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Relatório de atividade do Escritório de Projetos da Presidência - 2019
No full textVídeo com as principais atividades realizadas pelo Escritório de Projetos da Presidência da Fiocruz durante o ano de 2019
Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab
No full textThe potential benefits of early patient access to new medicines in areas of high unmet medical need are recognised, but uncertainties concerning effectiveness, safety and added value when new medicines are authorised, and subsequently funded based on initial preliminary data only, have important implications. In 2016 olaratumab received accelerated conditional approval from both the European Medicines Agency and the US Food and Drug Administration for the treatment of soft-tissue sarcoma, based on the claims of a substantial reduction in the risk of death with an 11.8-month improvement in median overall survival in a phase II trial in combination with doxorubicin vs. doxorubicin alone. The failure to confirm these benefits in the post-authorisation pivotal trial has highlighted key concerns regarding early access and conditional approvals for new medicines. Concerns include potentially considerable clinical and economic costs, so that patients may have received suboptimal treatment and any money spent has foregone the opportunity to improve access to effective treatments. As a result, it seems reasonable to reconsider current marketing authorisation models and approaches. Potential pathways forward include closer collaboration between regulators, pharmaceutical companies and payers to enhance the generation of rapid and comparative confirmatory trials in a safe and fair manner, with minimal patient exposure as required to achieve robust evidence. Additionally, it may be time to review early access systems, and to explore new avenues regarding who should pay or part pay for new treatments whilst information is being collected as part of any obligations for conditional marketing authorisation. Greater co-operation between countries regarding the collection of data in routine clinical care, and further research on post-marketing data analysis and interpretation, may also contribute to improved appraisal and continued access to new innovative cancer treatments.2030-12-3
Parasitismo intestinal e estado nutricional de crianças: estudo transversal em comunidades periurbanas no Maranhão
No full textPobreza, desnutrição e doenças tropicais negligenciadas, como helmintíases transmitidas pelo solo (HTS), interagem em uma rede de retroalimentação multicausal. Este estudo teve como objetivo avaliar as relações entre HTS, renda e estado nutricional de crianças em comunidades carentes da cidade de Caxias, estado do Maranhão, nordeste do Brasil. Realizou-se inquérito transversal (n=259 crianças) com coleta de amostras fecais e avaliação de dados sociodemográficos, antropométricos, dietéticos e sanitários. A ancilostomíase e ascaridíase apresentaram prevalências de 14,3% e 9,3%, respectivamente. A análise de regressão logística mostrou que a infecção por ancilostomíase foi mais frequente em homens (odds ratio [OR] = 3,43; intervalo de confiança de 95% [IC] = 1,45-8,08), crianças de 11-15 anos (OR = 3,72; IC 95% = 1,19-11,62), crianças de famílias pobres (OR = 2. 44; IC95% = 1,04-5,68) e residentes em casa alugada (OR = 5,74; IC95% = 1,91-17,25). Em relação à ascaridíase, residir na comunidade Caldeirões (OR = 0,01; IC95% = 0-0,17) e pertencer à faixa etária de 11-15 anos (OR = 0,21; IC95% = 0,04-1,02) foram fatores de proteção. Crianças pobres consomem em menor frequência carne, leite, vegetais, tubérculos e frutas do que crianças não pobres. O consumo frequente de carne, leite e tubérculos foi associado a valores significativamente maiores no parâmetro altura para idade, enquanto o consumo de carne e leite influenciou positivamente no peso para idade. As frequências de nanismo, baixo peso e emaciação foram de 8,1%, 4,9% e 2,9%, respectivamente. O modelo multivariado demonstrou que a baixa estatura foi significativamente associada à pobreza econômica (OR = 2,82; IC 95% = 1,03-7. 