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Resumo A fim de identificar e discutir opções informadas por evidências para abordar a judicialização da saúde no Brasil, utilizou-se as Ferramentas SUPPORT (Supporting Policy Relevant Reviews and Trials). A busca foi realizada nas bases PubMed; Health Systems Evidence; Campbell Collaboration; Cochrane Library; Rx for Change Database e PDQ-Evidence. A seleção e avaliação da qualidade metodológica foi feita por dois revisores independentes. Os resultados foram apresentados numa síntese narrativa. Dezenove revisões sistemáticas apontam quatro opções: 1) Serviço de respostas rápidas; 2) Programa de educação permanente; 3) Serviço de mediação entre as partes envolvidas; e 4) Adoção de ferramenta online (baseada em computador) de suporte à decisão e de intervenções mediadas por pacientes. Conclusões: Apresentamos e caracterizamos quatro opções que podem ser consideradas para abordar a judicialização da saúde. A implementação dessas opções deve garantir a participação de diferentes atores, refletindo sobre variados contextos. Recursos humanos e financeiros, capacitação das equipes, são os principais pontos críticos.

This article seeks to identify and discuss evidence-informed options to address the judicialization of health. The Supporting Policy Relevant Reviews and Trials Tools were used to define the problem and the search strategy, which was carried out in the following databases: PubMed, Health Systems Evidence, Campbell, Cochrane Collaboration, Rx for Change Database, and PDQ-Evidence. Selection and assessment of methodological quality was performed by two independent reviewers. The results were presented in a narrative synthesis. This study selected 19 systematic reviews that pointed out four strategies to address the judicialization of health in Brazil: 1) Rapid response service, 2) Continuous education program, 3) Mediation service between the parties involved, and 4) Adoption of a computer-based, online decision-making support tool and patient-mediated interventions. This study therefore presented and characterized four options that can be considered to address the judicialization of health. The implementation of these options must ensure the participation of different actors, reflecting on different contexts and the impact on the health system. The availability of human and financial resources and the training of teams are critical points for the successful implementation of the options.

Objective: To assess the cost-per-responder (CpR) of biologic therapies available in Brazil to treat moderate-to-severe plaque psoriasis (PsO) from the private healthcare system’s perspective. Methods: Number needed to treat (NNT) and (CpR) analyses were performed to evaluate biologic therapies’ cost-effectiveness for moderate-to-severe PsO available in Brazil. The effectiveness of biologic treatments for moderate-to-severe PsO was assessed based on a previously published metanalysis, which included studies considering PsO patients and outcomes of interest (PASI 75, 90, and 100). The clinical efficacy data in terms of estimated NNT based on the network metanalysis (NMA) results were combined with drug treatment costs to determine the CpR for each treatment arm in 3-time horizons: the primary response period, 1-year, and 2-years. Results: Risankizumab was the most cost-effective option when NMA base case scenario data was used to calculate NNT in all PASI response for both the primary response period and 1- and 2-years follow-up durations. Differences in CpR between risankizumab and other biologic drugs increased with more significant PASI improvements. CpR sensitivity analysis also confirmed these findings, indicating that risankizumab has a better performance for PASI 100, and both risankizumab and guselkumab are very similar in terms of cost per additional PASI 75 and PASI 90 responder. Conclusions: Risankizumab was estimated to have a lower cost per PASI 75, 90, and 100 responders in most simulated scenarios (primary response period [12-16 weeks], 1-year and 2-years), among the evaluated biologic therapies.

