Gerson Oliveira Penna

Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis in Brazil: A Randomized and Controlled Trial

Background 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. Methodology/Principal Findings This study is a randomized, open-label, controlled clinical trial aimed to evaluate the efficacy and safety of miltefosine versus pentavalent antimony (Sbv) 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 Sbv. Six months after treatment, in the intention-to-treat analyses, the definitive cure rate was 53.3% in the Sbv 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 Sbv 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 Sbv 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 Sbv group. Conclusions This study demonstrates that miltefosine therapy is more effective than standard Sbv and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil. Trial Registration Clinicaltrials.gov Identifier NCT00600548

Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil

Miltefosine has been used in the treatment of several new world cutaneous leishmaniasis (CL) species with variable efficacy. Our study is the first evidence on its clinical efficacy in Leishmania (Viannia) guyanensis. In this phase II/III randomized clinical trial, 90 CL patients were randomly allocated (2:1) to oral miltefosine (2.5 mg/kg/day/28 days) (N = 60) or parenteral antimony (15-20 mg/Sb/kg/day/20 days) (N = 30) according to age groups: 2-12 y/o and 13-65 y/o. Patients were human immunodeficiency virus (HIV) noninfected parasitological proven CL without previous treatment. Definitive cure was accessed at 6 months follow-up visit. No severe adverse events occurred. Vomiting was the most frequent adverse event (48.3%) followed by nausea (8.6%) and diarrhea (6.7%). Cure rates were 71.4% (95% confidence interval [CI] = 57.8-82.7) and 53.6% (95% CI = 33.9-72.5) (P = 0.05) for miltefosine and antimonial, respectively. There were no differences in cure rates between age groups within the same treatment arms. Miltefosine was safe and relatively well tolerated and cure rate was higher than antimony.

Imunopatologia da hanseníase: a complexidade dos mecanismos da resposta imune do hospedeiro ao Mycobacterium leprae

Leprosy, whose etiologic agent Mycobacterium leprae, is an illness of ample clinical and immunopathological spectrum. Its clinical manifestations are correlated with distinct immunologic forms, varying from a vigorous immune response mediated by cells to M. leprae, with Th1 standard in the tuberculoid polar region, to an absence of specific cellular response to antigens of M. leprae in the lepromatous polar region, with predominance of Th2 response and exacerbation of humoral response. It is probable that different polymorphic genes determine susceptibility to M. leprae. Additional studies are necessary to clarify the complex interactions between cytokines and the role of the phenotypic diversity of cells network that contribute to the host defense. The comprehension of such mechanisms will provide new insights for the identification of agonists and/or antagonists for pro- or anti-inflammatory effects, and also will indicate possible situations for its appropriate use in immunologic and/or immunotherapeutic interventions.

Prática de atividade física e sedentarismo em brasileiros: resultados da Pesquisa Nacional por Amostra de Domicílios (PNAD) 2008

Population surveys are a key component of the relevant activities for public health. There is growing interest in identifying behavioral aspects which influence individual and collective health, such as physical activity (PA). The aim of this study is to present PA data from the 2008 Brazilian National Household Survey (PNAD) according to regional distribution and the socio-demographic characteristics. A partnership between the Brazilian Institute of Geography and Statistics and the Ministry of Health was responsible for preparing the health supplement of the questionnaire. The sample size was 292,553 individuals. The proportion of subjects practicing PA at the recommended levels in leisure time was 10.5%, exactly the same proportion of subjects reporting active transportation to and from work. Males and younger adults were more active; schooling was directly related to leisure-time PA and inversely associated with transport-related physical activity. One fifth of the Brazilians did not report any physical activity at all and 35.7% watch TV for 3 hours or more, on average, per day. These data may help design public policies aimed at promoting health, in particular through PA, which may positively influence on the quality of life of the Brazilian population.

Vivência de violência entre escolares brasileiros: resultados da Pesquisa Nacional de Saúde do Escolar (PeNSE)

This article presents the main results of the National Adolescent School-based Health Survey (PeNSE). A questionnaire was applied to a sample of 60,973 students of the 9th year of Junior high school in public and private schools of the Brazilian state capitals and the Federal District, between March and June 2009. The prevalence and confidence interval of 95% (CI 95%) of the violence situations involving adolescents were analyzed. The following situations were identified: lack of safety on the way home-school (6.4%; CI95%: 6.1%-6.8%) and at school (5.5%; CI95%: 5.2%-5.8%); involving fights with physical aggression (12.9%; CI95%: 12.4%-13.4%), with knife (6.1%; CI95%: 5.7%-6.4%) or fire arm (4.0%; CI95%: 3.7%-4.3%); physical aggression by family member (9.5%; CI95%: 9.1%-9.9%). Violence situations were more prevalent among male students. There were great variations among the cities studied. Adolescents are exposed to different violence manifestations in the institutions that supposedly must assure their protection and healthy development: school and the home. These results aim to support health promotion measures and prevention of these risk factors.

