Alertas sanitarias de productos médicos subestándares, falsificados y no registrados al inicio de la pandemia de COVID-19 en las Américas / Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the Americas / Alertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas

RESUMEN Objetivo. Identificar y analizar los incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia de COVID-19. Métodos. Búsqueda detallada en los sitios web de las autoridades reguladoras de las Américas. Identificación de los incidentes de medicamentos y dispositivos médicos (incluidos los de diagnóstico in vitro) subestándares falsificados, no registrados y robados. Se determinaron los tipos de productos, las etapas de la cadena de suministro en las que se detectaron y las medidas tomadas por las autoridades. Resultados. Se identificaron 1 273 incidentes en 15 países (1 087 productos subestándares, 44 falsificados, 123 no registrados y 19 robados). La mayor cantidad de incidentes corresponden a dispositivos médicos, desinfectantes y antisépticos. El punto en la cadena de suministro con mayor frecuencia de informes fue la adquisición a través de internet. Las medidas tomadas por las autoridades reguladoras corresponden en su mayoría a: alerta, prohibición de uso, prohibición de publicidad y fabricación, retiro del mercado y seguimiento de eventos adversos. Conclusiones. Se evidenció un número destacable de incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia por COVID-19. La escasez de insumos, la flexibilización en los requisitos regulatorios y el aumento de la demanda son factores que pueden favorecer el incremento del número de incidentes. Las autoridades reguladoras nacionales de referencia presentaron mayores frecuencias de detección de incidentes y de aplicación de medidas sanitarias. Se observó que se debe abordar el canal de venta por internet con alguna estrategia reguladora para garantizar la distribución segura de productos médicos.

ABSTRACT Objective. Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods. Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results. A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions. A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

RESUMO Objetivo. Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos. Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados. Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões. Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.

Myopericarditis Associated with the Novavax COVID-19 Vaccine (NVX-CoV2373): A Retrospective Analysis of Individual Case Safety Reports from VigiBase.

BACKGROUND: Myocarditis and pericarditis have been associated most notably with mRNA vaccines, but the association with a recently authorized adjuvated vaccine (NVX-CoV2373) is controversial. OBJECTIVE: The aim was to analyze the cases of myocarditis and pericarditis in association with NVX-CoV2373 reported to the World Health Organization (WHO) global database of individual case safety reports (ICSRs) for drug monitoring (VigiBase), applying disproportionality analyses. PATIENTS AND METHODS: The main characteristics of the ICSRs reporting myopericarditis with NVX-CoV2373 have been summarized. Reporting odds ratios (RORs) as a measure of disproportionality for reported myopericarditis (November 1967-August 2022) have been calculated for NVX-CoV2373; mRNA and adenoviral vector-based vaccines were also included as a reference. RESULTS: In total, 61 ICSRs included NVX-CoV2373. Most of the reports originated in Australia (50; 82.0%); 24 (39.3%) were considered serious. None of them were fatal. The median age of individuals was 35.5 years old, and most were males (38; 62.3%). Chest pain was the most common co-reported event 43 (70.5%). The median induction period was 3 days after immunization. Increased disproportionality for myopericarditis was found for NVX-CoV2373 (ROR 14.47, 95% confidence interval [CI] 11.22-18.67) and mRNA vaccines: BNT162b2 (ROR 17.15, 95% CI 16.88-17.42) and mRNA-1273 (ROR 6.92, 95% CI 6.77-7.08). Higher values were found in males. The adenoviral vector-based vaccine Ad26.COV2.S showed slightly increased disproportionality (ROR 1.83, 95% CI 1.70-1.98), whereas no increased disproportionality was found for ChAdOx1. CONCLUSIONS: NVX-CoV2373 vaccine showed a similar increased disproportionality as mRNA vaccines. More evidence from controlled studies is necessary; however, a precautionary approach is warranted. Healthcare professionals should be aware of the potential occurrence of myopericarditis with this new vaccine.

Barriers of Access to Opioid Medicines within the Context of Palliative Care in Latin America: The Perception of Health Professionals.

