488 resultados para FDA


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Purpose: To evaluate the effects of Triesence (R) (TRI), a new preservative-free triamcinolone approved by the U. S. Food and Drug Administration (FDA) for intraocular use, on human retina pigment epithelial (ARPE-19) and rat neurosensory (R28) cells in culture. Methods: ARPE-19 and R28 cell cultures were treated 24 h with 1,000, 500, 200, or 100 mu g/mL of crystalline (cTRI) or 1,000, 500, or 200 mu g/mL of solubilized (sTRI). TRI was solubilized by centrifuging the drug, discarding the supernatant containing the vehicle and then resuspending the drug pellet in an equivalent amount of Dimethyl sulfoxide to achieve the same concentration as the commercial preparation. Percentage of cell viability (CV) was evaluated by a trypan blue dye-exclusion assay. The mitochondrial membrane potential (Delta Psi m) was analyzed with the JC-1 assay. The caspase-3/7 activity was measured by a fluorochrome assay. Results: In the ARPE-19 cultures, the cTRI caused a decrease in CV at 1,000 mg/mL (13.03 +/- 6.51; P < 0.001), 500 mu g/mL (28.87 +/- 9.3; P < 0.001), 200 mu g/mL (54.93 +/- 5.61; P < 0.001), and 100 mu g/mL (82.53 +/- 0.65; P < 0.005) compared with the untreated controls (96.98 +/- 0.16). In R28 cultures, the cTRI treatment also reduced CV values significantly (P < 0.001) for the 1,000 mu g/mL (22.73 +/- 2.44), 500 mu g/mL (34.63 +/- 1.91), 200 mu g/mL (58.70 +/- 1.39), and 100 mu g/m (75.33 +/- 2.47) compared with the untreated controls (86.08 +/- 3.54). Once the TRI was solubilized (sTRI), the CV and Delta Psi m remained similar to the untreated controls for both ARPE-19 and R28 cells. The sTRI treatment with 1,000, 500, and 200 mu g/mL increased in caspase-3/7 activity in ARPE-19 cells (P < 0.01) and in R28 cells (P < 0.05) compared with dimethyl sulfoxide equivalent controls. Conclusion: The crystalline form of TRI (cTRI) can cause a significant decrease in CV to cultured retinal cells. Once the TRI is solubilized (sTRI), at the same concentrations, the cells remain viable with no decrease in CV or Delta Psi m. The sTRI can, however, increase caspase-3/7 activity, thus suggesting some degree of apoptosis.

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Invocatio: I.H.N.

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14 x 21 cm

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The aim of this dissertation is to develop a theory on intercultural caring to deepen the understanding of caring between nurses and patients who have different cultural backgrounds. The research questions are: 1) What is intercultural caring? 2) How is intercultural caring described and understood? 3) How is intercultural caring described and understood in a maternity care context from the patients’ perspective? 4) What is the substance in a theory on intercultural caring? 5) What is the substance in a theory on intercultural caring in maternity care from the patients’ perspective? The theoretical perspective is based on caritative theory and the caring science-tradition (Eriksson, 2001, 2002) and has a hermeneutic approach. In the first study, 19 texts of Campinha-Bacote, Kim-Godwin, Leininger and Ray are analysed through content analysis. A model for intercultural caring is then created abductively. The second study is a metasynthesis of 40 studies on intercultural caring in maternity care research. The third study is a focused ethnography, in which 17 immigrant mothers are interviewed and observed. The theory on intercultural caring is created through a hermeneutic synthesis of the three studies. A synthesis of the studies with a maternity context results in five patterns of interpretation: the experience of caring is related to power; the family is always present; childbearing and change of culture can give women multiple vulnerabilities; both the mother and the nurse change when they meet; conflicts can cause change. The theory and patterns of interpretation consolidate into a contextual theory on intercultural caring for clinical maternity praxis. In this theory, caring consists of four dimensions: universal, cultural, contextual, and unique caring, which permeate each other. Universal caring is nondependent of time and space. Cultural caring considers the cultural background, the acculturation and the equality of each mother. In the maternity care culture, cultural competence, cultural safety, and acculturation of the nurse are emphasised. Contextual caring considers the specific cultural features of the childbearing mother. In this respect, the nurse is expected to be an expert and to clarify cultural assumptions in maternity care. In unique caring, the mother expects good communication, respect for the family, goodwill and somebody who cares for her and meets her needs, in order for trust to be built. In this respect, the nurse listens to the woman’s narrative, is flexible, open, courageous, and non-judgemental. The nurse shows an understanding for the life situation of the woman, and strives for continuity to preserve the care relationship. It was found that external circumstances affect intercultural caring. Moreover, intercultural caring is expected to decrease misunderstandings and conflicts, alleviate suffering and promote health and life. The theory adds knowledge to the phenomenon of intercultural caring for the nursing and caring sciences, and for the nursing care of patients with other cultural backgrounds than the nurses. The theory can be used in nursing, education, research and administration.

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