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Resumen: Los antitrombóticos son fármacos que se utilizan para prevenir la formación de coágulos sanguíneos, también conocidos como trombos. Estos coágulos pueden causar graves problemas de salud, como infartos o enfermedades cerebrovasculares. En este artículo se analizan diferentes tipos de antitrombóticos, como los antiplaquetarios y los anticoagulantes, y se discuten sus mecanismos de acción. Además, se examinan los beneficios y los riesgos asociados con el uso de antitrombóticos. Por un lado, estos fármacos pueden reducir el riesgo de eventos trombóticos, lo que puede ser especialmente beneficioso en pacientes con condiciones de alto riesgo, como aquellos que han sufrido un infarto o que tienen fibrilación auricular. Por otro lado, también se discuten los posibles efectos secundarios de los antitrombóticos, como el aumento del riesgo de sangrado. Además, se proporcionan pautas para su uso seguro en diferentes escenarios clínicos. Finalmente, se abordan las estrategias de monitoreo y ajuste de la dosis de estos medicamentos para garantizar su eficacia y seguridad en los pacientes.
Abstract: Antithrombotics are drugs used to prevent the formation of blood clots, also known as thrombi. These clots can cause serious health problems, such as heart attacks or strokes. Different types of antithrombotics, such as antiplatelets and anticoagulants, are analyzed and their mechanisms of action are discussed. Additionally, the benefits and risks associated with the use of antithrombotics are examined. On the one hand, these drugs can reduce the risk of thrombotic events, which may be especially beneficial in patients with high-risk conditions, such as those who have suffered a heart attack or who have atrial fibrillation. On the other hand, the possible side effects of antithrombotics, such as the increased risk of bleeding, are also discussed and guidelines for their safe use in different clinical scenarios are provided. Additionally, monitoring and dose adjustment strategies for these medications are addressed to ensure their effectiveness and safety in patients.
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Background: This study investigated the prognostic importance of the hemoglobin glycation index (HGI) for macrovascular and microvascular outcomes, mortality, and hypoglycemia occurrence in a type 2 diabetes cohort and compared it to glycated hemoglobin (HbA1c). Methods: Baseline and mean first-year HGI and HbA1c, and the variability thereof, were assessed in 687 individuals with type 2 diabetes (median follow-up, 10.6 years). Multivariable Cox regression was conducted to evaluate the associations of HGI and HbA1c parameters with macrovascular (total and major cardiovascular events) and microvascular outcomes (microalbuminuria, advanced renal failure, retinopathy, and peripheral neuropathy), mortality (all-cause and cardiovascular), and moderate/severe hypoglycemia occurrence. Results: During follow-up, there were 215 total cardiovascular events (176 major) and 269 all-cause deaths (131 cardiovascular). Microalbuminuria developed in 126 patients, renal failure in 104, retinopathy in 161, and neuropathy in 177. There were 90 hypoglycemia episodes. Both HGI and HbA1c predicted all adverse outcomes, except microalbuminuria and hypoglycemia. Their adjusted risks were roughly equivalent for all outcomes. For example, the adjusted hazard ratios (HRs) with 95% confidence intervals (CIs), estimated for 1 standard deviation increments, of mean first-year HGI were 1.23 (1.05 to 1.44), 1.20 (1.03 to 1.38), 1.36 (1.11 to 1.67), 1.28 (1.09 to 1.67), and 1.29 (1.09 to 1.54), respectively, for cardiovascular events, all-cause mortality, renal failure, retinopathy, and neuropathy; whereas the respective HRs (95% CIs) of mean HbA1c were 1.31 (1.12 to 1.53), 1.28 (1.11 to 1.48), 1.36 (1.11 to 1.67), 1.33 (1.14 to 1.55), and 1.29 (1.09 to 1.53). Conclusion: HGI was no better than HbA1c as a predictor of adverse outcomes in individuals with type 2 diabetes, and its clinical use cannot be currently advised.
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BACKGROUND: Drug resistance (DR) is one of the several challenges to global tuberculosis (TB) control. The implementation of bedaquiline (BED) for DR-TB after more than 40 years was expected to improve treatment outcomes as well as microbiologic conversion and adverse events (AE) occurrence. METHODS: Retrospective cohort study based on secondary data of patients with rifampicin-resistant (RR) or multidrug-resistant (MDR) TB reported to the Outpatient Clinic of Mycobacterial Diseases of the Thorax Diseases Institute - Federal University of Rio de Janeiro - Brazil, between 2016 and 2023. We aimed to evaluate microbiologic conversion, AE and TB treatment outcomes and compare them according to the treatment regimen used for RR/MDR-TB patients under routine conditions [Injectable Containing Regimens (ICR) versus BED Containing Regimens (BCR)]. Logistic regression and survival analysis using Cox regression and Kaplan Meier curve were used for statistical analysis. RESULTS: Of the 463 DR-TB patients notified during the study period, 297 (64.1%) were included for analysis (ICR = 197 and BCR = 100). Overall AEs were more frequent (83.7 vs. 16.3%, p < 0.001) and occurred earlier in the ICR group (15 days vs. 65 days, p = 0.003). There were no cases of cardiotoxicity requiring interruption of BED treatment. None of the regimens of treatment tested were associated with smear or culture conversion on Cox regression analysis (p = 0.60 and 0.88, respectively). BED-containing regimens were also associated with favorable outcomes in multivariable logistic regression [adjusted odds ratio (aOR) = 2.63, 95% confidence interval (CI)1.36-5.07, p = 0.004], as higher years of schooling, primary drug resistance, and no previous TB treatment. In the survival analysis, BCR was inversely associated with the occurrence of AE during treatment follow-up (aHR 0.24, 95% CI 0.14-0.41, p < 0.001). In addition, TB treatment regimens with BED were also associated with favorable outcomes (aHR 2.41, 95% CI 1.62-3.57, p < 0.001), along with no illicit drug use and primary drug resistance. CONCLUSIONS: The implementation of a fully oral treatment for RR/MDR-TB in a reference center in Brazil was safe and associated with favorable outcomes under routine conditions, despite social, demographic, and behavioral factors that may influence TB treatment completion.
