RESUMO
BACKGROUND: Published reports on tocilizumab in COVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues. METHODS: This open-label trial, structured according to Simon's optimal design, aims to identify factors predicting which patients could benefit from anti-IL6 strategies and to enhance the design of unequivocal and reliable future randomized trials. A total of 46 patients with COVID-19 pneumonia needing of oxygen therapy to maintain SO2 > 93% and with recent worsening of lung function received a single infusion of tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary end point was early and sustained clinical response. RESULTS: Twenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher baseline values of PaO2/FiO2 (P = 0.008) predicted a favourable response. CONCLUSIONS: Objective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function in patients selected according to our inclusion criteria warrants investigations in randomized trials.
Assuntos
Anticorpos Monoclonais Humanizados , Biomarcadores Farmacológicos/análise , COVID-19 , Monitoramento de Medicamentos/métodos , Interleucina-6 , Pneumonia Viral , Idoso , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/farmacocinética , COVID-19/diagnóstico , COVID-19/epidemiologia , COVID-19/fisiopatologia , COVID-19/terapia , Feminino , Humanos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/farmacocinética , Infusões Intravenosas , Interleucina-6/antagonistas & inibidores , Interleucina-6/sangue , Itália/epidemiologia , Masculino , Oximetria/métodos , Oxigenoterapia/métodos , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Pneumonia Viral/etiologia , Valor Preditivo dos Testes , Testes de Função Respiratória/métodos , SARS-CoV-2/isolamento & purificação , Resultado do TratamentoRESUMO
OBJECTIVES: To summarize the effects of garlic on several cardiovascular-related factors and to note its adverse effects. METHODS: English and non-English citations were identified from 11 electronic databases, references, manufacturers, and experts from January 1966 through February 2000 (depending on the database searched). Reports of cardiovascular-related effects were limited to randomized controlled trials lasting at least 4 weeks. Reports of adverse effects were not limited by study design. From 1798 pertinent records, 45 randomized trials and 73 additional studies reporting adverse events were identified. Two physicians abstracted outcomes and assessed adequacy of randomization, blinding, and handling of dropouts. Standardized mean differences of lipid outcomes from placebo-controlled trials were adjusted for baseline differences and pooled using random effects methods. RESULTS: Compared with placebo, garlic preparations may lead to small reductions in the total cholesterol level at 1 month (range of average pooled reductions, 0.03-0.45 mmol/L [1.2-17.3 mg/dL]) and at 3 months (range of average pooled reductions 0.32-0.66 mmol/L [12.4-25.4 mg/dL]), but not at 6 months. Changes in low-density lipoprotein levels and triglyceride levels paralleled total cholesterol level results; no statistically significant changes in high-density lipoprotein levels were observed. Trials also reported significant reductions in platelet aggregation and mixed effects on blood pressure outcomes. No effects on glycemic-related outcomes were found. Proven adverse effects included malodorous breath and body odor. Other unproven effects included flatulence, esophageal and abdominal pain, allergic reactions, and bleeding. CONCLUSIONS: Trials suggest possible small short-term benefits of garlic on some lipid and antiplatelet factors, insignificant effects on blood pressure, and no effect on glucose levels. Conclusions regarding clinical significance are limited by the marginal quality and short duration of many trials and by the unpredictable release and inadequate definition of active constituents in study preparations.
Assuntos
Doenças Cardiovasculares/terapia , Alho/uso terapêutico , Fitoterapia , Plantas Medicinais , Adolescente , Adulto , Idoso , Anti-Hipertensivos/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Feminino , Fibrinolíticos/efeitos adversos , Fibrinolíticos/uso terapêutico , Alho/efeitos adversos , Humanos , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/uso terapêutico , Hipolipemiantes/efeitos adversos , Hipolipemiantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Fatores de Risco , Resultado do TratamentoAssuntos
Doenças Cardiovasculares/prevenção & controle , Neoplasias/prevenção & controle , Administração Oral , Adulto , Medicina Baseada em Evidências , Alho/efeitos adversos , Humanos , Hipercolesterolemia/dietoterapia , Fitoterapia , Plantas Medicinais , Ensaios Clínicos Controlados Aleatórios como Assunto , PesquisaRESUMO
Recent changes in the Italian health care system are causing a complex redefinition of the traditional principles of nursing. Among the new principles that are being proposed, the implementation of a clinical practice based on the evidence generated by the medical research community appears to be prominent. However, objective time constraints in finding and evaluating the available information have often hampered the achievement of this highly desirable goal. In this perspective, exploitation of the intrinsic quickness of the internet-based information retrieval systems has the potential to effectively circumvent the problem. To provide nurses with a proper training in a timely search and evaluation of on-line data, we have designed and developed a guide to those websites providing clinical information. This guide consists of (1) reviews of existing websites, and (2) proposal of a standardized model for selection, evaluation, and description of existing and newly appearing websites. We believe that this guide might increase the capability of nurses to effectively exploit the medical and scientific information resources available on the net.