RESUMO
INTRODUCTION: Suicide is a complex, global public health problem. The Colombian clinical practice guideline provides relevant input for its prevention, diagnosis and treatment. The objective was to evaluate the methodological quality, credibility and applicability of the Colombian clinical practice guideline for suicidal behaviour. METHODS: An academic group of 12 evaluators was established to assess the guide and its recommendations in a standardised way, using the AGREE-II and AGREE-REX instruments. The evaluations were given in the range of 0.0-1.0 with 0.7 as a cut-off point for appropriate quality. RESULTS: The global assessment of the AGREE-II was greater than 0.7 in the dimensions: "scope and objective" (0.86), "clarity of presentation" (0.89), "applicability" (0.73) and "editorial independence" (0.89). The lowest scores were for "participation of those involved" (0.67) and "rigour in preparation" (0.69). With the AGREE-REX, the results in all dimensions were below 0.70, which indicates lower quality and suitability for use. CONCLUSIONS: The adoption process of the Colombian guideline for suicidal behaviour was a rigorous methodological process, while the practice recommendations were valued as of low applicability due to low support in local evidence. It is necessary to strengthen the generation and synthesis of evidence at the national level to give greater support and applicability to the practice recommendations.
Assuntos
Guias de Prática Clínica como Assunto , Ideação Suicida , Humanos , Colômbia , Prevenção do SuicídioRESUMO
Background: People living with HIV have an increased risk of cancer compared to the general population. However, with the increase in life expectancy and advances in antiretroviral therapy, the survival of patients with cancer and HIV has changed. Objective: To determine the survival of patients living with HIV and cancer in Cali, Colombia. Methods: A retrospective cohort study was conducted at the Fundación Valle del Lili, Cali, Colombia. Data from the HIV database was crossed with data from the hospital and population-based cancer registries between 2011-2019. Patients <18 years, limited available clinical information on the diagnosis and treatment of HIV and cancer, and non-oncological tumor diagnosis were excluded. Results: A total of 173 patients were included. The frequencies of AIDS-defining neoplasms were: Non-Hodgkin lymphoma (42.8%), Kaposi sarcoma (27.8%), and cervical cancer (4.6%). Overall survival was 76.4% (95% CI 68.9-82.3) at five years. Poorer survival was found in patients with AIDS-defining infections (56.9% vs. 77.8%, p=0.027) and non-AIDS-defining infections (57.8% vs. 84.2%, p=0.013), while there was better survival in patients who received antiretroviral therapy (65.9% vs. 17.9%, p=0.021) and oncological treatment (66.7% vs. 35.4%, p<0.001). The presence of non-AIDS-defining infections increases the risk of dying (HR = 2.39, 95% CI 1.05-5.46, p=0.038), while oncological treatment decreases it (HR = 0.33, 95% CI 0.14-0.80, p=0.014). Conclusions: In people living with HIV, Non-Hodgkin lymphoma and Kaposi sarcoma are the most common neoplasms. Factors such as AIDS-associated and non-AIDS-associated infections have been identified as determinants of survival. Cancer treatment seems to improve survival.
