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1.
Cancers (Basel) ; 13(19)2021 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-34638431

RESUMO

Early diagnosis of pediatric cancer is key for adequate patient management and improved outcome. Although multiparameter flow cytometry (MFC) has proven of great utility in the diagnosis and classification of hematologic malignancies, its application to non-hematopoietic pediatric tumors remains limited. Here we designed and prospectively validated a new single eight-color antibody combination-solid tumor orientation tube, STOT-for diagnostic screening of pediatric cancer by MFC. A total of 476 samples (139 tumor mass, 138 bone marrow, 86 lymph node, 58 peripheral blood, and 55 other body fluid samples) from 296 patients with diagnostic suspicion of pediatric cancer were analyzed by MFC vs. conventional diagnostic procedures. STOT was designed after several design-test-evaluate-redesign cycles based on a large panel of monoclonal antibody combinations tested on 301 samples. In its final version, STOT consists of a single 8-color/12-marker antibody combination (CD99-CD8/numyogenin/CD4-EpCAM/CD56/GD2/smCD3-CD19/cyCD3-CD271/CD45). Prospective validation of STOT in 149 samples showed concordant results with the patient WHO/ICCC-3 diagnosis in 138/149 cases (92.6%). These included: 63/63 (100%) reactive/disease-free samples, 43/44 (98%) malignant and 4/4 (100%) benign non-hematopoietic tumors together with 28/38 (74%) leukemia/lymphoma cases; the only exception was Hodgkin lymphoma that required additional markers to be stained. In addition, STOT allowed accurate discrimination among the four most common subtypes of malignant CD45- CD56++ non-hematopoietic solid tumors: 13/13 (GD2++ numyogenin- CD271-/+ nuMyoD1- CD99- EpCAM-) neuroblastoma samples, 5/5 (GD2- numyogenin++ CD271++ nuMyoD1++ CD99-/+ EpCAM-) rhabdomyosarcomas, 2/2 (GD2-/+ numyogenin- CD271+ nuMyoD1- CD99+ EpCAM-) Ewing sarcoma family of tumors, and 7/7 (GD2- numyogenin- CD271+ nuMyoD1- CD99- EpCAM+) Wilms tumors. In summary, here we designed and validated a new standardized antibody combination and MFC assay for diagnostic screening of pediatric solid tumors that might contribute to fast and accurate diagnostic orientation and classification of pediatric cancer in routine clinical practice.

2.
Cancer Rep (Hoboken) ; : e1533, 2021 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-34431241

RESUMO

BACKGROUND: The survival of children with acute lymphoblastic leukemia (ALL) has improved due to changes in the treatment and the disease diagnosis. A significant advance was the incorporation of asparaginase. However, hypersensitivity reactions are a common cause of early discontinuation of this drug. AIM: The proposed study aims to evaluate early interruptions and the influence of the number of asparaginase doses effectively administered on the prognosis of patients with ALL. METHODS AND RESULTS: An observational cohort study was carried out, with retrospective data collection, in medical records. The prognostic variables indicated in the protocol applied were used, and the principal outcomes were 5 years event-free survival (EFS) and 5 years of overall survival (OS) probability. Statistical analyzes were performed using SPPS 20.0 and R. In Cox's proportional hazards model for EFS and OS, variables of prognostic importance (n = 126 children) were: high-risk group (HGR), by the protocol classification, and less than 10 doses of asparaginase. The increased risk of events and death in HGR, who did less than 10 doses, was 3.6 and 7 times, respectively. The study did not show statistical significance for the number of asparaginase doses in patients who were not at high risk. CONCLUSIONS: We demonstrated that the early interruption of asparaginase treatment could negatively impact the prognosis of patients with ALL, especially HGR, reinforcing the need for careful diagnosis of reactions and the availability of alternative types of asparaginase.

3.
BMC Med Res Methodol ; 21(1): 141, 2021 07 08.
Artigo em Inglês | MEDLINE | ID: mdl-34238235

RESUMO

BACKGROUND: Children are more vulnerable to adverse drug reactions (ADRs) due to complex changes in the body during the growth process and lack specific pharmacoepidemiologic studies. Causality and Avoidability assessment of ADRs are relevant to clinical guidelines development and pharmacovigilance. This study aimed to translate and transcultural adapt two new tools-Liverpool Causality Assessment Tool (LCAT) and the Liverpool Avoidability Assessment Tool (LAAT)-to Brazilian-Portuguese and evaluate the psychometric properties of these tools to analyse ADRs in Brazilian children. METHODS: The validation of the cross-cultural adaptation of tools was obtained by the functional (conceptual, semantic, operational, and measurement) equivalence between the original and translated versions of each instrument. The translated version of LCAT and LAAT was applied to assessing the twenty-six case reports of suspected adverse drug reactions in a Brazilian teaching paediatric hospital. The inter-rater reliability (a pharmacist and a physician) was evaluated using Cronbach's alpha. The exact agreement percentages (%EA) and extreme disagreement (%ED) were computed. Overall Kappa index was calculated with a 95% confidence interval. RESULTS: There was a need to modify some terms translated into Portuguese for semantic and conceptual equivalence. The Cronbach's alpha coefficient values obtained were 0.95 and 0.85, and the weighted Kappa (95% confidence interval) were 0.82 (0.67-0.97) and 0.68 (0.45-0.91) for LCAT and LAAT, respectively. The Brazilian-Portuguese versions of the LCAT and LAAT showed reliable and valid tools for the diagnosis and follow-up of ADRs in children. CONCLUSION: The methodological approach allowed the translation, transcultural adaptation, and validation to Brazilian-Portuguese of two easy and quick to perform tools for causality and avoidability of ADRs in children by a multidisciplinary expert specialist committee, including the authors of original tools. We believe these versions may be applied by professionals (patient safety teams) and researchers in Brazil in groups or by a single reviewer. TRIAL REGISTRATION: This study was evaluated and approved by the Research Ethics Committee (Instituto de Pediatria e Puericultura Martagão Gesteira - Federal University of Rio de Janeiro - Number: 3.264.238.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Traduções , Brasil , Criança , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários
4.
PLoS One ; 15(11): e0242311, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33186402