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Antituberculosos , Diarilquinolinas , Rifampina , Tuberculose Resistente a Múltiplos Medicamentos , Humanos , Estudos Retrospectivos , Brasil , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Feminino , Diarilquinolinas/uso terapêutico , Diarilquinolinas/administração & dosagem , Diarilquinolinas/efeitos adversos , Masculino , Rifampina/uso terapêutico , Antituberculosos/uso terapêutico , Antituberculosos/efeitos adversos , Antituberculosos/administração & dosagem , Adulto , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem , Mycobacterium tuberculosis/efeitos dos fármacos , InjeçõesRESUMO
INTRODUCTION: The tetravalent live virus vaccine developed by Takeda called Qdenga® is available in Argentina and approved for use from 4 years of age without age limit. The objective was to describe clinical characteristics and evolution of the initial reports of rash after the first dose. MATERIAL AND METHODS: The records of Events Supposedly Attributable to Vaccination or Immunization Reported in a Private Vaccination Center were reviewed between 15/11/2023 and 12/12/2023. Cases with skin rash that occurred outside the application site area were included. The main variables analyzed were age, sex, history of dengue, characteristics of the skin rash, accompanying symptoms, time elapsed from vaccination to the onset of the rash and evolution. The incidence of rash was calculated: cases/10,000 vaccinated. RESULTS: Out of 12 551 doses applied, 15 cases were included. Median age: 35 years, female sex: 8/15. Clinical forms of presentation: generalized micropapular (3/15), maculopapular (3/15), scarlatiniform (1/15), urticarian (1/15), multiform (1/15), erythematous in the face (1/15) and unspecified (5/15). Most common concomitant symptoms: pruritus (5/15), fever or low-grade fever (6/15), headache (3/15), retro-ocular pain (2/15), asthenia (2/15). Three cases reported a history of dengue. The median number of days of rash presentation was 8 days' postvaccination. All patients progressed favorably. The overall incidence was 1.2/1000 vaccinated. CONCLUSIONS: In passive surveillance, after more than 12 000 first doses administered, the presence of rash was observed in less than 0.12% of those vaccinated. Everyone evolved favorably.
Introducción: La vacuna tetravalente a virus vivos del laboratorio Takeda, denominada Qdenga®, está disponible en Argentina y aprobada para su uso a partir de los 4 años sin límite de edad. El objetivo fue describir las características clínicas y evolución de los primeros reportes de exantema post primera dosis. Material y métodos: Se revisaron los registros de los Eventos Supuestamente Atribuidos a la Vacunación e Inmunización reportados en los Centros Vacunar entre el 15/11/2023 al 12/12/2023. Se incluyeron los casos con exantema cutáneo que se presentaron fuera del área del sitio de aplicación. Las principales variables analizadas fueron edad, sexo, antecedente de dengue, características del exantema cutáneo, síntomas acompañantes, tiempo transcurrido desde la vacunación al inicio del exantema y evolución. Se calculó la incidencia del exantema: casos/1000 vacunados. Resultados: Sobre 12551 dosis aplicadas se incluyeron 15 casos. Mediana de edad: 35 años, sexo femenino: 8/15. Formas clínicas de presentación: generalizado micropapular (3/15), maculopapular (3/15), escarlatiniforme (1/15), urticariano (1/15), multiforme (1/15), eritematoso en cara (1/15) y sin especificar (5/15). Síntomas concomitantes más frecuentes: prurito (5/15), fiebre o febrícula (6/15), cefalea (3/15), dolor retro ocular (2/15), astenia (2/15). Tres casos refirieron antecedente de dengue. La mediana de días de presentación del exantema fue de 8 días post vacunación. Todos los pacientes evolucionaron favorablemente. La incidencia fue de 1.2/1000 vacunados. Conclusiones: En la vigilancia pasiva, luego de más de 12 000 primeras dosis administradas, se observó la presencia de exantema en menos del 0.12% de los vacunados. Todos evolucionaron favorablemente.
