INTRODUÇÃO: Na Colômbia não existem estudos publicados sobre o tratamento da malária não complicada por Plasmodium falciparum comparando as terapias combinadas com artemisinina. Destarte, quer se demonstrar a não inferioridade dos perfis de eficácia/segurança dos tratamentos com artesunato+amodiaquina versus artemeter-lumefantrina. MÉTODOS: Foi realizado um estudo clínico de não inferioridade (∆≤5%), aleatório, controlado, aberto, em adultos com malária não complicada por P. falciparum usando o desenho validado de 28 dias e os desenhos validados/definidos pela Organização Mundial da Saúde. Os pacientes foram aleatorizados (1:1) para ambos artesunato+amodiaquina ou artemeter-lumefantrina orais. Critérios primários de eficácia: resposta clínica e parasitológica adequada; Criterios de eficácia secundários: as falhas de tratamento definidos pela Organização Mundial da Saúde. A segurança: avaliada através de eventos adversos. RESULTADOS: Foram incursos 105 pacientes em cada grupo: zero observações censuradas. As taxas médias da resposta clínica e parasitológica adequada (95% IC - intervalo de confiança): 100% para artesunato+amodiaquina e 99% para artemeter-lumefantrina; atingiu-se o critério de não inferioridade (∆=1.7%). Houve uma falha terapêutica parasitológica tardia (1%; grupo artemeter-lumefantrina), caracterizada mediante reação em cadeia da polimerase como o alelo MAD20 MSP1. Tempo de remissão da febre (grupo artesunato+amodiaquina), foi significativamente mais curto (p=0.002). Dor abdominal, para artesunato+amodiaquina e artemeter-lumefantrina, respectivamente, 1.9% e 3.8% (p=0.68) na linha de base, 1% e 13.3% pós-tratamento (p<0.001). CONCLUSÕES: O tratamento com artesunato+amodiaquina da malária não complicada por P. falciparum é não inferior ao tratamento normal com artemeter-lumefantrina. Os perfis de eficácia/segurança justificam estudos adicionais nesta e outras populações semelhantes.

INTRODUCTION: In Colombia, there are no published studies for the treatment of uncomplicated Plasmodium falciparum malaria comparing artemisinin combination therapies. Hence, it is intended to demonstrate the non-inferior efficacy/safety profiles of artesunate + amodiaquine versus artemether-lumefantrine treatments. METHODS: A randomized, controlled, open-label, noninferiority (Δ≤5%) clinical trial was performed in adults with uncomplicated P. falciparum malaria using the 28‑day World Health Organization validated design/definitions. Patients were randomized 1:1 to either oral artesunate + amodiaquine or artemether-lumefantrine. The primary efficacy endpoint: adequate clinical and parasitological response; secondary endpoints: - treatment failures defined per the World Health Organization. Safety: assessed through adverse events. RESULTS: A total of 105 patients was included in each group: zero censored observations. Mean (95%CI - Confidence interval) adequate clinical and parasitological response rates: 100% for artesunate + amodiaquine and 99% for artemether-lumefantrine; the noninferiority criteria was met (Δ=1.7%). There was one late parasitological therapeutic failure (1%; artemether-lumefantrine group), typified by polymerase chain reaction as the MAD20 MSP1 allele. The fever clearance time (artesunate + amodiaquine group) was significantly shorter (p=0.002). Respectively, abdominal pain for artesunate + amodiaquine and artemether-lumefantrine was 1.9% and 3.8% at baseline (p=0.68) and 1% and 13.3% after treatment (p<0.001). CONCLUSIONS: Uncomplicated P. falciparum malaria treatment with artesunate + amodiaquine is noninferior to the artemether-lumefantrine standard treatment. The efficacy/safety profiles grant further studies in this and similar populations.

OBJECTIVE: To estimate potential excess mortality attributable to influenza viruses A and B and human respiratory syncytial virus (HRSV) during peak seasons of influenza virus circulation in Colombia from 1997 to 2005. METHODS: A comparison of monthly, general mortality rates from pneumonia in children under 5 years of age and from pneumonia and cardiovascular disease in those more than 60 years of age in Bogota, Colombia, were compared to the city's peak seasons of influenza virus circulation. Mortality data were obtained from the National Bureau of Statistics of Colombia; peak seasons of virus circulation were defined as contiguous months in which the number of isolates was equal to or greater than half the total number of isolates for the year. Incidence rate ratios (IRR) and their 95% confidence intervals (95%CI) were determined. RESULTS: Influenza A demonstrated a pattern of seasonal circulation, but influenza B and HRSV did not. The increased circulation of influenza virus was associated with an average annual increase of 5% in overall mortality during the study period (IRR = 1.05; 95%CI: 1.046-1.064). During seasons of increased circulation of influenza viruses, the combined mortality from pneumonia and influenza for all ages was 11% higher than it was at other times (IRR = 1.11; 95%CI: 1.051-1.178). CONCLUSIONS: During peak seasons of influenza virus circulation in Colombia, there can be increased mortality, particularly from pneumonia and cardiovascular disease among those more than 60 years of age. Preventive actions specific to protecting against influenza should be taken, especially in these two age groups.

OBJETIVO: Estimar el exceso de mortalidad potencialmente atribuible a los virus de la influenza A y B y al virus sincitial respiratorio humano (VSRH) en las temporadas de mayor circulación de los virus de la influenza en Bogotá, Colombia entre 1997 y 2005. MÉTODOS: Se relacionaron las tasas mensuales de mortalidad general, por neumonía en menores de 5 años y por neumonía y afecciones cardiovasculares en mayores de 60 años, en Bogotá, Colombia, con las temporadas de mayor circulación de los virus de la influenza en esa ciudad. Los datos de mortalidad se obtuvieron del Departamento Nacional de Estadísticas de Colombia; las temporadas de mayor circulación de los virus se definieron como los meses contiguos en los que el número de aislamientos era igual o superior a la mitad del total de los aislamientos del año. Se calcularon las razones de tasas de incidencia (RTI) y sus intervalos de confianza de 95% (IC95%). RESULTADOS: El virus de la influenza A mostró un patrón de circulación estacional, pero no el de la influenza B y el VSRH. La mayor circulación de los virus de la influenza se asoció con un incremento promedio anual de 5% en la mortalidad general durante el período estudiado (RTI = 1,05; IC95%: 1,046 a 1,064). En las temporadas de mayor circulación de los virus de la influenza, la mortalidad combinada por neumonía e influenza en todas las edades fue mayor en 11% que en el resto del período (RTI = 1,11; IC95%: 1,051 a 1,178). CONCLUSIONES: En las temporadas de mayor circulación de los virus de la influenza en Colombia puede aumentar la mortalidad, en particular por neumonía y afecciones cardiovasculares en mayores de 60 años. Deben emprenderse acciones de prevención específicas para prevenir la influenza, especialmente en estos dos grupos de edad.