Efficacy and safety of ivermectin for treatment of non-hospitalized COVID-19 patients: a systematic review and meta-analysis of 12 randomized controlled trials with 7,035 participants.

INTRODUCTION: We systematically assessed benefits and harms of the use of ivermectin in non-hospitalized patients with early COVID-19. METHODS: Five databases were searched until October 17, 2023, for randomized controlled trials (RCTs) in adult patients with COVID-19 treated with ivermectin against standard of care (SoC), placebo, or active drug. Primary outcomes were hospitalization, all-cause mortality, and adverse events (AEs). Secondary outcomes included mechanical ventilation (MV), clinical improvement, clinical worsening, viral clearance, and severe adverse events (SAEs). Random effects meta-analyses were performed, with quality of evidence (QoE) evaluated using GRADE methods. Pre-specified subgroup analyses (ivermectin dose, control type, risk of bias, follow-up, and country income) and trial sequential analysis (TSA) were performed. RESULTS: Twelve RCTs (n=7,035) were included. The controls were placebo in nine RCTs, SoC in two RCTs, and placebo or active drug in one RCT. Ivermectin did not reduce hospitalization (relative risk [RR], 0.81, 95% confidence interval [95%CI] 0.64-1.03; 8 RCTs, low QoE), all-cause mortality (RR 0.98, 95%CI 0.73-1.33; 9 RCTs, low QoE), or AEs (RR 0.89, 95%CI 0.75-1.07; 9 RCTs, very low QoE) vs. controls. Ivermectin did not reduce MV, clinical worsening, or SAEs and did not increase clinical improvement and viral clearance vs. controls (very low QoE for secondary outcomes). Subgroup analyses were mostly consistent with main analyses, and TSA-adjusted risk for hospitalization was similar to main analysis. CONCLUSIONS: In non-hospitalized COVID-19 patients, ivermectin did not have effect on clinical, non-clinical or safety outcomes versus controls. Ivermectin should not be recommended as treatment in non-hospitalized COVID-19 patients.

Recent HIV infection and annualized HIV incidence rates among sexual and gender minorities in Brazil and Peru (ImPrEP seroincidence study): a cross-sectional, multicenter study.

Background: HIV incidence estimation is critical for monitoring the HIV epidemic dynamics and the effectiveness of public health prevention interventions. We aimed to identify sexual and gender minorities (SGM) with recent HIV infections, factors associated with recent HIV infection, and to estimate annualised HIV incidence rates. Methods: Cross-sectional multicentre study in HIV testing services in Brazil and Peru (15 cities). Inclusion criteria: 18+ years, SGM assigned male at birth, not using pre-/post-exposure prophylaxis. We identified recent HIV infection using the Maxim HIV-1 LAg-Avidity EIA assay as part of a recent infection testing algorithm (RITA). Annualized HIV incidence was calculated using the UNAIDS/WHO incidence estimator tool. Multivariable logistic regression models were used to estimate factors associated with recent HIV infection. Trial registration: NCT05674682. Findings: From 31-Jan-2021 to 29-May-2022, 6899 individuals participated [Brazil: 4586 (66.5%); Peru: 2313 (33.5%)]; 5946 (86.2%) cisgender men, 751 (10.9%) transgender women and 202 (2.9%) non-binary/gender diverse. Median age was 27 (IQR: 23-34) years. HIV prevalence was 11.4% (N = 784/6899); 137 (2.0%) SGM were identified with recent HIV infection. The overall annualized HIV incidence rate was 3.88% (95% CI: 2.86-4.87); Brazil: 2.62% (95% CI: 1.78-3.43); Peru: 6.69% (95% CI: 4.62-8.69). Participants aged 18-24 years had higher odds of recent HIV infection compared to those aged 30+ years in both countries. Interpretation: Our results highlight the significant burden of HIV epidemic among SGM in large urban centres of Brazil and Peru. Public health policies and interventions to increase access to effective HIV prevention methods such as PrEP are urgently needed in Latin America. Funding: Unitaid, WHO (Switzerland), Ministry of Health from Brazil and Peru.

Same-day initiation of oral pre-exposure prophylaxis among gay, bisexual, and other cisgender men who have sex with men and transgender women in Brazil, Mexico, and Peru (ImPrEP): a prospective, single-arm, open-label, multicentre implementation study.

