Background
Steroid use for COVID-19 is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by SARS-CoV-2. This study aimed at evaluating at evaluating the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19.
Methods
Parallel, double-blind, placebo-controlled, randomized, phase IIb clinical trial was performed with hospitalized patients aged ≥ 18 years with clinical, epidemiological and/or radiological suspected COVID-19, at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution), twice daily, for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. ClinicalTrials Identifier NCT04343729.
Findings
From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals. SARS-CoV-2 infection was confirmed by RT-PCR in 81.3%. Mortality at day 28 was not different between groups. A subgroup analysis showed that patients over 60 years in the MP group had a lower mortality rate at day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7.
Conclusion
The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population.
-There is a limited choice of psychometric tests for Portuguese speaking people which have been evaluated in well defined groups. A Portuguese version of CERAD neuropsychological battery was applied to a control group of healthy elderly (CG) (mean age 75.1 years/ education 7.9 years), 31 Alzheimer disease (AD) patients classified by clinical dementia rating (CDR) as CDR1 (71.4/ 9.0) and 12 AD patients CDR 2 (74.1/ 9.3). Cut-off points were: verbal fluency-11; modified Boston naming-12; Mini-mental State Examination (MMSE) -26; word list memory-13; constructional praxis-9; word recall-3, word recognition-7; praxis recall-4. There was a significant difference between CG and AD-CDR1 (p<0.0001) for all tests. There was a less significant difference for constructional praxis and no difference for Boston naming. Comparison between AD-CDR1 and AD-CDR2 showed difference only for MMSE, verbal fluency, and Boston naming. The performance of CG was similar to that of a US control sample with comparable education level. These results indicate that this adaptation may be useful for the diagnosis of mild dementia but further studies are needed to define cut-offs for illiterates/ low education people.KEY WORDS: CERAD, neuropsychology, Alzheimer disease.
Aplicabilidade da bateria neuropsicológica CERAD em idosos brasileirosRESUMO -Existem poucos instrumentos psicométricos em português aplicados em grupos bem definidos. Uma versão em português da bateria neuropsicológica CERAD foi aplicada a um grupo controle de 85 idosos saudáveis (GC) (média de idade 75,1/ média de educação 7,9), 31 indivíduos com doença de Alzheimer (DA) classificados pela Classificação Clínica para Demência (CDR) como CDR1 (71,4/ 9,0) e 12 indivíduos com DA CDR2 (74,1/ 9,3). Os pontos de corte foram: fluência verbal 11; teste de nomeação de Boston 12; MEEM 26; memória da lista de palavras 13; praxia construtiva 9; evocação de palavras 3; reconhecimento de palavras 7; evocação da praxia 4. Houve uma diferença significativa (p<0,0001) para todos os testes, exceto o de nomeação de Boston (p<0,368). A comparação entre AD-CDR1 e AD-CDR2 mostrou diferença apenas para o MEEM, fluência verbal e teste de nomeação de Boston. O desempenho do GC foi semelhante ao de uma população controle americana pareada para nível educacional. Estes resultados indicam que esta adaptação pode ser útil para o diagnóstico de demência inicial, mas estudos mais detalhados devem ser realizados para determinar os pontos de corte para pessoas analfabetas ou com baixa escolaridade. PALAVRAS-CHAVE: CERAD, avaliação neuropsicológica, doença de Alzheimer.
The European Marine Strategy Framework Directive (MSFD) requires EU Member States (MS) to achieve Good Environmental Status (GEnS) of their seas by 2020. We address the question of what GEnS entails especially with regard to the level at which targets are set (descriptors, criteria, indicators), to scales for assessments (regional, sub-divisions, site-specific), and to difficulties in putting into practice the GEnS concept. We propose a refined and operational definition of GEnS, indicating the data and information needed to all parts of that definition. We indicate the options for determining when GEnS has been met, acknowledge the data and information needs for each option, and recommend a combination of existing quantitative targets and expert judgement. We think that the MSFD implementation needs to be less complex than shown for other similar directives, can be based largely on existing data and can be centred on the activities of the Regional Seas Conventions.
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