RESUMO

INTRODUCTION: Hospital-acquired venous thromboembolism (HA-VTE) in children comprises multiple risk factors that should not be evaluated separately due to collinearity and multiple cause and effect relationships. This is one of the first case-control study of pediatric HA-VTE risk factors using a Directed Acyclic Graph (DAG) analysis. MATERIAL AND METHODS: Retrospective, case-control study with 22 cases of objectively confirmed HA-VTE and 76 controls matched by age, sex, unit of admission, and period of hospitalization. Descriptive statistics were used to define distributions of continuous variables, frequencies, and proportions of categorical variables, comparing cases and controls. Due to many potential risk factors of HA-VTE, a directed acyclic graph (DAG) model was created to identify confounding, reduce bias, and increase precision on the analysis. The final model consisted of a DAG-informed conditional logistic regression. RESULTS: In the initial conventional univariable model, the following variables were selected as potential risk factors for HA-VTE: length of stay (LOS, days), immobility, ICU admission in the last 30 days, LOS in ICU, infection, central venous catheter (CVC), number of CVCs placed, L-asparaginase, heart failure, liver failure, and nephrotic syndrome. The final model using the set of variables selected by DAG analysis revealed LOS (OR = 1.106, 95%CI = 1.021-1.198, p = 0.013), L-asparaginase (OR = 26.463, 95%CI = 1.609-435.342, p = 0.022), and nephrotic syndrome (OR = 29.127, 95%CI = 1.044-812.508, p = 0.004) as independent risk factors for HA-VTE. CONCLUSION: The DAG-based approach was useful to clarify the influence of confounders and multiple causalities of HA-VTE. Interestingly, CVC placement-a known thrombotic risk factor highlighted in several studies-was considered a confounder, while LOS, L-asparaginase use and nephrotic syndrome were confirmed as risk factors to HA-VTE. Large confidence intervals are related to the sample size; however, the results were significant.


Assuntos
Bioestatística , Gráficos por Computador , Hospitalização , Tromboembolia Venosa/epidemiologia , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Fatores de Risco , Tromboembolia Venosa/etiologia
5.
Rev Soc Bras Med Trop ; 53: e20200205, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32997050

RESUMO

INTRODUCTION: The diagnostic accuracy of Xpert MTB/RIF (Xpert) in pulmonary tuberculosis (PTB) in children is lower than in adults. In Brazil, the diagnosis of PTB is based on a diagnostic score system (DSS). This study aims to study the role of Xpert in children and adolescents with PTB symptoms. METHODS: cross-sectional study was conducted in 3 referral centers to TB. Children and adolescents (0-19 years old) whose respiratory samples were submitted to Xpert were included. Statistical analysis (bivariate and logistic regression) to assess the simultaneous influence of TB-related variables on the occurrence of Xpert detectable in TB cases was done. To evaluate the agreement or disagreement between Xpert results with acid-fast bacillus (AFB) and cultures, κ method was used (significancy level of 5%). RESULTS: Eighty-eight patients were included in the study and PTB occurred in 43 patients (49%) and Xpert was detectable in 21 patients (24%). Adolescents and positive culture results were independent predictive variables of Xpert positivity. DSS sensitivity compared with the final diagnosis of TB was 100% (95% CI, 88.1-100%), specificity was 97.2% (95% CI, 85.5-99.9%). The accuracy of the method was 98.5% (95% CI, 91.7-99.9%). CONCLUSIONS: Xpert contributed to diagnosis in 9% of patients with AFB and in culture negative cases. DSS indicated relevance for this diagnostic approach of intrathoracic TB (ITB) in reference centers for presenting data both with high sensitivity and specificity.