70) e baixo peso foi associado ao sexo masculino (OR = 6,43; IC95% = 1,35-30,68). Em conclusão, o estudo descreve as interações entre as dimensões do desenvolvimento representadas pela renda, HTS e estado nutricional revelando a importância da elevação dos níveis de renda para melhorar as condições de vida das famílias em comunidades empobrecidas no nordeste do Brasil.Poverty, malnutrition and neglected tropical diseases such as soil-transmitted helminthiases (STHs) interact in a multi-causal feedback network. This study aimed to assess the relationships between STHs, income and nutritional status of children in impoverished communities in the city of Caxias, Maranhao State, Northeastern Brazil. A cross-sectional survey (n=259 children) was carried out with the collection of fecal samples and assessment of sociodemographic, anthropometric, dietary and sanitation data. Hookworm infection and ascariasis presented prevalence rates of 14.3% and 9.3%, respectively. The logistic regression analysis showed that hookworm infection was more frequent in males (odds ratio [OR]=3.43; 95% confidence interval [CI]=1.45-8.08), children aged 11-15 years old (OR=3.72; 95% CI=1.19-11.62), children living in poor families (OR=2.44; 95% CI=1.04-5.68) and those living in rented houses (OR=5.74; 95%CI=1.91-17.25). Concerning ascariasis, living in the Caldeiroes community (OR=0.01; 95%CI=0-0.17) and belonging to the 11-15 years age group (OR=0.21; 95%CI=0.04-1.02) were protection factors. Poor children have a significantly lower frequency of consumption of meat, milk, vegetables, tubers and fruits than not poor children. The frequent consumption of meat, milk and tubers was associated with significant higher values in the parameter height-for-age, whereas the consumption of meat and milk positively influenced the weight-for-age. The frequencies of stunting, underweight and wasting were 8.1%, 4.9% and 2.9%, respectively. The multivariate model demonstrated that stunting was significantly associated with economic poverty (OR=2.82; 95%CI=1.03-7.70) and low weight was associated with male sex (OR=6.43; 95% CI=1.35-30.68). In conclusion, the study describes the interactions between the dimensions of development represented by income, STHs and nutritional status revealing the importance of raising income levels to improve the living conditions of families in impoverished communities in Northeastern Brazil
Endocardite Infecciosa: Ainda uma Doença Mortal
No full textShort Editorial related to the article: Risk Factors for In-Hospital Mortality in Infective Endocarditis./ Minieditorial referente ao artigo: Fatores de Risco para Mortalidade Hospitalar na Endocardite Infecciosa.A importante questão da mortalidade intra-hospitalar em endocardite infecciosa (EI) é discutida por Marques et al., A mortalidade intra-hospitalar na coorte International Collaboration in Endocarditis (ICE) (2000-2005) foi de 18%, semelhante à taxa de 17% na grande coorte europeia publicada recentemente, inaceitavelmente altas, considerando que a maioria dos pacientes incluídos era de países desenvolvidos e registros voluntários.The important issue of in-hospital mortality in infective endocarditis (IE) is discussed by Marques et al. In-hospital mortality in the International Collaboration in Endocarditis (ICE) cohort (2000-2005) was 18%, similar to the 17% in the large European cohort recently published, both unacceptably high, considering that most patients included were from developed countries and voluntary registries
Impact of pharmaceutical care on the quality of life of patients with heart failure due to chronic Chagas disease: Randomized clinical trial
No full textAims: Chronic Chagas disease (ChD) has high morbimortality and loss in quality of life due to heart failure (HF). Pharmaceutical care (PC) optimizes clinical treatment and can improve quality of life in HF. We evaluated if PC improves quality of life of patients with ChD and HF. Methods: Single-blinded, randomized, controlled trial that assigned adult patients with ChD and HF (81 patients; 61±11 years; 48% male) to PC (n=40) or standard care (n=41). Quality of life according to SF-36 and Minnesota Living with HF (MLHFQ) questionnaires, incidence of drug-related problems (DRPs), and adherence to medical treatment were determined at baseline and at every 3 months for one year. Intention-to-treat analyses were performed by mixed linear model to verify the treatment effect on the changes of these variables throughout the intervention period. Results: Relative changes from baseline to one year of follow-up of the domains physical functioning (+16.6 vs. -8.5;p<0.001), role-physical (+34.0 vs. +5.2;p=0.01), general health (+19.4 vs. -6.1;p<0.001), vitality (+11.5 vs. -5.8;p=0.003), social functioning (+7.5 vs. - 13.3;p=0.002), and mental health (+9.0 vs. -3.7;p=0.006) of the SF-36 questionnaire and the MLHFQ score (-12.7 vs +4.8;p<0.001) were superior in the PC group than in the standard care group. Adherence to medical treatment increased as early as after 3 months of follow-up and DRPs incidence decreased after 6 months of follow-up only in the PC group. Conclusions: Patients with ChD and HF who received PC presented improved quality of life, decrease in DRPs frequency, and increase in medication adherence.2021-04-0
