Background
Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.
Methods
We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.
Results
A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
Conclusions
Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number,
NCT04322123
.)
Based on empirical data, we have developed a brief and easy-to-use screening strategy with higher accuracy and some practical advantages compared with commonly used tools.
The instrument developed in this study proved to be a practical tool for classifying the majority of spontaneously reported cognitive complaints with high reliability. Further studies are needed to investigate clinical usefulness of this approach.
ResumoIntrodução: Quedas são um problema clínico comum nos idosos, que pode reduzir sua mobilidade e independência. O uso de instrumentos simples para detecção do risco de quedas é fundamental para prevenção e tratamento de tais eventos. Não há, porém, consenso quanto aos testes mais adequados para cada situação. A revisão mostrou que os dois testes podem ser bons preditores de quedas, mas os artigos diferiram quanto à definição de queda e caidor, tipo de estudo, quantidade e característica da amostra e avaliação de quedas, levando a diferentes resultados quanto a nota de corte, sensibilidade, especificidade e predição de quedas. Há controvérsias quanto à capacidade de predição em perfis específicos, como os idosos ativos. Conclusão: Os testes avaliados são eficazes para predição de quedas, desde que adaptados para cada perfil. Novos estudos devem ser realizados com metodologia homogênea, a fim de favorecer a comparação de resultados sobre a eficácia desses testes.
AbstractIntroduction: Fall is a common problem in the elderly and it can reduce their mobility and independence. The use of simple tools to detect risk of falls is essential to prevent and treat such events. However, there is no consensus about the most appropriate tools for each situation. Objective: To review studies about efficacy, sensitivity and specificity of Timed Up and Go Test (TUGT) and Berg Balance Scale (BBS) in order to ascertain which is the most appropriate to predict falls in the elderly. Methods: We performed a literature review from MEDLINE, PubMed, ISI, LILACS and Portal de Periódicos
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