937 resultados para PROSPECTIVE RANDOMIZED-TRIAL


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Aims and objectives. To examine the impact of written and verbal education on bed-making practices, in an attempt to reduce the prevalence of pressure ulcers. Background. The Department of Health has set targets for a 5% reduction per annum in the incidence of pressure ulcers. Electric profiling beds with a visco-elastic polymer mattress are a new innovation in pressure ulcer prevention; however, mattress efficacy is reduced by tightly tucking sheets around the mattress. Design. A prospective randomized pre/post-test experimental design. Methods. Ward managers at a teaching hospital were approached to participate in the study. Two researchers independently examined the tightness of the sheets around the mattresses. Wards were randomized to one of two groups. Groups A and B received written education. In addition, group B received verbal education on alternate days for one week. Beds were re-examined one month later. One researcher was blinded to the educational delivery received by the wards. Results. Twelve wards agreed to participate in the study and 245 beds were examined. Before education, 113 beds (46%) had sheets tucked correctly around the mattresses. Following education, this increased to 215 beds (87.8%) (chi(2) = 68.03, P < 0.001). There was no significant difference in the number of correctly made beds between the two different education groups: 100 (87.72%) beds correctly made in group A vs. 115 (87.79%) beds in group B (chi(2) = 0, P 0.987). Conclusions. Clear, concise written instruction improved practice but verbal education was not additionally beneficial. Relevance to clinical practice. Nurses are receptive to clear, concise written evidence regarding pressure ulcer prevention and incorporate this into clinical practice.

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Background and aims: Virgin olive oil (VOO) and nuts are basic components of the Mediterranean diet, a heart-healthy dietary pattern. Nuts have well known cholesterol lowering effects, while evidence is unclear for VOO. We designed a study in hypercholesterolemic patients to assess the effects on serum lipids and other intermediate markers of cardiovascular risk of replacing 40% of the fat in the background diet with VOO, walnuts or almonds. Methods and Results: After a 4 week run-in period with a healthy diet, eligible candidates were randomized into three diet sequences in a crossover design, with a common background diet enriched with VOO, walnuts or almonds, lasting 4 weeks each. Outcomes were changes of serum lipids and oxidation and inflammation markers, measured by standard methods. Plasma fatty acids were determined by gas chromatography to assess compliance. In 18 participants completing the study (9 women, mean age 56 y, BMI 25.7 kg/m(2)), LDL-cholesterol was reduced from baseline by 7.3%, 10.8% and 13.4% after the VOO, walnut and almond diets, respectively (P = 0.001, Friedman test). Total cholesterol and LDL/HDL ratios decreased in parallel. LDL-cholesterol decreases were greater than predicted from dietary fatty acid and cholesterol exchanges among diets. No changes of other lipid fractions, oxidation analytes or inflammatory biomarkers were observed. Plasma fatty acid changes after each diet sequence supported good compliance.

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Objective: To study the growth of children with complete unilateral cleft lip and palate (UCLP) from birth to 2 years of age and to construct specific UCLP growth curves. Design: Physical growth was a secondary outcome measure of a National Institutes of Health-sponsored longitudinal, prospective clinical trial involving the University of Florida (United States) and the University of Sao Paulo (Brazil). Patients: Six hundred twenty-seven children with UCLP, nonsyndromic, both genders. Methods: Length, weight, and head circumference were prospectively measured for a group of children enrolled in a clinical trial. Median growth curves for the three parameters (length, weight, head circumference) were performed and compared with the median for the National Center for Health Statistics (NCHS) curves. The median values for length, weight, and head circumference at birth and 6, 12, 18, and 24 months of age were plotted against NCHS median values and statistically compared at birth and 24 months. Setting: Hospital de Reabilitacao de Anomalias Craniofaciais, Universidade de Sao Paulo, Bauru, Brazil (HRAC-USP). Results: At birth, children of both genders with UCLP presented with smaller body dimensions in relation to NCHS median values, but the results suggest a catch-up growth for length, weight, and head circumference for girls and for weight (to some degree) and head circumference for boys. Conclusions: Weight was the most compromised parameter for both genders, followed by length and then head circumference. There was no evidence of short stature. This study established growth curves for children with UCLP.