A case-series of bloodstream infections caused by the Meyerozyma guilliermondii species complex at a reference center of oncology in Brazil
No full textBloodstream infections (BSI) caused by Candida species are the fourth cause of healthcare associated infections worldwide. Non-albicans Candida species emerged in the last decades as agents of serious diseases. In this study, clinical and microbiological aspects of six patients with BSI due to the Meyerozyma (Candida) guilliermondii species complex from an oncology reference center in Brazil, were evaluated. To describe demographic and clinical characteristics, medical records of the patients were reviewed. Molecular identification of the isolates was performed by ITS1-5.8S-ITS2 region sequencing. Antifungal susceptibility was evaluated by the EUCAST method and the minimal inhibitory concentrations (MIC) assessed according to the epidemiological cutoff values. Virulence associated phenotypes of the isolates were also studied. Ten isolates from the six patients were evaluated. Five of them were identified as Meyerozyma guilliermondii and the others as Meyerozyma caribbica. One patient was infected with two M. caribbica isolates with different genetic backgrounds. High MICs were observed for fluconazole and echinocandins. Non-wild type isolates to voriconazole appeared in one patient previously treated with this azole. Additionally, two patients survived, despite infected with non-wild type strains for fluconazole and treated with this drug. All isolates produced hemolysin, which was not associated with a poor prognosis, and none produced phospholipases. Aspartic proteases, phytase, and esterase were detected in a few isolates. This study shows the reduced antifungal susceptibility and a variable production of virulence-related enzymes by Meyerozyma spp. In addition, it highlights the poor prognosis of neutropenic patients with BSI caused by this emerging species complex.
Lay abstract: Our manuscript describes demographic, clinical and microbiological characteristics of patients with bloodstream infection by the Meyerozyma guilliermondii species complex at a reference center in oncology in Brazil
Physiology and immunity of the invasive giant African snail, Achatina (Lissachatina) fulica, intermediate host of Angiostrongylus cantonensis
No full textAs one of the most successful invasive land snail species, Achatina (Lissachatina) fulica Bowdich, 1822 has achieved wide global distribution, particularly in (sub)tropical regions, with further dispersal likely due to climate change. This species of giant African snails (up to 17 cm shell length) is a pest that has extensive negative impact on agriculture and can serve as vector for several parasites, including Angiostrongylus cantonensis, a nematode parasite that causes (human) eosinophilic meningitis, an emergent disease. Investigation showed that A. cantonensis infection negatively impacts the metabolism of A. fulica by depleting polysaccharide stores of the intermediate host, compromising the energy balance of the snail. A review of the literature indicates that A. fulica possesses potent innate type immune defenses to counter infection, including phagocytic hemocytes capable of deploying reactive oxygen species and lectins for non-self recognition, a serine protease-dependent coagulation response (not observed in other taxa of gastropods), as well as antimicrobial proteins including achacin, an antimicrobial protein. A recent chromosome level genome assembly will facilitate progressively detailed characterization of these immune features of A. fulica. We strongly encourage further immunological studies of A. fulica, ranging from organismal level to molecular biology to gain better understanding of the A. fulica internal defense response to nematode pathogens like A. cantonensis and the contribution of immune function to the invasiveness of (snail) species. Characterization of immunity of A. fulica, representing the understudied Stylommatophora (panpulmonate landsnails) will also broaden the comparative immunology of Gastropoda.2022-12-3
O apoiador institucional na UBSF: gestão da prestação de serviços de APS para populações rurais.
