Análise dos custos diretos e indiretos da COVID-19 em um hospital brasileiro / Analysis of the direct and indirect costs of COVID-19 in a Brazilian hospital

Objetivo: Avaliar os custos diretos na perspectiva hospitalar e do Sistema Único de Saúde (SUS), bem como os custos indiretos de pacientes hospitalizados por COVID-19. Métodos: Estudo observacional com coleta de dados por micro e macrocusteio, realizado com pacientes admitidos por COVID-19 em um hospital paulista (março a setembro de 2020). Custos indiretos foram obtidos pelos métodos de capital humano e de anos de vida ajustados pela incapacidade (DALY). Análises de Mann-Whitney e regressão linear foram realizadas. Resultados: Foram incluídos 158 indivíduos com mediana de idade de 57 anos (IIQ 42-68 anos). A mediana de custo da internação na perspectiva do SUS e hospitalar foi de, respectivamente, R$ 2.009,46 (IIQ: R$ 1.649,11; R$ 4.847,36), principalmente devido à unidade de terapia intensiva (UTI), e R$ 19.055,91 (IIQ: R$ 8.399,47; R$ 38.438,00), principalmente devido a recursos humanos. Tempo total de internação (p < 0,001), óbito (p < 0,001) e ventilação invasiva (p < 0,001) foram preditores de aumento de custo. Foi identificada perda de 381,5 DALY e perda de produtividade de 128 anos, equivalente a US$ 855.307. Conclusão: Os principais direcionadores de custo foram recursos humanos e UTI. Entretanto, na perspectiva da sociedade, foi identificado o maior impacto devido à perda de produtividade e DALY. Tempo de hospitalização foi um dos grandes contribuidores do custo, e esse fator pode estar atrelado a gravidade da doença e protocolos de cuidado ao paciente.

Objective: To evaluate the direct costs from the hospital and Unified Health System (SUS) perspective, as well as the indirect costs of patients hospitalized by COVID-19. Methods: Observational study with data collection by micro- and macro-costing, carried out with patients hospitalized in a hospital in São Paulo (March-September 2020). Indirect costs were obtained using human capital and disability-adjusted life years (DALY) methods. Mann-Whitney and linear regression analyzes were performed. Results: 158 individuals were included, with a median age of 57 years (IQR 42-68 years). The median cost of admission in the SUS and hospital perspective was, respectively, R$ 2,009.46 (IQR: R$ 1,649.11; R$ 4,847.36), mainly due to the intensive care unit (ICU) and R$ 19,055.91 (IQR: R$ 8,399.47; R$ 38,438.00), mainly due to human resources. The total length of stay in hospital (p < 0.001), death (p < 0.001) and invasive ventilation (p < 0.001) were predictors of cost increase.

Efficacy and safety of immunotherapies for the treatment of high-grade gliomas: a systematic review and meta-analysis

Background/Aim: High-grade gliomas are aggressive brain neoplasms usually refractory to treatment. Recently new treatment approaches have emerged, including immunotherapies. Hence, the aim of the present study was to evaluate the efficacy and safety of immunotherapies in adult patients with high-grade gliomas. Methods: Searches were performed in three databases for relevant studies published until December 2020. Title and abstract screening, full-text review, data extraction, and risk of bias assessment were performed independently by two reviewers. Risk of bias assessment was performed according to the revised Cochrane risk-of-bias tool for randomized trials (RoB 2). Meta-analyses were performed with Review Manager software (version 5.4.1), using risk ratio and 95% confidence intervals as measure of effect, the Mantel-Haenszel method, and random effects models. The quality of evidence assessment was conducted according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Nineteen studies were included in the systematic review, of which 15 reported comparable data for meta-analyses. The outcomes assessed in the meta-analyses were overall survival (OS) and progression-free survival (PFS), with subgroups at 6, 12, and more than 12 months. No statistical differences were observed between immunotherapy and conventional treatment, except for the OS subgroup over 12 months. The certainty on the evidence was moderate. Conclusion: There was no evidence of an additional benefit of immunotherapy compared to standard treatment in the synthesis of results from clinical trials. Further high-quality clinical trials are needed to improve the quality of evidence concerning immunotherapies for the treatment of high-grade gliomas.

Manifestações oculares da artrite reumatoide e positividade de autoanticorpos: uma revisão sistemática / Ocular manifestations of rheumatoid arthritis and autoantibodies positivity: a systematic review

Contexto: As manifestações oculares da artrite reumatoide representam cerca de 40% das manifestações extra-articulares, acarretando comprometimento da qualidade de vida. O fator reumatoide e o anticorpo contra peptídeos citrulinados cíclicos são marcadores sorológicos para diagnóstico laboratorial da doença. Objetivo: Identificar as principais manifestações oculares da artrite reumatoide e a sua relação com a positividade do fator reumatoide e anticorpo contra peptideos citrulinados cíclicos, através de uma revisão sistemática. Métodos: Uma revisão sistemática foi conduzida nas bases de dados: PubMed, Scopus, Web of Science e SciELO, até janeiro de 2018. Critérios de inclusão e exclusão foram aplicados e dados dos estudos selecionados foram extraídos e organizados em tabelas e gráficos. Avaliação metodológica e análise estatística, incluindo duas meta-análises, foram realizadas. Os estudos selecionados foram armazenados no Software Endnote X8 versão student (Serial Number: 3151802521 e Product Key: L899B-8N8FJ-SX9JW-BEQ58-U9HCD). Análises estatísticas foram realizadas com o Software Review Manager versão 5.3 (software gratuito). Resultados: Dos 1.985 estudos encontrados através da busca em bases de dados, quatro estudos foram incluídos. A síndrome sicca e síndrome de Sjögren secundária representaram cerca de 50% das manifestações oculares. Meta-análises aplicadas em dois estudos não identificaram associação de risco estatisticamente significativa entre o anticorpo contra peptideos citrulinados cíclicos e fator reumatoide e o desenvolvimento de manifestações oculares. Conclusão: As manifestações oculares da Artrite Reumatoide correspondem à significativa parcela das manifestações extra-articulares. No entanto, não foram constatadas associação de risco entre autoanticorpos e tais manifestações. [au]