BACKGROUND: Although gay, bisexual, and other cisgender men who have sex with men (MSM) and transgender women have the highest HIV burden in Latin America, pre-exposure prophylaxis (PrEP) implementation is poor. We aimed to assess the feasibility of same-day oral PrEP delivery in Brazil, Mexico, and Peru. METHODS: Implementation PrEP (ImPrEP) was a prospective, single-arm, open-label, multicentre PrEP implementation study conducted in Brazil (14 sites), Mexico (four sites), and Peru (ten sites). MSM and transgender women were eligible to participate if they were aged 18 years or older, HIV-negative, and reported one or more prespecified criteria. Enrolled participants received same-day initiation of daily oral PrEP (tenofovir disoproxil fumarate [300 mg] coformulated with emtricitabine [200 mg]). Follow-up visits were scheduled at week 4 and quarterly thereafter. We used logistic regression models to identify factors associated with early loss to follow-up (not returning after enrolment), PrEP adherence (medication possession ratio ≥0·6), and long-term PrEP engagement (attending three or more visits within 52 weeks). This study is registered at the Brazilian Registry of Clinical Trials, U1111-1217-6021. FINDINGS: From Feb 6, 2018, to June 30, 2021, 9979 participants were screened and 9509 were enrolled (Brazil n=3928, Mexico n=3288, and Peru n=2293). 543 (5·7%) participants were transgender women, 8966 (94·3%) were cisgender men, and 2481 (26·1%) were aged 18-24 years. There were 12 185·25 person-years of follow-up. 795 (8·4%) of 9509 participants had early loss to follow-up, 6477 (68·1%) of 9509 were adherent to PrEP, and 5783 (70·3%) of 8225 had long-term PrEP engagement. Transgender women (adjusted odds ratio 1·60, 95% CI 1·20-2·14), participants aged 18-24 years (1·80, 1·49-2·18), and participants with primary education (2·18, 1·29-3·68) had increased odds of early loss to follow-up. Transgender women (0·56, 0·46-0·70), participants aged 18-24 years (0·52, 0·46-0·58), and those with primary education (0·60, 0·40-0·91) had lower odds of PrEP adherence. Transgender women (0·56, 0·45-0·71), participants aged 18-24 years (0·56, 0·49-0·64), and those with secondary education (0·74, 0·68-0·86) had lower odds of long-term PrEP engagement. HIV incidence was 0·85 per 100 person-years (95% CI 0·70-1·03) and was higher for transgender women, participants from Peru, those aged 18-24 years, Black and mixed-race participants, and participants who were non-adherent to PrEP. INTERPRETATION: Same-day oral PrEP is feasible for MSM and transgender women in Latin America. Social and structural determinants of HIV vulnerability need to be addressed to fully achieve the benefits of PrEP. FUNDING: Unitaid, WHO, and Ministries of Health in Brazil, Mexico, and Peru. TRANSLATIONS: For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.

Beneficial and Harmful Effects of Monoclonal Antibodies for the Treatment and Prophylaxis of COVID-19: Systematic Review and Meta-Analysis.

BACKGROUND: We systematically assessed beneficial and harmful effects of monoclonal antibodies for coronavirus disease 2019 (COVID-19) treatment, and prophylaxis in individuals exposed to severe acute respiratory syndrome coronavirus 2. METHODS: We searched 5 engines and 3 registries until November 3, 2021 for randomized controlled trials evaluating monoclonal antibodies vs control in hospitalized or non-hospitalized adults with COVID-19, or as prophylaxis. Primary outcomes were all-cause mortality, COVID-19-related death, and serious adverse events; hospitalization for non-hospitalized; and development of symptomatic COVID-19 for prophylaxis. Inverse variance random effects models were used for meta-analyses. Grading of Recommendations, Assessment, Development, and Evaluations methodology was used to assess certainty of evidence. RESULTS: Twenty-seven randomized controlled trials were included: 20 in hospitalized patients (n = 8253), 5 in non-hospitalized patients (n = 2922), and 2 in prophylaxis (n = 2680). In hospitalized patients, monoclonal antibodies slightly reduced mechanical ventilation (relative risk [RR] 0.74; 95% confidence interval [CI], 0.60-0.9; I2 = 20%, low certainty of evidence) and bacteremia (RR 0.77; 95% CI, 0.64-0.92; I2 = 7%, low certainty of evidence); evidence was very uncertain about the effect on adverse events (RR 1.31; 95% CI, 1.02-1.67; I2 = 77%, very low certainty of evidence). In non-hospitalized patients, monoclonal antibodies reduced hospitalizations (RR 0.30; 95% CI, 0.17-0.53; I2 = 0%, high certainty of evidence) and may slightly reduce serious adverse events (RR 0.47; 95% CI, 0.22-1.01; I2 = 33%, low certainty of evidence). In prophylaxis studies, monoclonal antibodies probably reduced viral load slightly (mean difference -0.8 log10; 95% CI, -1.21 to -0.39, moderate certainty of evidence). There were no effects on other outcomes. CONCLUSIONS: Monoclonal antibodies had limited effects on most of the outcomes in COVID-19 patients, and when used as prophylaxis. Additional data are needed to determine their efficacy and safety.

Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil.

INTRODUCTION: Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. METHODS: This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/kg/day for 20 days) or amphotericin B deoxycholate (1 mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. RESULTS: In total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. CONCLUSIONS: N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL.

Vigilância, Prevenção, Atenção e Controle da Leishmaniose Visceral

Este recurso educacional compõe o Curso Vigilância, Prevenção, Atenção e Controle da Leishmaniose Visceral, oferecido pela UNASUS/UFMA na modalidade autoinstrucional, com carga horária sugerida de 30h, divididas em três módulos de 10h. O curso visa apresentar as principais ações de intervenção da Atenção Primária em Saúde e da Vigilância em Saúde na vigilância, atenção e controle da leishmaniose visceral. Desta forma, será possível compreender as ações de vigilância e controle da leishmaniose visceral integradas à atenção primária; as ações de vigilância e controle da LV contidas nas diretrizes nacionais, considerando a realidade local; a suspeita, o diagnóstico, o tratamento e o acompanhamento adequado ao paciente com leishmaniose visceral no âmbito da atenção primária.

Vigilância e Controle da leishmaniose visceral

Este recurso educacional compõe o curso Vigilância em Saúde, ofertado pela UNA-SUS/UFMA. Trata-se de um e-book com o objetivo de reconhecer os aspectos epidemiológicos e evidencia algumas ações de vigilância e controle da leishmaniose visceral. Aborda o ciclo de transmissão da leishmaniose visceral e apresenta um vídeo com um estudo de caso na cidade de Samambaia. Além deste, há mais 16 e-books tratando sobre diversas questões relacionadas à Vigilância em Saúde. Todos eles fornecem conteúdos interessantes para a formação dos profissionais que atuam no SUS, especialmente os vinculados à Vigilância em Saúde, e acadêmicos da área da saúde.

Manejo de pacientes com leishmaniose visceral na atenção primária

Este recurso educacional compõe o curso Vigilância em Saúde, ofertado pela UNA-SUS/UFMA. Trata-se de um e-book com o objetivo de promover a compreensão dos aspectos epidemiológicos, clínicos e laboratoriais necessários para diagnosticar, tratar, recuperar e acompanhar oportuna e adequadamente os casos de leishmaniose na atenção primária. Além deste, há mais 16 e-books tratando sobre diversas questões relacionadas à Vigilância em Saúde. Todos eles fornecem conteúdos interessantes para a formação dos profissionais que atuam no SUS, especialmente os vinculados à Vigilância em Saúde, e acadêmicos da área da saúde.

Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil

ABSTRACT INTRODUCTION Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. METHODS This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/kg/day for 20 days) or amphotericin B deoxycholate (1 mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. RESULTS In total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. CONCLUSIONS N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL.

Are opossums a relevant factor associated with asymptomatic Leishmania infection in the outskirts of the largest Brazilian cities?

Abstract A population survey was conducted to explore the prevalence and factors associated with Leishmania infection in the Fercal region of the Federal District. The Fercal region is a group of neighborhoods in Brasília in which the first cases of visceral leishmaniasis were described. Leishmania infection was established by a positive leishmanin test. Although other tests were performed in the study (an immunochromatographic assay (Kalazar detect®) and a molecular assay), only the leishmanin skin test provided sufficient results for the measurement of the disease prevalence. Data on the epidemiological, clinical and environmental characteristics of individuals were collected along with the diagnostic tests. After sampling and enrollment, seven hundred people from 2 to 14 years of age were included in the study. The prevalence of Leishmania infection was 33.28% (95% CI 29.87–36.84). The factors associated with Leishmania infection according to the multivariate analysis were age of more than seven years and the presence of opossums near the home. Age is a known factor associated with Leishmania infection; however, the presence of wild animals, as described, is an understudied factor. The presence of opossums, which are known reservoirs of Leishmania, in peri-urban areas could be the link between the rural and urban occurrence of visceral leishmaniasis in the outskirts of largest Brazilian cities, as suggested by previous studies.