No full textEste estudo analisa o perfil de atuação do apoio institucional em Unidade Básica de Saúde Fluvial na prestação de serviços de atenção primária à saúde ofertados pelo Distrito de Saúde Rural, da Secretaria Municipal de Saúde de Manaus, à população rural-ribeirinha que vive na margem esquerda do Baixo Rio Negro, no trecho compreendido entre os municípios de Manaus e Novo Airão, Amazonas. Estudo qualitativo, que entrevistou 100% (onze) da equipe de gestão das unidades móveis fluviais da Secretaria Municipal de Saúde de Manaus. A análise dos dados foi pautada através da Análise de Conteúdo Categorial, apoiada pelo software MAXQDA Analytics Pro 2020. Os resultados evidenciaram o pouco reconhecimento institucional do cargo de apoiador em contexto rural, com apenas um profissional oficialmente nomeado. A equipe de gestão do Distrito de Saúde Rural apresentou um conhecimento incipiente a respeito do profissional apoiador e de sua política institucional, embora tenham desenvolvido atribuições deste perfil profissional nas rotinas de atendimento às comunidades rurais. Quanto ao apoiador, diferentemente do contexto urbano, observou-se a importância de sua imersão nas atividades itinerantes junto às equipes de Unidades Básicas de Saúde Fluvial (UBSFs) para o desenvolvimento de suas ações. No entanto, para além das atividades que lhe são prescritas, este assume responsabilidade sobre demandas consideradas essenciais para as ações das equipes de UBSFs, como logística, provisão de insumos e materiais necessários aos atendimentos, ações de caráter administrativo, o que pode ser consequência de um conhecimento pouco satisfatório do território rural pela gestão. Pode-se concluir que o apoio institucional se mostra essencial ao desenvolvimento das atividades de equipes de UBSFs em cenário rural. Deve-se ressaltar que o trabalho de apoiador é insuficiente para instituir práticas democráticas entre equipes de gestão, equipe multiprofissionais e comunidades fazendo-se necessária a ampliação do conhecimento sobre os cenários rurais e suas peculiaridades para lograr a reformulação do modelo de gestão de o perfil assistencial vigentes.o Programa de Pesquisa para o Sistema Único de Saúde/Fundação de Amparo à Pesquisa no Estado do Amazonas (PPSUS/FAPEAM).This study analyzes the profile of institutional support in a Basic Health Unit River in the provision of primary health care services offered by the Health District of the Municipal Health Department of Manaus, to the rural river population that lives on the left bank of the Lower Rio Negro, in the stretch between the municipalities of Manaus and Novo Airão, Amazonas. Qualitative study, which interviewed 100% (eleven) of the team management of mobile fluvial units of the Municipal Health Department of Manaus. THE Data analysis was guided by Categorical Content Analysis, supported by the MAXQDA Analytics Pro 2020 software. The results showed how little institutional recognition of the role of supporter in a rural context, with only one officially appointed professional. The management team of the Rural Health District presented an incipient knowledge about the supporting professional and its institutional policy, although they have developed attributions of this professional profile in the care routines to rural communities. As for the supporter, unlike the urban context, it was observed the importance of their immersion in itinerant activities with the Basic Units teams of River Health (UBSFs) for the development of their actions. However, in addition to the activities that are prescribed to him, he assumes responsibility for demands considered essential for the actions of the UBSFs teams, such as logistics, provision of inputs and materials necessary for care, administrative actions, which can be consequence of an unsatisfactory knowledge of the rural territory by the management. you can conclude that institutional support is essential for the development of UBSF teams in a rural setting. It should be noted that the supporter's work is insufficient to institute democratic practices among management teams, professionals and communities, making it necessary to expand knowledge about rural scenarios and their peculiarities to achieve the reformulation of the current care profile.2022-12-0
Nota Técnica. Limites e possibilidades dos municípios brasileiros para o enfrentamento dos casos graves de COVID19
No full textUma das grandes preocupações no enfrentamento da pandemia da covid-19 tem sido a disponibilidade de estrutura hospitalar capaz de atender cerca de 20% de casos que requerem cuidados mais complexos. Mais especificamente, aproximadamente 5% exigem cuidados intensivos em unidades de saúde com capacidade de oferta de atendimento de alta complexidade. Algumas notas técnicas já foram recentemente divulgadas no país, concentradas specialmente na disponibilidade de leitos de UTI e respiradores em regiões de
saúde e Unidades da Federação, com base no Cadastro Nacional de Estabelecimentos de Saúde (CNES)2-5. Esses estudos apresentam a insuficiência da atual capacidade instalada de equipamentos (leitos clínicos, leitos de UTI, respiradores, laboratórios) no sistema de saúde
brasileiro (oferta SUS e privada), assim como desigualdades regionais, reportando para maiores ou menores ajustes frente ao crescimento das curvas de expansão da pandemia. Esta nota técnica insere-se neste contexto de produção. Na perspectiva do monitoramento da estrutura hospitalar frente à evolução da pandemia de covid-19 causada pelo novo coronavírus (SARS-CoV-2) no país, objetiva caracterizar o ponto inicial de
observação - fevereiro de 2020 - buscando adicionar contribuições em dois sentidos: 1) considerar, para além dos leitos de UTI e respiradores/ventiladores, a disponibilidade de outros equipamentos importantes para a provisão de cuidados a pacientes que requeiram
estabilização em quadros graves; 2) identificar um conjunto de municípios inicialmente aptos para o atendimento hospitalar de pacientes com covid-19