Introduction:In Brazil, health is a constitutional right and the government is responsible for its guarantee. The Brazilian health system is characterized by universality, equality, and integrality, but citizens still strive to guarantee their rights through litigation. This work aimed to develop an evidence brief to support the decision-making process of judges with respect to health technologies, based on scientific evidence.Methods:Support tools from the Evidence-Informed Policy Network (EVIPNet) were used to develop the evidence brief. After defining and describing the problem, a comprehensive search was conducted in PubMed, Health Systems Evidence, The Campbell Library, The Cochrane Library, Rx for Change, and PDQ-Evidence for systematic reviews published from 2010 to 2016. Nine systematic reviews were found. Review selection and quality appraisal were conducted independently by two reviewers. Three strategies for addressing the health litigation were defined. Evidence was summarized on benefits, harms, resource use, cost-effectiveness, uncertainties, and implementation. Implementation barriers and facilitators were also described.Results:Three strategies were found: (i) Rapid response services to support evidence-informed decision making in health technology decisions—educational activities and materials were described as an effective way to involve different stakeholders and inform decision making, even when financial reallocation is needed; (ii) Continuing education programs focused on developing health technology assessment knowledge among law workers—continued education and educational outreach may be effective in knowledge and ability acquisition and retention, changing professional practices. Eventual lack of interest from or availability of the professionals can be addressed by involving leaders and opinion makers, as well as offering multimedia educational materials and activities adapted for the public; and (iii) Restorative justice conferencing (RJC) focused on the litigation of health technologies—the use of RJC through face-to-face meetings or social councils involves citizens in the decision-making process, including resource management. There are multiple barriers to this option (e.g. a lack of understanding among the public, conflicts of interest, a lack of professionals capable of conducting RJCs, and the need for legal reformulation) because of its unprecedented use in the healthcare setting. Opinion leaders should be invited to facilitate communication and the decision-making process among citizens, government, and the law.Conclusions:This evidence brief will be debated among interested parties and presented to the health minister and state secretaries in order to implement the strategy options, once regional specificities are taken into account.

Neospora caninum is a parasite of the Apicomplexa phylum responsible for abortion and losses of fertility in cattle. As part of its intracellular cycle, the first interaction of the parasite with the target cell is performed with the surface proteins known as the SRS superfamily (Surface Antigen Glycoprotein - Related Sequences). SAG related or SRS proteins have been a target of intense research due to its immunodominant pattern, exhibiting potential as diagnostic and/or vaccine candidates. The aim of this study was the cloning, expression and characterization of the gene NcSRS67 of N. caninum using a novel designed plasmid. The coding sequence of NcSRS67 (without the signal peptide and the GPI anchor) was cloned and expressed constitutively instead of the ccdB system of pCR-Blunt II-TOPO. The protein was purified in a nickel sepharose column and identified by mass spectrometry (MS/MS). The constitutive expression did not affect the final bacterial growth, with a similar OD 600nm compared to the non-transformed strains. The recombinant NcSRS67 was over expressed and the native form was detected by the anti-rNcSRS67 serum on 1D western blot as a single band of approximately 38kDa as predicted. On an in vitro assay, the inhibitory effect of the polyclonal antiserum anti-rNcSRS67 was nearly 20% on adhesion/invasion of host cells. The NcSRS67 native protein was localised on part of the surface of N. caninum tachyzoite when compared to the nucleus by confocal immunofluorescence.

INTRODUCTION:The increase of litigation in Brazil on the right to health, and the Brazilian Public Health System (SUS) targets of litigation, are phenomena that generate discussions both in the judiciary, and among researchers and managers of health. The lawsuits are based on the integrality that includes the right to any health technology. Our aim was to gather information on the use of scientific evidence by judges and other law professionals to support their decisions in lawsuits involving health care in Brazil.METHODS:A narrative review by literature search using key terms of legalization in specific databases was conducted.RESULTS:Twenty-five studies showed litigation matters relating to health care which were focused on legal claims about drugs. In general, law operators used the scientific evidences in a limited way when making decisions, by considering the medical report and medication label indications and disregarding therapeutic alternatives contemplated in the SUS list. The access to health technologies, by litigation, reveals that the gap between scientific knowledge and legal practice are similar to those found between science and decision-making in the formulation and implementation of health policies. The Health Technology Assessment studies have high potential for use by the judiciary as a reference source to support technical and scientific decisions in lawsuits on health care.CONCLUSIONS:For the judiciary to ensure not only access to health technologies, but also the efficacy and safety of technologies to system users, their decisions must be substantiated by scientific evidence. The National Committee for Health Technology Incorporation (CONITEC) in SUS has established actions in conjunction with law operators and society, such as a communication using e-mail, aiding the decision for the injunction and elaboration of technical reports and a policy brief, with the intention that the decisions are taken with the greatest possible knowledge about technologies provided by SUS, and based on scientific evidence.

