53 resultados para SAFETY OF STRUCTURES


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Optical microscopy and centrifugation were used to observe the Structural changes during evaporation of a commercial skin lotion of unknown composition. The degree of evaporation was determined from the changed weight of a microscope slide with the emulsion on a defined area and thickness, the evaporation loss versus time being measured by a balance under an infrared lamp. The results revealed not only which parts of the emulsion were most prone to evaporation without chemical analysis, but also gave surprising information as to which kind of structures would appear after extensive evaporation. The importance of these changes for the action of a skin lotion is briefly discussed.

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Aim of the study: Yacon [Smallanthus sonchifolius (Poepp. 82 Endl.) H. Robinson, Asteraceae] is an Andean species that has traditionally been used as an anti-diabetic herb in several countries around the world, including Brazil. Its hypoglycaemic action has recently been demonstrated in normal and diabetic rats. However, studies about the safety of prolonged oral consumption of yacon leaf extracts are lacking. Thus, this work was undertaken to evaluate the repeated-dose toxicity of three extracts from yacon leaves: the aqueous extract (AE) prepared as a tea infusion; the leaf-rinse extract (LRE), which is rich in sesquiterpene lactones (STLs); and a polar extract from leaves without trichomes, or polar extract (PE), which lacks STLs but is rich in chlorogenic acids (CGAs). Materials and methods: The major classes of the compounds were confirmed in each extract by IR spectra and HPLC-UV-DAD profiling as well as comparison to standard compounds. The toxicity of each extract was evaluated in a repeated-dose toxicity study in Wistar rats for 90 days. Results: The PE was rich in CGAs, but we did not detect any STLs. The AE and LEE showed the presence of STLs. The polar extract caused alterations in some biochemical parameters, but the animals did not show signs of behavioural toxicity or serious lesions in organs. Alterations of specific biochemical parameters in the blood (creatinine 7.0 mg/dL, glucose 212.0 mg/dL, albumin 2.8 g/dL) of rats treated with AE (10,50 and 100 mg/kg) and LRE (10 and 100 mg/kg) pointed to renal damage, which was confirmed by histological analysis of the kidneys. Conclusions: The renal damage was associated with increased blood glucose levels after prolonged oral administration of the AE. This observation suggested that the hypoglycaemic effect observed after treatment for 30 days in an earlier study is reversible and was likely the result of renal injury caused by the toxicity of yacon. Because STLs were detected in both AE and LRE, there is strong evidence that these terpenoids are the main toxic compounds in the leaves of the yacon. Based on our results, we do not recommend the oral use of yacon leaves to treat diabetes. (C) 2010 Elsevier Ireland Ltd. All rights reserved.

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Minimally processed leafy vegetables are ready-to-eat (RTE) products very attractive to consumers looking for healthy and convenient meals. However, the microbiological safety of these foods is of special concern due to the absence of lethal treatments during processing. In the present study, indicator microorganisms, Listeria spp. and Salmonella spp. were determined for 162 samples of minimally processed leafy vegetables commercialized in Brazil. Psychrotrophic aerobic bacterial populations >5 log CFU/g were found in 96.7% of the samples, while total and thermotolerant coliforms were detected respectively in 132 (81.5%) and 107 (66%) of vegetables analyzed. Escherichia coil was present in 86 (53.1%) samples analyzed and Listeria spp. and Salmonella spp. were detected respectively in 6 (3.7%) and 2 (1.2%) samples. These results indicate the need of implementing quality programs in the production chain of RTE vegetables to improve shelf life and microbiological safety. (C) 2011 Elsevier Ltd. All rights reserved.

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Aiming at international competitiveness of the Brazilian dairy sector, new governmental policies were released to improve quality and safety of bovine milk. In this context, it is important to quantify essential and toxic chemical elements. Here, the composition of milk samples taken at 32 dairy farms in Minas Gerais State was assessed by instrumental neutron activation analysis (INAA) and inductively coupled plasma mass spectrometry (ICP-MS), besides the evaluation of usual quality parameters. Significant differences were found for Ba, K, Na and fat content amongst dairy farms with diverse quality levels established on basis of somatic cell and total bacterial count.