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Background and Objectives: Several studies have suggested that low-level laser therapy (LLLT) can ameliorate oral mucositis, however, the mechanisms involved are not well understood. The aim of this study was to investigate the mechanisms of action of LLLT on chemotherapy-induced oral mucositis, as related to effects on collagen expression and inflammation Materials and Methods: A hamster cheek pouch model of oral mucositis was used with all animals receiving intraperitoneal 5-fluorouracil, followed by surface irritation. Animals were randomly allocated into three groups, and treated with an InGaAIP diode laser at a wavelength of 660 nm and output power of 35 or 100 mW laser, or no laser Clinical severity of mucositis was assessed at four time-points by a blinded examiner Buccal pouch tissue was harvested from a subgroup of animals in each group at four time-points. Collagen was qualitatively and quantitatively evaluated after picrosinus staining. The density of the neutrophil infiltrate was also scored Results: Peak clinical severity of mucositis was reduced in the 35 mW laser group as compared to the 100 mW and control groups The reduced peak clinical severity of mucositis in the 35 mW laser group was accompanied by a decrease in the number of neutrophils and an increase in the proportion of mature collagen as compared to the other two groups. The total quantity of collagen was significantly higher in the control (no laser) group at the day 11 time-point, as compared to the 35 mW laser group, consistent with a more prolonged inflammatory response in the control group. Conclusion: This study supports two mechanisms of action for LLLT in reducing mucositis severity. The increase in collagen organization in response to the 35 mW laser indicates that LLLT promotes wound healing In addition, LLLT also appears to have an anti-inflammatory effect, as evidenced by the reduction in neutrophil infiltrate Lasers Surg Med 42 546-552, 2010. (C) 2010 Wiley-Liss, Inc.

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The aim of this study was to investigate the mechanisms whereby low-intensity laser therapy may affect the severity of oral mucositis. A hamster cheek pouch model of oral mucositis was used with all animals receiving intraperitoneal 5-fluorouracil followed by surface irritation. Animals were randomly allocated into three groups and treated with a 35 mW laser, 100 mW laser, or no laser. Clinical severity of mucositis was assessed at four time-points by a blinded examiner. Buccal pouch tissue was harvested from a subgroup of animals in each group at four time-points. This tissue was used for immunohistochemistry for cyclooxygenase-2 (COX-2), vascular endothelial growth factor (VEGF), and factor VIII (marker of microvessel density) and the resulting staining was quantified. Peak severity of mucositis was reduced in the 35 mW laser group as compared to the 100 mW laser and control groups. This reduced peak clinical severity of mucositis in the 35 mW laser group was accompanied by a significantly lower level of COX-2 staining. The 100 mW laser did not have an effect on the severity of clinical mucositis, but was associated with a decrease in VEGF levels at the later time-points, as compared to the other groups. There was no clear relationship of VEGF levels or microvessel density to clinical mucositis severity. The tissue response to laser therapy appears to vary by dose. Low-intensity laser therapy appears to reduce the severity of mucositis, at least in part, by reducing COX-2 levels and associated inhibition of the inflammatory response.

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Background and Objective: Mucositis is the most common oral complication of cancer chemotherapy, which causes pain on mastication and swallowing, impairs patients` ability to eat and take oral drugs and may determine interruption of the treatment. The aim of this study was to evaluate the effect of light-emitting diode (LED) therapy on chemotherapy-induced mucositis in hamsters. Study Design/Materials and Methods: Animals of both experimental (Group 1; n = 32) and positive control (Group II; n = 32) groups received intraperitoneal injections of 5-fluorouracil on days 0 and 2. All animals had their right and left cheek pouch irritated by superficial scratching on days 3 and 4. In Group I, LED irradiation (630 nm +/- 10 nm, 160 mW, 12 J/cm(2)) was applied during 37.5 seconds at days 3, 4, 6, 8, 10, 12, and 14. In Group II, mucositis was induced, but LED therapy was not performed. The oral mucosa was photographed from day 4 to 14 at 2-day intervals. Photographs were randomly scored according to the severity of induced mucositis (0 to 5). In the negative control group (Group III; n = 6), no mucositis was induced. Biopsies of the cheek pouches of 8 animals (Group I and Group II) were surgically obtained on days 5, 9, 13 and 15 and processed for histological examination. Results: The statistical analysis showed significant differences between irradiated and non-irradiated groups (P < 0.05). However, muscular degeneration was observed in 18% of the samples of Group I. Conclusion: It may be concluded that the LED therapy protocol established for this in vivo study was effective in reducing the severity of oral mucositis, although the oral lesions were not completely prevented. Lasers Surg. Med. 40:625-633, 2008. (c) 2008Wiley-Liss, Inc.