Assuntos
Mycobacterium tuberculosis/isolamento & purificação , Escarro/microbiologia , Tuberculose Pulmonar/diagnóstico , Adolescente , Adulto , Brasil/epidemiologia , Criança , Pré-Escolar , Estudos Transversais , Humanos , Lactente , Recém-Nascido , Mycobacterium tuberculosis/genética , Encaminhamento e Consulta , Tuberculose Pulmonar/epidemiologia , Adulto Jovem
6.
Rev. Soc. Bras. Med. Trop ; 53: e20200205, 2020. tab, graf
Artigo em Inglês | LILACS, Coleciona SUS, Sec. Est. Saúde SP | ID: biblio-1136899

RESUMO

Abstract INTRODUCTION: The diagnostic accuracy of Xpert MTB/RIF (Xpert) in pulmonary tuberculosis (PTB) in children is lower than in adults. In Brazil, the diagnosis of PTB is based on a diagnostic score system (DSS). This study aims to study the role of Xpert in children and adolescents with PTB symptoms. METHODS: A cross-sectional study was conducted in 3 referral centers to TB. Children and adolescents (0-19 years old) whose respiratory samples were submitted to Xpert were included. Statistical analysis (bivariate and logistic regression) to assess the simultaneous influence of TB-related variables on the occurrence of Xpert detectable in TB cases was done. To evaluate the agreement or disagreement between Xpert results with acid-fast bacillus (AFB) and cultures, κ method was used (significancy level of 5%). RESULTS: Eighty-eight patients were included in the study and PTB occurred in 43 patients (49%) and Xpert was detectable in 21 patients (24%). Adolescents and positive culture results were independent predictive variables of Xpert positivity. DSS sensitivity compared with the final diagnosis of TB was 100% (95% CI, 88.1-100%), specificity was 97.2% (95% CI, 85.5-99.9%). The accuracy of the method was 98.5% (95% CI, 91.7-99.9%). CONCLUSIONS: Xpert contributed to diagnosis in 9% of patients with AFB and in culture negative cases. DSS indicated relevance for this diagnostic approach of intrathoracic TB (ITB) in reference centers for presenting data both with high sensitivity and specificity.


Assuntos
Humanos , Recém-Nascido , Lactente , Pré-Escolar , Criança , Adolescente , Adulto , Adulto Jovem , Escarro/microbiologia , Tuberculose Pulmonar/diagnóstico , Mycobacterium tuberculosis/isolamento & purificação , Encaminhamento e Consulta , Tuberculose Pulmonar/epidemiologia , Brasil/epidemiologia , Estudos Transversais , Mycobacterium tuberculosis/genética
7.
Rev. bioét. (Impr.) ; 27(4): 621-629, out.-dez. 2019.
Artigo em Inglês | LILACS | ID: biblio-1057435

RESUMO

Abstract Alasdair MacIntyre is a contemporary philosopher of Ethics and Politics best known for his book "After virtue", 1981. The originality and relevance of this work lie in the presentation of his articles from the 1970's about medicine and medical ethics, which are unexplored in Bioethics. In these articles, MacIntyre criticizes changes in society transforming the physician-patient relationship: fragmentary moral views, individualism, misunderstanding of scientism and fallibility of the practice, as well as the lost background of common values and medical authority. From a teleological perspective, MacIntyre describes internal goods of medicine and physician's virtues: reliability, fairness, courage, humility and even, friendship.


Resumen Alasdair MacIntyre es un filósofo contemporáneo de Ética y Política, mejor conocido por su libro "Tras la virtud", de 1981. La originalidad y relevancia de este trabajo se encuentran en la presentación de sus artículos de la década de 1970 sobre medicina y ética médica, que no han sido explorados en Bioética. En estos artículos, MacIntyre critica los cambios en la sociedad que transforman la relación médico-paciente: visiones morales fragmentarias, individualismo, incomprensión del cientificismo y la falibilidad de la práctica, además de las pérdidas de la base en valores comunes y la autoridad médica. En una perspectiva teleológica, MacIntyre describe los bienes internos de la medicina y las virtudes de los médicos: fiabilidad, justicia, coraje, humildad e incluso amistad.


Resumo Alasdair MacIntyre é um filósofo contemporâneo de ética e política, mais conhecido por seu livro "Depois da virtude", 1981. A originalidade e a relevância deste trabalho estão na apresentação de artigos escritos por ele nos anos 1970 sobre medicina e ética médica, inexplorados no campo da bioética. Nestes artigos, MacIntyre critica as mudanças na sociedade que transformam a relação médico-paciente: visões morais fragmentárias, individualismo, a incompreensão da cientificidade e falibilidade da prática, além das perdas do embasamento em valores comuns e da autoridade médica. Em perspectiva teleológica, MacIntyre define bens internos à medicina e virtudes que os médicos devem possuir: confiabilidade, justiça, coragem, humildade e até amizade.


Assuntos
Relações Médico-Paciente , Papel do Médico , Prática Profissional , Bioética , Ética Médica
8.
Adv Rheumatol ; 59: 20, 2019. tab
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1088591