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Vacinas contra Dengue , Exantema , Adolescente , Adulto , Idoso , Criança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Argentina/epidemiologia , Dengue/prevenção & controle , Vacinas contra Dengue/efeitos adversos , Vacinas contra Dengue/administração & dosagem , Exantema/induzido quimicamente , Incidência , Estudos Retrospectivos , Vacinação/efeitos adversosRESUMO
RESUMEN Introducción: La miocardiopatía chagásica (MC) difiere de otras causas de insuficiencia cardíaca en múltiples aspectos, destacándose el riesgo de embolias sistémicas. Sin embargo, pocos estudios han evaluado el riesgo de eventos embólicos en pacientes anticoagulados con MC en comparación con otras miocardiopatías. Objetivo: Nuestro objetivo fue analizar la incidencia de embolias sistémicas en una cohorte de pacientes anticoagulados con diagnóstico de fibrilación auricular (FA) con y sin MC. Material y métodos: Se realizó un estudio de cohorte retrospectivo en hospital de cuarto nivel en Colombia durante el periodo 2014-2020. Se incluyeron todos los pacientes con diagnóstico de miocardiopatía de cualquier etiología y FA que estuvieran en régimen de anticoagulación. El resultado primario fue la incidencia de eventos embólicos. Se realizó un análisis de supervivencia mediante modelos de riesgos proporcionales de Cox ajustados. Un valor de p <0,05 se consideró significativo. Todas las pruebas estadísticas fueron de dos colas. Resultados: Se evaluaron 149 pacientes anticoagulados con miocardiopatía (mediana de edad: 71 años; mujeres: 30,20%). La incidencia acumulada de eventos embólicos fue significativamente mayor en los pacientes con MC (17,50%) en comparación con aquellos con otras miocardiopatías (4,95%), a pesar de que estos últimos tenían una puntuación CHA2DS2-VASc significativamente mayor (p=0,013). Tras el análisis multivariado, los pacientes con MC tuvieron un riesgo significativamente mayor de eventos embólicos independientemente de la puntuación CHA2DS2-VASc y del tipo de anticoagulante prescrito (HR 5,65; IC 95% 1,46-21,83; p=0,012). Conclusiones: La MC se asoció con un riesgo significativamente mayor de eventos embólicos, a pesar del tratamiento anticoagulante en ambos grupos. Se requiere más investigación para comprender el origen de este riesgo observado y traducir este conocimiento en indicaciones específicas de anticoagulación para pacientes con MC.
ABSTRACT Background: Chagasic cardiomyopathy (CC) differs from other heart failure causes in multiple aspects, highlighting the risk of systemic embolisms. However, few studies have evaluated the risk of embolic events in anticoagulated patients with CC compared with other cardiomyopathies. Objective: We aimed to analyze the incidence of systemic embolisms in a cohort of anticoagulated patients diagnosed with atrial fibrillation (AF) with and without CC. Methods: A retrospective cohort study was carried out at a fourth level hospital in Colombia during the period 2014-2020. All patients diagnosed with cardiomyopathy of any etiology and AF, who were on an anticoagulation regimen were included. The primary outcome was the incidence of embolic events. A survival analysis was performed using adjusted Cox proportional hazard models. A p-value <0.05 was considered significant. All statistical tests were two-tailed. Results: A total of 149 anticoagulated patients with cardiomyopathy were evaluated (median age: 71 years; women: 30.20%). The cumulative incidence of embolic events was significantly higher in patients with CC (17.50%) compared with those presenting other cardiomyopathies (4.95%), despite that the latter had a significantly higher CHA2DS2-VASc score (p=0.013). After multivariate analysis, patients with CC had a significantly higher risk of embolic events regardless of the CHA2DS2-VASc score and the type of anticoagulant prescribed (HR 5.65; 95% CI 1.46-21.83; p=0.012). Conclusions: Chagasic cardiomyopathy was associated with a significantly higher risk of embolic events, despite anticoagulation therapy in both groups. More research is required to understand the origin of the risk observed in order to translate this knowledge into specific indications for anticoagulation in patients with CC.
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BACKGROUND: There is scarce data concerning the relationship between negative life events (NLEs)* and current and new depressive episodes by age. METHODS: Cross-sectional (baseline) and prospective analyses (4-year/8-year follow-ups) were performed in 15,105 civil servants in 6 cities in Brazil classified according to age strata at baseline: 1st(35-44), 2nd(45-54), 3rd(55-64), and 4th(65-74) years. The independent variable was NLEs in the last year (robbery, hospitalization, death of a relative, financial hardship, and rupture of a love relationship) collected at baseline. The dependent variable was depressive episodes assessed at baseline (current), and 4-year/8-year follow-ups (new). We built logistic (Odds Ratio[OR];95 % Confidence Interval[CI]) in the cross-sectional analysis and Poisson regression models (Relative Risk[RR], [CI]) in the prospective analysis. RESULTS: Robbery, hospitalization, financial hardship, rupture of a relationship were associated with current depressive episodes concentrated in the 35-44 age range, while for new depressive episodes, the association of hospitalization, death of a relative, and financial hardship were concentrated in the 45-54 age stratum. Financial hardship was associated with current depressive episodes in all age-strata: 1st: OR, 2.77(CI, 1.83-4.19); 2nd: OR, 1.71(CI, 1.26-2.34); 3rd: OR, 1.68(CI,1.15-2.46); 4th, OR, 4.07(CI, 1.24-13.34), and new depressive episodes: 1st: RR, 1.45(CI, 1.09-1.93); 2nd RR, 1.46(CI: 1.15-1.84); 3rd: RR, 1.97(CI, 1.38-2.82). Rupture of a relationship was associated only with current depressive episode, while death of a relative only with new depressive episode. LIMITATION: We cannot rule out the possibility of recall bias, since NLEs` information was self-reported. CONCLUSION: The association between NLEs with depressive episodes was concentrated in youngers.