Background: Ocular involvement represents about 40% of extra-articular manifestations of Rheumatoid Arthritis, pointing to impairment in patients' quality of life. Anti-cyclic citrullinated peptide antibody and rheumatoid factor are serological markers to laboratorial diagnosis of disease. Objective: Identify main ocular manifestations of Rheumatoid Arthritis and its relationship between positivity of rheumatoid factor and anti-cyclic citrullinated peptide antibody, through a Systematic Review of literature. Methods: Systematic Review was conducted on database search, including: PubMed, Scopus, Web of Science and SciELO until January, 2018. Inclusion and exclusion criteria were applied and data of select studies were extracted and organized in tables and graphics. Methodological appraisal and statistical analysis, including meta-analyses, were performed. Selected studies were stored in software Endnote X8 student (Serial Number: 3151802521 e Product Key: L899B-8N8FJ-SX9JW-BEQ58-U9HCD). Statistical analyses were performed with Review Manager software version 5.3 (free software). Results: From 1,985 studies found by database search, four studies were selected and analyzed. Sicca syndrome and secondary Sjögren's syndrome represented about 50% of ocular manifestations. Meta-analyses applied in two studies demonstrated no statistical significative risk association between anti-cyclic citrullinated peptide and development of ocular manifestations. Conclusion: From extra-articular manifestations of Rheumatoid Arthritis, ocular manifestations correspond to a significative amount. Nevertheless, there were no statistical significative risk association between autoantibodies and these manifestations. [au]

Evaluation of the epidemiological aspects and the impact of COVID-19 on tuberculosis notifications in São Paulo

Objective: This study aimed to analyze the incidence and epidemiological profile of tuberculosis (TB) cases registered in a region of the State of São Paulo (SP) and to assess the impact of COVID19 on TB incidence and completeness of notifications. Methods: This is a retrospective crosssectional study analyzing reports of adult patients with TB, who were notified in the TB-Web from January 2010 to December 2020. Sociodemographic (e.g. sex, race and scholarity) and clinical variables (e.g., clinical form, types of cases and comorbidities) were collected and analyzed. The completeness of TB notifications and the impact of COVID-19 on TB notifications were evaluated, considering the year of 2020. The study was reported following Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for cross-sectional studies [CAAE 33166620.0.0000.0102]. Results: A total of 1,509 notifications were included, with a mean incidence of 48.5/100,000 inhabitants. The median age was 42 years, most notification included males (71%), were of white race (42%) and had the pulmonary form of TB (85%). In assessing the impact of the pandemic on notifications in 2020, there was a decrease of 36% in the number of TB notifications, with an emphasis between July and August, which was the peak period of COVID-19 cases in the region. No change in the completeness of TB notifications was observed in this period. Conclusions: Results indicate the clinical and epidemiological profile in a region of SP between 2010 and 2020. The pandemic led to a decrease in the number of TB notifications but did not change the completeness of notifications.

Possíveis desfechos de longo prazo da Covid-19: uma revisão sistemática de escopo / Possible long-term outcomes of Covid-19: a systematic scoping review

Objetivo: mapear os possíveis desfechos de longo prazo da COVID-19 no mundo. Métodos: em acordo com as recomendações do Joanna Briggs Institute, foi realizada uma revisão sistemática de escopo de estudos experimentais e observacionais com busca nas bases de dados PubMed e Scopus, complementada por busca manual. Resultados: de 5.325 registros, 121 atenderam aos critérios de elegibilidade, os quais incluíram 1.638 recuperados da COVID-19. Foram identificados 52 potenciais desfechos de longo prazo da COVID-19, principalmente disfunção olfatória (n=605), disfunção gustativa (n=372), dispneia (n=233) e lesões pulmonares (n=225). Entre os cuidados de longo prazo, destacam-se início de terapia medicamentosa, terapia de substituição renal e amputação. Conclusão: foram mapeados 52 possíveis desfechos de longo prazo da COVID-19 e recomendações de continuação de cuidados, que variaram de manifestações leves a graves com duração menor ou igual a um mês e maior que um mês.

Objective: to map these possible long-term outcomes of COVID-19 worldwide. Methods: In accordance with the recommendations of the Joanna Briggs Institute, a systematic scoping review of experimental and observational studies was carried out with a search in PubMed and Scopus databases, complemented by manual search. Results: Of 5,325 records, 121 met eligibility criteria, which included 1,638 recovered from COVID-19. Fifty-two (52) potential long-term outcomes of COVID-19 were identified, mainly olfactory dysfunction (n=605), taste dysfunction (n=372), dyspnea (n=233) and lung injuries (n=225). Long-term care included initiation of drug therapy, renal replacement therapy and amputation. Conclusion: Fifty-two (52) possible long-term outcomes of COVID-19 and recommendations for continued care were mapped, ranging from mild to severe manifestations lasting less than or equal to one month and greater than one month.

