53 resultados para 290309 Safety and Quality

em Scielo Saúde Pública - SP


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The aim of this study was to determine if bone marrow mononuclear cell (BMMC) transplantation is safe for moderate to severe idiopathic dilated cardiomyopathy (IDC). Clinical trials have shown that this procedure is safe and effective for ischemic patients, but little information is available regarding non-ischemic patients. Twenty-four patients with IDC, optimized therapy, age 46 ± 11.6 years, 17 males, NYHA classes II-IV, and left ventricular ejection fraction <35% were enrolled in the study. Clinical evaluation at baseline and 6 months after stem cell therapy to assess heart function included echocardiogram, magnetic resonance imaging, cardiopulmonary test, Minnesota Quality of Life Questionnaire, and NYHA classification. After cell transplantation 1 patient showed a transient increase in enzyme levels and 2 patients presented arrhythmias that were reversed within 72 h. Four patients died during follow-up, between 6 and 12 weeks after therapy. Clinical evaluation showed improvement in most patients as reflected by statistically significant decreases in Minnesota Quality of Life Questionnaire (63 ± 17.9 baseline vs 28.8 ± 16.75 at 6 months) and in class III-IV NYHA patients (18/24 baseline vs 2/20 at 6 months). Cardiopulmonary exercise tests demonstrated increased peak oxygen consumption (12.2 ± 2.4 at baseline vs 15.8 ± 7.1 mL·kg-1·min-1 at 6 months) and walked distance (377.2 ± 85.4 vs 444.1 ± 77.9 m at 6 months) in the 6-min walk test, which was not accompanied by increased left ventricular ejection fraction. Our findings indicate that BMMC therapy in IDC patients with severe ventricular dysfunction is feasible and that larger, randomized and placebo-controlled trials are warranted.

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Salted lamb meat blanket, originated from boning, salting, and drying of whole lamb carcass, was studied aiming at obtaining information that support the search for guarantees of origin for this typical regional product from the city of Petrolina-Pernambuco-Brazil. Data from three processing units were obtained, where it was observed the use of a traditional local technology that uses salting, an ancient preservation method; however, with a peculiar boning technique, resulting in a meat product with great potential for exploitation in the form of meat blanket. Based on the values of pH (6.22 ± 0.22), water activity (0.97 ± 0.02), and moisture (69.86 ± 2.26) lamb meat blanket is considered a perishable product, and consequently it requires the use of other preservation methods combined with salt, which along with the results of the microbiological analyses (absence of Salmonella sp, score <10 MPN/g of halophilic bacteria, total coliforms between 6.7 × 10³ and 5.2 × 10(6) FUC/g, and Staphylococcus from 8.1 × 10³ CFU/g at uncountable) reinforce the need of hygienic practices to ensure product safety. These results, together with the product notoriety and the organization of the sector are important factors in achieving Geographical Indication of the Salted lamb Meat blanket of Petrolina.

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The objective of this work was to evaluate the quality of fruits and the nutritional status of cucumber CV. Aodai cultivated in nutrient solutions with different N:K ratios. The hydroponic cultivation was initially performed, during the vegetative growth, in nutrient solution with 1:2.0 mmol L-1 N:K, and, later, during fruit setting, in four different nutrient solutions with N:K (w/w) at the ratios 1:1.4, 1:1.7, 1:2.0 and 1:2.5. An additional treatment with a nutrient solution containing the ratio 1:2.2 (w/w) N:K during the vegetative growth and N:K 1:1.4 (w/w) during fruit setting, both with 10% ammonium (NH4+) was included. The treatments were arranged in a randomized design with six replicates. Irrigation was carried out with deionized water until seed germination, and then with nutrient solution until 30 days after germination, when plants were transplanted. Plants in the hydroponic growing beds were irrigated with the solutions for vegetative growth, and, after 21 days, the solutions were replaced by solutions for fruit setting. At 45 and 60 days after transplanting, the fresh weight, length, diameter, volume and firmness of the fruit were evaluated, and, at 45 days after transplanting, the macronutrient concentrations in the leaves were determined. The use of different N:K ratios during fruit setting influenced the cucumber production. The ratio of 1.0:1.7 N: K (w/w), with 10% of N in the form of ammonia, is recommended for the whole cycle.

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Besides its importance in the coffee tree nutrition, there is almost no information relating zinc nutrition and bean quality. This work evaluated the effect of zinc on the coffee yield and bean quality. The experiment was conducted with Coffea arabica L. in "Zona da Mata" region, Minas Gerais, Brazil. Twelve plots were established at random with 4 competitive plants each. Treatments included plants supplemented with zinc (eight plots) and control without zinc supplementation (four plots). Plants were subjected to two treatments: zinc supplementation and control. Yield, number of defective beans, beans attacked by berry borers, bean size, cup quality, beans zinc concentration, potassium leaching, electrical conductivity, color index, total tritable acidity, pH, chlorogenic acids contents and ferric-reducing antioxidant activity of beans were evaluated. Zinc positively affected quality of coffee beans, which presented lower percentage of medium and small beans, lower berry borer incidence, lower potassium leaching and electrical conductivity, higher contents of zinc and chlorogenic acids and higher antioxidant activity in comparison with control beans.