Background: Different sets of barriers have been identified to explain the difficulties in the access and availability of opioid analgesics in palliative care, particularly in low- and middle-income countries, including Latin America. Objective: To validate a structured questionnaire for the access to opioid medicines and to investigate the perception of health professionals regarding access barriers to opioid analgesics in 17 countries of the Latin American Region. Design: Survey to identify the domains and barriers of access to opioid medicines according to health professionals, including physicians, nurses, and pharmacists affiliated to institutions that provide palliative care in Latin America between August 2019 and October 2020. Results: We analyzed responses from 426 health professionals. The median age was 44 years old (ranging from 23 to 73 years) with an average experience in palliative care of 10 years (range: 1-35), 71.8% were women, and 49.8% were affiliated to specialized health care facilities of urban areas (94.6%). The main barriers perceived to be extremely relevant by the respondents were "belief that patients can develop addiction" and "financial limitations of patients" for the patient's domain and the "appropriate education, instruction, and training of professionals" for health professional's domain. Conclusions: It is necessary to develop strategies to strengthen less-developed health systems of the region to review legal frameworks, ensure integrated palliative care systems, and deploy multidisciplinary strategies for sensitizing, training, and raising the awareness of patients, caregivers and, particularly, health professionals regarding appropriate prescription and rational use of opioid analgesics.

Acceptability of short message service (SMS) as a tool for malaria treatment adherence in the Brazilian Amazon: a qualitative study

ABSTRACT Background: Malaria is one of the leading causes of morbidity worldwide, and patient adherence to prescribed antimalarials is essential for effective treatment. Methods: This cross-sectional study, with in-depth telephone interviews, analyzed participants' perceptions of short message service (SMS) in adherence to treatment. Results: Five thematic categories emerged: decreased forgetfulness, the novelty of the tool, easy-to-understand language, the impact of SMS messages during treatment, and suggestions for improvement and complaints. Conclusions: SMS could assist patients in adhering to prescribed antimalarials.

Regulación de la venta de productos médicos por Internet: experiencias y estrategias para Latinoamérica / Regulation of the online sale of medical products: experiences and strategies for Latin America / Regulamentação da venda de produtos médicos pela internet: experiências e estratégias para a América Latina

RESUMEN El objetivo de este informe especial es presentar los avances en Latinoamérica sobre la regulación de la venta de productos médicos a través de internet y ofrecer orientación a las Autoridades Reguladoras Nacionales (ARN) en la planificación y ejecución de estrategias para la regulación y fiscalización del comercio electrónico de productos médicos. Se presentan los avances regulatorios y de programas, e iniciativas efectuadas por cuatro países de América Latina para el control de la venta de productos médicos a través de Internet, incluyendo revisiones complementarias de la literatura y de programas para el control del comercio electrónico de agencias de referencia. A partir de esta revisión, se proponen las siguientes líneas estratégicas: fortalecimiento del marco regulatorio y normativo; fortalecimiento de la capacidad fiscalizadora; colaboración con autoridades y otros actores clave nacionales e internacionales; y comunicación y sensibilización con la comunidad y los profesionales de salud. Cada una de estas estrategias deben ir acompañadas con acciones específicas, que pueden servir como orientaciones para las ARN de las Américas, y de países con contextos similares para el fortalecimiento de sus marcos regulatorios y la protección de los pacientes y consumidores.

ABSTRACT The objective of this special report is to present the advances in Latin America on regulation of the online sale of medical products and to offer guidance to national regulatory authorities (NRAs) on planning and implementing strategies to regulate and oversee the e-commerce of medical products. The regulatory advances and the programs and initiatives implemented in four Latin American countries to control the online sale of medical products are presented, including complementary reviews of the literature and reviews of e-commerce control programs of agencies of reference. Based on this review, the following strategies are proposed: strengthening the regulatory and policy framework; strengthening the capacity for oversight; collaboration with national and international authorities and other key players; and communication and awareness-raising with the community and health care professionals. Each of these strategies should be accompanied by specific actions that can serve as guidelines for NRAs in the Americas and in countries with similar contexts, to strengthen their regulatory frameworks and patient and consumer protections.

RESUMO O objetivo deste relatório especial é apresentar os avanços na regulamentação da comercialização de produtos médicos pela internet na América Latina e oferecer orientações às Autoridades Reguladoras Nacionais (ARN) sobre planejamento e execução de estratégias de regulamentação e fiscalização do comércio eletrônico de produtos médicos. São apresentados avanços regulatórios e programáticos, bem como iniciativas realizadas por quatro países latino-americanos para controlar a venda de produtos médicos pela internet, incluindo revisões complementares da literatura e programas de controle do comércio eletrônico por agências reguladoras de referência. Com base nesta revisão, propõem-se as seguintes linhas estratégicas: fortalecimento do marco regulatório e normativo; fortalecimento da capacidade de fiscalização; colaboração com autoridades e outros atores-chave nacionais e internacionais; e comunicação e sensibilização da comunidade em geral e dos profissionais de saúde. Cada uma dessas estratégias deve ser acompanhada de ações específicas, que podem servir de diretrizes para as ARN das Américas - e de países com contextos semelhantes - para fortalecer seus marcos regulatórios e a proteção de pacientes e consumidores.