Are opossums a relevant factor associated with asymptomatic Leishmania infection in the outskirts of the largest Brazilian cities?

A population survey was conducted to explore the prevalence and factors associated with Leishmania infection in the Fercal region of the Federal District. The Fercal region is a group of neighborhoods in Brasília in which the first cases of visceral leishmaniasis were described. Leishmania infection was established by a positive leishmanin test. Although other tests were performed in the study (an immunochromatographic assay (Kalazar detect(®)) and a molecular assay), only the leishmanin skin test provided sufficient results for the measurement of the disease prevalence. Data on the epidemiological, clinical and environmental characteristics of individuals were collected along with the diagnostic tests. After sampling and enrollment, seven hundred people from 2 to 14 years of age were included in the study. The prevalence of Leishmania infection was 33.28% (95% CI 29.87-36.84). The factors associated with Leishmania infection according to the multivariate analysis were age of more than seven years and the presence of opossums near the home. Age is a known factor associated with Leishmania infection; however, the presence of wild animals, as described, is an understudied factor. The presence of opossums, which are known reservoirs of Leishmania, in peri-urban areas could be the link between the rural and urban occurrence of visceral leishmaniasis in the outskirts of largest Brazilian cities, as suggested by previous studies.

Cirugía endoscópica de oído: aplicaciones / Endoscopic surgery of the ear: applications

La tecnología de endoscopia, de uso común en cirugía de senos paranasales, ha ganado espacio en otología, en especial para procedimientos de oído crónico mediante abordaje transcanal mínimamente invasivo. En la actualidad, los endoscopios de cuerpo rígido permiten nuevas aplicaciones en la visualización de la anatomía y patología del oído medio, que no es fácil obtener con microscopio. Del mismo modo, su aplicación se puede extender a cirugías neurotológicas. En el presente estudio realizamos una breve descripción de la utilización más común de los endoscopios en cirugía otológica...

The endoscopy technology, commonly used in nasal sinus surgery, has gained acceptance in otology specially for chronic ear procedures through transcanal approach minimally invasive. Rigid endoscopes allow new applications in middle ear anatomy and pathology view that is no easy to obtain with microscope. In the same way, its application can be extended to neurotological surgeries. In the present document, we make a brief description of the most common uses of endoscopes in otological surgery...

Implantes auditivos de conducción ósea percutáneo, transcutáneo: comparación / Percutaneous, Transcutaneous Bone Conduction Hearing Implants: comparison

Introducción: Los implantes de conducción ósea son alternativas en rehabilitación para pacientes con sordera conductiva/mixta o unilateral. Objetivo: Analizar desenlaces audiológicos, calidad de vida y percepción subjetiva de beneficios en pacientes con sordera conductiva y/o mixta o unilateral, usuarios del sistema transcutáneo Bonebridge®, o del sistema percutáneo BAHA®. Método: Estudio prospectivo en diez pacientes usuarios del sistema transcutáneo, y comparación con diez usuarios del sistema percutáneo. Evaluación audiológica, percepción de calidad de vida y satisfacción. Resultados: Con el sistema transcutáneo en sordera conductiva/mixta se registró ganancia promedio de 39 dB SPL (desviación estándar [DE] ±4; intervalo de confianza [IC] 95% 35-43), y con el sistema percutáneo, 33 dB SPL (DE ±7; IC 95% 26-40); diferencia de 6 dB SPL (EE ±3; IC 95% -1-13, p = 0,09). Discriminación de lenguaje con sistema transcutáneo 100% a 63 dB (DE ±2 dB; IC 95% 61-65) y con sistema percutáneo 100% a 58 dB (DE ±7 dB; IC 95% 51-65), diferencia de 5 dB (EE ±3 dB; IC 95% -2-12, p = 0,12). En sordera unilateral, la comparación de umbrales promedio con los dispositivos: 37 dB SPL (DE ±4; IC 95% 31-43) para el sistema transcutáneo y 32 dB SPL (DE ±3, IC 95% 27-37) para el sistema percutáneo, diferencia de 5 dB SPL (EE ±3; IC 95% -1-11, p = 0,09). Discriminación de lenguaje para sistema transcutáneo 100% a 66 dB SPL (DE ±7; IC 95% 55-77) y con sistema percutáneo 100% a 64 dB SPL (DE ±5; IC 95% 56-72), diferencia de 2 dB SPL (EE ±4; IC 95% –9-13, p = 0,7). Promedio total para percepción de beneficios con el uso de los dispositivos: 33 (DE ±18; IC 95% 20-46) para el sistema transcutáneo y 22 (DE ±12; IC 95% 13-31) en sistema percutáneo, diferencia de 11 puntos (EE ±7; IC 95% –3-25, p = 0,12). El nivel de satisfacción fue cuantificado de manera semejante, excepto en: Aspectos generales, sub-ítem Comodidad a favor del sistema transcutáneo. Conclusiones: Los beneficios audiológicos, satisfacción y calidad de vida identificados en los pacientes con el sistema Bonebridge son evidentes y comparables a los que han logrado los pacientes con el sistema BAHA...

