ABSTRACT
OBJECTIVE: To analyze the treatment of patients with severe stroke requiring respiratory support, and identify predictors of death. MATERIAL AND METHODS: A multicenter observational clinical study «REspiratory Therapy for Acute Stroke¼ (RETAS) was conducted under the aegis of the «Federation of Anaesthesiologists and Reanimatologists¼ (FAR). The study involved 14 clinical centers and included 1289 stroke patients with respiratory support. RESULTS: We found that initial hypoxemia in the 28-day period was associated with higher mortality than in absence of hypoxemia (in patients with 20 or more NIHSS scores) (76.22% versus 63.45%, p=0.004). Risk factors for lethal outcome: hyperventilation used to relieve intracranial hypertension compared with group of patients who were not treated with hyperventilation (in patients with 20 or more NIHSS scores) (79.55% versus 72.75%, p=0.0336); volume-controlled ventilation (VC) versus pressure-controlled ventilation (PC) (in patients with 20 or more NIHSS scores) (p<0.001); use of clinical methods for monitoring ICP in comparison with instrumental ones (87.64% versus 62.33%, p<0.001). It has been proved that the absence of nutritional insufficiency in patients with stroke is associated with a higher probability of a positive outcome (GOS 4 and 5) in comparison with patients with signs of nutritional insufficiency, for the group with NIHSS less than 14 points (p<0.001). CONCLUSIONS: A group of factors associated with a deterioration in the prognosis of outcomes in patients with stroke who are undergoing ventilation has been identified: hypoxemia at the start of respiratory support, lack of instrumental monitoring of ICP, the use of hyperventilation to correct ICP, ventilation with volume control (VC), as well as the presence of nutritional insufficiency.
Subject(s)
Stroke , Humans , Prognosis , Respiratory Therapy , Risk Factors , Russia , Stroke/complications , Stroke/diagnosis , Stroke/therapyABSTRACT
Pharmaceutical equivalence studies, useful for checking the interchangeability of generic medicines and their respective innovator medicines, have been carried out in Brazil since 1999, as a consequence of the establishment of the generic medicine policy. For medicines containing antibiotics, microbiological assays are often the most appropriate method. However, the statistical methods applied in these assays are not widely known due to the difficult access to official codes and/or little knowledge of the statistical tools of analysis. Thus, the aim of this work was to compare the statistical methods for determining the potency of antibiotics through the cylinder-plate method using parallel lines and a three-dose level model, as described in the Brazilian Pharmacopeia (4th edition, 1988), British Pharmacopoeia 2011, European Pharmacopoeia (7th edition), The International Pharmacopoeia (4th edition), and United States Pharmacopeia (34th edition). The assay is illustrated with the antibiotic ofloxacin, and details on orthogonal coefficients, normality test, homogeneity of variance test, and detection of outliers are discussed. The calculations obtained by statistical analyses from different pharmacopeias lead to the same final interpretation. In practice, with the availability of alternative pharmacopeial methods, the analyst can choose the most appropriate statistical calculation to be used.
Os estudos de equivalência farmacêutica, úteis na verificação da intercambialidade entre os medicamentos genéricos e respectivos medicamentos de referência, têm sido realizados no Brasil desde 1999, como consequência do estabelecimento da política de medicamentos genéricos. Para medicamentos contendo antibióticos, os ensaios microbiológicos são, muitas vezes, o método mais adequado. Entretanto, os métodos estatísticos aplicados nesses ensaios não são amplamente conhecidos devido à dificuldade de acesso aos compêndios oficiais e/ou pouca compreensão das ferramentas estatísticas de análises. Portanto, o objetivo desse trabalho foi comparar os métodos estatísticos para determinação de potência de antibióticos pelo delineamento por retas paralelas e três níveis de doses, descritos nas farmacopeias Brasileira 4. ed. (1988), Britânica 2011, Europeia 7. ed., Internacional 4. ed. e na Farmacopeia dos Estados Unidos 34. ed. (2011). O ensaio é exemplificado com o antibiótico ofloxacino e detalhes sobre coeficientes ortogonais, teste de normalidade, teste de homogeneidade de variância e detecção de outliers são discutidos. Os cálculos obtidos pelas análises estatísticas segundo as diferentes farmacopeias resultaram na mesma interpretação final. Na prática, métodos farmacopéicos alternativos permitem ao analista a escolha do cálculo estatístico mais apropriado a ser utilizado.