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Introdução e Objetivos: O sistema nervoso central (SNC) é o um sítio freqüente de recaída na criança com leucemia linfocítica aguda (LLA). Existe evidência de que a punção lombar traumática (PLT) pode representar um risco adicional de recaída no SNC quando ocorre inoculação de blastos no liqüido céfalorraquidiano (LCR). Este estudo tem por objetivo determinar se a ocorrência da PLT ao diagnóstico afeta o prognóstico de pacientes com essa patologia. Material e Métodos: Setenta e sete pacientes com diagnóstico de LLA, tratados entre 1992 a 2002, foram incluídos na análise. Quimioterapia intratecal (QIT) foi instilada imediatamente após a PL inicial (precoce), ou na segunda PL (tardia), realizada no período de 24 a 48 horas após a realização da PL inicial. Foi feita análise da influência da PLT e do momento (precoce x tardia) de administração da QIT em relação a recaída no SNC. Resultados: Entre os 19 pacientes que apresentaram PLT ao diagnóstico e receberam QIT tardia, seis tiveram recaída isolada no SNC e dois recaída combinada em SNC e medula óssea (MO). Entre os nove pacientes que tiveram PLT e receberam QIT precoce, somente um apresentou recaída combinada em SNC e MO (P=0,20); não houve, portanto, influência estatisticamente significativa da PLT na sobrevida livre de eventos (SLE) (55% para QIT precoce x 49% para QIT tardia) (P=0,37). Entretanto, em análise estratificada, de acordo com grupos de risco, observamos que para pacientes de baixo ou médio risco o OR foi de 0,8 quando recebiam QIT tardia (P=0,99) e 0,17 quando recebiam QIT precoce (P=0,47). Por outro lado, entre pacientes de alto risco o OR para recaída foi de 21,0 para aqueles que recebiam QIT tardia (P=0,09) e 1,5 para o grupo que recebia Q IT precoce (P=0,99). Conclusão: Os resultados do presente estudo são sugestivos de que a ocorrência da PLT tem uma influência adversa no prognóstico de pacientes com LLA de alto risco de recaída. Como estes resultados são decorrentes de um estudo retrospectivo, recomenda-se que sejam confirmados em estudos prospectivos randomizados.

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Introdução: Níveis de fator de necrose tumoral–alfa (TNF-α), N-peptídeo do pró-colágeno III (PIIINP) e metaloproteinase de matriz –1 (MMP-1), marcadores biológicos de remodelamento ventricular, estão elevados em pacientes com insuficiência cardíaca (IC), talvez refletindo elevadas pressões de enchimento. A correlação destes marcadores com variáveis clínicas e hemodinâmicas permanece pouco compreendida, particularmente no contexto ambulatorial da IC. Objetivo: Avaliar níveis séricos de marcadores biológicos de remodelamento ventricular em pacientes com IC, comparando tratamento guiado por ecocardiografia (ECO), buscando redução de pressões de enchimento, versus tratamento convencional (CLÍNICO), baseado em sinais e sintomas. Métodos: Ensaio clínico randomizado. Pacientes estáveis com IC e fração de ejeção menor do que 40% foram alocados entre os grupos de tratamento e submetidos a ecocardiograma e coletas de sangue no início do estudo e em 180 dias. TNF-α e MMP- 1 foram medidos por ELISA, e PIIINP, por radioimunoensaio. Resultados: Incluiu-se 80 pacientes, com 59 ± 15 anos e fração de ejeção de 26 ± 7%; 25% isquêmicos e 52% masculinos. Houve redução dos marcadores biológicos intragrupos, não havendo diferença entre os tratamentos. No grupo CLÍNICO, os níveis de TNF-α, MMP-1 e PIIINP apresentaram diferenças estatisticamente significativas entre os momentos basal e final (respectivamente, 3,11 ± 2,90 versus 1,24 ± 0,60 pg/mL p < 0,0003; 2,66 ± 1,00 versus 1,16 ± 0,40 ng/mL p < 0,0001; 6,12 ± 2,60 versus 3,89 ± 1,60 μg/L p < 0,0001). De maneira semelhante, tal diferença também foi observada no grupo ECO para os três marcadores (respectivamente, 3,90 ± 4,90 versus 1,40 ± 1,30 pg/mL p < 0,0001; 2,50 ± 0,90 versus 1,09 ± 0,40 ng/mL p < 0,0001; 6,09 ± 2,60 versus 3,50 ± 1,30 μg/L p<0,0001). Ao final da intervenção, no entanto, não foi observada diferença significativa dos valores de TNF-α , MMP-1 e PIIINP entre os dois grupos de tratamento (p = 0,7; p = 0,8; e p = 0,2; respectivamente). A combinação dos valores basais das variáveis biológicas gerou um escore que se associou significativamente com o comportamento final das pressões atrial direita e sistólica da artéria pulmonar. Pacientes com marcadores biológicos basais no quartil 75% mantiveram níveis superiores de pressões atrial direita (13 mmHg; p = 0,034) e sistólica de artéria pulmonar (60 mmHg; p = 0,007) ao final do seguimento. Conclusão: Independente do tratamento alocado, houve redução dos níveis de marcadores biológicos ao final do seguimento; no entanto, níveis basais mais elevados destes marcadores foram preditores de menor redução das pressões em átrio direito e sistólica da artéria pulmonar. Os dados sugerem que indicativos de intenso processo de remodelamento ventricular se associam à progressão da IC e a pressões de enchimento elevadas.