Reacciones adversas a medicamentos utilizados para la COVID-19 en cinco países de América Latina / Adverse reactions to drugs used for COVID-19 in five Latin American countries / Reações adversas a medicamentos utilizados para a COVID-19 em cinco países da América Latina

RESUMEN Objetivo. Caracterizar y describir las notificaciones de sospechas de reacciones adversas de un grupo de medicamentos que se utilizaron en Colombia, Costa Rica, Cuba, Chile, El Salvador, México y Perú para tratar o prevenir la enfermedad por el coronavirus (COVID-19, por su sigla en inglés) entre el 1 de marzo y el 31 de agosto del 2020. Métodos. Se elaboró una lista de los 13 medicamentos utilizados para tratar o prevenir la COVID-19, según fuentes oficiales y no oficiales. Desde las bases de datos de los programas nacionales de farmacovigilancia de los países participantes, se recopilaron las notificaciones de sospechas de reacciones adversas a estos medicamentos recibidas en el período comprendido entre el 1 de marzo y 31 de agosto de año 2020. Resultados. Se recibieron 3 490 notificaciones de sospechas de reacciones adversas desde los programas de farmacovigilancia de Perú (n = 3 037), Cuba (n = 270), Colombia (n = 108), Chile (n = 72) y El Salvador (n = 3). Los medicamentos con mayor número de notificaciones de reacciones adversas fueron la azitromicina, la ivermectina y la hidroxicloroquina. La diarrea fue el evento más frecuente (15,0%). Del total de las sospechas de reacciones adversas, 11,9% fueron notificadas como graves. La más frecuente fue la prolongación del intervalo QT posterior al uso de hidroxicloroquina. De estas sospechas de reacciones adversas graves, 54,5% ocurrieron en personas mayores de 65 años. Conclusión. Si bien no es posible establecer una relación causal a partir de la evaluación de informes espontáneos, el presente estudio confirma la presencia de reacciones adversas, algunas graves, con medicamentos que se utilizaron para tratar o prevenir la COVID-19.

ABSTRACT Objective. Characterize and describe reports of suspected adverse reactions to a group of drugs used in Colombia, Costa Rica, Cuba, Chile, El Salvador, Mexico, and Peru to treat or prevent coronavirus disease (COVID-19) between 1 March and 31 August 2020. Methods. A list of the 13 drugs used to treat or prevent COVID-19 was prepared, based on official and unofficial sources. Drawing on the databases of the national pharmacovigilance programs of the participating countries, reports of suspected adverse reactions to these drugs were collected for the period from 1 March and 31 August 2020. Results. A total of 3 490 reports of suspected adverse reactions were received from the pharmacovigilance programs of Peru (n = 3 037), Cuba (n = 270), Colombia (n = 108), Chile (n = 72), and El Salvador (n = 3). The drugs with the highest number of reported adverse reactions were azithromycin, ivermectin, and hydroxychloroquine. Diarrhea was the most frequent event (15.0%). Of the total suspected adverse reactions, 11.9% were reported as serious. The most frequent was QT prolongation following use of hydroxychloroquine. Of these suspected serious adverse reactions, 54.5% occurred in people over 65 years of age. Conclusions. While it is not possible to establish a causal relationship from the evaluation of spontaneous reports, the present study confirms the presence of adverse reactions—some of them serious—involving drugs used to treat or prevent COVID-19.

RESUMO Objetivo. Caracterizar e descrever as notificações de suspeitas de reações adversas a um grupo de medicamentos utilizados na Colômbia, Costa Rica, Cuba, Chile, El Salvador, México e Peru, para tratar ou prevenir a doença do coronavírus (COVID-19), entre 1º de março e 31 de agosto de 2020. Métodos. Foi elaborada uma lista dos 13 medicamentos usados para tratar ou prevenir a COVID-19, segundo fontes oficiais e não oficiais. A partir das bases de dados dos programas nacionais de farmacovigilância dos países participantes, foram coletadas notificações de suspeitas de reações adversas a esses medicamentos, recebidas no período entre 1º de março e 31 de agosto de 2020. Resultados. Foram recebidas 3.490 notificações de suspeitas de reações adversas dos programas de farmacovigilância do Peru (n = 3.037), Cuba (n = 270), Colômbia (n = 108), Chile (n = 72) e El Salvador (n = 3). Os medicamentos com maior número de notificações de reações adversas foram azitromicina, ivermectina e hidroxicloroquina. A diarreia foi o evento mais frequente (15,0%). Do total de suspeitas de reações adversas, 11,9% foram notificadas como graves. A mais frequente foi o prolongamento do intervalo QT após o uso de hidroxicloroquina. Dessas suspeitas de reações adversas graves, 54,5% ocorreram em pessoas com mais de 65 anos. Conclusão. Embora não seja possível estabelecer uma relação causal com base na avaliação de relatos espontâneos, o presente estudo confirma a presença de reações adversas - algumas graves - a medicamentos que foram usados para tratar ou prevenir a COVID-19.