Evaluation of the application of the Diabetes Quality of Life Questionnaire in patients with diabetes mellitus

ABSTRACT Objective Diabetes mellitus (DM) is a chronic disease with great impact on patients' quality of life (QoL). This variable can be measured using reliable, standardized, and validated instruments. The purpose of this study was to evaluate the application and reporting of the Diabetes Quality of Life Measure (DQOL) or the Diabetes Quality of Life for Youths Measure (DQOLY), an adapted version for young patients with DM. Materials and methods A systematic review of interventional and observational studies using the DQOL or DQOLY was performed. Searches were conducted in the electronic databases Medline, Scopus, Web of Science, Lilacs, and SciELO. Results After conducting the searches, 111 studies met the inclusion criteria and were included in the qualitative analysis. Of these, 32 studies were classified as interventional and 79 as observational, with 27,481 patients. The DQOL was applied in 82 studies, the DQOLY in another 27, and two studies used both instruments. DM was classified as type 1 DM in 69 studies and type 2 DM in 35 studies. Six studies included both patients. Improvement in patients' QoL after an intervention was observed in 13 interventional studies. Most of the studies (90%) provide a detailed description of the instrument and 52% the previous validation. The interpretation of the scores obtained varies among the studies, probably due to the differences inherent in cultural validations, translations, and adaptations. Conclusion The application of the instruments in clinical practice must be rigorously standardized and requires an accurate understanding of psychometric and statistical concepts. Arch Endocrinol Metab. 2020;64(1):59-65

Effect of different interval training protocols on adiposity indicators in overweight-obese children and adolescents: a systematic review and meta-analysis / Efeito de diferentes protocolos de treinamento intervalado sobre indicadores de adiposidade em crianças e adolescentes com sobrepeso e obesidade: uma revisão sistemática e metanálise

ABSTRACT The present meta-analysis verified the impact of different protocols of high-intensity interval training (HIIT) on indicators of adiposity in overweight and obese children and adolescents. Searches were performed in the databases: PubMed, ScienceDirect, SPORTDiscus, LILACS and SciELO. Were included studies without caloric restriction that aimed to verify the effect of HIIT interventions on the adiposity indicators in overweight children and adolescents published until December 2018. The PEDro scale was used to assess the risk of bias. The meta-analysis was conducted in the Revman software using standardized mean difference (SMD) data and 95% confidence intervals (CI). Seventeen studies were selected, which involved 289 children and adolescents with overweight and obesity. HIIT interventions (mean=11.7±5.9 weeks) produced significant decreases in body fat percentage (SMD=-0.65; CI=-1.07, -0.23) and waist circumference (SMD=-0.34; CI=-0.49, -0.18). Also, major relative risk of decrease in body fat percentage were observed in favour to protocols with work/recovery interval ratios of 1:1 and 2:1. HIIT protocols with ratios (work/recovery intervals) 1:1 and 2:1 promote significant reductions in fat percentage and waist circumference in overweight and obese children, independently of the total work time.

RESUMO A presente meta-análise verificou o impacto de diferentes protocolos de treinamento intervalado de alta intensidade (HIIT) sobre indicadores de adiposidade em crianças e adolescentes com sobrepeso e obesidade. As buscas foram realizadas nas bases de dados: PubMed, ScienceDirect, SPORTDiscus, LILACS e SciELO. Foram incluídos estudos sem restrição calórica, que objetivaram verificar o efeito das intervenções do HIIT nos indicadores de adiposidade em crianças e adolescentes acima do peso publicados até dezembro de 2018. A escala PEDro foi utilizada para avaliar o risco de viés. A meta-análise foi conduzida no software Revman a partir dos dados de diferença média padronizada (SMD) e intervalos de confiança de 95% (IC). Foram selecionados 17 estudos, envolvendo 289 crianças e adolescentes com sobrepeso e obesidade. As intervenções de HIIT (duração=11,7±5,9 semanas) produziram reduções significativas no percentual de gordura corporal (SMD=-0,65; IC=-1,07,-0,23) e circunferência da cintura (SMD=-0,34; IC=-0,49-0.18). Também foi observado um risco relativo maior de diminuição do percentual de gordura corporal a favor de protocolos com proporção de intervalos de trabalho/recuperação de 1:1 e 2:1. Protocolos HIIT com proporções 1:1 e 2:1 promovem reduções significativas no percentual de gordura e circunferência da cintura em crianças com sobrepeso e obesidade, independentemente do tempo total de trabalho.

Custo da Doença em Pacientes com Carcinoma Mamário Tratados com Tamoxifeno / Cost of the Disease in Patients with Breast Cancer Treated with Tamoxifen / Costo de la Enfermedad en Pacientes com Carcinoma Mamário Tratados com Tamoxifeno

Introdução: A estimativa do Instituto Nacional de Câncer José Alencar Gomes da Silva para o Brasil, para cada ano do biênio 2018-2019, foi de 59.700 novos casos de câncer de mama, com um risco estimado de 56,33 casos a cada 100 mil mulheres. Em 2014, os gastos públicos com atenção oncológica foram de aproximadamente R$ 2,5 bilhões. Objetivo: Avaliar o impacto dos custos diretos médicos em pacientes com carcinoma mamário tratados com tamoxifeno pelo Sistema Único de Saúde. Método: Estudo exploratório de custo da doença, quantitativo, retrospectivo, com caráter de prevalência e de abordagem bottom-up. A coleta dos dados foi realizada no ambulatório de Oncologia do Hospital São Vicente em Curitiba, Paraná. Resultados: A média do custo do tratamento dos pacientes foi R$ 14.497,70 em tratamento neoadjuvante ou adjuvante e de R$ 9.108,60 em tratamento paliativo. Em relação a essas variáveis, o custo do tamoxifeno foi o que mais impactou em relação ao custo total do tratamento, representando mais de 80% deste valor. A média do custo anual gasto com tamoxifeno por paciente foi de R$ 1.947,60. Conclusão: O custo médio do tratamento demonstrou ser alto em relação à média salarial dos brasileiros de R$ 2.110.00 (IBGE-2017). Os custos levantados neste estudo podem auxiliar os gestores de saúde pública em estratégias para racionalização dos gastos, otimização do capital e manutenção do atendimento à população.