Antecedentes: Las personas que viven con VIH tienen un riesgo mayor de cáncer en comparación con la población general. Sin embargo, con el aumento de la esperanza de vida y los avances en la terapia antirretroviral, la supervivencia de los pacientes con cáncer y VIH ha cambiado. Objetivo: Determinar la supervivencia de los pacientes que viven con VIH y cáncer en Cali, Colombia. Métodos: Se realizó un estudio de cohorte retrospectivo en la Fundación Valle del Lili, Cali, Colombia. Los datos de la base de datos de VIH se cruzaron con los datos de los registros de cáncer de base hospitalaria y poblacional entre 2011-2019. Se excluyeron los pacientes <18 años, con información clínica limitada disponible sobre el diagnóstico y tratamiento del VIH y el cáncer y los casos con diagnóstico de tumor no oncológico. Resultados: Se incluyeron un total de 173 pacientes. Las frecuencias de neoplasias definitorias de SIDA fueron: linfoma no Hodgkin (42.8%), sarcoma de Kaposi (27.8%) y cáncer cervical (4.6%). La supervivencia global fue del 76.4% (IC 95% 68.9-82.3) a los cinco años. Se encontró una peor supervivencia en pacientes con infecciones definitorias de SIDA (56.9% vs. 77.8%, p=0.027) e infecciones no definitorias de SIDA (57.8% vs. 84.2%, p=0.013), mientras que hubo una mejor supervivencia en pacientes que recibieron terapia antirretroviral (65.9% vs. 17.9%, p=0.021) y tratamiento oncológico (66.7% vs. 35.4%, p<0.001). La presencia de infecciones no definitorias de SIDA aumentó el riesgo de morir (HR = 2.39, IC 95% 1.05-5.46, p=0.038), mientras que el tratamiento oncológico lo disminuyó (HR = 0.33, IC 95% 0.14-0.80, p=0.014). Conclusiones: En las personas que viven con VIH, el linfoma no Hodgkin y el sarcoma de Kaposi son las neoplasias más comunes. Se han identificado factores como las infecciones asociadas al SIDA y las infecciones no asociadas al SIDA como determinantes de la supervivencia. El tratamiento del cáncer parece mejorar la supervivencia.
Assuntos
Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Linfoma não Hodgkin , Neoplasias , Sarcoma de Kaposi , Neoplasias do Colo do Útero , Feminino , Humanos , Sarcoma de Kaposi/epidemiologia , Sarcoma de Kaposi/complicações , Síndrome da Imunodeficiência Adquirida/complicações , Síndrome da Imunodeficiência Adquirida/tratamento farmacológico , Síndrome da Imunodeficiência Adquirida/epidemiologia , Colômbia/epidemiologia , Estudos Retrospectivos , Sistema de Registros , Neoplasias/epidemiologia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Linfoma não Hodgkin/epidemiologia , Linfoma não Hodgkin/terapia , Linfoma não Hodgkin/complicações , Neoplasias do Colo do Útero/epidemiologiaRESUMO
In experimental studies, researchers apply an intervention to a group of study participants and analyze the effects over a future or prospective timeline. The prospective nature of these types of studies allows for the determination of causal relationships, but the interventions they are based on require rigorous bioethical evaluation, approval from an ethics committee, and registration of the study protocol prior to implementation. Experimental research includes clinical and preclinical testing of a novel intervention or therapy at different phases of development. The main objective of clinical trials is to evaluate an interventions efficacy and safety. Conventional clinical trials are blinded, randomized, and controlled, meaning that participants are randomly assigned to either the study intervention group or a comparator (a control group exposed to a placebo intervention or another non-placebo or active interventionor not exposed to any intervention) to reduce selection and confounding biases, and researchers are also unaware of the type of intervention being applied. Intention-to-treat analysis (inclusion of all originally randomized subjects) should be done to avoid the effects of attrition (dropout) and crossover (variance in the exposure or treatment over time). A quasi-experimental design and external controls may also be used. Metrics used to measure the magnitude of effects include relative risk, absolute and relative risk reductions, and numbers needed to treat and harm. Confounding factors are controlled by randomization. Other types of bias to consider are selection, performance, detection, and reporting. This review is the fifth of a methodological series on general concepts in biostatistics and clinical epidemiology developed by the Chair of Scientific Research Methodology at the School of Medicine, University of Valparaíso, Chile. It describes general theoretical concepts related to randomized clinical trials and other experimental studies in humans, including fundamental elements, historical development, bioethical issues, structure, design, association measures, biases, and reporting guidelines. Factors that should be considered in the execution and evaluation of a clinical trial are also covered.