Epistaxis grave durante el embarazo, resistente al tratamiento: reporte de un caso y revisión bibliográfica / Refractory severe epistaxis during pregnancy: a case report and a literature review

Resumen ANTECEDENTES: La epistaxis durante el embarazo, aparte de ser una urgencia, tiene una prevalencia tres veces superior a la de la población general. Se controla con medidas conservadoras, aunque a veces deben indicarse tratamientos que implican intervenciones quirúrgicas. CASO CLÍNICO: Paciente de 37 años, con embarazo de 37 semanas, que acudió a Urgencias por epistaxis, sin reacción a las técnicas conservadoras (taponamiento nasal de diversa índole), que provocó anemia progresiva y requirió ligadura de la arteria esfenopalatina para detener el sangrado. Enseguida se llevó a cabo la cesárea, indicada por rotura prematura de membranas e imposibilidad de realizar la maniobra de Valsalva; nació un varón con Apgar 9-10-10. La paciente continuó con alteraciones en la anatomía de los senos paranasales debido a la intervención quirúrgica y en seguimiento en consulta de Otorrinolaringología. CONCLUSIONES: La epistaxis, aunque es un evento frecuente durante el embarazo, puede afectar a la madre y su hijo; por tanto, es importante conocer los tratamientos disponibles al respecto, notificar los nuevos casos y el tratamiento para aumentar el conocimiento de esta alteración infrecuente pero grave.

Abstract BACKGROUND: Epistaxis is a frequent emergency, which prevalence during pregnancy is three times higher than the general female population. It is usually managed with conservative measures, but sometimes more aggressive treatments like surgery may be required. Due to the limited bibliography currently available, new cases and their management should be recorded in order to assess outcomes. CASE REPORT: A 37-week-old pregnant woman went to the Emergency Department with an epistaxis that did not stop despite the use of conservative techniques. As a result of progressive anemization a sphenopalatine artery ligation was required to stop the bleeding. A cesarean section was performed for premature rupture of membranes and the impossibility of Valsalva maneuver. A male infant was born with APGAR test results of 9-10-10. During follow up the patient presented changes in the anatomy of her paranasal sinuses caused by the sphenopalatine artery ligation and is being followed up by Ear-Nose-Throat specialist. CONCLUSION: Epistaxis during pregnancy rarely leads to maternal and/or fetal involvement; it is therefore essential to know all treatments available as well to record new cases and their management to increase knowledge about this uncommon but severe pathology.

Crecimiento intrauterino restringido como síntoma guía para el diagnóstico genético prenatal del síndrome de Wolf-Hirschhorn en gestación gemelar bicorial biamniótica / Restricted Intrauterine Growth as a Guiding Symptom for Prenatal Genetic Diagnosis of Wolf-Hirschhorn Syndrome in Bicorial Diamniotic Twin Gestation

El síndrome de Wolf Hirschhorn, también conocido como monosomía del brazo corto del cromosoma 4 (4p) o síndrome 4p-, es una rara enfermedad genética descrita por primera vez en el año 1961 por los doctores Cooper y Hirschhorn. El objetivo del trabajo es presentar un caso clínico sobre el síndrome de Wolf-Hirschhorn, que es un trastorno genético raro y aún bastante desconocido que cursa con múltiples anomalías morfológicas congénitas, así como con un retraso neurológico e intelectual de grado variable. La prevalencia de este síndrome es extremadamente baja, teniendo en cuenta que la cifra puede estar infraestimada, dada las pérdidas gestacionales precoces y la dificultad en el diagnóstico prenatal. Reportamos el caso de una paciente con gestación gemelar bicorial biamniótica tras un ciclo de FIV-ICSI, en el que al segundo gemelo se diagnosticó un Síndrome de Wolf-Hirschhorn, luego del estudio por una discordancia de pesos estimados y crecimiento intrauterino restringido de este segundo feto. El patrón clásico de presentación clínica se caracteriza por el desarrollo de alteraciones craneofaciales importantes, retraso en el crecimiento normal tanto prenatal como posnatal y deficiencia mental e intelectual de grado variable. El diagnóstico prenatal debe ser realizado por expertos. Puede sospecharse por un crecimiento intrauterino restringido, ya que se da en 80-90 por ciento de los fetos con esta patología. Una vez diagnosticado, se recomienda el estudio genético de los padres, dado que hasta 15 por ciento de los progenitores pueden padecer un reordenamiento cromosómico equilibrado en el brazo corto del cromosoma 4(AU)