RESUMO

Abstract Background: To date there are no specific classification criteria for childhood-onset systemic lupus erythematosus (cSLE). This study aims to compare the performance among the American College of Rheumatology (ACR) 1997, the Systemic Lupus International Collaborating Clinics criteria (SLICC) and the new European League Against Rheumatism (EULAR)/ACR criteria, in a cSLE cohort. Methods: We conducted a medical chart review study of cSLE cases and controls with defined rheumatic diseases, both ANA positive, to establish each ACR1997, SLICC and EULAR/ACR criterion fulfilled, at first visit and 1-year-follow-up. Results: Study population included 122 cSLE cases and 89 controls. At first visit, SLICC criteria had higher sensitivity than ACR 1997 (89.3% versus 70.5%, p < 0.001), but similar specificity (80.9% versus 83.2%, p = 0.791), however performance was not statistically different at 1-year-follow-up. SLICC better scored in specificity compared to EULAR/ACR score ≥ 10 at first visit (80.9% versus 67.4%, p = 0.008) and at 1-year (76.4% versus 58.4%, p = 0.001), although sensitivities were similar. EULAR/ACR criteria score ≥ 10 exhibited higher sensitivity than ACR 1997 (87.7% versus 70.5%, p < 0.001) at first visit, but comparable at 1-year, whereas specificity was lower at first visit (67.4% versus 83.2%, p = 0.004) and 1-year (58.4% versus 76.4%, p = 0.002). A EULAR/ACR score ≥ 13 against a score ≥ 10, resulted in higher specificity, positive predictive value, and cut-off point accuracy. Compared to SLICC, a EULAR/ACR score ≥ 13 resulted in lower sensitivity at first visit (76.2% versus 89.3%, p < 0.001) and 1-year (91% versus 97.5%, p = 0.008), but similar specificities at both assessments. When compared to ACR 1997, a EULAR/ACR total score ≥ 13, resulted in no differences in sensitivity and specificity at both observation periods. Conclusions: In this cSLE population, SLICC criteria better scored at first visit and 1-year-follow-up. The adoption of a EULAR/ACR total score ≥ 13 in this study, against the initially proposed ≥10 score, was most appropriate to classify cSLE. Further studies are necessary to address if SLICC criteria might allow fulfillment of cSLE classification earlier in disease course and may be more inclusive of cSLE subjects for clinical studies.

9.
Rev. bras. hematol. hemoter ; 39(4): 337-342, Oct.-Dec. 2017. tab
Artigo em Inglês | LILACS | ID: biblio-898955

RESUMO

Abstract Introduction: Although it is an essential component of the treatment of acute lymphoid leukemia in children, asparaginase causes adverse reactions that sometimes make it impossible to use it fully. Hypersensitivity reactions are the most frequent and may lead to early discontinuation of treatment. The present study aimed to investigate suspicions of adverse reactions during the infusion of asparaginase in a pediatric cohort. Methods: A retrospective observational study was carried out at a university pediatric institute in the state of Rio de Janeiro. Information regarding clinical features and characteristics of adverse reactions was collected from hospital medical records. Suspicions of adverse reactions were classified regarding causality and severity. Results: Seventy-three suspicions of adverse reactions were recorded during asparaginase infusion in 72 children in the study period. Allergic hypersensitivity reactions were suspected in 60.5% of the cases. Of these, 25% of the reactions occurred during induction and 61.1% in concomitant use with vincristine, findings that diverge from other studies. High-risk classification and younger age were considered risk factors for these reactions. A total of 72.4% of the reactions were classified as grade 1 or 2, which suggest that not all are related to antibody formation; this highlights the importance of differential diagnosis with other reactions, such as non-allergic hypersensitivity and hyperammonemia. Conclusion: The implementation of the differential diagnosis of reactions related to infusion of asparaginase with ammonia dosage and classification of the grade of reactions is crucial to facilitate the identification and proper management of each type of reaction.


Assuntos
Humanos , Masculino , Feminino , Asparaginase , Infusões Intravenosas , Leucemia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Leucemia-Linfoma Linfoblástico de Células Precursoras
10.
Rev Bras Hematol Hemoter ; 39(4): 337-342, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29150106

RESUMO

INTRODUCTION: Although it is an essential component of the treatment of acute lymphoid leukemia in children, asparaginase causes adverse reactions that sometimes make it impossible to use it fully. Hypersensitivity reactions are the most frequent and may lead to early discontinuation of treatment. The present study aimed to investigate suspicions of adverse reactions during the infusion of asparaginase in a pediatric cohort. METHODS: A retrospective observational study was carried out at a university pediatric institute in the state of Rio de Janeiro. Information regarding clinical features and characteristics of adverse reactions was collected from hospital medical records. Suspicions of adverse reactions were classified regarding causality and severity. RESULTS: Seventy-three suspicions of adverse reactions were recorded during asparaginase infusion in 72 children in the study period. Allergic hypersensitivity reactions were suspected in 60.5% of the cases. Of these, 25% of the reactions occurred during induction and 61.1% in concomitant use with vincristine, findings that diverge from other studies. High-risk classification and younger age were considered risk factors for these reactions. A total of 72.4% of the reactions were classified as grade 1 or 2, which suggest that not all are related to antibody formation; this highlights the importance of differential diagnosis with other reactions, such as non-allergic hypersensitivity and hyperammonemia. CONCLUSION: The implementation of the differential diagnosis of reactions related to infusion of asparaginase with ammonia dosage and classification of the grade of reactions is crucial to facilitate the identification and proper management of each type of reaction.