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Acontecimentos que Mudam a Vida , Humanos , Brasil/epidemiologia , Pessoa de Meia-Idade , Feminino , Adulto , Masculino , Estudos Transversais , Idoso , Estudos Longitudinais , Estudos Prospectivos , Fatores Etários , Hospitalização/estatística & dados numéricos , Depressão/epidemiologia , Depressão/psicologia , Transtorno Depressivo/epidemiologia , Transtorno Depressivo/psicologia , Estresse Financeiro/psicologia , Estresse Financeiro/epidemiologia , Fatores de RiscoRESUMO
Infective Endocarditis (IE) is a complex, life-threatening disease. The aim of the present study was to evaluate the impact of the Endocarditis-Team on management of IE. This observational study conducted at a university hospital (2015â22), included adult patients with IE. The study period was divided in two periods: before (pre-Endocarditis-Team; pre-ET) and after the establishment of the Endocarditis-Team (post-Endocarditis-Team; post-ET) on January 2018. Among 505 IE episodes (187 in pre-Endocarditis-Team, 318 in post-ET period), 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography was more commonly used in post-ET period (14 % vs. 28 %; p < 0.001). Overall, thirty-day and one-year mortality were 14 % and 27 %, respectively; no difference was observed between the two periods. In post-ET period, the administration of 4-weeks, rather than 6-weeks, of intravenous antimicrobial treatment was higher than in the post-ET period (15 % vs. 45 %; p < 0.001). Indication for surgery was present in 115 (61 %) patients in pre-ET and in 153 (48 %) in the post-ET period. In post-ET period, among patients with indication, valve surgery was more frequently performed (66 % vs. 78 %; p = 0.038). Such difference was due to a higher acceptance of operative indication by the cardiac surgeon (69 % vs. 94 %; p = 0.013). The observed increase in number of patients benefiting from cardiac surgery in the post-ET period led to a decrease of subsequent embolic events, since among patients with operative indication (n = 268), new embolic events after the establishment of the indication were more common in the pre-ET period compared to post-ET (23 % vs. 12 %; p = 0.033). After the implementation of the multidisciplinary Endocarditis-Team we observed several improvements in the general management of IE patients.
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Endocardite , Equipe de Assistência ao Paciente , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Endocardite/mortalidade , Idoso , Adulto , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Antibacterianos/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: BNT162b2 and mRNA-1273 COVID-19 vaccines have been used for mass vaccinations in Curaçao, the Caribbean but information on adverse events (AEs)in this population is unavailable. This study describes the characteristics of vaccinees that incurred AEs, explores the associations between AEs by vaccine and doses, and estimates the rate of AEs. METHODS: Vaccination and AEs data for all persons of age 5 years (range 5-105 years) and older who received two doses of COVID-19 vaccine at 71 centres in Curaçao between February 24, 2021, and April 5, 2023, were included in this retrospective observational study. RESULTS: The vaccines differed significantly in the frequency distribution of vaccinees by age, age groups, sex, AEs, and prior COVID-19 infection. Occurrence of AEs was strongly associated with mRNA vaccine brand, sex, number of doses, but not with age, age group, and prior COVID-19 infection. Of 209,720 doses, 84 persons (0.04%) incurred AEs following two doses of mRNA vaccines (overall rate of 40.1 per 100,000 persons (95% CI 32.4-49.6). AEs were also significantly higher in females compared to males.AE rates associated with BNT162b2, and mRNA-1273 vaccines were low, but BNT162b2 vaccinees incurred substantially significantly higher AE rates (58.3 per 100,000 persons, 95% CI 45.4-74.9) than mRNA-1273 vaccinees (21.9 per 100,000 persons, 95% CI 14.6-32.8). mRNA-1273 vaccine was associated with a significantly lower risk of AEs. CONCLUSIONS: AE reporting varied by age, sex, and vaccine used as well as the number of doses. Future studies with follow-up and longer-term reporting of AEs should be conducted.
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OBJECTIVE: Severe weather events exacerbate existing health disparities due to poorly managed non-communicable diseases (NCDs). Our objective is to understand the experiences of staff, providers, and administrators (employees) of Federally Qualified Health Centers (FQHCs) in Puerto Rico and the US Virgin Islands (USVI) in providing care to patients living with NCDs in the setting of recent climate-related extreme events. METHODS: We used a convergent mixed-methods study design. A quantitative survey was distributed to employees at 2 FQHCs in Puerto Rico and the USVI, assessing experience with disasters, knowledge of disaster preparedness, the relevance of NCDs, and perceived gaps. Qualitative in-depth interviews explored their experience providing care for NCDs during recent disasters. Quantitative and qualitative data were merged using a narrative approach. RESULTS: Through the integration of quantitative and qualitative data, we recognize: (1) significant gaps in confidence and preparedness of employees with a need for more training; (2) challenges faced by persons with multiple NCDs, especially cardiovascular and mental health disorders; and (3) most clinicians do not discuss disaster preparedness with patients but recognize their important role in community resilience. CONCLUSION: With these results, we recommend strengthening the capacity of FQHCs to address the needs of their patients with NCDs in disasters.