Wolf Hirschhorn syndrome, also known as monosomy of the short arm of chromosome 4 (4p) or 4p-syndrome, is a rare genetic disorder first described in 1961 by doctors Cooper and Hirschhorn. The prevalence of this syndrome is extremely low, taking into account that the figure may be underestimated given the early gestational losses and the difficulty in prenatal diagnosis. The objective of the study is to present a clinical case of Wolf-Hirschhorn syndrome, presenting with multiple congenital morphological anomalies, as well as a neurological and intellectual retardation of variable degree. We report the case of a patient with a bicorial biamniotic twin gestation after a cycle of IVF-ICSI. The second twin was diagnosed with a Wolf-Hirschhorn syndrome, after performing the corresponding study due to a discordance of estimated weights and restricted intrauterine growth of this second fetus. The development of important craniofacial alterations, delay of normal prenatal and postnatal growth, and mental and intellectual deficiency of variable degree characterize the classic clinical presentation. Experts must make prenatal diagnosis. Wolf-Hirschhorn syndrome can be suspected by a restricted intrauterine growth, as it occurs in 80-90 percent of fetuses with this pathology. Once diagnosed, the genetic study of the parents is recommended, since up to 15 percent of the parents can suffer a balanced chromosomal rearrangement in the short arm of chromosome 4(AU)

Angioplastía con stent en la estenosis de la arteria renal: nuestra experiencia / Angioplasty with stent in renal artery stenosis: our experience

Abstract. The aim of this study is to demonstrate the outcomes and efficacy of percutaneous treatment in patients with refractory or poorly controlled hypertension and renal insufficiency secondary to renal artery stenosis. Retrospective study including 16 patients treated by angioplasty and stent implantation. Blood pressure and renal function were evaluated in the first 24 hours, and at 6 months and 12 months follow-up. The mean systolic blood pressure decreased from 170 mm Hg to 145 mm Hg in the first 24 hrs, and to 138 mm Hg after 12 months of follow-up, with the diastolic pressure decreasing from 95 mm Hg to 77 mm Hg in the first 24 hrs and to 70 mm Hg after 12 months of follow-up. The renal function, according to the creatinine values remained stable.

En este estudio proporcionaremos los resultados y la eficacia de la angioplastia con stent en pacientes con estenosis de la arteria renal que presentaron secundariamente una hipertensión arterial mal controlada o refractaria e insuficiencia renal. Estudio retrospectivo donde se incluyeron a 16 pacientes tratados mediante angioplastia con stent, con seguimiento en las primeras 24 h, 6 meses y 12 meses postangioplastia, para vigilancia de las cifras tensionales y de la función renal, logrando reducir la tensión arterial sistólica de 170 mm Hg a 145 mm Hg en las primeras 24 h y a 138 mm Hg en el control de los 12 meses; la presión arterial diastólica pasó de 95 mm Hg a 77 mm Hg en las primeras 24 h, y 70 mm Hg en el control a los 12 meses. En cuanto a la función renal hubo estabilidad.

Fibrinólisis como tratamiento en la trombosis de la vena subclavia: nuestra experiencia en causas primarias y secundarias / Fibrinolysis as Treatment in Subclavian Vein Thrombosis: Our Experience in Primary and Secondary Causes

La trombosis de la vena subclavia reviste especial gravedad por las secuelas funcionales y las posibles complicaciones sistémicas que puede desencadenar cuando no se diagnostica a tiempo. Aunque en muchos casos la presentación clínica puede ser diagnóstica, siempre se requieren pruebas de imagen, ya sean no invasivas, como la ecografía con Doppler color, o invasivas, como la flebografía, que es considerada el patrón de oro, ya que demuestra el trombo y confirma la permeabilidad de la circulación colateral. El objetivo de este estudio es demostrar los resultados de la fibrinólisis por catéter y comprobar que su tratamiento agresivo está justificado para evitar secuelas incapacitantes, especialmente en gente joven. Entre el 1 enero de 2006 y el 31 de diciembre de 2012 se atendieron cinco pacientes diagnosticados con trombosis en la vena subclavia, y fueron tratados con fibrinólisis endovenosa con uroquinasa a 100.000 UI/hora. El criterio para escoger los pacientes a trombolizar, fue el tiempo de evolución menor de 6 días y las características agudas del trombo (trombo hipoecogénico-homogéneo, que ocasiona aumento del calibre venoso), así como las características del paciente, edad y repercusión clínica. En nuestra limitada experiencia hemos tenido un éxito del 80 %, con resolución de la sintomatología en el 100 % en trombólisis con uroquinasa, por lo cual la recomendamos como el manejo inicial de las trombosis subclavias, siempre y cuando cumplan las indicaciones y haya ausencia de contraindicaciones absolutas o relativas para trombólisis.