Introduction: Hearing bone conduction implants are alternatives available for hearing rehabilitation in patients with conductive mixed hearing loss or unilateral deafness. Objective: To analyze audiological outcomes, quality of life and subjective hearing benefits perception in patients with conductive mixed hearing loss or unilateral deafness, users of percutaneous BAHA® system, or transcutaneous active bone conduction system Bonebridge®. Materials and Methods: Prospective study on 10 patients with transcutaneous system compared with 10 users of percutaneous system. Audiometries, speech recognition with and without the system, Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) surveys tools. Results: With transcutaneous system, conductive mixed hearing loss group, achieved postoperatory mean gain of 33 dB SPL (Standard error [SE] ±3, 95% confidence interval [95% CI] 26-40, p>0.00001); with percutaneous system 38 dB SPL (SE ±6) 5% CI 25-51, p>0.00001); difference 5 dB SPL (SE ±3, 95% CI 1-11, p = 0.09). Postoperative speech discrimination, transcutaneous system 100% @63 dB (Standard deviation [SD] ±2 dB, 95% CI 61-65); percutaneous system 100% @58 dB (SD ±7 dB, 95% CI 51-65); difference 5 dB (SE ±3 dB, 95% CI -2 – 12, p = 0.12). In Single Sided Deafness (SSD), postoperative, transcutaneous system 82 dB SPL (SE ±4, 95% CI 72-92); percutaneous system 92 dB SPL (SE ±7, 95% CI 76-108); difference of 10 dB SPL (SE ±4, 95% CI 0.1-20, p = 0.047). Speech discrimination, postoperative, transcutaneous system 100% @66 dB SPL (SD ±7, 95% CI 55-77), percutaneous system 100% @64 dB (SD ±5, 95% CI 56-72); difference 2 dB (SE ±4, 95% CI -9-13, p = 0.7). For benefit perception with the devices, for transcutaneous system mean total scored 33 (SD ±18, 95% CI 20-46); for percutaneous system, 22 (SD ±12, 95% CI 13-31); difference 11 points (EE ±7, 95% CI -3-25, p = 0.12). Satisfaction with the device survey scored similarly except for the Comfort sub-item in the General Aspects favorable to the transcutaneous system. Conclusions: Audiological, satisfaction and –quality of life benefits identified in patients with Bonebridge® system are evident and comparable to those achieved by patients with the BAHA® system...

Lyme disease in the state of Tocantins, Brazil: report of the first cases

Lyme disease is an underdiagnosed zoonosis in Brazil. There are no cases registered in the state of Tocantins, the newest Brazilian state. The cases of three patients in contact with rural areas in three Tocantins' districts are herein described, and the Brazilian literature is reviewed.

Lyme disease in the state of Tocantins, Brazil: report of the first cases.

Lyme disease is an underdiagnosed zoonosis in Brazil. There are no cases registered in the state of Tocantins, the newest Brazilian state. The cases of three patients in contact with rural areas in three Tocantins' districts are herein described, and the Brazilian literature is reviewed.