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Pesquisa Qualitativa , Humanos , Porto Rico , Inquéritos e Questionários , Masculino , Feminino , Estados Unidos , Adulto , Defesa Civil/métodos , Defesa Civil/estatística & dados numéricos , Defesa Civil/normas , Ilhas Virgens Americanas , Pessoa de Meia-Idade , Planejamento em Desastres/métodos , Planejamento em Desastres/estatística & dados numéricosRESUMO
The aim of this study was to investigate the vertical transfer of microbiota from dams to the offspring. We studied a pair of 20 dams and its offspring. Maternal sources (colostrum, feces and vaginal secretion) and newborn fecal samples were analyzed using 16S rDNA amplicon sequencing on days 1, 3, 7, 14 and 28. Overall, newborns were maintained healthy and did not receive antimicrobial therapy. The Source Tracker analysis indicated that the newborn fecal microbiota was similar to colostrum and vaginal secretion from day 1 up to 7. However, an unknown source (probably from the environment) showed a gradual increase in its similarity with fecal samples from calves measured from day 3 to 28. The most abundant bacteria groups on meconium (day 1) and calf fecal samples on day 3 were Escherichia-Shigella and Clostridium, respectively. On day 7, the predominant genus were Bifidobacterium and Lactobacillus, while Fusobacterium was the most abundant genus on day 14, coinciding with the diarrhea peak. Faecalibacterium showed a gradual increase throughout the neonatal period. Maternal sources contribute to the neonatal microbiota, however other unknown sources (probably environment) had a strong influence on development of the gut microbiota later in the neonate period.
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Animais Recém-Nascidos , Colostro , Fezes , Microbioma Gastrointestinal , Animais , Microbioma Gastrointestinal/genética , Bovinos , Feminino , Fezes/microbiologia , Colostro/microbiologia , RNA Ribossômico 16S/genética , Bactérias/classificação , Bactérias/genética , Bactérias/isolamento & purificação , Gravidez , Vagina/microbiologia , Mecônio/microbiologiaRESUMO
OBJECTIVES: To assess whether genotype-guided selection of oral antiplatelet drugs using a clinical decision support (CDS) algorithm reduces the rate of major adverse cardiovascular and cerebrovascular events (MACCEs) among Caribbean Hispanic patients, after 6 months. DESIGN: An open-label, multicentre, non-randomised clinical trial. SETTING: Eight secondary and tertiary care hospitals (public and private) in Puerto Rico. PARTICIPANTS: 300 Caribbean Hispanic patients on clopidogrel, both genders, underwent percutaneous coronary intervention (PCI) for acute coronary syndromes, stable ischaemic heart disease and documented extracardiac vascular diseases. INTERVENTIONS: Patients were separated into standard-of-care (SoC) and genotype-guided (pharmacogenetic (PGx)-CDS) groups (150 each) and stratified by risk scores. Risk scores were calculated based on a previously developed CDS risk prediction algorithm designed to make actionable treatment recommendations for each patient. Individual platelet function, genotypes, clinical and demographic data were included. Ticagrelor was recommended for patients with a high-risk score ≥2 in the PGx-CDS group only, the rest were kept or de-escalated to clopidogrel. The intervention took place within 3-5 days after PCI. Adherence medication score was also measured. PRIMARY AND SECONDARY OUTCOMES: The occurrence rate of MACCEs (primary) and bleeding episodes (secondary). Statistical associations between patient time free of events and predictor variables (ie, treatment groups, risk scores) were tested using Kaplan-Meier survival analyses and Cox proportional-hazards regression models. RESULTS: The genotype-guided group had a clinically lower but not significantly different risk of MACCEs compared with the SoC group (8.7% vs 10.7%, p=0.56; HR=0.56). Among high-risk score patients, genotype-driven guidance of antiplatelet therapy showed superiority over SoC in reducing MACCE incidence 6 months postcoronary stenting (adjusted HR=0.104; p< 0.0001). CONCLUSIONS: The potential benefit of implementing our PGx-CDS algorithm to significantly reduce the incidence rate of MACCEs in post-PCI Caribbean Hispanic patients on clopidogrel was observed exclusively among high-risk patients, with apparently no evident effect in other patient groups. TRIAL REGISTRATION NUMBER: NCT03419325.