Subclavian vein thrombosis can be particularly serious due to the functional consequences and possible systemic complications that can be triggered when not diagnosed early. Although in many cases the clinical presentation may be diagnostic, imaging is always required, either non-invasive (Doppler ultrasound) and / or invasive, as is the case with venography which is considered the gold standard because it shows the thrombus and confirms the permeability of the collateral circulation. The purpose of the study is to demonstrate the results of catheter directed fibrinolysis and suggests that aggressive treatment of this condition is justified to prevent the possible disabling sequelae, particularly in young people. During the period between January 1, 2006 to December 31, 2012, 5 patients were treated for thrombosis in the subclavian vein with catheter directed thrombolysis with urokinase at 100,000 UI/hour. The selection criteria for thrombolysis, was the time of evolution (less than 6 days) and acute characteristics of thrombus in ultrasound (hypo echogenic-homogenous thrombus, which causes an increase in venous caliber), as well as the characteristics of the patient, the age, and clinical repercussions. In our limited experience we had a success rate of 80% due to the dissolution of the thrombus, with a 100% resolution of symptoms in thrombolysis with urokinase; so we recommend it as the initial management of the subclavian thrombosis as long as the patients are symptomatic and have not contraindications to thrombolysis.

Bringing testing to the people - benefits of mobile unit HIV/syphilis testing in Lima, Peru, 2007-2009.

Mobile unit (MU) HIV testing is an alternative method of providing healthcare access. We compared demographic and behavioural characteristics, HIV testing history and HIV prevalence between participants seeking testing at a MU vs. fixed clinic (FC) in Lima, Peru. Our analysis included men and transgender women (TW) in Lima aged ≥ 18 years old seeking HIV testing at their first visit to a community-based MU or FC from October 2007 to November 2009. HIV testing history, HIV serostatus and behavioural characteristics were analysed. A large percentage of MU attendees self-identified as transgender (13%) or heterosexual (41%). MU attendees were more likely to engage in transactional sex (24% MU vs. 10% FC, p < 0.001), use alcohol/drugs during their last sexual encounter (24% MU vs. 20% FC, p < 0.01) and/or be a first-time HIV tester (48% MU vs. 41% FC, p < 0.001). MU HIV prevalence was 9% overall and 5% among first-time testers (49% in TW and 11% in men who have sex with men [MSM] first-time testers). MU testing reached large numbers of at-risk (MSM/TW) populations engaged in unsafe sexual behaviours, making MU outreach a worthy complement to FC testing. Investigation into whether MU attendees would otherwise access HIV testing is warranted to determine the impact of MU testing.

Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study.

BACKGROUND: The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose. OBJECTIVE: To study whether the use of hemoclips reduces PPB complications. MATERIALS AND METHODS: Prospective, randomised study of patients with pedunculated polyps larger than 10 mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-). This study has been registered with the trial registration number NCT01565993. RESULTS: 105 polypectomies were performed (98 patients), 66 (62.9%) in the HC group. The total rate of complications was 10,6% in the HC group (4.5% early bleeding, 1.5% severe delayed bleeding, 4,5% mucosal burns, 1.5% perforation). In the SP group, the rate of total complications was 7,7%, (7,7% early bleeding, no significant differences). In view of the unexpected increase in the morbidity of the hemoclip group, the study was suspended without reaching the sample size. In an ad hoc analysis, which includes the standard polypectomy patients who refused to participate in the study (35 polyps), the total morbidity was 5,7% (no perforations and 2 patients with premature bleeding).When we compared the morbidity of the HC group to the morbidity of SP group plus R group (74 polyps), we also failed to detect any significant differences in terms of PPB, but did in terms of perforation. CONCLUSION: The prophylactic use of hemoclips in polypectomies of large pedunculated polyps leads to a further risk of mucosal burns and perforation that is not acceptable, and does not reduce the risk of PPB.

Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study.