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Introdução: A anfotericina B é a droga de escolha para o tratamento de doenças fúngicas severas, estando associada, no entanto, a alta incidência de nefrotoxicidade. O uso de anfotericinas modificadas está associado a elevado custo. Em grupos de baixo risco o uso de sobrecarga hidrossalina pode ser suficiente para evitar perda severa de função renal. Métodos: Foram estudados prospectivamente pacientes internados em hospital universitário, com idade superior a 12 anos, e que estavam dentro das primeiras 24 horas de uso de anfotericina B. Foram excluídos pacientes em centros de terapia intensiva e que estivessem em uso de drogas vasoativas. Solução salina 0,9% (500 ml) foi infundida antes e após a anfotericina B. Foram coletados exames na inclusão e no término do tratamento. A dosagem de creatinina sérica foi repetida após 30 dias do término do tratamento. Resultados: Foram estudados 48 pacientes. A média de elevação da creatinina sérica foi de 0,3 (0,18-0,41) mg/dl., representando um decréscimo médio de 25 (12,8-36,9) ml/min na depuração de creatinina endógena (DCE). Insuficiência renal aguda (IRA), definida pela elevação maior do que 50% da creatinina basal, ocorreu em 15 pacientes (31,3%). Pacientes que utilizaram antibióticos e aqueles em status pós-quimioterapia ou submetidos a transplante de medula óssea foram os que apresentaram maior risco de desenvolverem IRA. A creatinina e a DCE após 30 dias do término do tratamento não diferiram de seus valores basais. Conclusão: Em pacientes de baixo risco, o uso de anfotericina B com adminstração profilática de solução fisiológica foi associado à alteração pequena e reversível da função renal. Devido ao alto custo, o uso de métodos mais dispendiosos nestes pacientes não parece justificado no momento. Ensaios clínicos randomizados são necessários nesta população.

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Objective-To compare the pre-emptive analgesic effects of epidural ketamine or S(+)-ketamine on post-incisional hyperalgesia.Study Design-Prospective randomized study.Animals-Twenty-four mongrel dogs (1-5 years, weighing 11.9 +/- 1.8 kg).Methods-Dogs were anesthetized with propofol (5 mg/kg intravenously) and a lumbosacral epidural catheter was placed. Dogs were randomly allocated to 3 groups, each with 8 dogs. The control group (CG) was administered saline solution (0.3 mL/kg); the ketamine group (KG) ketamine (0.6 mg/kg); and the S(+)-ketamine group (SG) S(+)-ketamine (0.6 mg/kg). The final volume was adjusted to 0.3 mL/kg in all groups. Five minutes after the epidural injection a surgical incision was made in the common pad of the right hind limb and was immediately closed with simple interrupted nylon suture. Respiratory (RR) and heart (HR) rates, rectal temperature (7, sedation (S), lameness score, and mechanical nociceptive threshold by von Frey filaments were evaluated before the propofol anesthesia and at 15, 30, 45, 60, 75, and 90 minutes and then at 2, 4, 6, 8, 12, and 24 hours after epidural injection.Results-There were no differences in RR, HR, T, or S between groups. Motor blockade of the hind limbs was observed during 20 +/- 3.6 minutes in KG and during 30.6 +/- 7.5 minutes in SG (mean SD). Mechanical force applied to obtain an aversive response was higher from 45 minutes to 12 hours in KG and from 60 to 90 minutes in SG, when compared with CG.Conclusions-Pre-emptive epidural ketamine induced no alterations in RR and FIR, and reduced post-incisional hyperalgesia for a longer time than did S(+) ketamine.Clinical Relevance-Although anesthetic and analgesic potency of S(+) ketamine is twice that of ketamine, the racemic form is seemingly better for post-incisional hyperalgesia. (C) Copyright 2004 by the American College of Veterinary Surgeons.

