ABSTRACT
Abstract We critically analyzed clinical trials performed with chloroquine (CQ) and hydroxychloroquine (HCQ) with or without macrolides during the first wave of COVID-19 and discussed the design and limitations of peer-reviewed studies from January to July 2020. Seventeen studies were eligible for the discussion. CQ and HCQ did not demonstrate clinical advantages that justified their inclusion in therapeutic regimens of free prescription for treatment or prophylactic purposes, as suggested by health authorities, including in Brazil, during the first wave. Around August 2020, robust data had already indicated that pharmacological effects of CQ, HCQ and macrolides as anti-SARS-CoV-2 molecules were limited to in vitro conditions and largely based on retrospective trials with low quality and weak internal validity, which made evidence superficial for decision-making. Up to that point, most randomized and nonrandomized clinical trials did not reveal beneficial effects of CQ or HCQ with or without macrolides to reduce lethality, rate of intubation, days of hospitalization, respiratory support/mechanical ventilation requirements, duration, type and number of symptoms, and death and were unsuccessful in increasing virus elimination and/or days alive in hospitalized or ambulatory patients with COVID-19. In addition, many studies have demonstrated that side effects are more common in CQ-or HCQ-treated patients.
Subject(s)
Macrolides/analysis , Pandemics/classification , COVID-19/pathology , Antimalarials/analysis , Comorbidity , Clinical Trials as Topic/instrumentation , Coronavirus/drug effects , Aminoquinolines/agonists , HospitalizationABSTRACT
El emblemático ensayo clínico 329, financiado por Smith Kline Beecham (actualmente GlaxoSmith-Kline) y publicado en2001, permitió posicionar a la paroxetina como un tratamiento efectivo y seguro para la depresión mayor en adolescentes. En la presente editorial el autor describe los sucesos ocurridos luego de su publicación, partiendo de los cuestionamientos iniciales respecto de su eficacia, hasta llegar a los resultados de su reciente reanálisis (llevando adelante por la iniciativa internacional RIAT), el cual concluyo que dicho fármaco no solo no provee un beneficio adicional al placebo para la condición y población utilizada, sino que además se asocia a efectos adversos sustanciales que no habían sido reportados en el informe original. Se exploran además las repercusiones de este suceso en la comunidad científica y se hace un señalamiento de la necesidad de permitir el acceso a las bases de datos originales que sustentan los resultados y conclusiones de las investigaciones publicadas, como mecanismo de transparencia superador a la revisión por pares. (AU)
The emblematic 329 study, funded by Smith Kline Beecham (now GlaxoSmith-Kline) and published in 2001, allowed to position paroxetine as an effective and safe treatment for major depression in adolescents. In this editorial, the author describes the events after its publication, from the initial concerns about its effectiveness, to the results of its recent reanalysis (accounted by the international RIAT initiative), which concluded that the drug not only does not provide an additional benefit than placebo, but is also associated with significant adverse effects that were not reported in the original report. It also explores the repercussions generated in the scientific community by this event, pointing out the need to allow access to original databases that support the findings and conclusions of published research, as an overcoming mechanism for transparency to the traditional peerreview. Agustín Ciapponi Study's 329 hiddens face and scientifics evidence manipulation. (AU)
Subject(s)
Humans , Male , Female , Adolescent , Clinical Trials as Topic/ethics , Paroxetine/adverse effects , Peer Review/ethics , Suicide/statistics & numerical data , Analysis of Variance , Clinical Trials as Topic/instrumentation , Clinical Trials as Topic/methods , Databases as Topic/trends , Depression/drug therapy , Research Financing , Off-Label Use/ethics , Suicidal Ideation , Imipramine/administration & dosageABSTRACT
Se describe un métoso inmunoturbidimétrico para la cuantificación de transferrina en sangre utilizando como lector un equipo para el sistema ultramicroanalítico (SUMA) de la serie 121. En la estandarización del ensayo se emplearon 108 sueros de individuos sanos, provenientes de bancos de sangre. Se obtuvieron porcentajes de recuperación del 99,7 (rango de 93 a 106) y coeficiente de correalción de 0,935, al compararse con la inmunodifusión radial simple. El cambio de la absorbancia fue lineal en un rango de concentración de 0,6 a 4,8 g/L a una longitud de onda de 356 nm, pudiendo procesar simultáneamente 40 muestras en sólo 10 minutos