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.

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.

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.

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 percent. The positivities of the cultures from skin lesions, kDNA-PCR and the combination of the two methods were 78.2 percent (95 percent CI: 73-82.6 percent), 89.3 percent (95 percent CI: 85.1-92.4 percent) and 97.1 percent (95 percent CI: 94.5-98.5 percent). 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.

Efeito de uma formulação hidrofílica de paromomicina tópica na leishmaniose cutânea em pacientes com contra-indicações de tratamento com antimonial pentavalente / Effect of a hydrophilic formulation of topical paromomycin on cutaneous leishmaniasis among patients with contraindications for treatment with pentavalent antimonials

Descrevem-se o efeito terapêutico e os eventos adversos associados com o uso tópico de paromomicina 10 por cento em gel na leishmaniose cutânea. Quinze pacientes com leishmaniose cutânea cumpriram os critérios de inclusão descritos a seguir: contra-indicação para o uso de antimoniato de meglumina, intradermorreação de Montenegro positiva e até quatro lesões ulceradas. A fórmula foi prescrita duas vezes ao dia por 20 dias. Quatorze pacientes estiveram disponíveis para a avaliação do desfecho terapêutico e a proporção de cura foi de 21,4 por cento (3/14), 50 por cento melhoraram até a epitelização completa e a proporção de falha foi de 28,6 por cento. Nove pacientes que não apresentaram cura inicialmente foram re-tratados. Oito receberam uma nova série de paromomicina tópica e um foi tratado com antimoniato de meglumina. Dois pacientes não receberam novo tratamento e tiveram melhora lenta e contínua. Cinco de oito pacientes retratados com paromomicina tópica alcançaram a cura clínica, e três apresentaram falha, incluindo um paciente que tinha apresentado melhora com o primeiro tratamento. Os eventos adversos foram leves e locais em 53,3 por cento dos pacientes e nunca levaram à suspensão do tratamento.

The therapeutic effect of and adverse events associated with topical use of 10 percent paromomycin gel on cutaneous leishmaniasis are described. Fifteen patients with cutaneous leishmaniasis fulfilled the following inclusion criteria: contraindication for the use of meglumine antimoniate, positive Montenegro skin test and up to four ulcerated lesions. The formula was prescribed twice a day for 20 days. Fourteen patients were available for the therapeutic outcome evaluation. The cure rate was 21.4 percent (3/14); 50 percent improved as far as complete epithelialization; and the failure rate was 28.6 percent. Nine patients who did not initially present cure were retreated. Eight received a new series of topical paromomycin and one was treated with meglumine antimoniate. Two patients did not receive any new treatment and had continuous slow improvement. Five out of the eight patients retreated with topical paromomycin achieved clinical cure, and three presented failure, including one patient who had shown any improvement with the first treatment. For 53.3 percent of the patients, the adverse events were mild and local and never led to treatment suspension.

Febre crônica associada a abscesso esplênico causado por Staphylococcus epidermidis / Chronic fever associated with splenic abscess due to Staphylococcus epidermidis

Abscessos ocultos são causa freqüente de febre crônica. Os abscessos esplênicos são entidades raras, usualmente associadas a quadros subjacentes de cirurgia abdominal, endocardite ou imunodepressão. Apresenta-se um caso de paciente com febre prolongada causada por um abscesso esplênico, cujo principal diagnóstico diferencial era leishmaniose visceral, que provavelmente esteve associado a traumatismo abdominal. O tratamento consistiu em antibioticoterapia seguida de esplenectomia.

Occult abscesses are frequent causes of chronic fever. Splenic abscesses are rare entities that are usually associated with underlying conditions such as abdominal surgery, endocarditis or immunodepression. We report on the case of a patient with prolonged fever caused by a splenic abscess, whose main differential diagnosis was visceral leishmaniasis. However, this condition was probably related to abdominal trauma. The treatment consisted of antibiotics followed by splenectomy.

Estudio estadistico de apendicectomias de emergencia efectuadas en el Hospital Militar de Guayaquil-Ecuador / Statistic study of emergency appendectomy executed in Militar Hospital of Guayaquil-Ecuador

De Agosto de 1982 a Agosto de 1987, un total de 158 apendicectomías de emergencia fueron efectuadas en el Hospital Militar de Guayaquil