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Algoritmos , Clopidogrel , Hispânico ou Latino , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária , Ticagrelor , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Masculino , Feminino , Pessoa de Meia-Idade , Clopidogrel/uso terapêutico , Porto Rico , Idoso , Ticagrelor/uso terapêutico , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/genética , Síndrome Coronariana Aguda/terapia , Sistemas de Apoio a Decisões Clínicas , Genótipo , Farmacogenética , Citocromo P-450 CYP2C19/genética , Medição de Risco , Região do Caribe/etnologia , Hemorragia/induzido quimicamenteRESUMO
BACKGROUND: Suicide is the third leading cause of death among youth aged 15 to 29 years old globally. Guyana has the highest rate of youth suicide in the world, yet only limited research exists. AIM: The aim of this study is to identify key features of the suicide pathway for Guyanese children and youth and to distinguish meaningful subgroups. METHOD: The psychological autopsy (PA) method was used to generate life charts for 15 Guyanese children and youth (10-29 years) who died by suicide. Nineteen close contacts of these individuals were interviewed about the life events of the decedent between 6 months and 5 years after their death. Semi-structured interviews lasting 30 to 150 min took place between November 2021 and January 2022. The interview data were converted into life charts and these were reviewed to uncover meaningful subgroups of suicide pathways. RESULTS: Three groups with distinct suicide pathways were identified: hard life (46%), mental illness (20%) and interpersonal stress (20%). There were also two male youths for whom the suicidal antecedents and pathways were unclear. Interpersonal stress, alcohol, exposure to suicide and family history of suicide were common factors identified across groups. CONCLUSIONS: The findings emphasise the role of both acute and protracted interpersonal stress for child and youth suicide in Guyana. The structure and dynamics of Indo-Guyanese families are discussed. Interventions recommended include enhancing child and youth community engagement, improving mental health and suicide literacy, alcohol restriction, increasing access to support services, and reducing stigma.
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Background: Selective cyclooxygenase-2 inhibitor anti-inflammatory drugs (coxibs) are associated with the development of adverse events, mainly gastrointestinal and cardiovascular, but renal effects are less known. Objective: To assess the renal risks of coxibs compared to placebo by means of a systematic review and meta-analysis. Methods: Randomized controlled trials that assessed renal effects of coxibs (celecoxib, etoricoxib, lumiracoxib, parecoxib, and valdecoxib) were searched in PubMed, Embase, Scopus and other sources up to March 2024. Two independent reviewers performed study screening, data extraction, and risk of bias assessment. Random effect meta-analysis was employed to calculate the relative risks (RR) and 95% confidence intervals (CI) of renal effects of coxibs compared to placebo and inconsistency among studies (I 2 ). Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Results: Out of 5284 retrieved records, 49 studies (comprising 46 reports) were included. Coxibs increased the risk of edema (RR 1.46; 95% CI 1.15, 1.86; I 2 = 0%; 34 studies, 19,754 participants; moderate-certainty evidence), and celecoxib increased hypertensive or renal events (RR 1.24; 95% CI 1.08, 1.43; I 2 = 0%; 2 studies, 3589 participants; moderate-certainty evidence). Etoricoxib increased the risk of hypertension (RR 1.98; 95% CI 1.14, 3.46; I 2 = 34%; 13 studies, 6560 participants; moderate-certainty evidence); no difference was observed when pooling all coxibs (RR 1.26; 95% CI 0.91, 1.76; I 2 = 26%; 30 studies, 16,173 participants; moderate-certainty evidence). Conclusions: Coxibs likely increase the renal adverse effects, including hypertension and edema. Awareness about the renal risks of coxibs should be increased, mainly in high-risk patient.
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Bruton tyrosine kinase (BTK) inhibitors play an important role in targeted treatment of B-cell lymphoproliferative disorders. However, adverse events may limit the proper course of treatment in many patients. The purpose of this study is to compare the risk of cardiovascular and non-cardiovascular adverse events in patients with chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL) treated with the first-generation BTK inhibitor ibrutinib versus second-generation acalabrutinib, using real-world data from a collaborative multinational network. We used data from the network (TriNetX), which encompasses more than 100 healthcare organizations worldwide. We queried the database for patients aged ≥ 18 years with chronic lymphocytic leukemia or small-cell lymphomas treated with ibrutinib or acalabrutinib in the past ten years before the analysis. We used propensity score matching to balance the cohorts. The 3-year cumulative incidences and hazard ratios for the following outcomes were calculated: atrial flutter or fibrillation, other arrhythmias, heart failure, ischemic stroke or peripheral embolism, acute coronary syndrome, bleeding, and sepsis. We compared 2,107 patients in each group. Atrial fibrillation or flutter occurred in 150 (7.1%) patients with acalabrutinib and 310 (14.7%) patients with ibrutinib during the 3-year follow-up (hazard ratio, 0.68, 95% CI 0.55-0.84). New-onset hypertension occurred in 342 (16.3%) patients in the acalabrutinib group and 584 (27.7%) patients in the ibrutinib group (hazard ratio 0.81, 95% CI 0.66-0.98). Sepsis was diagnosed in 136 (6.5%) patients in the acalabrutinib group versus 239 (11.3%) patients in the ibrutinib group (hazard ratio 0.77, 95 CI 0.60-0.98). The two groups had no significant differences concerning the other adverse events. In a large retrospective cohort using real-world data from electronic medical registers, patients with CLL or SLL treated with acalabrutinib had a better cardiovascular and non-cardiovascular safety profile than those treated with ibrutinib, with lower risks of atrial flutter or fibrillation, new-onset arterial hypertension, and sepsis.