11.
Rev Paul Pediatr ; 35(1): 110-114, 2017.
Artigo em Português, Inglês | MEDLINE | ID: mdl-28977304

RESUMO

OBJECTIVE: Therapeutic approach of children with multiple malformations poses many dilemmas, making it difficult to build a line between the treatment of uncertain benefit and therapeutic obstinacy. The aim of this paper was to highlight possible sources of uncertainty in the decision-making process, for this group of children. CASE DESCRIPTION: An 11-month-old boy, born with multiple birth defects and abandoned by his parents, has never been discharged home. He has complex congenital heart disease, main left bronchus stenosis and imperforate anus. He is under technological support and has gone through many surgical procedures. The complete correction of the cardiac defect seems unlikely, and every attempt to wean the ventilator has failed. COMMENTS: The first two main sources of uncertainty in the management of children with multiple birth defects are related to an uncertain prognosis. There is a lack of empirical data, due to the multiple possibilities of anatomic or functional organ involvement, with few similar cases described. Prognosis is also unpredictable for neuro-developmental evolution, as well as the capacity for the development and regeneration of other organs. Another source of uncertainty is how to qualify the present and future life as worth living, by weighing the costs and benefits. The fourth source of uncertainty is who has the decision: physicians or parents? Finally, if a treatment is defined futile then, how to limit support? No single framework exists to help these delicate decision-making processes. We propose, then, that physicians should be committed to develop their own perception skills in order to understand patient's manifestations of needs and family values.


Assuntos
Anormalidades Múltiplas/terapia , Cuidados para Prolongar a Vida , Futilidade Médica , Humanos , Lactente , Masculino
12.
Arq. bras. cardiol ; 109(1): 39-46, July 2017. tab, graf
Artigo em Inglês | LILACS | ID: biblio-887897

RESUMO

Abstract Background: There is growing concern about the economic impact of cardiovascular diseases (CVD) in Brazil and worldwide. Objective: To estimate the economic impact of CVD in Brazil in the last five years. Methods: The information to estimate CVD costs was taken from national databases, adding the direct costs with hospitalizations, outpatient visits and benefits granted by social security. Indirect costs were added to the calculation, such as loss of income caused by CVD morbidity or mortality. Results: CVD mortality accounts for 28% of all deaths in Brazil in the last five years and for 38% of deaths in the productive age range (18 to 65 years). The estimated costs of CVD were R$ 37.1 billion in 2015, a 17% increase in the period from 2010 to 2015. The estimated costs of premature death due to CVD represent 61% of the total cost of CVD, Direct costs with hospitalizations and consultations were 22%, and costs related to the loss of productivity related to the disease were 15% of the total. Health expenditures in Brazil are estimated at 9.5% of GDP and the average cost of CVD was estimated at 0.7% of GDP. Conclusion: CVD costs have increased significantly in the last five years. It is estimated that CVD costs increase as the Brazilian population ages and the prevalence of CVD increases.


Resumo Fundamento: Existe uma preocupação crescente com o impacto econômico das doenças cardiovasculares (DCV) no Brasil e no mundo. Objetivo: Estimar o impacto econômico das DCV no Brasil nos últimos cinco anos. Métodos: As informações para estimar os custos em DCV foram retiradas de bancos de dados nacionais, somando os custos diretos com hospitalizações, atendimentos ambulatoriais e benefícios concedidos pela previdência. Custos indiretos foram acrescidos ao cálculo, como a perda de renda causada pela morbidade ou pela mortalidade da DCV. Resultados: A mortalidade por DCV representa 28% do total de óbitos ocorridos no Brasil nos últimos cinco anos e atinge 38% dos óbitos na faixa etária produtiva (18 a 65 anos). Os custos estimados por DCV foram de R$ 37,1 bilhões de reais no ano de 2015, um aumento percentual de 17% no período de 2010 a 2015. Os custos estimados pela morte prematura por DCV representam 61% do total de custo por DCV, os custos diretos com internações e consultas foram de 22% e os custos pela perda da produtividade relacionados à doença foram de 15% do total. Os gastos com saúde no Brasil são estimados em 9,5% do PIB e o custo médio das DCV foi estimado em 0,7% do PIB. Conclusão: Os custos com DCV vêm aumentando significativamente nos últimos cinco anos. Estima-se que os custos por DCV aumentem à medida que a população brasileira envelhece e que a prevalência de DCV aumenta.


Assuntos
Humanos , Adulto , Pessoa de Meia-Idade , Idoso , Doenças Cardiovasculares/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Gastos em Saúde/estatística & dados numéricos , Fatores de Tempo , Brasil , Seguro por Invalidez
13.
Cad Saude Publica ; 33(5): e00169515, 2017 Jun 12.
Artigo em Português | MEDLINE | ID: mdl-28614452

RESUMO

This study aimed to characterize the clinical trials with medicines enrolling Brazilian children and adolescents, registered in the databases of Clinical Trials and the Brazilian Clinical Trials Network (ReBEC) from 1994 to 2014. Only 462 clinical trials enrolled Brazilian children and adolescents. There was an increase in registrations beginning in 2003, with an important drop in 2011. Among these trials, 35.5% were hosted in Brazil. The international clinical trials were mostly conducted by North American companies. In both cases, multinational industry was the principal source of funding. The clinical trials were predominantly phase III with injectable and solid oral pharmaceutical forms of antiviral drugs. Domestic clinical trials showed wider variation in the pharmaceutical forms and higher percentage of liquid formulations, when compared to the international trials. In addition to heavy external dependence for conducting clinical trials, the study emphasized the challenge for pediatric care in Brazil, which presents epidemiological peculiarities in an environment prone to the use of unlicensed medicines for children.