En los estudios experimentales, el investigador aplica una intervención sobre los participantes, por lo que su eje temporal es prospectivo. Estas características permiten probar relaciones causales, pero implican una rigurosa evaluación bioética y una inscripción previa del protocolo de estudio. Entre las investigaciones experimentales se encuentran los estudios preclínicos y diversos ensayos con objetivos distintos según la fase de desarrollo en que se encuentre. Entre ellos se incluyen los ensayos clínicos, cuyo objetivo principal es evaluar la eficacia y la seguridad de alguna intervención o terapia. El diseño convencional de ensayo clínico es aleatorizado controlado enmascarado, donde se asigna aleatoriamente a los participantes a una intervención y a sus comparadores (otra intervención, placebo o nada); lo que permite controlar el sesgo de selección y el de confusión. Asimismo, los participantes y los investigadores no conocen la intervención que fue asignada. El análisis de sus resultados debe considerar a todos los sujetos originalmente aleatorizados, lo que se conoce como análisis por intención de tratar. Otros tipos de estudios experimentales incluyen los estudios cuasiexperimentales y los estudios experimentales con controles externos. Las medidas de magnitud del efecto utilizadas son el riesgo relativo, las reducciones absolutas y relativas de riesgo y los números necesarios a tratar y dañar. Si bien los factores de confusión son controlados por el proceso de aleatorización, otros sesgos que hay que considerar son los de selección, desarrollo, detección, desgaste y reporte. En este artículo, se abordan los conceptos teóricos generales sobre los estudios experimentales en seres humanos, fundamentalmente sobre los ensayos clínicos aleatorizados, considerando sus elementos fundamentales, desarrollo histórico, aspectos bioéticos, construcción, variantes en el diseño, medidas de asociación, sesgos y pautas de reporte. Finalmente, se sintetizan algunas consideraciones que siempre hay que tener en mente durante la ejecución y la evaluación de un ensayo clínico. Esta revisión es la quinta entrega de una serie metodológica sobre conceptos generales en bioestadística y epidemiologia clínica desarrollada por la Cátedra de Metodología de la Investigación Científica de la Escuela de Medicina de la Universidad de Valparaíso, Chile.
Assuntos
Bioestatística/métodos , Métodos Epidemiológicos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Viés , Estudos Epidemiológicos , Humanos , Projetos de PesquisaRESUMO
BACKGROUND: Gastric cancer is one of the main important causes of cancer death in Chile. OBJECTIVE: To report the results of adjuvant radiochemotherapy in advanced gastric cancer. MATERIAL AND METHODS: Between 2000 and 2018, 214 subjects aged 23-85 (median, 62) years with lymph node and/or serosa involvement were treated with adjuvant chemoradiotherapy after curative resection. RESULTS: With a median follow-up of 41 months, overall 3- and 5-year survival was 54.9% and 40.85%, respectively. On multivariate analysis, the factors associated with lower survival were aged >65 years, stage group and number of lymph nodes involved. CONCLUSION: In patients with locoregionally advanced gastric cancer treated with curative intent with surgery and adjuvant radiochemotherapy, the overall 5-year survival reported from local clinical practice is similar to that reported in randomised series and supports its use as an effective treatment for this type of patients in our country.
RESUMO
Upper airway obstruction is a potentially life-threatening emergency often encountered in the acute care, perioperative, and critical care settings. One important complication of acute obstruction is negative-pressure pulmonary edema (NPPE). We describe two cases of acute upper airway obstruction, both of which resulted in flash pulmonary edema complicated by acute hypoxic respiratory failure. Though NPPE was suspected, these patients were also found to have Takotsubo syndrome (TTS). Neither patient had prior cardiac disease, and both subsequently had a negative ischemic workup. Because TTS is a condition triggered by hyperadrenergic states, the acute airway obstruction alone or in combination with NPPE was the likely explanation for TTS in each case. These cases highlight the importance of also considering cardiogenic causes of pulmonary edema in the setting of upper airway obstruction, which we suspect generates a profound catecholamine surge and places patients at increased risk of TTS development.
RESUMO
Sleep plays an integral role in maintaining health and quality of life. Obstructive sleep apnea (OSA) is a prevalent sleep disorder recognized as a risk factor for cardiovascular disease (CVD) and arrhythmias. Sudden cardiac death (SCD) is a common and devastating event. Out-of-hospital SCD accounts for the majority of deaths from cardiac disease, which is the leading cause of death globally. A limited but emerging body of research have further elaborated on the link between OSA and SCD. In this article, we aim to provide a critical review of the existing evidence by addressing the following: What epidemiologic evidence exists linking OSA to SCD? What evidence exists for a pathophysiologic connection between OSA and SCD? Are there electrocardiographic markers of SCD found in patients with OSA? Does heart failure represent a major effect modifier regarding the relationship between OSA and SCD? What is the impact of sleep apnea treatment on SCD and cardiovascular outcomes? Finally, we elaborate on ongoing research to enhance our understanding of the OSA-SCD association.