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High-risk human papillomavirus (HR-HPV) is associated with the development of different types of cancer, such as cervical, head and neck (including oral, laryngeal, and oropharyngeal), vulvar, vaginal, penile, and anal cancers. The progression of premalignant lesions to cancer depends on factors associated with the host cell and the different epithelia infected by HPV, such as basal cells of the flat epithelium and the cells of the squamocolumnar transformation zone (STZ) found in the uterine cervix and the anal canal, which is rich in heparan sulfate proteoglycans and integrin-like receptors. On the other hand, factors associated with the viral genotype, infection with multiple viruses, viral load, viral persistence, and type of integration determine the viral breakage pattern and the sites at which the virus integrates into the host cell genome (introns, exons, intergenic regions), inducing the loss of function of tumor suppressor genes and increasing oncogene expression. This review describes the role of viral integration and the molecular mechanisms induced by HR-HPV in different types of tissues. The purpose of this review is to identify the common factors associated with the role of integration events in the progression of premalignant lesions in different types of cancer.
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BACKGROUND: The use of technologies has had a significant impact on patient safety and the quality of care and has increased globally. In the literature, it has been reported that people die annually due to adverse events (AEs), and various methods exist for investigating and measuring AEs. However, some methods have a limited scope, data extraction, and the need for data standardization. In Brazil, there are few studies on the application of trigger tools, and this study is the first to create automated triggers in ambulatory care. OBJECTIVE: This study aims to develop a machine learning (ML)-based automated trigger for outpatient health care settings in Brazil. METHODS: A mixed methods research will be conducted within a design thinking framework and the principles will be applied in creating the automated triggers, following the stages of (1) empathize and define the problem, involving observations and inquiries to comprehend both the user and the challenge at hand; (2) ideation, where various solutions to the problem are generated; (3) prototyping, involving the construction of a minimal representation of the best solutions; (4) testing, where user feedback is obtained to refine the solution; and (5) implementation, where the refined solution is tested, changes are assessed, and scaling is considered. Furthermore, ML methods will be adopted to develop automated triggers, tailored to the local context in collaboration with an expert in the field. RESULTS: This protocol describes a research study in its preliminary stages, prior to any data gathering and analysis. The study was approved by the members of the organizations within the institution in January 2024 and by the ethics board of the University of São Paulo and the institution where the study will take place. in May 2024. As of June 2024, stage 1 commenced with data gathering for qualitative research. A separate paper focused on explaining the method of ML will be considered after the outcomes of stages 1 and 2 in this study. CONCLUSIONS: After the development of automated triggers in the outpatient setting, it will be possible to prevent and identify potential risks of AEs more promptly, providing valuable information. This technological innovation not only promotes advances in clinical practice but also contributes to the dissemination of techniques and knowledge related to patient safety. Additionally, health care professionals can adopt evidence-based preventive measures, reducing costs associated with AEs and hospital readmissions, enhancing productivity in outpatient care, and contributing to the safety, quality, and effectiveness of care provided. Additionally, in the future, if the outcome is successful, there is the potential to apply it in all units, as planned by the institutional organization. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55466.
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Assistência Ambulatorial , Aprendizado de Máquina , Humanos , Brasil , Segurança do PacienteRESUMO
Adverse events (AEs), and particularly adverse drug events (ADEs), represent a health problem as they can cause permanent damage or death. Understanding the frequency, location, and causes of ADEs can prevent harm to patients. The Global Trigger Tool, produced by the Institute for Healthcare Improvement (GTT/IHI), is widely used to identify AEs. Recognizing the profile of patients who suffer ADEs can reveal clinical or individual characteristics that predispose to the occurrence of AEs. A cross-sectional study was carried out through a retrospective analysis of 120 medical charts of patients discharged from hospital between October 2020 and April 2021. Patients over 18 years old, with a length of stay of more than 24 h, were included. The list of triggers used was from the medication module of the GTT/IHI, which was adapted for use in the institution. Two primary reviewers and a medical reviewer applied this tool. The primary reviewers independently assessed the randomized charts. A meeting to achieve consensus among the reviewers was held every 2 weeks to validate the identified ADEs; classifications were based on harm severity. Multivariate logistic regression was utilized to assess the variables that predicted the occurrence of ADEs, using the backward stepwise method. A total of 43 ADEs were identified, with a frequency of 36 per 100 admissions (43/120). Of these, five ADEs (12%) were responsible for patients being admitted to hospital. In the case of in-hospital ADEs, there were 42.2 per 1000 patients/day. The clinical manifestation of altered kidney function (16%) and the anatomical drug group of the nervous system (33%) were the most frequent ADEs. The multivariate logistic regression model was significant (×2 = 44.960, P < .001), indicating that factors such as: known drug allergy [odds ratio 5.728; 95% confidence interval (CI): 1.249, 26.274, P = .025]; being clinically hospitalized (odds ratio 7.504; 95% CI: 1.654, 34.037; P = .009); number of medicines used (odds ratio 1.100; 95% CI: 1.054, 1.148; P < .001); and being under the care of internal medicine (odds ratio 3.633; 95% CI: 1.257, 10.511; P = .017) were predictor variables associated with the occurrence of ADEs. A significant percentage of hospitalized patients experienced at least one ADE, with rates surpassing those found in similar studies. The GTT/IHI effectively assessed medication-related harm, emphasizing the need for tailored triggers based on population characteristics. Predictor variables can inform preventive strategies. Overall, the tool facilitated a localized risk assessment of medication use.