BACKGROUND: The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose. OBJECTIVE: To study whether the use of hemoclips reduces PPB complications. MATERIALS AND METHODS: Prospective, randomised study of patients with pedunculated polyps larger than 10 mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-). This study has been registered with the trial registration number NCT01565993. RESULTS: 105 polypectomies were performed (98 patients), 66 (62.9%) in the HC group. The total rate of complications was 10,6% in the HC group (4.5% early bleeding, 1.5% severe delayed bleeding, 4,5% mucosal burns, 1.5% perforation). In the SP group, the rate of total complications was 7,7%, (7,7% early bleeding, no significant differences). In view of the unexpected increase in the morbidity of the hemoclip group, the study was suspended without reaching the sample size. In an ad hoc analysis, which includes the standard polypectomy patients who refused to participate in the study (35 polyps), the total morbidity was 5,7% (no perforations and 2 patients with premature bleeding).When we compared the morbidity of the HC group to the morbidity of SP group plus R group (74 polyps), we also failed to detect any significant differences in terms of PPB, but did in terms of perforation. CONCLUSION: The prophylactic use of hemoclips in polypectomies of large pedunculated polyps leads to a further risk of mucosal burns and perforation that is not acceptable, and does not reduce the risk of PPB.

Surface-enhanced Raman scattering of 5-fluorouracil adsorbed on silver nanostructures.

Raman and surface-enhanced Raman scattering (SERS) of 5-fluorouracil (5-FU) have been recorded under several experimental conditions. SERS spectra have been analysed according to a resonant charge-transfer (CT) mechanism similar to a resonance Raman (RR) process, involving the photoinduced transfer of an electron from the Fermi level of the metal to vacant orbitals of the adsorbate (SERS-CT). In order to detect the enhancement mechanism and to identify the chemical species that give rise to the spectra, the theoretical SERS-CT intensities for the dienolic and diketo forms, and its respective N1 and N3 deprotonated anions (5-FU(-)), have been calculated and compared with the experimental results. In this way, the presence of N1 deprotonated anion is confirmed by SERS given that the calculated SERS-CT intensities predict the selective enhancement of the band at ca. 1680 cm(-1) in agreement with the experiment. Therefore, the metal-to-adsorbate CT process involves the transient formation of the respective radical dianion (5-FU (2-)), which is new evidence of the relevance of the CT enhancement mechanism in SERS.

The International Union Against Tuberculosis and Lung Disease: past, present and future.

The International Union Against Tuberculosis and Lung Disease (The Union) is the oldest international non-governmental organization involved in the fight against tuberculosis. This review documents the history and structure of The Union up to 2009, and describes the achievements that have taken place in the field of tuberculosis and lung health. The progress made in tackling the major killer (pneumonia) of children less than 5 years of age, the barrier to affordable essential asthma medicines, the complex issue of tobacco control, the move into the realm of HIV and AIDS, and new ideas and activities around the increasingly important domain of operational research are described and discussed. Finally, as with many institutions that have seen a rapid phase of growth, expansion and decentralisation to regional offices around the world, the review highlights the internal strategic initiative that aims to fine-tune the organisational structure, clarify lines of authority, create more efficient business, human resource and financial systems and revise, where necessary, The Union's guiding mission, vision and values for the future.

Gestación a término en una paciente con síndrome de turner en mosaico / Gestation at term in a patient with turner syndrome in mosaic

El Síndrome de Turner es la entidad más frecuente que compromete los cromosomas sexuales. Se caracteriza por la ausencia parcial o total del cromosoma X (45XO), aunque también se han descrito variantes en mosaico con cariotipo 45XO/46XX. Este síndrome se caracteriza por una falla ovárica temprana y disgenesia gonadal, la cual se traduce en infertilidad e incapacidad para lograr embarazos a término. El objetivo del presente estudio es presentar una mujer de 30 años de edad, con historia clínica de talla baja y disgenesia gonadal, quien a los 14 años se le diagnosticó un Síndrome de Turner en mosaico con cariotipo 45XO / 46XX; un año mas tarde tuvo la menarca y a los 24 años se le diagnosticó un embarazo que llegó a término sin ninguna complicación. Este es el primer caso que se informa en nuestro país.

Turner syndrome is the most common abnormality affecting sex chromosomes. It is usually caused by the complete or partial loss of an X-chromosome (45XO). This condition may also occur with a chromosomal change in some cells (45XO/46XX), which is known as X chromosome mosaicism.The most common characteristics include being shorter in height than average,premature ovarian failure and gonadal dysgenesis. Furthermore, most of women affected by the syndrome can not become pregnant. This is the case of a thirty year old woman with short stature and gonadal dysgenesis whose diagnosis was made when she was fourteen. One year later she had spontaneous menarche and became pregnant at age twenty-four. There were no complications during the pregnancy and she was able to deliver a healthy newborn baby. This is the first case of a woman with turner syndrome who achieved a successful pregnancy reported in Colombia.