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Obejective To study the echocardiographic effects of isoflurane at an end-tidal concentration approximating 1.0 times the minimum alveolar concentration (MAC) in healthy unpremedicated dogs.Study design Prospective experimental trial.Animals Sixteen mature mongrel dogs of either sex weighing 11.06 +/- 2.72 kg.Methods After performing a baseline echocardiogram in the awake animal, anesthesia was induced with increasing inspired concentrations of isoflurane via a face mask until tracheal intubation was possible. Following intubation, the end-tidal concentration was decreased to 1.4% for the rest of the anesthetic period. Serial echocardiograms were recorded at 25, 40, and 55 minutes after the end-tidal concentration was reached.Results No changes were observed in heart rate. However, significant decreases were seen in left ventricular end-diastolic diameter (Mean maximal change: 13.8%), interventricular septal thickness during systole (15.2%), interventricular septal thickening fraction (72.2%), left ventricular free wall thickening fraction (63.5%), ejection fraction (39.9%), and fractional shortening (46.7%). In addition, peak flow velocities across mitral, pulmonic, and aortic valves were significantly lower than baseline values. Decreases were also observed in end-diastolic left ventricular volume index (approximately 32.1% from the awake value), stroke index (58.2%), and cardiac index (55.3%) when compared with awake measurements.Conclusions Our results indicate that 1 x MAC isoflurane caused significant myocardial depression in healthy dogs. These changes in myocardial function need to be considered carefully when isoflurane is to be used in dogs with poor cardiovascular reserve.

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Objective To establish the correlation between the bispectral index (BIS) and different rates of infusion of propofol in dogs.Study design Prospective experimental trial.Animals Eight adult dogs weighing 6-20 kg.Methods Eight animals underwent three treatments at intervals of 20 days. Propofol was used for induction of anesthesia (10 mg kg(-1) IV), followed by a continuous rate infusion (CRI) at 0.2 mg kg(-1) minute(-1) (P2), 0.4 mg kg(-1) minute(-1) (P4) or 0.8 mg kg(-1) minute(-1) (P8) for 55 minutes. The BIS values were measured at 10, 20, 30, 40, and 50 minutes (T10, T20, T30, T40, and T50, respectively) after the CRI of propofol was started. Numeric data were submitted to analysis of variance followed by Tukey test (p < 0.05).Results The BIS differed significantly among groups at T40, when P8 was lower than P2 and P4. At T50, P8 was lower than P2. The electromyographic activity (EMG) in P2 and P4 was higher than P8 at T40 and T50.Conclusion An increase in propofol infusion rates decreases the BIS values and EMG.

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Objective To examine the anesthetic effects of a xylazine-diazepam-ketamine (XDK) combination in roosters.Study design Prospective experimental trial.Animals Six healthy white Leghorn roosters weighing 2.03 +/- 0.08 kg.Methods Each rooster was pre-medicated with xylazine (3 mg kg(-1), IM) and after 15 minutes anesthesia was induced with a diazepam (4 mg kg(-1)) and ketamine (25 mg kg(-1)) combination injected into the pectoral muscles. Heart and respiratory rates were recorded before anesthesia and every 15 minutes after induction for 165 minutes. Cloacal temperature was measured before and 15 minutes after pre-medication and every 75 minutes thereafter during anesthesia. Quality of induction and recovery were scored subjectively; duration of loss of righting reflex, abolition of response to a painful stimulus and palpebral reflex were also recorded.Results Intramuscular injection of xylazine smoothly induced loss of the righting reflex within 3-4 minutes. Loss of response to a painful stimulus occurred at 13.1 +/- 2.9 minutes (mean +/- SD) after the administration of the D-K combination, and lasted for 63.0 +/- 5.3 minutes. Roosters anesthetized with this combination had a significant decrease in heart and respiratory rates and cloacal temperature. The recovery period lasted for up to 4 hours (227.5 +/- 15.4 minutes). Quality of recovery was satisfactory for four roosters but excitation was noted in two birds.Conclusions and clinical relevance The XDK combination was a useful anesthetic technique for typhlectomy in roosters. Nevertheless this drug combination should be used with caution and cardiopulmonary parameters monitored carefully. Under the conditions of this experiment it was associated with a decreased cloacal temperature and prolonged recoveries.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)