Assuntos
Ensaios Clínicos como Assunto , Adolescente , Brasil , Criança , Pré-Escolar , Sistemas de Informação em Saúde , Humanos , Lactente , Preparações Farmacêuticas/classificação , Estudos Retrospectivos
14.
Arq Bras Cardiol ; 109(1): 39-46, 2017 07.
Artigo em Inglês, Português | MEDLINE | ID: mdl-28591251

RESUMO

Background: There is growing concern about the economic impact of cardiovascular diseases (CVD) in Brazil and worldwide. Objective: To estimate the economic impact of CVD in Brazil in the last five years. Methods: The information to estimate CVD costs was taken from national databases, adding the direct costs with hospitalizations, outpatient visits and benefits granted by social security. Indirect costs were added to the calculation, such as loss of income caused by CVD morbidity or mortality. Results: CVD mortality accounts for 28% of all deaths in Brazil in the last five years and for 38% of deaths in the productive age range (18 to 65 years). The estimated costs of CVD were R$ 37.1 billion in 2015, a 17% increase in the period from 2010 to 2015. The estimated costs of premature death due to CVD represent 61% of the total cost of CVD, Direct costs with hospitalizations and consultations were 22%, and costs related to the loss of productivity related to the disease were 15% of the total. Health expenditures in Brazil are estimated at 9.5% of GDP and the average cost of CVD was estimated at 0.7% of GDP. Conclusion: CVD costs have increased significantly in the last five years. It is estimated that CVD costs increase as the Brazilian population ages and the prevalence of CVD increases.


Assuntos
Doenças Cardiovasculares/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Gastos em Saúde/estatística & dados numéricos , Adulto , Idoso , Brasil , Humanos , Seguro por Invalidez , Pessoa de Meia-Idade , Fatores de Tempo
15.
Rev. paul. pediatr ; 35(1): 110-114, jan.-mar. 2017.
Artigo em Português | LILACS | ID: biblio-845731

RESUMO

RESUMO Objetivo: A abordagem terapêutica de crianças com múltiplas malformações inclui muitos dilemas, tornando difícil diferenciar um tratamento de benefício duvidoso da obstinação terapêutica. O objetivo deste artigo foi destacar as possíveis fontes de incerteza no processo de tomada de decisão para esse grupo de crianças. Descrição do caso: Lactente de 11 meses de idade, que nasceu com múltiplas malformações congênitas e foi abandonado por seus pais, nunca recebeu alta hospitalar. Ele tem cardiopatia congênita cianótica, estenose do brônquio fonte esquerdo e imperfuração anal. Passou por muitos procedimentos cirúrgicos e permanece sob suporte tecnológico. A correção total do defeito cardíaco parece improvável, e todas as tentativas de desmame do ventilador falharam. Comentários: As duas principais fontes de incerteza no processo de tomada de decisão para crianças com múltiplos defeitos congênitos estão relacionadas ao prognóstico incerto. Dados empíricos escassos são por conta das múltiplas possibilidades de envolvimento (anatômico ou funcional) de órgãos, com poucos casos semelhantes descritos na literatura. O prognóstico é também imprevisível para a evolução da capacidade cognitiva e para o desenvolvimento de outros órgãos. Outra fonte de incertezas é como qualificar uma vida como valendo a pena ser vivida, ponderando custos e benefícios. A quarta fonte de incerteza é quem tem a decisão: os médicos ou os pais? Finalmente, se um tratamento é definido como fútil, então, como limitar o suporte? Na ausência de um método universal para essa tomada de decisão, ficamos com a responsabilidade dos médicos em desenvolver suas habilidades de percepção das necessidades dos pacientes e dos valores familiares.


ABSTRACT Objective: Therapeutic approach of children with multiple malformations poses many dilemmas, making it difficult to build a line between the treatment of uncertain benefit and therapeutic obstinacy. The aim of this paper was to highlight possible sources of uncertainty in the decision-making process, for this group of children. Case description: An 11-month-old boy, born with multiple birth defects and abandoned by his parents, has never been discharged home. He has complex congenital heart disease, main left bronchus stenosis and imperforate anus. He is under technological support and has gone through many surgical procedures. The complete correction of the cardiac defect seems unlikely, and every attempt to wean the ventilator has failed. Comments: The first two main sources of uncertainty in the management of children with multiple birth defects are related to an uncertain prognosis. There is a lack of empirical data, due to the multiple possibilities of anatomic or functional organ involvement, with few similar cases described. Prognosis is also unpredictable for neuro-developmental evolution, as well as the capacity for the development and regeneration of other organs. Another source of uncertainty is how to qualify the present and future life as worth living, by weighing the costs and benefits. The fourth source of uncertainty is who has the decision: physicians or parents? Finally, if a treatment is defined futile then, how to limit support? No single framework exists to help these delicate decision-making processes. We propose, then, that physicians should be committed to develop their own perception skills in order to understand patient’s manifestations of needs and family values.