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Mice show urinary scent marking behavior as a form of social communication. Marking to a conspecific stimulus mouse or odor varies with stimulus familiarity, indicating discrimination of novel and familiar animals. This study investigated Fos immunoreactivity in inbred C57BL/6J (C57) males following scent marking behavior in response to detection of a social stimulus, or discrimination between a familiar and an unfamiliar conspecific. In Experiment 1 C57 mice were exposed for four daily trials to an empty chamber; on a test day they were exposed to the same chamber or to a male CD-1 mouse in that chamber. Increased scent marking to the CD-1 mouse was associated with increased Fos-immunoreactive cells in the basolateral amygdala, medial amygdala, and dorsal and ventral premammillary nuclei. In Experiment 2 C57 mice were habituated to a CD-1 male for 4 consecutive days and, on the 5th day, exposed to the same CD-1 male, or to a novel CD-1 male. Mice exposed to a novel CD-1 displayed a significant increase in scent marking compared to their last exposure to the familiar stimulus, indicating discrimination of the novelty of this social stimulus. Marking to the novel stimulus was associated with enhanced activation of several telencephalic, as well as hypothalamic and midbrain, structures in which activation had not been seen in the detection paradigm (Experiment 1). These included medial prefrontal and piriform cortices, and lateral septum; the paraventricular nuclei, ventromedial nuclei, and lateral area of the hypothalamus, and the ventrolateral column of the periaqueductal gray. These data suggest that a circumscribed group of structures largely concerned with olfaction is involved in detection of a conspecific olfactory stimulus, whereas discrimination of a novel vs. a familiar conspecific stimulus engages a wider range of forebrain structures encompassing higher-order processes and potentially providing an interface between cognitions and emotions. (C) 2009 IBRO. Published by Elsevier Ltd. All rights reserved.

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Background: Obesity is a serious chronic disease and the prevalence of this condition is increasing among the elderly. Although the benefits of weight loss to improve control of associated diseases are well known in young adults, they are not in older patients. The use of anti-obesity drugs to promote weight loss is widespread in Brazil and other countries, and obesity specialists frequently prescribe medicines in doses and for durations previously unreported in the literature. Sibutramine, orlistat and amfepramone (diethylpropion) have been evaluated in clinical trials of more than 2 years` duration in adults, demonstrating safety and efficacy, but long-term studies in obesity treatment are absent for other drugs. The efficacy and safety of obesity pharmacotherapy among the elderly is unknown. Objective: To describe the experience of obesity pharmacotherapy in the elderly in a specialized obesity care setting in Brazil, with a focus on efficacy and safety. Methods: A retrospective evaluation was conducted on medical charts from an outpatient clinic of a specialized tertiary centre for the treatment of obesity. We included patients who had had at least one consultation between January and December 2007, were aged >= 60 years at the beginning of the treatment, had had at least 6 months of follow-up and had received a prescription of at least one potential weight-loss drug. Diagnoses reported on medical records were documented. Age, weight, height and body mass index (BMI) were recorded at admission, after 6, 12, 18 and 24 months, and at the last available visit. The medicines prescribed, together with the dose, duration of use, adverse effects and reasons for discontinuation, were documented. Results: The group consisted of 44 women (86%) and 7 men (14%), with a mean +/- SD age of 65.2 +/- 4.5 years, weight of 95.3 +/- 12.5 kg and BMI of 38.5 +/- 4.3 kg/m(2). The mean +/- SD time of follow-up was 39.3 +/- 26.4 months, and the mean weight loss was 6.65 kg (p < 0.01). After the first 6 months, the mean +/- SD weight loss was 5.7 +/- 3.8 kg (p < 0.0001). A smaller weight loss was seen between the 6th and 12th months, with no statistically significant change in weight thereafter. A weight loss of >= 5% was achieved by 64.71%, 63.64%, 62.16% and 69.70% in the 6th, 12th, 18th and 24th months, respectively, and a weight loss of >= 10% was achieved by 17.65%, 34.09%, 32.43% and 39.39% in the 6th, 12th, 18th and 24th months, respectively. The medicines prescribed were sibutramine, orlistat, fluoxetine, sertraline, topiramate, fenproporex, mazindol and amfepramone, alone or in combinations, concomitantly or sequentially. The reasons for discontinuation were lack of response (n = 13), loss of response (development of tolerance) [n= 11], lack of adherence (n = 14) and adverse effects (n= 14). One episode of atrial flutter occurred in a patient taking fenproporex. The weight-loss medications were generally well tolerated, and only transient adverse events were reported. Conclusions: Long-term pharmacotherapy for obesity was effective and well tolerated by this group of elderly patients.

