Prospective, randomized, controlled trial assessing the effects of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome due to community-acquired pneumonia (STAMINA trial): protocol and statistical analysis plan.

BACKGROUND: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. OBJECTIVE: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. METHODS: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. OUTCOMES: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. CONCLUSION: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.

Anti-inflammatory and healing effect of the polysaccharidic extract of Opuntia ficus-indica cladodes in cutaneous excisional wounds in rats.

This study aimed to investigate the anti-inflammatory and wound healing effects of the polysaccharide extract from Opuntia ficus-indica cladodes (TPL-Ofi) using a rat cutaneous wound model. After anaesthesia, four 7-mm-diameter dorsal wounds per animal (n = 6/group for each experimental day of evaluation) were created in female Wistar rats using a surgical punch. The animals were treated topically twice daily with TPL-Ofi (0.01-1%; treated group) or sterile saline (control group) for a period of 21 days. Ulcerated tissue was collected for analysis of histological parameters (inflammation score, number of polymorphonuclear, mononuclear, fibroblast/myofibroblasts and blood vessels), immunohistochemical (fibroblast growth factor 2 [FGF-2]) and oxidative stress markers (myeloperoxidase [MPO] and glutathione [GSH]). After 21 days of treatment, body weight, net organ weight and plasma biochemical levels were measured. TPL-Ofi, containing a total carbohydrate content of 65.5% and uronic acid at 2.8%, reduced oedema on the second day and increased the nociceptive threshold on the second and third days. TPL-Ofi reduced mononuclear infiltrate on the second and MPO activity on the fifth day. TPL-Ofi increased GSH levels on the second day, as well as fibroblast/myofibroblasts counts, neoangiogenesis and FGF-2 levels on the fifth and seventh days. No changes were observed in body weight, net organ weight or toxicology assessment. Topical application of TPL-Ofi exhibited anti-inflammatory and antinociceptive effects, ultimately improving wound healing in cutaneous wounds.

"Metabolically Healthy" Obesity: Fact or Threat?

INTRODUCTION: Obesity is a serious, worldwide and growing problem, with associated complications ranging from cardiovascular disease to cancer. It has been suggested that a subgroup of obese patients- the "metabolically healthy" (MH)- would constitute a phenotype whose cardiovascular risk would be closer to that of normal weight individuals and lower than that of obese patients with other risk factors. The definitions of MH obesity are heterogeneous, what makes the estimation of its prevalence quite difficult. Besides that, data are still controversial about the risk of incident cardiovascular disease in these patients and therefore this remains an unresolved matter. In parallel, the possibly lower risk of MH obesity may raise questions about the need for weight loss in MH obese patients. CONCLUSION: This issue should be carefully addressed, and evidence for a "benign" profile of MH obesity critically evaluated, as obesity is a risk factor for numerous health outcomes, and weight loss in obese people additionally offers protection against these nonmetabolic diseases.

Cetuximab desensitization protocol in two patients with metastatic colorectal cancer after grade 3 infusion reaction to cetuximab

Targeted monoclonal antibodies have become an important therapeutic option for patients with cancer. Cetuximab, a chimeric mouse-human (30:70) immunoglobulin G1 monoclonal antibody against epidermal growth factor receptor, has been approved by the US Food and Drug Administration for the treatment of head and neck and metastatic colorectal cancer (mCRC). Severe (grade 3/4) hypersensitivity-infusion reactions (HIRs) occur in 2-3% of the patients, with fatal outcomes in 0.1%. It is recommended that patients showing severe HIRs to cetuximab should avoid further exposure to it, but in some cases there is no alternative treatment. Two options are currently available for patients with HIRs to cetuximab: desensitization protocol and panitumumab. We describe here two patients with mCRC who successfully underwent a cetuximab desensitization protocol following a severe HIR to cetuximab.

Uso da Escala de Experiência Sexual do Arizona (ASEX) na avaliação de disfunção sexual em pacientes oncológicos brasileiros / Use of Arizona Sexual Experience Scale (ASEX) for the evaluation of sexual dysfunction in Brazilian oncologic patients

Objetivo: Este estudo tem por objetivo a validação da escala de Experiência Sexual do Arizona (ASEX), na versão brasileira, como instrumento capaz de identificar disfunção sexual em mulheres portadoras de neoplasia. Métodos: Foram entrevistadas 64 pacientes do sexo feminino com idade média de 47,5 +- 9,8 anos, sendo a maioria da raça branca (64,1 por cento) e casada (73 por cento). Resultados: A comparação da média do total dos valores da escala ASEX entre as pacientes que declararam ser portadoras de disfunção sexual e aquelas que o negaram resultou numa pontuação de 22,84 +- 3,9 vs. 15,1 +- 2,3 respectivamente. Os resultados obtidos em nosso estudo foram semelhantes aos do estudo original de validação da escala. A sensibilidade e a especificidade da ASEX para a identificação de disfunção sexual (escore >= 19) foram de 92 por cento e 98,4 por cento, respectivamente. A área sob a curva (AUC) foi de 0,96. O valor preditivo positivo (VPP) foi 92 por cento e o valor preditivo negativo (VPN), 94,8 por cento. Conclusão: Esses dados demonstram que, apesar das diferenças metodológicas entre os dois estudos, a versão brasileira da ASEX foi capaz de discriminar as pacientes que apresentam disfunção sexual das que não apresentam de maneira similar ao original em inglês.