Introduction: The estimate of the National Cancer Institute José Alencar Gomes da Silva, for each year of the 2018-2019 biennium in Brazil, was 59,700 new cases of breast cancer, with an estimated risk of 56.33 cases per 100,000 women. In 2014, public expenditures on cancer care were approximately R$ 2.5 billion. Objective: To evaluate the impact of direct medical costs on breast cancer patients treated with tamoxifen using the Unified Health System. Method: Prospective, quantitative, retrospective, cost-of-disease study with prevalence and bottom-up approach. Data collection was performed at the Oncology Outpatient Clinic of the Hospital São Vicente in Curitiba, Paraná. Results: The mean cost of the treatment was R$ 14,497.70 for neoadjuvant or adjuvant treatment and R$ 9,108.60 for palliative treatment. In relation to these variables, the cost of tamoxifen was the one that most impacted, in relation to the total cost of the treatment, representing more than 80% of this value. The mean annual cost of tamoxifen per patient was R$ 1,947.60. Conclusion: The average cost of treatment was high in relation to the Brazilian average salary of R$ 2,110.00 (IBGE-2017). The costs investigated in this study can help public health managers in strategies to rationalize expenditures, optimize capital and maintain patient care.

Introducción: La estimación del Instituto Nacional del Cáncer José Alencar Gomes da Silva para Brasil, para cada año del bienio 2018-2019, fue de 59,700 casos nuevos de cáncer de mama, con un riesgo estimado de 56.33 casos por 100,000 mujeres. En 2014, los gastos públicos con atención oncológica fueron de aproximadamente R $ 2,5 mil millones. Objetivo: Evaluar el impacto de los costos directos médicos en pacientes con carcinoma mamario tratados con tamoxifeno por el Sistema Único de Salud. Método: Estudio exploratorio de costo de la enfermedad, cuantitativo, retrospectivo, con carácter de prevalencia y de enfoque bottom-up. La recolección de los datos fue realizada en el Ambulatorio de Oncología del Hospital São Vicente en Curitiba, Paraná. Resultados: El promedio del costo del tratamiento de los pacientes fue R$ 14.497,70 en tratamiento neoadyuvante o adyuvante y de R$ 9.108,60 en tratamiento paliativo. En relación a estas variables el costo del tamoxifeno fue el que más impactó en relación al costo total del tratamiento, representando más del 80% de este valor. El promedio del costo anual gastado con tamoxifeno por paciente fue de R$ 1.947,60. Conclusión:El costo promedio del tratamiento demostró ser alto en relación al promedio salarial de los brasileños de R $ 2.110.00 (IBGE-2017). Los costos levantados en este estudio pueden auxiliar a los gestores de salud pública en estrategias para racionalización de los gastos, optimización del capital y mantenimiento de la atención a la población.

Effectiveness and tolerability of direct-acting antivirals for chronic hepatitis C patients in a Southern state of Brazil

ABSTRACT Background This study aimed to evaluate the clinical effectiveness in terms of sustained virological response and tolerability of available second generation direct-acting antivirals in Brazilian patients. Methods This was a retrospective observational study conducted in six centers in Southern Brazil. The sample comprised adult patients who were chronically infected with hepatitis C virus, regardless of virus genotype, fibrosis stage, or prior treatment. Statistical analysis was performed to compare the effectiveness among the treatments, and also to uncover the factors influencing the achievement of sustained virological response. Results A total of 296 patients were included in the study, with the majority receiving sofosbuvir with daclatasvir (59%) or sofosbuvir with simeprevir (26%). Overall sustained virological response rates were approximately 91.6%. For genotype 1, sofosbuvir with daclatasvir had an sustained virological response rate of approximately 95%, while the sustained virological response rate of sofosbuvir with simeprevir was 92%; this difference was statistically significant only for subtype 1b. The only treatment used for genotype 3 patients was sofosbuvir with daclatasvir, and lower rates of sustained virological response were observed for this group, compared to genotype 1 (84% versus 95%, p < 0.05). Apart from this difference between genotypes, and a difference between patients who achieved rapid virologic response compared with those who did not, there were no other statistically significant factors associated with sustained virological response. Conclusions The results point to the effectiveness of second-generation direct-acting antivirals in hepatitis C virus Brazilian patients, especially those with genotype 1. Furthermore, that patients with genotype 3 need more attention and adjustments in available treatment options.