[Microsatellite instability among patients with colorectal cancer]. / Análisis genético en pacientes con cáncer colorrectal.

BACKGROUND: In patients with colorectal carcinoma, insertions or deletions of short sequences of DNA, a phenomenon called microsatellite instability, are observed. AIM: To look for microsatellite instability and mutations of MLH1 and MSH2 gene mutations in patients with colorectal carcinoma. MATERIAL AND METHODS: Ten patients with sporadic colorectal carcinoma and 31 patients fulfilling criteria for hereditary nonpolyposis colon cancer (HNPCC), aged 9 to 70 years, were studied. Microsatellite instability was studied in samples of tumor and peripheral blood mononuclear cell DNA. Six markers were amplified by polymerase chain reaction and capillary electrophoresis. In samples with microsatellite instability, mutations of MLH1 and MSH2 genes were studied by direct sequencing. RESULTS: Thirty four percent of patients had microsatellite instability and among these, 76% had a high degree of instability. BAT40 marker had the higher frequency of instability. No mutations for MLH1 and MSH2 genes were observed. However a new polymorphism, C399T, was identified in exon 3 of MSH2 gene. This polymorphism was observed both in patients with sporadic colorectal carcinoma and patients with HNPCC. CONCLUSIONS: There is a high frequency of microsatellite instability among patients with colorectal cancer. A new polymorphism, not previously reported, was identified in MSH2 gene.

Análisis genético en pacientes con cáncer colorrectal / Microsatellite instability among patients with colorectal cancer

Background: In patients with colorectal carcinoma, insertions or deletions of short sequences of DNA, a phenomenon called microsatellite instability, are observed. Aim: To look for microsatellite instability and mutations of MLH1 and MSH2 gene mutations in patients with colorectal carcinoma. Material and Methods: Ten patients with sporadic colorectal carcinoma and 31 patients fulfilling criteria for hereditary nonpolyposis colon cancer (HNPCC), aged 9 to 70 years, were studied. Microsatellite instability was studied in samples of tumor and peripheral blood mononuclear cell DNA. Six markers were amplified by polymerase chain reaction and capillary electrophoresis. In samples with microsatellite instability, mutations of MLH1 and MSH2 genes were studied by direct sequencing. Results: Thirty four percent of patients had microsatellite instability and among these, 76 percent had a high degree of instability. BAT40 marker had the higher frequency of instability. No mutations for MLH1 and MSH2 genes were observed. However a new polymorphism, C399T, was identified in exon 3 of MSH2 gene. This polymorphism was observed both in patients with sporadic colorectal carcinoma and patients with HNPCC. Conclusions: There is a high frequency of microsatellite instability among patients with colorectal cancer. A new polymorphism, not previously reported, was identified in MSH2 gene.

[Endoscopic treatment of gastrointestinal fistulas with biological fibrin glue]. / Tratamiento endoscópico de fístulas gastrointestinales con un pegamento biológico tisular.

OBJECTIVE: We summarize our experience of endoscopic treatment of gastrointestinal fistulas with fibrin glue. PATIENTS AND METHOD: We retrospectively reviewed the outcome of 30 patients with gastrointestinal fistulas (9 internal and 21 external) refractory to standard conservative treatment for at least 10 days. Once the fistula was endoscopically located, 4 to 8 ml of reconstituted fibrin glue (Tissucol 2.0) at 37 degrees C was injected through a Duplocath catheter on a weekly basis. RESULTS: The mean age was 59 years (32-87) and 63% were men. A total of 21.9% of the patients had high output fistulas. We were able to find all fistular orifices what were located close to the surgical anastomosis. Healing time was 17 days (4-90); 2.8 sessions were required per patient (1-5) but only 2.3 sessions were required in responders. Complete sealing of fistulas was achieved in 75%; (80% in low-output, 25% in high-output and 55.5% in internal fistulas). The frequency of fistula recurrence was 3.3%. No complications related to the sealing procedure were found. Overall mortality was 10%, but only 6.6% was related to persistence of the fistula. CONCLUSIONS: Endoscopic treatment of fistulas with biological glue has a high success rate in sealing without complications, helping to speed up the healing process and reduce costs, particularly in low-output enterocutaneous fistulas.