Assuntos
Humanos , Masculino , Lactente , Anormalidades Múltiplas/terapia , Futilidade Médica , Cuidados para Prolongar a Vida
16.
Cad. Saúde Pública (Online) ; 33(5): e00169515, 2017. tab, graf
Artigo em Português | LILACS | ID: biblio-839703

RESUMO

Resumo: Este estudo visou a caracterizar os ensaios clínicos com medicamentos envolvendo crianças e adolescentes brasileiros, registrados nas bases de dados do Clinical Trials e da Registro Brasileiro de Ensaios Clínicos (ReBEC), entre os anos de 1994 e 2014. Apenas 462 ensaios clínicos envolveram brasileiros nessa faixa etária. A partir de 2003, houve aumento no número de registros, com expressiva queda em 2011. Dentre esses, 35,5% foram sediados no Brasil. Os ensaios clínicos internacionais foram majoritariamente conduzidos por empresas norte-americanas. Em ambos os casos, a indústria multinacional foi a principal fonte de apoio financeiro. Predominaram ensaios clínicos de fase III com antivirais em formas farmacêuticas injetáveis e sólidas orais. Os ensaios clínicos nacionais apresentaram maior variação quanto às formas farmacêuticas e maior porcentual de formulações líquidas investigadas, em comparação aos internacionais. Além da forte dependência externa para a realização dos ensaios clínicos, destacou-se o desafio para o cuidado pediátrico no Brasil, que apresenta peculiaridades epidemiológicas em um ambiente propício ao uso de medicamentos não licenciados para crianças.


Abstract: This study aimed to characterize the clinical trials with medicines enrolling Brazilian children and adolescents, registered in the databases of Clinical Trials and the Brazilian Clinical Trials Network (ReBEC) from 1994 to 2014. Only 462 clinical trials enrolled Brazilian children and adolescents. There was an increase in registrations beginning in 2003, with an important drop in 2011. Among these trials, 35.5% were hosted in Brazil. The international clinical trials were mostly conducted by North American companies. In both cases, multinational industry was the principal source of funding. The clinical trials were predominantly phase III with injectable and solid oral pharmaceutical forms of antiviral drugs. Domestic clinical trials showed wider variation in the pharmaceutical forms and higher percentage of liquid formulations, when compared to the international trials. In addition to heavy external dependence for conducting clinical trials, the study emphasized the challenge for pediatric care in Brazil, which presents epidemiological peculiarities in an environment prone to the use of unlicensed medicines for children.


Resumen: Este estudio tuvo como objetivo caracterizar los ensayos clínicos con medicamentos, involucrando a niños y adolescentes brasileños, registrados en las bases de datos de Clinical Trials y de la Red Brasileña de Ensayos Clínicos (ReBEC), entre los años de 1994 y 2014. Solamente 462 ensayos clínicos involucraron a brasileños en esa franja de edad. A partir de 2003, hubo un aumento en el número de registros, con una expresiva caída en 2011. Entre ellos, un 35,5% estuvieron ubicados en Brasil. Los ensayos clínicos internacionales fueron mayoritariamente dirigidos por empresas norteamericanas. En ambos casos, la industria multinacional fue la principal fuente de apoyo financiero. Predominaron ensayos clínicos de fase III con antivirales en formas farmacéuticas inyectables y orales sólidas. Los ensayos clínicos nacionales presentaron una mayor variación, en cuanto a las formas farmacéuticas y mayor porcentaje de formulaciones líquidas investigadas, en comparación con los internacionales. Además de la fuerte dependencia externa para la realización de los ensayos clínicos, se destacó el desafío para el cuidado pediátrico en Brasil, que presenta peculiaridades epidemiológicas en un ambiente propicio al uso de medicamentos sin licencia para niños.


Assuntos
Humanos , Lactente , Pré-Escolar , Criança , Adolescente , Ensaios Clínicos como Assunto , Brasil , Preparações Farmacêuticas/classificação , Estudos Retrospectivos , Sistemas de Informação em Saúde
18.
Rev. bioét. (Impr.) ; 24(2): 243-249, maio-ago. 2016.
Artigo em Inglês, Espanhol, Português | LILACS | ID: lil-792923

RESUMO

A bioética é vista por muitos médicos como disciplina que deve substanciar decisões e condutas em situações dilemáticas, indicando regras de ação racionais e universais. Nesse cenário, a perspectiva da ética das virtudes propõe substituição da pergunta de “como agir” para “como se constituir”; e, formando o próprio caráter, permitir que a pessoa seja capaz de tomar as decisões da vida, inclusive profissionais, de forma sábia e prudente. Neste ensaio, apresentar-se-á a perspectiva da ética aristotélica, seus autores contemporâneos e as respostas às principais críticas, explicitando vantagens que esse referencial oferece à deliberação médica – suas características valorativa, particularista e teleológica. Mais do que proclamar um paciente autônomo e um profissional que busca regras externamente estabelecidas, a ética das virtudes reconhece que paciente e profissional estão inseridos em comunidades, tradições e culturas, respeitando valores e virtudes, em busca do fim determinado de suas práticas e vidas.


Many doctors understand bioethics as the discipline that should substantiate decisions and conduct in dilemmatic cases, indicating rational and universal rules of action. In this scenario, the perspective of Virtue Ethics proposes the modification of the question “what to do” to “how to be” and, how to constitute one’s own character in order to take wise and prudent decisions in life, including professional ones. This theoretical essay will present the Aristotelian Ethics perspective, its contemporary authors, the answers to the main criticisms and will underline the advantages this framework offers to medical decision-making processes - its evaluative, particularistic and teleological characteristics. It will lead to a conclusion that more than proclaiming an autonomous patient and a profefssional who seeks externally established rules, Virtue Ethics recognizes that both patient and professional are integrated in communities, traditions and cultures, respecting values and virtues, in the pursuit of a particular purpose for their practices and lives.