Treatment interruption of biological drugs and tofacitinib in rheumatoid arthritis: A systematic review of case reports

The aim of this study was to evaluate interruption of treatment with biological drugs and tofacitinib due to adverse events in patients with rheumatoid arthritis. A systematic review was performed in the electronic databases MEDLINE, Cochrane, Scopus, CRD, IPA, Lilacs and Scielo. Case reports addressing interruption of treatment due to any adverse event related to abatacept (ABA), adalimumab (ADA), anakinra (ANA), certolizumab pegol (CER), etanercept (ETA), golimumab (GOL), infliximab (IFX), rituximab (RTX), secukinumab (SEC), tocilizumab (TCZ), tofacitinib (TOF) or ustekinumab (UST) in rheumatoid arthritis patients were evaluated. Baseline data, patient profile, previous and current treatments, cause of discontinuation and information on reintroduction of treatment were extracted from the case reports. One hundred and fifty-four studies (154 patients) reported 162 discontinuations of rheumatoid arthritis treatment due to adverse events (ETA = 57; IFX = 46; ADA = 32; TCZ = 13; RTX = 5; ANA = 3; GOL = 2; ABA = 2; TOF = 1; CER = 1; SEC = 0 and UST = 0). The mean age of patients was 56 (± 12.1) years and 82% were female. Seventy-four adverse events were confirmed (related to used drug), and 138 were observed in patients using anti-TNF. The most common adverse events were infections (21%), skin disease (15%), autoimmune disease (13%) and hematological disorders (9%). Case reports are important in the detection of rare adverse events and should be considered in the choice of appropriate therapy for patients.

Reduction of glycated hemoglobin (HbA1c) and cost analysis of treatment with insulin analogues in the state of Paraná: a retrospective cohort study / Redução de hemoglobina glicada (HbA1c) e análise de custo do tratamento com análogas insulinas no estado do Paraná: estudo de coorte retrospectivo

Objective: Diabetes mellitus (DM) is a serious public health problem in Brazil. The goal of this study was to evaluate the effectiveness of long-acting insulin analogues in controlling glycemia in type 1 DM patients and to analyze the direct costs of the treatment. Methods: A retrospective cohort study was undertaken with data collected from the State Health Secretary's 2nd Regional Health Center from the State of Paraná. After randomization, socio-demographic data, the source of their drug prescriptions, and the pharmacotherapeutic profiles of the drugs were collected, along with clinical outcome information, such as glycated hemoglobin (HbA1c) and fasting plasma glucose levels. The direct costs of treatment with analogue insulin were evaluated based on the drugs and supplies acquisition data from the Center for Drugs, Paraná Cemepar. Results: One hundred and forty-eight type 1 diabetes mellitus patients, older than 18 years of age, were included in the cohort study. The HbA1c reduction after the insulin treatment was 0.36 ± 2.75, and the direct costs to reduce this parameter by 1% over a period of 24 months were U$ 1,806. The estimated costs to reduce HbA1c by 1% are U$ 5,016. Conclusions: In this study, we were able to estimate the public health system costs of using insulin analogues to reduce HbA1c by 1% in patients with type 1 DM. This information will assist clinicians in decision-making regarding insulin treatment.

Objetivo: Diabetes mellitus (DM) é um grave problema de saúde pública no Brasil. O objetivo deste estudo foi avaliar a redução da HbA1c em pacientes usuários de insulinas análogas de longa duração no controle glicêmico de pacientes com DM tipo 1 e avaliar custos diretos do tratamento com insulinas análogas. Métodos: O estudo é uma coorte retrospectiva e análise de custos para o tratamento de DM tipo 1, com pacientes pertencentes a 2a Regional de Saúde do estado do Paraná. Após randomização dos pacientes, foram coletados dados sociodemográficos, origem da prescrição e seu perfil farmacoterapêutico, além dos desfechos clínicos, como hemoglobina glicada (HbA1c) e glicemia em jejum. Foi realizada uma análise dos custos diretos do tratamento com insulinas análogas, e os valores foram obtidos por meio dos dados de compra dos medicamentos e insumos realizados pelo Centro de Medicamentos Básicos do Paraná (Cemepar). Resultados: Foram incluídos 148 pacientes maiores de 18 anos. A variável avaliada foi redução na HbA1c que, entre os pacientes, foi de 0,36 ± 2,75. Os resultados médios dos custos diretos totais do tratamento com DM tipo 1 durante 24 meses foram de R$ 7.224,00, para obter redução em 0,36% dos valores de HbA1c. O custo teórico para a redução em 1% de HbA1c é de R$ 20.064,00. Conclusões: Neste estudo foi possível estimar o custo para o sistema público de saúde, da redução de 1% da HbA1c em pacientes com DM tipo 1 usando insulinas análogas. Essa informação serve de subsídios para gestores e clínicos na tomada de decisão do tratamento com insulinas.

New drugs for the treatment of agitation in schizophrenia: a systematic review and meta-analysis of inhaled loxapine and infused sodium nitroprusside / Novos fármacos para o tratamento da agitação na esquizofrenia: revisão sistemática e meta-análise da loxapina inalável e nitroprussiato de sódio

The use of novel drugs such as inhaled loxapine (LOXi) for schizophrenia and the off-label use of substances such as sodium nitroprusside (NIT) for the management of mental disorders require further investigation. We aimed to evaluate the efficacy and safety of LOXi and NIT for the treatment of agitation associated with schizophrenia. A systematic review of randomized controlled trials (RCTs) comparing the use of LOXi or NIT versus placebo or other antipsychotic agents was conducted, and we evaluated the efficacy (CGI-scale) and safety (adverse events) of the therapies. Altogether, 71 studies were identified, of which 2 (LOXi) were included in the meta-analysis, and 1 (NIT) was included in the systematic review only. The efficacy data showed superiority of LOXi against placebo, regardless of the dose (5 and 10 mg). No significant differences were observed concerning the safety results. Treatment with NIT showed favorable results, with significant reduction of the symptoms. The efficacy of these medications is difficult to assess because of the lack of RCTs. However, there is some information regarding the efficacy and safety of LOXi in the treatment of agitation in schizophrenic patients.

