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Objectives: To compare topical granulocyte and macrophage colony-stimulating factor (GM-CSF) and miltefosine (G + M) versus placebo and miltefosine (P + M) or parenteral meglumine antimoniate (MA) in the treatment of 150 patients with cutaneous leishmaniasis (CL) caused by Leishmania guyanensis in the Amazon. Design: A randomized and double-blinded clinical trial. Results: At 90 days after the initiation of therapy, the cure rates were 66%, 58%, and 52% for the groups P + M, G + M, and MA, respectively (p > 0.05). Cure rates at 180 days did not differ. Healing time was similar in the 3 groups, but faster in the MA group as compared to the G + M group (p = 0.04). Mild and transitory systemic adverse events were frequent in all groups (above 85%). Nausea (85%) and vomiting (39%) predominated in the miltefosine groups and arthralgia (51%) and myalgia (48%) in the MA group. One patient (group MA) stopped treatment after presenting with fever, exanthema, and severe arthralgia. Conclusions: Miltefosine did not present a higher cure rate than MA, and the association of GM-CSF did not improve the therapeutic response. Nevertheless, because of its less toxicity, easier administration, and a similar cure rate when compared with MA, miltefosine should remain as one of the main drugs for treating CL due to L. guyanensis.(Clinicaltrials.gov Identifier NCT03023111).

Cutaneous leishmaniasis (CL) due to L. braziliensis is associated with an exaggerated inflammatory response and tissue damage. Miltefosine is more effective than pentavalent antimony (Sbv) in the treatment of CL, and here, we evaluate the ability of Sbv, miltefosine, and GM-CSF administered intravenously, orally, or topically, respectively, to modify the immune response. Patients were treated with miltefosine plus GM-CSF, miltefosine plus placebo, or Sbv. Mononuclear cells were stimulated with soluble Leishmania antigen (SLA) on day 0 and day 15 of therapy, and cytokine levels were determined in supernatants by ELISA. The lymphocyte proliferation and oxidative burst were evaluated by flow cytometry, and the degree of infection and Leishmania killing by optical microscopy. Proliferation of CD4+ T cells were enhanced in patients using miltefosine and in CD8+ T cells when GM-CSF was associated. Enhancement in the oxidative burst occurred in the miltefosine plus GM-CSF group on day 15 of therapy. Moreover, the number of L. braziliensis in infected monocytes on day 15 as well as the percentage of infected cells was lower after 48- and 72-hour culture in cells from patients treated with miltefosine plus GM-CSF. In addition to the ability of miltefosine to kill Leishmania, the changes in the immune response caused by miltefosine and GM-CSF may increase the cure rate of CL patients using these drugs.

The Center for Data and Knowledge Integration for Health (CIDACS) was created in 2016 in Salvador (Bahia, Brazil). This paper aims to present a profile of CIDACS, including its current databases. CIDACS aims to conduct interdisciplinary studies and research, develop new scientific methodology and promote professional training using linked large-scale databases and high-performance computational resources in a secure environment. Administrative data is at the core of the activities conducted by CIDACS. The advantages of administrative data include significantly larger sample sizes, an inherent longitudinal structure and high-quality information. The center’s research projects are primarily focused on enhancing the understanding surrounding the impact of social protection policies (e.g., public cash-transfer and housing programs) on health outcomes in low-income populations throughout Brazil. CIDACS’ primary data source is citizens who register with the Cadastro Único program, which encompasses individuals eligible to receive benefits from over 20 governmental social programs. CIDACS has two separate environments for data handling: 1) Data Production Center, a secure room housing the computational infrastructure for ingesting, storing, cleaning, processing and linking original databases, as well as extracting research-ready datasets and 2) Data Analysis Environment, a computational infrastructure based on data safe haven principles, which allows researchers to access and process requested datasets. Brazil has a large public health community that uses national health and social databases for research programs, and the linkage of different databases has been a widely employed practice in the country. CIDACS is the result of efforts by researchers, policymakers and public health officials to use and improve the quality of Brazilian health databases. CIDACS is expected to be an important resource for researchers and policymakers interested in improving the evidence base in different aspects of health, as well as with regard to the social determinants of health and the effects of social and environmental policies on health in general.

In Brazil, reportable diseases are the responsibility of the Secretariat of Health Surveillance of the Brazilian Federal Ministry of Health. During 2001–2006, to determine incidence and hospitalization rates, we analyzed 5 diseases (malaria, leishmaniasis [cutaneous and visceral], dengue fever, leprosy, and tuberculosis) that are endemic to the Amazon region of Brazil. Data were obtained from 773 municipalities in 3 regions. Although incidence rates of malaria, leishmaniasis, tuberculosis, and leprosy are decreasing, persons in lower socioeconomic classes with insufficient formal education are affected more by these diseases and other health inequalities than are other population groups in the region.