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OBJECTIVE: Phrenic nerve transfer has been used for treating lesions of the brachial plexus since 1970. Although, today, surgeons are more experienced with the technique, there are still widespread concerns about its effects on pulmonary function. This study was undertaken to evaluate the effectiveness and safety of this procedure. METHODS: Fourteen patients with complete palsy of the upper limb were submitted to phrenic nerve transfer as part of a strategy for surgical reconstruction of their plexuses. Two patients were lost to follow-up, and 2 patients were followed for less than 2 years. Of the remaining 10 patients, 9 (90%) were male. The lesions affected both sides equally. The mean age of the patients was 24.8 years (range, 14-43 years), and the mean interval from injury to surgery was 6 months (range, 3-9 months). The phrenic nerve was always transferred to the musculocutaneous nerve, and a nerve graft (mean length, 8 cm; range, 4.5-12 cm) was necessary in all cases. RESULTS: There was no major complication related to the surgery. Seven patients (70%) recovered functional level biceps strength (Medical Research Council grade >= 3). All of the patients exhibited a transient decrease in pulmonary function tests, but without clinical respiratory problems. CONCLUSION: On the basis of our small series and data from the literature, we conclude that phrenic nerve transfer in well-selected patients is a safe and effective procedure for recovering biceps function.

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Aims: We evaluated the effect of botulinum toxin type A (BTX-A) injections in the trigone on the antireflux mechanism and evaluated its short-term efficacy. Materials and Methods: Between April and December 2006, 21 patients (10 men and 11 women) were prospectively evaluated. All were incontinent due to refractory NDO and underwent detrusor injection of 300 units of BTX-A, including 50 units into the trigone. Baseline and postoperative evaluation after eight weeks included cystogram, urinary tract ultrasound and urodynamics. Results: At baseline, 20 patients had no vesicoureteral (VUR) and one had grade II unilateral VUR. Postoperative evaluation revealed no cases of de novo VUR and the patient with preinjection VUR had complete resolution of the reflux. Ultrasound showed 5 (23.8%) patients with hydronephrosis before BTX-A injection and only one (4.8%) at the followup evaluation (p=0.066). After treatment, 9 (42.8%) patients became dry, 11 (52.4%) were improved and one (4.8%) had no improvement. Improved patients received antimuscarinic treatment and 8 (38.1%) became dry, with a final total continence rate of 80.1%. Cystometric capacity increased from 271 +/- 92 to 390 +/- 1189 ml (p = 0.002), reflex volume varied from 241 +/- 96 to 323 +/- 201 ml (p = 0.020) and maximum detrusor pressure reduced from 66 +/- 39 to 38 +/- 37 cm H2O (p < 0.001). Conclusions: Our results confirm the safety of trigone injections of BTX-A in terms of development of VUR and upper urinary tract damage. Whether they are beneficial for patients with NDO or other causes of voiding dysfunction will need further studies.