La bioética es vista por muchos médicos como la disciplina que debe justificar las decisiones y conductas en casos dilemáticos indicando reglas de acción racionales y universales. En este escenario, la perspectiva de la Ética de las Virtudes propone la modificación de la cuestión de “qué hacer” al “cómo ser” – cómo construir su propio carácter con el objetivo de tomar decisiones sabias y prudentes, incluyendo las profesionales. En este ensayo teórico, se presentará la perspectiva ética aristotélica, algunos autores contemporáneos, las respuestas a las principales críticas, destacando las ventajas que ofrece este marco para las decisiones médicas – sus características evaluativa, particularista y teleológica. Más que proclamar un paciente autónomo y un profesional que busca reglas establecidas externamente, se concluye que la Ética de las Virtudes reconoce que ambos se insertan en comunidades, tradiciones y culturas, con valores y virtudes, en busca de los fines particulares de sus prácticas y vidas.


Assuntos
Humanos , Masculino , Feminino , Relações Profissional-Paciente , Bioética , Pessoal de Saúde , Teoria Ética , Tomada de Decisões , Ética Médica , Comportamento , Autonomia Profissional , Ética Baseada em Princípios
19.
PLoS One ; 11(6): e0156692, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27253887

RESUMO

L-asparaginase is an enzyme used as a chemotherapeutic agent, mainly for treating acute lymphoblastic leukemia. In this study, the gene of L-asparaginase from Zymomonas mobilis was cloned in pET vectors, fused to a histidine tag, and had its codons optimized. The L-asparaginase was expressed extracellularly and intracellularly (cytoplasmically) in Escherichia coli in far larger quantities than obtained from the microorganism of origin, and sufficient for initial cytotoxicity tests on leukemic cells. The in silico analysis of the protein from Z. mobilis indicated the presence of a signal peptide in the sequence, as well as high identity to other sequences of L-asparaginases with antileukemic activity. The protein was expressed in a bioreactor with a complex culture medium, yielding 0.13 IU/mL extracellular L-asparaginase and 3.6 IU/mL intracellular L-asparaginase after 4 h of induction with IPTG. The cytotoxicity results suggest that recombinant L-asparaginase from Z. mobilis expressed extracellularly in E.coli has a cytotoxic and cytostatic effect on leukemic cells.


Assuntos
Antineoplásicos/uso terapêutico , Asparaginase/uso terapêutico , Escherichia coli/metabolismo , Leucemia/tratamento farmacológico , Proteínas Recombinantes/uso terapêutico , Zymomonas/enzimologia , Antineoplásicos/farmacologia , Apoptose/efeitos dos fármacos , Asparaginase/genética , Asparaginase/farmacologia , Sequência de Bases , Reatores Biológicos , Ciclo Celular/efeitos dos fármacos , Linhagem Celular Tumoral , Forma do Núcleo Celular/efeitos dos fármacos , Proliferação de Células/efeitos dos fármacos , Sobrevivência Celular/efeitos dos fármacos , Criança , Pré-Escolar , Clonagem Molecular , Simulação por Computador , Feminino , Humanos , Lactente , Leucemia/patologia , Masculino , Filogenia , Proteínas Recombinantes/genética , Proteínas Recombinantes/farmacologia
20.
PLoS One ; 11(5): e0154843, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27149514

RESUMO

BACKGROUND: Routine data on the use of isoniazid preventive therapy (IPT) in children and adolescents are scarce in high tuberculosis (TB) burden countries. OBJECTIVE: To describe the factors related to abandonment of IPT in children and adolescents with latent tuberculosis infection (LTBI) receiving routine care. METHODS: Retrospective (2005-2009) descriptive study of 286 LTBI cases with indication of IPT and serviced at a pediatric hospital in the State of Rio de Janeiro, Brazil. Survival analysis of the risk of abandonment of IPT over six months was performed, including multivariate analysis using the Cox proportional hazards model. RESULTS: Out of the 245 cases of LTBI included, 62 abandoned IPT (25.3%; 95% CI: 20%-31%). On multivariate analysis, the variables related to the IPT abandonment hazard ratio were the Human Development Index (HDI) (hazard ratio-HR: 0.004; 0.000-0.569) of the place of residence and the contact with adults that were not undergoing anti-TB treatment (HR: 7.30; 1.00-53.3). CONCLUSION: This study reveals the relevance of the relation of abandonment of IPT to the socioeconomic conditions at the place of residence and poor adherence to the active TB treatment. Educational measures to stimulate preventive treatment of child contacts and curative treatment of index cases should target the full familial setting.


Assuntos
Antituberculosos/uso terapêutico , Isoniazida/uso terapêutico , Tuberculose Latente/tratamento farmacológico , Fatores Socioeconômicos , Adolescente , Brasil/epidemiologia , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Tuberculose Latente/epidemiologia , Estudos Longitudinais , Masculino , Estudos Retrospectivos
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