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Today, managers are increasingly interested in knowing how the work in organizations aftects employees' health. Less common is the interest in stress erupting in the academic community - among students, faculty and administrators. The authors present a reflection paper focused on student stress. In this paper, they first examine McLean 's model of context, vulnerability and stressors. This model provides the framework for the student surveys and for the entire paper. Based on the students surveys, an assessment is made of how asma" group of students are coping with stress. The paper fina"y suggests what can be done by students, faculty, and administrators to insta" and/or improve social support systems that might reduce the harmful eftects of stress on students and thus impact the quality of education.

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OBJECTIVE: Various support measures useful for promoting joint change approaches to the improvement of both shiftworking arrangements and safety and health management systems were reviewed. A particular focus was placed on enterprise-level risk reduction measures linking working hours and management systems. METHODS: Voluntary industry-based guidelines on night and shift work for department stores and the chemical, automobile and electrical equipment industries were examined. Survey results that had led to the compilation of practicable measures to be included in these guidelines were also examined. The common support measures were then compared with ergonomic checkpoints for plant maintenance work involving irregular nightshifts. On the basis of this analysis, a new night and shift work checklist was designed. RESULTS: Both the guidelines and the plant maintenance work checkpoints were found to commonly cover multiple issues including work schedules and various job-related risks. This close link between shiftwork arrangements and risk management was important as shiftworkers in these industries considered teamwork and welfare services to be essential for managing risks associated with night and shift work. Four areas found suitable for participatory improvement by managers and workers were work schedules, ergonomic work tasks, work environment and training. The checklist designed to facilitate participatory change processes covered all these areas. CONCLUSIONS: The checklist developed to describe feasible workplace actions was suitable for integration with comprehensive safety and health management systems and offered valuable opportunities for improving working time arrangements and job content together.

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OBJECTIVE: To evaluate the reliability and validity of the Portuguese version of the Women's Health Questionnaire. METHODS: In order to evaluate the Women's Health Questionnaire (WHQ), an analytical cross-sectional study was carried out at the women's menopause outpatient clinic of a university hospital in São Paulo, Brazil. There were studied 87 women in perimenopause or menopause, defined as experiencing at least one year's absence of menstrual flow. The following variables were collected: demographic data, clinical variables (Kupperman index and correlate numeric scale) and quality of life indexes (SF-36 and utility). RESULTS: The WHQ proved to be a questionnaire easily translated into Portuguese and well-adjusted to Brazilian women. The internal consistency of the overall WHQ was excellent (Cronbach alpha =0.83; 95% CI: 0.71-0.91). Test-retest reliability was also excellent (intraclass correlation coefficient [ICC]=0.92; 95% IC: 0.86-0.96) and had good absolute agreement (0.84; 95% CI: 0.71-0.92). A satisfactory clinical validity was observed. The construct validity was corroborated by clear associations with others scales. A good index of responsiveness after the intervention was reached. CONCLUSIONS: The Portuguese version of the WHQ is of easy and fast administration and understanding. Its measuring properties were related, allowing its use in the evaluation of Brazilian climacteric women's quality of life for various purposes.

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OBJECTIVE: To assess the association between health-related behaviors and quality of life among the elderly. METHODS: A population-based cross-sectional study was carried out including 1,958 elderly living in four areas in the state of São Paulo, southeastern Brazil, 2001/2002. Quality of life was assessed using the Medical Outcomes Study SF-36-Item Short Form Health Survey instrument. This instrument's eight subscales and two components were the dependent variables. Independent variables were physical activity, weekly frequency of alcohol consumption and smoking. Multiple linear regression models were used to control for the effect of gender, age, schooling, work, area of residence and number of chronic conditions. RESULTS: Physical activity was positively associated with the eight SF-36 subscales. The stronger associations were found for role-physical (β=11.9), physical functioning (β=11.3) and physical component. Elderly individuals who consumed alcohol at least once a week showed a better quality of life than those did not consume alcohol. Compared to non-smokers, smokers had a poorer quality of life for the mental component (β=-2.4). CONCLUSIONS: The study results showed that physical activity, moderate alcohol consumption and no smoking are positively associated with a better quality of life in the elderly.

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OBJECTIVE To analyze the association between sleep quality and quality of life of nursing professionals according to their work schedules.METHODS A prospective, cross-sectional, observational study was conducted between January and December 2010, with 264 nursing professionals, drawn from 989 subjects at Botucatu General Hospital and stratified by professional category. The Pittsburg Sleep Quality Index and the WHOQOL-bref were administered to evaluate sleep quality and quality of life, respectively. Self-reported demographic data were collected with a standard form. Continuous variables were reported as means and standard deviations, and categorical variables were expressed as proportions. Associations were evaluated using Spearman’s correlation coefficient. The association of night-shift work and gender with sleep disturbance was evaluated by logistic regression analysis using a model adjusted for age and considering sleep disturbance the dependent variable. The level of significance was p < 0.05.RESULTS Night-shift work was associated with severe worsening of at least one component of sleep quality in the model adjusted for age (OR = 1.91; 95%CI 1.04;3.50; p = 0.036). Female gender was associated with sleep disturbance (OR = 3.40; 95%CI 1.37;8.40; p = 0.008). Quality of life and quality of sleep were closely correlated (R = -0.56; p < 0.001).CONCLUSIONS Characteristics of the nursing profession affect sleep quality and quality of life, and these two variables are associated.