Plantas do gênero Alternanthera (Amaranthaceae) vêm sendo estudadas por suas propriedades antiparasitária, antibacteriana e antiviral. No Brasil a planta Alternanthera tenella Colla, objeto de nossa investigação, é utilizada na medicina popular por possuir atividade antiinflamatória. Considerando a importância do sistema imunológico em infecções e em doenças auto-imunes sistêmicas que apresentam intensa reação inflamatória, o objetivo do atual estudo foi investigar a ação imunomoduladora de extratos de A. tenella no sistema imune de camundongos BALB/c e sua atividade em modelo de artrite experimental induzida pelo óleo mineral pristane (2,6,10,14-tetrametilpentadecano) em camundongos AIRmax, obtidos por seleção genética para reação inflamatória aguda máxima. Extratos brutos orgânicos (etanólico e hexânico), aquosos, frações e flavonóides foram inoculados via intraperitoneal em camundongos BALB/c imunizados ou não com eritrócitos de carneiro (EC). Efeitos imunomoduladores e imunotóxicos foram avaliados através da determinação do peso corporal e dos órgãos linfóides, celularidade do baço e de ensaios funcionais como enumeração de células formadoras de placas (PFC, plaque forming cells), produção de anticorpos anti-EC e edema de pata induzido por carragenina. Posteriormente foram avaliados os efeitos dos extratos aquosos nas subpopulações de linfócitos esplênicos (CD3, CD4, CD8 e CD19), na expressão de marcadores de ativação de linfócitos (CD25, CD40, CD45RB e CD69) e na indução de apoptose nessas células. Os extratos avaliados não induziram alterações no peso dos animais e dos órgãos (baço, timo e fígado) após 4 e 14 dias. Animais imunizados com EC e tratados com o flavonóide 2-O--L-ramnopiranosilvitexina (15 mg/kg), isolado de extrato bruto etanólico (E) ou com o extrato aquoso extraído a frio (AF - 100 mg/kg) apresentaram aumento significativo (p

A quantidade de decisões judiciais para o fornecimento de tecnologias em saúde e, em especial medicamentos, segue uma trajetória crescente desde a Constituição Federal de 1988, trazendo dificuldades à gestão do SUS. A Lei 12.401/2011, ao instituir a Comissão Nacional de Incorporação de Tecnologias no SUS - CONITEC com a finalidade de assessorar tecnicamente o Ministério da Saúde trouxe um componente importante a essa questão, na medida em que disciplinou o processo de avaliação e incorporação de tecnologias em saúde, propiciando a tomada de decisão baseada em evidências científicas, com o estabelecimento de prazos processuais e mecanismos para a participação social. No âmbito de sua atuação, a CONITEC, por meio de sua Secretaria-Executiva, tem estabelecido canais de comunicação com os operadores do Direito e com a sociedade, visando a apresentar esclarecimentos e informações para que as respectivas ações e decisões sejam tomadas com o maior conhecimento possível acerca das tecnologias em saúde disponibilizadas pelo SUS. Este artigo apresenta um estudo de caso descritivo e analítico, que utilizou como fonte de dados 889 respostas e 260 informações técnicas enviadas no período de 2012 a 2015 e os indicativos da sua contribuição para a prevenção da judicialização da saúde.