Fármacos mais recentes como a loxapina inalável (LOXi) para o tratamento da esquizofrenia e o uso off- label de substâncias como o nitroprussiato de sódio (NIT) para o manejo de desordens mentais requerem mais investigações. O objetivo do estudo foi avaliar eficácia e segurança da LOXi e do NIT para tratamento da agitação na esquizofrenia. Foi realizada revisão sistemática de ensaios clínicos randomizados (ECR) comparando o uso de LOXi ou NIT versus placebo ou outros antipsicóticos. Foram avaliados desfechos de eficácia (escala CGI-I) e segurança (eventos adversos). Ao todo 71 estudos foram identificados, dos quais dois foram incluídos nas meta-análises (ambos da LOXi) e 1 sobre NIT foi incluído somente na revisão sistemática. Os dados de eficácia demonstraram superioridade da LOXi frente ao placebo, independente das doses avaliadas (5 ou 10 mg). Não foram observadas diferenças significativas entre os resultados de segurança com o controle. O único estudo incluído sobre o NIT mostrou resultados favoráveis, com redução significativa dos sintomas. Apesar da carência de ECR com esses fármacos dificultar a determinação e a reunião de informações, há potenciais evidências de eficácia e segurança da LOXi no tratamento da agitação em pacientes com esquizofrenia.

Multicriteria decision analysis for health care decision making in Brazil: a scoping review

Everyday health care professionals and managers are invited to make complex decisions involving multiple factors and alternatives with impacts on the health of the interested population. In this sense, the multicriteria decision analysis (MCDA) considers the perception of different stakeholders about multiple attributes that can affect decision making, thus representing a decision support tool. Despite the relevance of MCDA, little is known about the application of different methods in health care in Brazil. To identify the characteristics of the Brazilian publications about MCDA in health care. A scoping review was conducted in PubMed, Scopus, and LILACS. Published primary studies, regardless of language, were included. This scoping review identified 45 studies in databases and one by manual search. Of these, 14 studies were evaluated by eligibility and included in scoping review: most of the publications were developed in health services (n=6) using MACBETH technic (n=6), including different actors (n=11), mainly for performance evaluation (n=6). Besides MACBETH, other methods of MCDA were TODIM (Interactive and Multicriteria Decision Making, in English), analytic hierarchy process, and discrete choice experiment. It was identified that the application of MCDA is still incipient in Brazilian health care. This review may contribute to the dissemination of knowledge about these methods and possibilities of applications among health professionals, as well as to alert them to the importance of using ethical, consistent and objective tools for more robust and transparent decision making.(AU)

Custos da infecção relacionada a cateter venoso central em adultos: revisão integrativa / Costos de la infección relacionada al catéter venoso central em adultos: revisión integradora / Costs of central venous catheter-related infections in adults: integrative review

Objetivo conhecer o impacto financeiro da infecção primária de corrente sanguínea para as organizações hospitalares. Método revisão integrativa desenvolvida nas bases de dados LILACS e EMBASE com MEDLINE, publicadas entre jun/2005 e jun/2015 com os descritores: cateteres venosos centrais, infecções relacionadas a cateter e custos e análises de custos. Resultados foram elencadas 13 publicações e houve predomínio de estudos de coorte retrospectiva, desenvolvidos na Europa ou Estados Unidos com pacientes críticos. O custo para um episódio de infecção variou de $24.090 até $34.544. Estudos europeus encontraram valores entre €16.814 e €29.909. A infecção aumentou os dias de internação entre 1,5 e 26 dias, e a mortalidade entre 1,8% e 34%. Conclusão as infecções relacionadas ao cateter representaram um custo elevado para as organizações hospitalares e, devido à discrepância entre os valores em diferentes países, há necessidade de avaliar o custo em cada realidade.

Objetivo conocer el impacto financiero de la infección primaria de corriente sanguínea para las organizaciones hospitalarias. Método revisión integradora desarrollada en las bases de datos LILACS y EMBASE con MEDLINE, publicadas entre jun/2005 y jun/2015 con los descriptores: catéteres venosos centrales, infecciones relacionadas a catéter y costos y análisis de costos. Resultados fueron listados 13 publicaciones y hubo predominio de estudios de cohorte retrospectiva, desarrollados en la Europa o Estados Unidos con pacientes críticos. El costo para un episodio de infección varió de $24.090 a $34.544. Estudios europeos encontraron valores entre €16.814 y €29.909. La infección aumentó los días de internación entre 1,5 y 26 días, y la mortalidad entre 1,8% y 34%. Conclusión las infecciones relacionadas al catéter representaron un costo elevado para las organizaciones hospitalarias y, debido a la discrepancia entre los valores en diferentes países, hay una necesidad de evaluar el costo en cada realidad.

Objective to know the financial impact of primary bloodstream infection for hospital organizations. Method integrative review carried out in the LILACS and EMBASE databases with MEDLINE, published between June 2005 and June 2015 with the descriptors: central venous catheters, catheter-related infections and costs and cost analyses. Results thirteen publications were included, and there was predominance of retrospective cohort studies conducted in Europe and the United States with critical patients. The cost for an episode of infection ranged from $ 24,090 to $ 34,544. European studies found values between €16,814 and €29,909. The infection increased the length of hospitalization between 1.5 and 26 days, and the mortality between 1.8% and 34%. Conclusion catheter-related infections incur a high cost for hospital organizations, and it is necessary to assess the cost in the case of each country because of discrepant values in different nations.