RESUMO
Background: People living with HIV have an increased risk of cancer compared to the general population. However, with the increase in life expectancy and advances in antiretroviral therapy, the survival of patients with cancer and HIV has changed. Objective: To determine the survival of patients living with HIV and cancer in Cali, Colombia Methods: A retrospective cohort study was conducted at the Fundación Valle del Lili, Cali, Colombia. Data from the HIV database was crossed with data from the hospital and population-based cancer registries between 2011-2019. Patients <18 years, limited available clinical information on the diagnosis and treatment of HIV and cancer, and non-oncological tumor diagnosis were excluded. Results: A total of 173 patients were included. The frequencies of AIDS-defining neoplasms were: Non-Hodgkin lymphoma (42.8%), Kaposi sarcoma (27.8%), and cervical cancer (4.6%). Overall survival was 76.4% (95% CI 68.9-82.3) at five years. Poorer survival was found in patients with AIDS-defining infections (56.9% vs. 77.8%, p=0.027) and non-AIDS-defining infections (57.8% vs. 84.2%, p=0.013), while there was better survival in patients who received antiretroviral therapy (65.9% vs. 17.9%, p=0.021) and oncological treatment (66.7% vs. 35.4%, p<0.001). The presence of non-AIDS-defining infections increases the risk of dying (HR = 2.39, 95% CI 1.05-5.46, p=0.038), while oncological treatment decreases it (HR = 0.33, 95% CI 0.14-0.80, p=0.014). Conclusions: In people living with HIV, Non-Hodgkin lymphoma and Kaposi sarcoma are the most common neoplasms. Factors such as AIDS-associated and non-AIDS-associated infections have been identified as determinants of survival. Cancer treatment seems to improve survival.
Antecedentes: Las personas que viven con VIH tienen un riesgo mayor de cáncer en comparación con la población general. Sin embargo, con el aumento de la esperanza de vida y los avances en la terapia antirretroviral, la supervivencia de los pacientes con cáncer y VIH ha cambiado. Objetivo: Determinar la supervivencia de los pacientes que viven con VIH y cáncer en Cali, Colombia. Métodos: Se realizó un estudio de cohorte retrospectivo en la Fundación Valle del Lili, Cali, Colombia. Los datos de la base de datos de VIH se cruzaron con los datos de los registros de cáncer de base hospitalaria y poblacional entre 2011-2019. Se excluyeron los pacientes <18 años, con información clínica limitada disponible sobre el diagnóstico y tratamiento del VIH y el cáncer y los casos con diagnóstico de tumor no oncológico. Resultados: Se incluyeron un total de 173 pacientes. Las frecuencias de neoplasias definitorias de SIDA fueron: linfoma no Hodgkin (42.8%), sarcoma de Kaposi (27.8%) y cáncer cervical (4.6%). La supervivencia global fue del 76.4% (IC 95% 68.9-82.3) a los cinco años. Se encontró una peor supervivencia en pacientes con infecciones definitorias de SIDA (56.9% vs. 77.8%, p=0.027) e infecciones no definitorias de SIDA (57.8% vs. 84.2%, p=0.013), mientras que hubo una mejor supervivencia en pacientes que recibieron terapia antirretroviral (65.9% vs. 17.9%, p=0.021) y tratamiento oncológico (66.7% vs. 35.4%, p<0.001). La presencia de infecciones no definitorias de SIDA aumentó el riesgo de morir (HR = 2.39, IC 95% 1.05-5.46, p=0.038), mientras que el tratamiento oncológico lo disminuyó (HR = 0.33, IC 95% 0.14-0.80, p=0.014). Conclusiones: En las personas que viven con VIH, el linfoma no Hodgkin y el sarcoma de Kaposi son las neoplasias más comunes. Se han identificado factores como las infecciones asociadas al SIDA y las infecciones no asociadas al SIDA como determinantes de la supervivencia. El tratamiento del cáncer parece mejorar la supervivencia.