Estudio comparativo en pacientes usuarios de implantes Vibrant Soundbridge® (VSB) y sistema osteointegrado BAHA® / Comparative study on patients users of Vibrant Soundbridge® and osseointegrated BAHA® implants

Objetivo: presentar la experiencia de una institución en la rehabilitación de pacientes con pérdida auditiva utilizando el implante de oído medio Vibrant Soundbridge® (VSB). Diseño: estudio retrospectivo. Materiales y métodos: se revisaron registros médicos, quirúrgicos y audiológicos de pacientes a los que se les implantó el sistema Vibrant Soundbridge (VSB), evaluando la ganancia auditiva establecida por la diferencia en los promedios de las frecuencias 0.5 a 3 kHz en la audiometría tonal postimplante con el sistema y sin él. Se evaluó también la satisfacción de uso con el dispositivo mediante la encuesta Escala de Satisfacción de Audición con Dispositivo (HDSS, Hearing Device Satisfaction Scale). Realizamos comparación de desenlaces audiológicos con una población de usuarios de similares características del sistema osteointegrado BAHA®. Resultados: 25 pacientes con pérdida auditiva predominantemente mixta recibieron un implante VSB colocando el Transductor de Masa Flotante (FMT) en ventana redonda en 23 casos (92%). La ganancia auditiva promedio fue de 36 ± 16 decibeles (dB). No se identificaron diferencias significativas en la ganancia auditiva entre los procesadores AP404-36 dB y Amadé-38 dB, p = 0.6. La ganancia auditiva en el grupo de usuarios del sistema BAHA fue de 37 dB y la discriminación de lenguaje a 65 dB fue de 93% y 100% para VSB y BAHA® respectivamente. En ambos sistemas el puntaje global de satisfacción fue de 4/5.

Objective: Present the institutional experience on the auditory rehabilitation of patients implanted with the middle ear prosthesis Vibrant Soundbridge®. Design: Retrospective study of a cases series. Materials and Methods: Medical, surgical and audiological charts review of patients implanted with the middle ear system VSB. Hearing gain was established by the mean differences calculated on 0.5 to 3 kHz in the pure tone audiometries pre and post implantation, with and without the device. Satisfaction with the device was assessed with the Hearing Device Satisfaction Scale tool. In addition, audiological and satisfaction comparison with a population with similar characteristics of BAHA implant users was made. Results: 25 patients with conductive and mixed hearing loss were implanted with the VSB, placing the FMT on the round window in 23cases (92%). Mean auditory gain was 36 ± 16 decibels (dB). There were no significance gains between processors AP404-36 dB and Amadé-38 dB, p = 0.6. Mean auditory gain in the BAHA® users was 37 dB; speech discrimination at 65 dB was 93% and 100% for VSB and BAHA® users respectively. Overall satisfaction score for both systems was 4/5. Conclusion: The middle ear implant system VSB gives a satisfactory hearing gain to patients with moderate mixed hearing loss comparable with the BAHA® as well in satisfaction and quality of life issues.

Clinical investigations for SUS, the Brazilian public health system.

CONTEXT AND OBJECTIVE: Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. DESIGN AND SETTING: Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. METHODS: The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. RESULTS: The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. CONCLUSION: The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

Autochthonous visceral leishmaniasis in Brasília, Federal District, Brazil.

INTRODUCTION: Visceral leishmaniasis is a public health threat in Brazil considering the high lethality rates and increasing geographical dispersion to large urban conglomerates over the past 25 years. This study aimed to confirm suspected autochthonous cases of visceral leishmaniasis reported from 2005 to 2009 among individuals living in Brasilia, Federal District. METHODS: A retrospective review of the surveillance data obtained on a regular basis and clinical records of the reported cases were performed in 2009. RESULTS: Data from entomological and canine surveys revealed the presence of both Lutzomyia longipalpis and positive serology for Leishmania in dogs within 19 of the 21 neighborhoods where human cases occurred since 2005. The review of surveillance data and medical records, together with the entomological and canine survey data, permitted confirmation of 21 autochthonous human cases in the Federal District. The disease predominantly affected children (12/21) and those from the Sobradinho region (16/21); the typical presentation of fever, hepatosplenomegaly and pancytopenia was observed in 67% of cases. Three deaths occurred during the study period. Leishmania (Leishmania) chagasi was successfully isolated from one human case and twelve canine cases. CONCLUSIONS: Visceral leishmaniasis should be considered endemic in Brasilia based on the documented epidemiological behavior herein described and the confirmed autochthony of human cases.