Quality of life perception of type 1 diabetic patients treated with insulin analogs and receiving medication review with follow-up in a public health care service from Ponta Grossa-PR, Brazil

ABSTRACT Glycemic control in patients with diabetes mellitus type 1 (DM1) reduces the risk of complications but requires a rigorous health care routine. Thus, diabetes education is central to increasing treatment compliance and self-care practices. This study aimed to evaluate the quality of life (QoL) and glycemic control of DM1 patients being treated with insulin analogs and receiving medication review with follow-up. This was a transversal study that included 110 patients registered at the 3rd Health Regional of Ponta Grossa-PR, aged ≥ 18 years, and receiving pharmaceutical care for at least 1 year. The Diabetes Quality of Life Measure (DQOL)-Brazil was used to evaluate QoL. The data were statistically analyzed using SPSS version 17.0 with 95% confidence levels. Of the 110 patients, 58.2% were women. The average age was 33.7 years (±10.5), and the average glycated hemoglobin (HbA1c) value was 8% (±1.4). The mean total DQOL-Brazil score was 2.11 (95% confidence interval, 2.02 - 2.21). All DQOL-Brazil scores were lower in patients with HbA1c ≤ 8%, indicating a better QoL. Good glycemic control, thus, appears to have a positive influence on the QoL, and pharmaceutical interventions are able to contribute to the achievement of therapeutic targets.

Economic evaluation of treatments for chronic hepatitis B

The aim of this study was to conduct a cost-utility study of adefovir, entecavir, interferon alpha, pegylated interferon alpha, lamivudine and tenofovir for chronic hepatitis B in the context of Brazilian Public Health Care System. A systematic review was carried out for efficacy and safety. Another review was performed to collect utility data and transition probabilities between health states. A Markov model was developed in a time horizon of 40 years with annual cycles for three groups of: HBeAg positive, HBeAg negative, and all patients. These strategies were compared to a fourth group that received no treatment. Discount rates of 5% were applied and sensitivity analyses were performed. Tenofovir offered the best cost-utility ratio for the three evaluated models: U$397, U$385 and U$384 (per QALY, respectively, for HBeAg positive, negative, and all patients). All other strategies were completely dominated because they showed higher costs and lower effectiveness than tenofovir. The sequence of cost-utility in the three models was: tenofovir, entecavir, lamivudine, adefovir, telbivudine, pegylated interferon alpha, and interferon alpha. In the sensitivity analysis, adefovir showed lower cost-utility than telbivudine in some situations. The study has some limitations, primarily related to the creation of scenarios and modeling. In this study, tenofovir presented the best cost-utility ratio. The results obtained in this study will be valuable in decision-making and in the review of the clinical protocol, mainly involving the allocation of available resources for health care.

The characteristics, clinical manifestations and outcomes of pandemic influenza A (H1N1) 2009 in the elderly

Introduction The objetctive of this study was to evaluate the 2009 Pandemic Influenza A (H1N1) in the elderly and identify the clinical characteristics, mortality and prognostic factors of the infection in these patients. Methods This was an observational, retrospective study. Data were collected from the National Notifiable Diseases (SINAN), from the Brazilian Ministry of Health. Only patients 60 years old or more that had laboratory confirmed infections were included. The socio-demographic and clinical variables and outcomes were evaluated to compare mortality rates in the presence or absence of these factors. Results We included 93 patients in the study, 16.1% of whom died. The symptoms of cough and dyspnea, the use of the antiviral oseltamivir, influenza vaccine and comorbidities influenced the outcomes of cure or death. Chest radiography can aid in diagnosis. Conclusions Although relatively few elderly people were infected, this population presented high lethality that can be justified by the sum of clinical, physical and immunological factors in this population. Treatment with oseltamivir and vaccination against seasonal influenza have significantly reduced rates of hospitalization and mortality. .

Manifestações clínicas da influenza pandêmica A (H1N1) 2009 / Clinical features of pandemic influenza A (H1N1) 2009

Objetivos: Realizar uma definição mais precisa do quadro clínico da infecção pela influenza pandêmica A (H1N1) 2009, para auxiliar na realização do diagnóstico clínico-epidemiológico da doença. Métodos: Os sinais e sintomas relatados por 4.740 pacientes que apresentaram a infecção, confirmada pelo diagnóstico laboratorial (RT-PCR), foram avaliados pelos métodos estatísticos do quiquadrado, Kruskal-Wallis e teste-z, considerando significativos os valores de p < 0,05. Resultados: Os sintomas mais frequentes foram febre, tosse, mialgia, coriza, calafrio e dor de garganta, tendo sido relatados por mais de 50% dos pacientes avaliados. Os sintomas indicativos de maior gravidade clínica foram dispneia, dor torácica, hemoptise e pneumonia. Enquanto na influenza sazonal o sintoma diarreia é mais frequente em crianças, na infecção pela influenza pandêmica A (H1N1) 2009 este sintoma foi mais comum em adultos com idade entre 30 e 49 anos. Conclusões: A sintomatologia pode ser diferenciada em relação à faixa etária e ao gênero do paciente, auxiliando, assim, no diagnóstico clínico da doença. A realização da radiografia do tórax pode contribuir para a decisão do tratamento precoce dos casos graves.