RESUMO
The efficacy and safety of two polyvalent horse-derived antivenoms in Bothrops asper envenomings were tested in a randomized, double-blind, clinical trial performed in Colombia. Both antivenoms were manufactured from the same pool of hyperimmune plasma. Antivenom A was made of F(ab')2 fragments, generated by pepsin digestion and caprylic acid precipitation, whereas antivenom B consisted of whole IgG molecules produced by caprylic acid precipitation followed by ion-exchange chromatography. Besides the different nature of the active substance, antivenom B had higher protein concentration, slightly higher turbidity and aggregate content. No significant differences were observed in the efficacy of antivenoms. Both halted local and systemic bleeding (P = 0.40) within 6-12 h of treatment in 100% of the cases, and restored blood coagulation (P = 0.87) within 6-24 h in 84.7% of patients, and within 48 h in all of them, in agreement with restoration of plasma fibrinogen concentration. Venom concentrations in serum dropped significantly (P < 0.001), to very low levels, 1 h after antivenom infusion. Nevertheless, eight patients (11.1%), four for each antivenom, presented recurrence of venom antigenaemia at different times, from 6 to 96 h, with clinical significance (recurrent coagulopathy) only in one group B patient (2.9%). Serum creatine kinase (CK) activity was increased, as a consequence of local myonecrosis. There was no significant difference (P = 0.51) in the incidence of early adverse reactions to antivenom administration (28.9% for patients of group A and 20.6% for patients of group B), most of the reactions being mild, mainly cutaneous. The most frequent complications were cellulitis (16.7%), abscess formation (5.6%), acute renal failure (8.3%), and compartmental syndrome (5.6%). In conclusion, IgG and F(ab')2 antivenoms, prepared by caprylic acid fractionation, presented similar efficacy and safety profiles for the treatment of B. asper envenomings in Colombia.
Assuntos
Antivenenos/uso terapêutico , Bothrops/metabolismo , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/metabolismo , Mordeduras de Serpentes/tratamento farmacológico , Adolescente , Animais , Coagulação Sanguínea , Transtornos da Coagulação Sanguínea/tratamento farmacológico , Caprilatos/farmacologia , Fracionamento Químico/métodos , Cromatografia por Troca Iônica/métodos , Colômbia , Venenos de Crotalídeos/metabolismo , Método Duplo-Cego , Avaliação de Medicamentos , Feminino , Fibrinogênio/análise , Hemorragia/tratamento farmacológico , Humanos , Fragmentos Fab das Imunoglobulinas/uso terapêutico , Imunoglobulina G/uso terapêutico , Incidência , Masculino , Pepsina A/metabolismo , Resultado do TratamentoRESUMO
Se ha desarrollado un protocolo para la producción y masificación de células de achiote en suspensión, a partir de callos friables obtenidos de tejidos de hojas, como estrategia para la obtención de metabolitos antiofídícos, especialmente compuestos fenólicos, y para ello se ha evaluado el efecto de las concentraciones de inóculo, glucosa, fósforo y nitrógeno sobre la cinética de crecimiento celular, en el medio ½MS+2,4-D (5 ppm)+BAP (1 ppm), almacenados a 25º C, en oscuridad y a 140 rpm, utilizando un diseño factorial completamente aleatorizado de cuatro factores y dos niveles, con evaluación a los 20 y 40 días de establecimiento. El tratamiento que presenta la mayor producción de biomasa de células de achiote en suspensión tiene una concentración inicial de biomasa 4 g/l, 20 g/l de glucosa, 0.13 g/l de fósforo y 2.52 g/l de nitrógeno. La cinética de crecimiento de las células de achiote en suspensión, a las condiciones de cultivo de este tratamiento, presenta una fase exponencial bien definida de 25 días; a partir de allí se establece una fase estacionaria hasta el tiempo final de la evaluación (40 días). Se comparan los contenidos de fenoles totales entre el material obtenido in vitro y el material vegetal proveniente de plantas crecidas ex-vitro, como criterio válido para justificar posteriores trabajos de producción metabólica in-vitro en esta especie vegetal