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OBJECTIVE To assess the inequalities in access, utilization, and quality of health care services according to the socioeconomic status. METHODS This population-based cross-sectional study evaluated 2,927 individuals aged ≥ 20 years living in Pelotas, RS, Southern Brazil, in 2012. The associations between socioeconomic indicators and the following outcomes were evaluated: lack of access to health services, utilization of services, waiting period (in days) for assistance, and waiting time (in hours) in lines. We used Poisson regression for the crude and adjusted analyses. RESULTS The lack of access to health services was reported by 6.5% of the individuals who sought health care. The prevalence of use of health care services in the 30 days prior to the interview was 29.3%. Of these, 26.4% waited five days or more to receive care and 32.1% waited at least an hour in lines. Approximately 50.0% of the health care services were funded through the Unified Health System. The use of health care services was similar across socioeconomic groups. The lack of access to health care services and waiting time in lines were higher among individuals of lower economic status, even after adjusting for health care needs. The waiting period to receive care was higher among those with higher socioeconomic status. CONCLUSIONS Although no differences were observed in the use of health care services across socioeconomic groups, inequalities were evident in the access to and quality of these services.

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ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. RESULTS Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals) were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year), 3.8 kg (six months) and 1.55 kg (two months) in average, in relation to diet and exercise only (three trials). Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. CONCLUSIONS There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern.

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Recombinant yeast-derived hepatitis B vaccine manufactured by Instituto Butantan was administered in two groups of adult volunteers (I, II) following two different schedules of immunization. In the first trial (10 mg doses and 0, 1, 3 months vaccination schedule) 106 individuals completed the full immunization program. The results of seroconversion by age group varied from 70 to 100% and the GMT from 46.5 to 124.9 mIU mL-1. In the second trial with 68 individuals (for dosage comparison and 0, 1, 6 months vaccination schedule) indicated that the vaccine formulated in 20 mg was more effective than in 10 mg. The adverse reactions observed in the vaccinees were less frequent than the ones previously found since the introduction of similar vaccines.

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In this study, we report on the safety and skin delayed-type hypersensitivity (DTH), responses of the Leishmania donovani whole cell sonicate antigen delivered in conjunction with alum-BCG (AlBCG), Montanide ISA 720 (MISA) or Monophosphoryl lipid A (MPLA) in groups of vervet monkeys. Following three intradermal injections of the inoculums on days 0, 28 and 42, safety and DTH responses were assessed. Preliminary tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) levels were also measured and these were compared with DTH. Only those animals immunized with alum-BCG reacted adversely to the inoculum by producing ulcerative erythematous skin indurations. Non-parametric analysis of variance followed by a post-test showed significantly higher DTH responses in the MISA+Ag group compared with other immunized groups (p < 0.001). The MPLA+Ag group indicated significantly lower DTH responses to the sonicate antigen compared with the AlBCG+Ag group. There was a significant correlation between the DTH and cytokine responses (p < 0.0001). Based on this study we conclude that Leishmania donovani sonicate antigen containing MISA 720 is safe and is associated with a strong DTH reaction following immunization.

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Objective: The objective of this article was to investigate the biopsychosocial factors that influence adherence to treatment and the quality of life of individuals who have been successfully following the HIV/AIDS treatment. Methods: It is a cross-sectional study carried out with 120 HIV positive participants in the south of Brazil. Among the variables studied, of note are: perceived stress, social support, symptoms of anxiety and depression and quality of life. Results: The results show that a moderate to high adherence to the treatment paired with a strong sense of social support indicate a higher quality of life. Conclusion: The combination of social support and antiretroviral treatment have an impact on physical conditions, improving immune response and quality of life.

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Objective: To identify the associations among quality of life (QoL), social determinants and psychological distress in primary care in two cities in Brazil. Methods: A cross-sectional study with 1,466 patients from 2009 to 2010. The statistical analysis used the t-test to compare the variables of interest to the study. Results: The prevalence of Common Mental Disorders (CMD3), severe forms of Common Mental Disorders (CMD5), anxiety and depression were 20.5%, 32%, 37% and 25.1% respectively. Thes presence of psychological distress is associated with worse QoL among the patients studied, especially those older than 40 years of age. In cases of CMD3, those with higher income and educational levels presented higher QoL in the psychical and psychological domains. For the cases of probable anxiety, those with higher educational levels presented lower scores on the physical and social relationship scores. Conclusion: Psychological distress can be associated with a worse QoL among those studied and can be influenced by socioeconomic conditions. Therefore, it is important to structure patient-centered help, which should also include patients’ social contexts.