Perfil dos usuários de anticitocinas disponibilizadas pelo Sistema Único de Saúde no estado do Paraná para o tratamento da artrite reumatoide / Profile of users of anticytokines off ered by the health care system in the state of Paraná for the treatment of rheumatoid arthritis

INTRODUÇÃO: O tratamento da artrite reumatoide (AR) no âmbito do Sistema Único de Saúde (SUS) tem financiamento do Ministério da Saúde e cofinanciamento das Secretarias Estaduais. O Protocolo Clínico e Diretrizes Terapêuticas (PCDT) para o tratamento da AR descreve o esquema terapêutico para a patologia, inclusive com as anticitocinas adalimumabe, etanercepte ou infliximabe. OBJETIVO: Traçar o perfil dos usuários de anticitocinas, medicamentos biológicos cadastrados no Sistema de Informação do Componente Especializado da Assistência Farmacêutica, gerenciado pelo Centro de Medicamentos do Paraná. MÉTODOS: Foi realizado um estudo transversal tomando como referência o mês de março de 2010. Com base em dados de dispensação, foram coletadas informações relativas a idade, gênero, regional de saúde (RS), Código Internacional de Doenças (CID) e medicamento dispensado. Calculou-se também o custo mensal com anticitocinas para o SUS. RESULTADOS: No estado do Paraná foram encontrados 923 pacientes recebendo anticitocinas, dos quais 40 por cento recebiam adalimumabe, 44 por cento etanercepte e 16 por cento infliximabe, gerando um custo mensal de R$3.403.195,59. Com relação ao CID, 55 por cento dos indivíduos apresentavam CID M05.8, 27 por cento CID M06.0, 9 por cento CID M6.8, 8 por cento CID M5.0 e 1 por cento dos indivíduos apresentava os outros CIDs relacionados com a doença. As RS do Paraná com o maior número de indivíduos em tratamento com anticitocinas foram as de Ponta Grossa, Cornélio Procópio, Londrina, Cianorte, Maringá, Irati e Campo Mourão. CONCLUSÃO: Por meio deste estudo foi possível verificar a distribuição e o perfil dos usuários de anticitocinas para o tratamento da AR no Paraná no âmbito do SUS no mês de março de 2010.

INTRODUCTION: The Brazilian Unified Health Care System (SUS) offers treatment for patients with RA through federal funding (Ministry of Health) and state co-financing. The Clinical Protocol and Therapeutic Guidelines for the treatment of rheumatoid arthritis describe the therapeutic regimen for the disease, including the anticytokines adalimumab, etanercept or infliximab. OBJECTIVES: The aim of this study was to evaluate the profile of registered users of those anticytokines, biologics registered in the Information System of the Pharmaceutical Assistance Specialized Division, managed by the Paraná State Drug Center. METHODS: A cross-sectional study regarding data from March 2010 was conducted. Based on dispensation data, information regarding the following variables were collected: age; gender; regional health care centers; International Classification of Diseases (ICD); and drug dispensed. In addition, the monthly cost with anticytokines for the SUS was calculated. RESULTS: In the state of Paraná, 923 patients on anticytokines were identified, 40 percent, 44 percent and 16 percent of whom receiving adalimumab, etanercept and infliximab, respectively. This generated a monthly cost of R$3,403,195.59. Regarding the ICD, the distribution of patients was as follows: 55 percent had ICD M05.8; 27 percent, ICD M06.0; 9 percent, ICD M6.8; 8 percent, ICD M5.0; and 1 percent had other ICDs related to the disease. The regional health care centers of the state of Paraná with the largest number of patients on anticytokines were in the following municipalities: Ponta Grossa; Cornélio Procópio; Londrina; Cianorte; Maringá; Irati; and Campo Mourão. CONCLUSION: This study assessed the distribution and profile of users of anticytokines for the rheumatoid arthritis treatment covered by the SUS in the state of Paraná, in March 2010.

Evaluation of the Effectiveness of Oseltamivir for the Treatment of 2009 Pandemic Influenza A (H1N1).

Aims: Evaluate retrospectively the effectiveness of treatment with oseltamivir in a Brazilian subpopulation infected during the 2009 pandemic influenza A(H1N1) and compare drug activity based on the presence or absence of other disease risk factors and also the time from onset of symptoms to initiation of treatment. Study Design: Observational and retrospective. Place and Duration of Study: Federal University of Paraná and Parana State Secretary of Health, between April 2009 and December 2010. Methodology: 1,917 patients were included (842 men, 1,075 women; age range 0-90 years) with positive diagnosis for the 2009 influenza virus A (H1N1) characterized by RT-PCR, whose notification forms were available at the time of data collection and that contained information of the use or not of oseltamivir. The patients were categorized by age, gender, symptoms, presence or absence of co morbidities, outcomes (cure or death) and treated or untreated with oseltamivir. The odds ratio (OR) was estimated using a multivariate logistic regression analysis. Kaplan-Meier method was used to determine if differences existed between the survival of untreated patients and oseltamivir treated patients. Results: Out of 1,917 patients, 1,644 had cleared the infection and 273 patients died. Age, education level, cardiopathies, nephropathies, immunodepression, smoking, diabetes, systemic arterial hypertension, obesity, diarrhea, dyspnea, hemoptysis and pneumonia were considered risk factors. The use of oseltamivir provided about 32.3 times more likely to clear the infection compared with untreated patients. Moreover, the effectiveness of oseltamivir is reduced by approximately 7-fold in smoking patients. For each day that passed to initiate treatment after the onset of symptoms, the risk of death increased by 32.3%. Conclusion: The findings suggest that treatment with oseltamivir was effective in producing favorable patient outcomes in those who contracted the 2009 influenza A (H1N1) strain.