Nos últimos anos, tem havido uma maior preocupação internacional com a disseminação ou propagação de agentes etiológicos e doenças, de natureza infecciosa, química e radionuclear. Visando adequar os conceitos e as medidas para evitar ou reduzir o risco dessa disseminação, foi adotado pelos países o novo conceito de emergência de saúde pública de importância internacional, no âmbito do RSI (2005), e implementadas novas estratégias para preparação e resposta a essas emergências. Com base em análise de risco contextualizada sobre eventos de saúde que podem se disseminar internacionalmente, busca-se contar com instrumentos mais oportunos que permitam a identificação e a atuação precoce sobre esses eventos. A adaptação desse conceito, para o propósito da vigilância em saúde e rede de atenção dos serviços de saúde nacional, tem permitido um melhor gerenciamento dos eventos de saúde que constituem risco de disseminação ou propagação de doenças ou agravos dentro do território nacional, além de oferecer uma resposta mais oportuna. A análise sobre esses eventos, realizada no presente trabalho, indica que a ocorrência de desastres ambientais, em número mais reduzido quando comparada com os eventos de natureza infecciosa, coloca em situação de risco a população ou gera danos à saúde em um contingente populacional maior. Por sua vez, os eventos de natureza infecciosa, que em sua maioria ocorrem sob a forma de surtos ou epidemias, acometem um maior número de municípios e apresentam maior letalidade. As medidas adotadas no país para aperfeiçoar o sistema de vigilância em saúde na detecção, preparação e resposta às emergências de saúde pública são descritas neste artigo e são destacados os principais desafios colocados pelos níveis de gestão do sistema.During recent years has increased international concern about the spread of diseases or agents from infectious, chemical or radio-nuclear sources. Aiming to adapt the concepts and measures to prevent or reduce the risk of this spread, was adopted by the countries the new concept of "public health emergency of international concern" under the IHR (2005), and implemented new strategies for strengthening the activities to prepare and response to such emergencies. Based on contextualized risk analysis of health events that can spread internationally, one search to get more appropriate tools to timely identification and intervention on these events. The adaptation of this concept for the purpose of national health surveillance and health care services in Brazil, has allowed a better management of health events that may represent risk of spread of diseases or injuries in the national territory and provide a more timely response. The analysis of these events, presented in this work, shows that the occurrence of environmental disasters with fewer number of events than infectious events, may constitute risk of damage or affect directly larger contingent of population. On the other hand, the infectious events, which usually occur as outbreaks or epidemics, affect a larger number of municipalities and have higher lethality. The measures adopted at the country to improve the health surveillance system on detection, preparedness and response to public health emergencies are described here and the main challenges in terms of managing this system are highlighted.

To detect areas with increased case-detection rates, we used spatial scan statistics to identify 5 of 10 clusters of leprosy in the Amazon region of Brazil. Despite increasing economic development, population growth, and road infrastructure, leprosy is endemic to this region, which is a source of case exportation to other parts of Brazil.

Cutaneous leishmaniasis (CL) is treated with parenteral drugs for decades with decreasing rate cures. Miltefosine is an oral medication with anti-leishmania activity and may increase the cure rates and improve compliance.This study is a randomized, open-label, controlled clinical trial aimed to evaluate the efficacy and safety of miltefosine versus pentavalent antimony (Sb(v)) in the treatment of patients with CL caused by Leishmania braziliensis in Bahia, Brazil. A total of 90 patients were enrolled in the trial; 60 were assigned to receive miltefosine and 30 to receive Sb(v). Six months after treatment, in the intention-to-treat analyses, the definitive cure rate was 53.3% in the Sb(v) group and 75% in the miltefosine group (difference of 21.7%, 95% CI 0.08% to 42.7%, p = 0.04). Miltefosine was more effective than Sb(v) in the age group of 13-65 years-old compared to 2-12 years-old group (78.9% versus 45% p = 0.02; 68.2% versus 70% p = 1.0, respectively). The incidence of adverse events was similar in the Sb(v) and miltefosine groups (76.7% vs. 78.3%). Vomiting (41.7%), nausea (40%), and abdominal pain (23.3%) were significantly more frequent in the miltefosine group while arthralgias (20.7%), mialgias (20.7%) and fever (23.3%) were significantly more frequent in the Sb(v) group.This study demonstrates that miltefosine therapy is more effective than standard Sb(v) and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil.Clinicaltrials.gov Identifier NCT00600548.