A Avaliação de Tecnologias em Saúde (ATS) é um campo multidisciplinar de análise de políticas, que estuda as implicações clínicas, sociais, éticas e econômicas das tecnologias em saúde, levando-se em consideração eficácia, efetividade, segurança, custo-efetividade, etc. Entretanto, impactos éticos, legais e sociais, direcionados a perspectivas de pacientes e sociedade, são postergados em detrimento de atributos clínicos e econômicos. Com a crescente ênfase sobre o engajamento dos pacientes pelo direito aos seus próprios cuidados, há necessidade de determinar meios efetivos para envolver a sociedade nos processo de avaliação e de decisão. O objetivo do presente trabalho foi explorar os desafios presentes no contexto internacional e nacional para envolver o público nos processos de ATS do Sistema Único de Saúde (SUS). Adotou-se método integrativo, composto por revisão da literatura e análise de registro oficiais do Ministério da Saúde. A análise dos resultados mostrou experiências internacionais em franco desenvolvimento, destacando-se Reino Unido e Canadá. No Brasil, existem instrumentos legais para envolver o cidadão na ATS, mas sua implementação é recente e tem sido realizada gradualmente. Os principais desafios em âmbito nacional e internacional estão relacionados aos aspectos culturais. Com base nos resultados foi possível apontar proposições para aprimorar esses mecanismos de envolvimento. Descritores: Avaliação da Tecnologia Biomédica; participação social; participação comunitária.

F1 fraction from Paracoccidioides brasiliensis is a potent activator of the complement system. Considering that complement receptors CR1 and CR2 are involved in the regulation of B cell response, we evaluated the in vitro effect of the F1 in the activation of B lymphocytes, as well as the participation of complement receptors in this process. Murine splenocytes were cultured in order to evaluate the expression of CD40, CD45RB and CD69 on B lymphocyte, and IgG and IgM were quantified in the culture supernatant. F1 participated in the activation of B cells, showing a positive modulation effect on all markers analyzed. An increase in the production of IgG was detected in the supernatants when the opsonized F1 fraction was present. Complement receptor blockade with monoclonal antibodies led to a partial reduction in immunoglobulin secretion, suggesting that these receptors, especially CR2, play a role in modulating the function of B lymphocyte stimulated with the opsonized F1 fraction. These results may contribute for a better understanding of the B cell activation and differentiation processes in response to the F1 fraction from P. brasiliensis.

Alternanthera tenella Colla extracts are used in Brazilian traditional folk medicine to treat a variety of infectious diseases as well as inflammation and fever. In this work, the immunomodulatory, anti-inflammatory and potential toxic effects of cold (CAE) and hot (HAE) aqueous extracts of A. tenella were investigated in vivo. In addition, we analyzed the phytochemical properties of both extracts. BALB/c mice were immunized in vivo with sheep red blood cells and concomitantly inoculated intraperitoneally (i.p.) with each extract (50, 100 or 200 mg/kg). Specific antibody-producing cells were enumerated using plaque-forming cell assays (PFC) and anti-SRBC IgG and IgM serum levels were measured via enzyme-linked immunosorbent assay. Body and lymphoid organ weights were determined after treatments in order to evaluate toxic effects. Carrageenan-induced paw edema was employed to investigate anti-inflammatory activity in mice inoculated i.p. with CAE or HAE (200 or 400 mg/kg). Phytochemical screening was performed using spectrometric and chromatographic approaches and revealed that CAE possessed higher tannin and flavonoid levels than HAE. PFC numbers were increased after treatment with CAE (100 mg/kg) four days after immunization, as were the serum antibody titers after four and seven days, suggesting immunostimulatory activity through modulation of B lymphocyte functions. Body and organ weights did not show major changes, suggesting that extracts administered to mice did not induce significant toxicity. Both extracts had significant anti-inflammatory activity in the paw edema assay. These results suggested that aqueous extracts from A. tenella contained several chemical compounds that possess positive and/or negative modulator effects on the immune system, which appeared to correlate with tannin and flavonoid levels in those extracts. In summary, these studies provide important insight into the biological activities of A. tenella.