compararon posteriormente con un grupo control. Los casos identificados fueron un rash morbiliforme, una reacción inflamatoria local tipo celulitis y un rash urticariforme. La incidencia obtenida fue más baja de lo esperado, atribuyéndose a las características de atención del centro estudiado.
Mucocutaneous adverse reactions to drugs (MCRD) are one of the most frequent manifestations of adverse drug reaction. Its incidence, according to international data, reaches 2 to 3 percent in hospitalized patients. We studied the incidence of MCRD in the Internal Medicine Service of the Base Hospital, located in the city of Los Angeles, Chile. 1,052 patients were hospitalized during the June-September 2006 period, and three cases of MCRD were diagnosed, representing 0.3 percent. The drugs causing to MCRD were cloxacilin, tetanic toxoid and antituberculosis drugs; these were later compared to a control group. The identified cases were morbiliform rash, a cellulitis-type local inflammatory reaction, and urticariform rash. The obtained incidence was lower than expected, attributed to the characteristics of the studied center.