Autochthonous visceral leishmaniasis in Brasília, Federal District, Brazil / Leishmaniose visceral autóctone em Brasília, Distrito Federal, Brasil

INTRODUCTION: Visceral leishmaniasis is a public health threat in Brazil considering the high lethality rates and increasing geographical dispersion to large urban conglomerates over the past 25 years. This study aimed to confirm suspected autochthonous cases of visceral leishmaniasis reported from 2005 to 2009 among individuals living in Brasilia, Federal District. METHODS: A retrospective review of the surveillance data obtained on a regular basis and clinical records of the reported cases were performed in 2009. RESULTS: Data from entomological and canine surveys revealed the presence of both Lutzomyia longipalpis and positive serology for Leishmania in dogs within 19 of the 21 neighborhoods where human cases occurred since 2005. The review of surveillance data and medical records, together with the entomological and canine survey data, permitted confirmation of 21 autochthonous human cases in the Federal District. The disease predominantly affected children (12/21) and those from the Sobradinho region (16/21); the typical presentation of fever, hepatosplenomegaly and pancytopenia was observed in 67 percent of cases. Three deaths occurred during the study period. Leishmania (Leishmania) chagasi was successfully isolated from one human case and twelve canine cases. CONCLUSIONS: Visceral leishmaniasis should be considered endemic in Brasilia based on the documented epidemiological behavior herein described and the confirmed autochthony of human cases.

INTRODUÇÃO: A leishmaniose visceral é uma ameaça para a saúde pública no Brasil, considerando a elevada taxa de letalidade e a sua dispersão geográfica para grandes conglomerados urbanos durante os últimos 25 anos. Este trabalho teve como objetivo confirmar a suspeita de autoctonia de casos de leishmaniose visceral notificados de 2005 até 2009 em moradores de Brasília, Distrito Federal. MÉTODOS: Foi realizado em 2009 um estudo retrospectivo dos dados da vigilância obtidos na rotina e dos registros clínicos dos casos humanos notificados. RESULTADOS: Os dados dos inquéritos canino e entomológico revelaram a presença de Lutzomyia longipalpis e de cães com sorologia positiva para Leishmania na vizinhança onde ocorreram 19 dos 21 casos humanos desde 2005. A revisão das fichas de notificação e prontuários dos pacientes, em conjunto com os dados dos inquéritos canino e entomológico permitiram a comprovação da autoctonia de 21 casos humanos no Distrito Federal. A doença afetou predominantemente crianças (12/21), da região de Sobradinho (16/21), com quadro típico de febre, hepatoesplenomegalia e pancitopenia em 67 por cento dos casos. Houve três óbitos no período. Houve sucesso no isolamento de Leishmania (Leishmania) chagasi de um caso humano e de doze casos caninos. CONCLUSÕES: A leishmaniose visceral deve ser considerada endêmica em Brasília, considerando o comportamento epidemiológico aqui descrito e a confirmação da autoctonia dos casos humanos.

Genus-specific kinetoplast-DNA PCR and parasite culture for the diagnosis of localised cutaneous leishmaniasis: applications for clinical trials under field conditions in Brazil.

The positivities of two methods for the diagnosis of localised cutaneous leishmaniasis (CL) were estimated in 280 patients enrolled in a clinical trial. The trial was conducted in an endemic area of Leishmania (Viannia) braziliensis and trial participants were patients with skin ulcers and positive leishmanin skin tests. Patients underwent aspirative skin punctures of the ulcerated lesions and lymph nodes for in vitro cultures, which were processed under field conditions at the local health centre. Skin lesion biopsies were tested at a reference laboratory using kinetoplastid DNA (kDNA)-PCR to detect DNA. The median time required to obtain a positive culture from the skin samples was seven days and the contamination rate of the samples was 1.8%. The positivities of the cultures from skin lesions, kDNA-PCR and the combination of the two methods were 78.2% (95% CI: 73-82.6%), 89.3% (95% CI: 85.1-92.4%) and 97.1% (95% CI: 94.5-98.5%). We conclude that parasite culture is a feasible method for the detection of Leishmania in field conditions and that the combination of culture and PCR has a potential role for the diagnosis of CL in candidates for clinical trials.