Direção de veículos motorizados após consumo abusivo de bebidas alcoólicas, Brasil, 2006 a 2009

The present study aimed to analyze the proportion of adults who drive under the influence of alcohol in the Brazilian capitals and in the Federal District, after Law 11,705 was established. Data from the Vigilância de Fatores de Risco e Proteção para Doenças Crônicas por Inquérito Telefônico System (VIGITEL - Surveillance System of Risk and Protective Factors for Chronic Diseases by Telephone Interview) were analyzed. In 2008, 1.5% of individuals interviewed reported having driven a motor vehicle after binge drinking in at least one occasion. The frequency of adults who drove after binge drinking remained between 1.8% and 2.2% in the eight months preceding the Law, decreased in the month following its establishment, and increased again two months later, reaching a maximum of 2.6% by the end of 2008 and returning to the initial levels in the first months of 2009.Com o objetivo de analisar a proporcao de adultos que dirigem alcoolizados nas capitais brasileiras e no Distrito Federal apos instituicao da Lei no 11.705 foram analisados dados do sistema de Vigilância de Fatores de Risco e Protecao para Doencas Cronicas por Inquerito Telefonico (VIGITEL). Em 2008, 1,5% dos individuos entrevistados referiram em pelo menos uma ocasiao ter conduzido veiculo motorizado apos consumo abusivo de bebida alcoolica. A frequencia de adultos que dirigiram apos o consumo abusivo se manteve entre 1,8% e 2,2% nos oito meses anteriores a Lei, caindo no mes sequente a promulgacao da mesma, voltando a crescer dois meses depois, atingindo o maximo de 2,6% ao final de 2008 e retornando aos niveis iniciais nos primeiros meses de 2009.

Hazards of setting targets to eliminate disease: lessons from the leprosy elimination campaign.

Diana Lockwood and colleagues reflect on the global leprosy elimination programme and challenge the wisdom of WHO’s elimination strategies

Fatores de risco e proteção para doenças crônicas não transmissíveis entre beneficiários da saúde suplementar: resultados do inquérito telefônico Vigitel, Brasil, 2008

This article aims at estimating the prevalence of adults engaging in protective and risk health behaviors among members of private health insurance plans. It was used a random sample of individuals over the age of 18 living in the Brazilian state capitals collected on 28,640 telephone interviews in 2008. The results showed that among males there was a high prevalence of the following risk factors: tobacco, overweight, low fruit and vegetable consumption, high meat with fat consumption and alcohol drinking. Among females we found a high prevalence of high blood pressure, diabetes, dyslipidemia and osteoporosis. Men were generally more physically active and women consumed more fruit and vegetables. As more educated males were lower was the prevalence of tobacco, high blood pressure, but also a higher prevalence of overweight, consumption of meat with fat, dyslipidemia and lower number of yearly check-ups done. For females, tobacco smoking, overweight, obesity, decreasing with schooling, and consumption of fruit and vegetables, physical activity, mammography and PAP test, increased with schooling. The health insurance user population constitutes about 26% of Brazilian people and the current study aims to accumulate evidence for health promotion actions by this public.

Trend of case detection and leprosy elimination in Brazil

Only six countries did not meet the leprosy elimination target during 2005, amongst them Brazil. In 2006, the Brazilian Ministry of Health announced a reduction of the detection rate of 24% or 10 900 cases from 2004 to 2005. A negative binomial parabolic regression model was adjusted to the detection rate historical series from 1980 to 2004, in order to predict the 2005 detection rate and its 95% confidence interval. This analysis showed that the number of new leprosy cases for 2005 could not be predicted from the previous behaviour of the data what calls for an epidemiological or operational explanation hypothesis. The hypothesis that this drop in detected case number is due to operational change, as a reduction in diagnosis or a modification in the reporting routine, is more likely. Recent change in prevalence case definition turned the prevalence ratio a function of only one variable, the detection rate, as the duration of the diagnosed disease became fixed. In the early nineties, based on epidemiological data evaluation, the BMoH recognized the impossibility of reaching the elimination goal, but it committed to seek leprosy control. This position changed after some years. Leprosy Elimination is a strategy supported by the national and international public opinion. As a one for all recipe, it may cause unwanted effects for it is not flexible enough to deal with different epidemiological behaviours and public health traditions.

Effect of the Brazilian conditional cash transfer and primary health care programs on the new case detection rate of leprosy.

Background Social determinants can affect the transmission of leprosy and its progression to disease. Not much is known about the effectiveness of welfare and primary health care policies on the reduction of leprosy occurrence. The aim of this study is to evaluate the impact of the Brazilian cash transfer (Bolsa Família Program-BFP) and primary health care (Family Health Program-FHP) programs on new case detection rate of leprosy. Methodology/Principal Findings We conducted the study with a mixed ecological design, a combination of an ecological multiple-group and time-trend design in the period 2004–2011 with the Brazilian municipalities as unit of analysis. The main independent variables were the BFP and FHP coverage at the municipal level and the outcome was new case detection rate of leprosy. Leprosy new cases, BFP and FHP coverage, population and other relevant socio-demographic covariates were obtained from national databases. We used fixed-effects negative binomial models for panel data adjusted for relevant socio-demographic covariates. A total of 1,358 municipalities were included in the analysis. In the studied period, while the municipal coverage of BFP and FHP increased, the new case detection rate of leprosy decreased. Leprosy new case detection rate was significantly reduced in municipalities with consolidated BFP coverage (Risk Ratio 0.79; 95% CI  = 0.74–0.83) and significantly increased in municipalities with FHP coverage in the medium (72–95%) (Risk Ratio 1.05; 95% CI  = 1.02–1.09) and higher coverage tertiles (>95%) (Risk Ratio 1.12; 95% CI  = 1.08–1.17). Conclusions At the same time the Family Health Program had been effective in increasing the new case detection rate of leprosy in Brazil, the Bolsa Família Program was associated with a reduction of the new case detection rate of leprosy that we propose reflects a reduction in leprosy incidence.