RESUMO
The coronavirus disease 2019 pandemic has caused a breakdown in the healthcare system worldwide. The need to rapidly update guidelines in order to control the transmission in the population and for evidenced-based healthcare care has led to the need for timely, voluminous and valid research. Amid the quest for a vaccine and better therapies, researchers clamouring for information has led to a wide variety of ethical issues due to the unique situation. This paper aims to examine the positive and negative aspects of recent changes in the process of obtaining informed consent. The article outlines the various aspects, from history, previously described exemptions to consenting as well as those implemented during the pandemic and the current impact of virtual methods. Further, the authors make recommendations based on the outcome of suggested adjustments described in the literature. This article looks into increasing the awareness of physicians and researchers about ethical issues that need to be addressed to provide optimal care for patients while assuring their integrity and confidentiality.
Assuntos
COVID-19 , Consentimento Livre e Esclarecido/ética , Editoração/ética , SARS-CoV-2 , COVID-19/prevenção & controle , COVID-19/terapia , COVID-19/transmissão , Medicina Baseada em Evidências , Disparidades em Assistência à Saúde/ética , Humanos , Pandemias , Educação de Pacientes como Assunto/ética , Relações Médico-Paciente/éticaRESUMO
The objectives of this study were: 1) to evaluate the effects of a fructose enriched diet (FED) on rat sperm quality, epididymal function (i.e. oxidative stress and alpha-glucosidase expression) and testosterone concentrations; 2) to determine if the administration of ghrelin (Ghrl), reverses the effects induced by FED. After validating the protocol as an inductor of metabolic syndrome like-symptoms, adult male rats were assigned to one of the following treatments for 8 weeks: FED = 10% fructose enriched in water (v/v); FED + Ghrl = fructose enriched diet plus Ghrl (6 nmol/animal/day, s.c.) from week 6-8; or C = water without fructose (n = 5-10 animals/group). FED significantly decreased sperm concentration and motile sperm count/ml vs C (FED: 19.0 ± 1.6 × 106sperm/ml and 834.6 ± 137.0, respectively vs C: 25.8 ± 2.8 × 106 and 1300.4 ± 202.4, respectively; p < 0.05); ghrelin injection reversed this negative effect (23.5 ± 1.6 × 106sperm/ml and 1381.7 ± 71.3 respectively). FED resulted in hypogonadism, but Ghrl could not normalize testosterone concentrations (C: 1.4 ± 0.1 ng/ml vs FED: 0.8 ± 0.2 ng/ml and FED + Ghrl: 0.6 ± 0.2 ng/ml; p < 0.05). Ghrelin did not reverse metabolic abnormalities secondary to FED. FED did not alter epididymal expression of antioxidants enzymes (superoxido-dismutase, catalase and glutathione peroxidases -Gpx-). Nevertheless, FED + Ghrl significantly increased the expression of Gpx3 (FED + Ghrl: 3.47 ± 0.48 vs FED: 0.69 ± 0.28 and C: 1.00 ± 0.14; p < 0.05). The expression of neutral alpha-glucosidase, which is a marker of epididymal function, did not differ between treatments. In conclusion, the administration of Ghrl modulated the negative effects of FED on sperm quality, possibly by an epididymal increase in Gpx3 expression. However, Ghrl could not neither normalize the metabolism of FED animals, nor reverse hypogonadism.
RESUMO
El abordaje terapéutico de pacientes con dos o más enfermedades autoinmunes es un verdadero desafío, especialmente cuando el tratamiento enfocado en una de ellas podría precipitar la progresión de la otra. Si bien la asociación de artritis reumatoidea (AR) con colangitis biliar primaria (CBP) no es tan frecuente, cuando coexisten, la utilización de metotrexato u otras drogas hepatotóxicas debe decidirse con cautela. Con la indicación más generalizada de las drogas biológicas modificadoras del curso de la AR (DMARb) han aparecido algunos reportes de pacientes con AR y CBP tratados con etanercept, infliximab, rituximab, tocilizumab y abatacept. Presentamos una serie de casos de 4 pacientes con AR y CBP que fueron tratados con DMARb. Nuestro reporte sería el primero en describir dos casos con golimumab para controlar la AR y el segundo en reportar un caso con adalimumab y otro con abatacept. Con rituximab, ya existen tres casos publicados. En ninguno de los pacientes de nuestra serie empeoraron los síntomas de CBP y, al contrario, en dos de ellos hubo mejoría de los parámetros bioquímicos. En conclusión, según lo observado y lo reportado en la literatura, el uso DMARb podría ser considerado en el caso de pacientes con AR activa que además padecen CBP
The therapeutic approach of patients with two or more autoimmune diseases is quite a challenge, especially when the treatment of one of them, can precipitate the progression of the other. Even though the association of rheumatoid arthritis (RA) and primary biliary cholangitis (PBC) is rare; when both coexist, the use of methotrexate and other hepatotoxic drugs should be used with caution. With a most widespread indication of biologic diseasemodifying antirheumatic drugs (bDMARDs) some reports of patients with RA and PBC treated with etanercept, infliximab, rituximab, tocilizumab and abatacept have been published. We report a case series that includes 4 patients with RA and PBC treated with bDMARDs. This is the first report to describe two cases in which golimumab was used to control RA and the second to report patients who received adalimumab and abatacept. Three cases of patients treated with rituximab have been published to date. None of the patients of our report suffered a progression of their PBC; matter in fact, two of them showed an improvement in their biochemical parameters. PBC symptoms did not get worse in any of the patients. On the contrary, laboratory parameters improved in two of the four patients. In conclusion, according to the literature reviewed and to our findings, the use of bDMARDs could be considered in RA patients with concomitant PBC