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hospitais Gerais , Humanos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Estudos Transversais , Masculino , Feminino , Estudos Retrospectivos , Fatores de Risco , Pessoa de Meia-Idade , Idoso , AdultoRESUMO
BACKGROUND AND OBJECTIVE: Immune checkpoint inhibitors (ICIs) have shown remarkable efficacy against various cancers in clinical practice. However, ICIs can cause immune checkpoint inhibitor-associated pancreatic injury, often leading to drug withdrawal, and then patients must go to specialized treatment. The patients, their primary tumors are sensitive to ICIs therapy, may experience treatment delays due to such adverse reactions. Therefore, there is a need for systematic clinical researches on immune-related pancreatic toxicity to provide a clinical basis for its prevention and treatment. METHODS: This study involved the collection of data from patients treated with ICIs and addressed pancreatic injury with preemptive treatment before continuing ICIs therapy. Then, we also statistically analyzed the incidence of pancreatic injury in patients with different courses and combined treatment, and the success rate of rechallenge treatment. RESULTS: The study included 62 patients, with 33.9% (21/62) experiencing varying degrees of pancreatic injury. Patients with pancreatic injury, 10 cases evolved into pancreatitis, representing 47.6% (10/21) in the pancreatic injury subgroup and 16.1% (10/62) of the total patient cohort. Preemptive treatment was administered to 47.6% (10/21) of patients with pancreatitis, the effective rate was 100%. Among these patients, 70% (7/10) underwent successful rechallenge with ICIs. The occurrence of pancreatic injury was positively correlated with the treatment duration (P < 0.05) but showed no significant correlation with combination therapies (P > 0.05). CONCLUSION: The likelihood of pancreatic injury increased with longer treatment durations with ICIs; no significant association was found between the incidence of ICIs-related pancreatic damage and combination therapies. Preemptive treatment for immune-related pancreatitis is feasible, allowing some patients to successfully undergo rechallenge with ICIs therapy.
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The safety of exercise practice by individuals with cardiovascular disease is due to a good clinical evaluation to identify patients with a higher risk of adverse events, thus the study of simple variables capable of predicting the rate of events during exercise is relevant and may provide better screening tools to be applied in the clinical practice. The study aimed to evaluate if clinical and physical parameters can predict the rate of adverse events during exercise-based cardiac rehabilitation. This was a cohort study that followed 73 patients during 24 sessions of exercise. Were registered 217 simple adverse events, at a rate of 2.5 events per hour of exercise. We found that higher adiposity, worse pulmonary function, lower functional capacity, and reduced heart rate variability were significant and acceptable predictors of adverse events during exercise, according to the ROC curve analysis. We state that these simple physical parameters may be useful for cardiac risk stratification in cardiac rehabilitation programs with low resources, contributing to its safety.
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Reabilitação Cardíaca , Humanos , Reabilitação Cardíaca/métodos , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Frequência Cardíaca , Exercício Físico/fisiologia , Estudos de Coortes , Terapia por Exercício/métodos , Doenças Cardiovasculares/fisiopatologia , Curva ROCRESUMO
BACKGROUND: Patients with peripheral arterial disease have an increased risk of developing cardiovascular complications in the postoperative period of arterial surgeries known as Major Adverse Cardiac Events (MACE), which includes acute myocardial infarction, heart failure, malignant arrhythmias, and stroke. The preoperative evaluation aims to reduce mortality and the risk of MACE. However, there is no standardized approach to performing them. The aim of this study was to compare the preoperative evaluation conducted by general practitioners with those performed by cardiologists. METHODS: This is a retrospective analysis of medical records of patients who underwent elective arterial surgeries from January 2016 to December 2020 at a tertiary hospital in São Paulo, Brazil. The authors compared the preoperative evaluation of these patients according to the initial evaluator (general practitioners vs. cardiologists), assessing patients' clinical factors, mortality, postoperative MACE incidence, rate of requested non-invasive stratification tests, length of hospital stay, among others. RESULTS: 281 patients were evaluated: 169 assessed by cardiologists and 112 by general practitioners. Cardiologists requested more non-invasive stratification tests (40.8%) compared to general practitioners (9%) (p < 0.001), with no impact on mortality (8.8% versus 10.7%; p = 0.609) and postoperative MACE incidence (10.6% versus 6.2%; p = 0.209). The total length of hospital stay was longer in the cardiologist group (17.27 versus 11.79 days; p < 0.001). CONCLUSION: The increased request for exams didn't have a significant impact on mortality and postoperative MACE incidence, but prolonged the total length of hospital stay. Health managers should consider these findings and ensure appropriate utilization of human and financial resources.