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Background-Peculiar aspects of Chagas cardiomyopathy raise concerns about efficacy and safety of sympathetic blockade. We studied the influence of beta-blockers in patients with Chagas cardiomyopathy. Methods and Results-We examined REMADHE trial and grouped patients according to etiology (Chagas versus non-Chagas) and beta-blocker therapy. Primary end point was all-cause mortality or heart transplantation. Altogether 456 patients were studied; 27 (5.9%) were submitted to heart transplantation and 202 (44.3%) died. Chagas etiology was present in 68 (14.9%) patients; they had lower body mass index (24.1+/-4.1 versus 26.3+/-5.1, P=0.001), smaller end-diastolic left ventricle diameter (6.7+/-1.0 mm versus 7.0+/-0.9 mm, P=0.001), smaller proportion of beta-blocker therapy (35.8% versus 68%, P<0.001), and higher proportion of spironolactone therapy (74.6% versus 57.8%, P=0.003). Twenty-four (35.8%) patients with Chagas disease were under beta-blocker therapy and had lower serum sodium (136.6+/-3.1 versus 138.4+/-3.1 mEqs, P=0.05) and lower body mass index (22.5+/-3.3 versus 24.9+/-4.3, P=0.03) compared with those who received beta-blockers. Survival was lower in patients with Chagas heart disease as compared with other etiologies. When only patients under beta-blockers were considered, the survival of patients with Chagas disease was similar to that of other etiologies. The survival of patients with beta-blockers was higher than that of patients without beta-blockers. In Cox regression model, left ventricle end-diastolic diameter (hazard ratio, 1.78; CI, 1.15 to 2.76; P=0.009) and beta-blockers (hazard ratio, 0.37; CI, 0.14 to 0.97; P=0.044) were associated with better survival. Conclusions-Our study suggests that beta-blockers may have beneficial effects on survival of patients with heart failure and Chagas heart disease and warrants further investigation in a prospective, randomized trial.

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Background: Silastic rings are used in gastric bypass procedures for the treatment of obesity, but ring slippage may lead to gastric pouch outlet stenosis (GPOS). Conventional management has been ring removal through abdominal surgery. Objective: To describe a novel, safe, minimally invasive, endoscopic technique for the treatment of GPOS caused by ring slippage after gastric bypass. Design: Case series. Setting: Federal University of Pernambuco and sao Paulo University. Patients: This study involved 39 consecutive patients who-were screened for inclusion. Intervention: Endoscopic dilation with an achalasia balloon. Main Outcome Measurements: Technical success and safety of the procedure. Results: Among the 39 patients, 35 underwent endoscopic dilation at the ring slippage site for the relief of GPOS. The 4 patients who did not undergo endoscopic dilation underwent surgical removal of the ring, based on the exclusion criteria. The endoscopic approach was successful in 1 to 4 sessions in 100% of cases with radioscopic control (n = 12). The duration of the procedures ranged from 5 to 30 minutes, and the average internment was 14.4 hours. Dilation promoted either rupture (65.7%) or stretching (34.3%) of the thread within the ring, thereby increasing the luminal diameter of the GPOS. Complications included self-limited upper digestive tract hemorrhage (n = 1) and asymptomatic ring erosion (n = 4). There were no recurrences of obstructive symptoms during the follow-up period (mean of 33.3 months). Limitations: This was not a randomized, comparison study, and the number of patients was relatively small. Conclusion: The technique described promotes the relief of GPOS with low overall morbidity and avoids abdominal reoperation for ring removal. (Gastrointest Endosc 2010;72:44-9.)

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Background/Aims: Safety of laparoscopic colectomy education methods remains unknown. This study aimed at comparing the outcomes of patients undergoing preceptored laparoscopic colectomy with patients operated on by the same preceptor. Methodology: A prospective analysis of 30 preceptored operations performed by nine surgeons (PD group) between 2006 and 2008 was conducted. Data of 30 operations matched for diagnosis and surgery type conducted by the same preceptor (P group) were evaluated. Results: Median age was 56.2 (26-80) and 55.2 (22-81) respectively in P and PD group (p=0.804). Eleven (36.7%) were male in P group, 16 (53.3%) in PD group (p=0.194). Preceptored operations were not significantly longer than operations performed by the preceptor (198 vs. 156 min) - p=0.072. Length of hospital stay did not differ [4 days (3-12) in P group, and 5 (3-15) in PD group, p=0.296]. Conversion occurred in 4 cases in PD and in 2 in P group (p=0.389). Morbidity was similar (23.3% in P and 26.7% in PD group). One patient from P and two from PD group needed re-operation. No deaths occurred. Conclusions: Laparoscopic colorectal surgery preceptorship programs in surgeon learner`s place are safe. Surgeons` introduction through basic and hands-on courses is required for skills acquisition needed to minimize adverse outcomes.

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Background: There has been an increase in worldwide infections caused by carbapenem-resistant Acinetobacter. This poses a therapeutic challenge as few treatment options are available. Objectives: The aim of this study was to evaluate the efficacy and safety of polymyxins and ampicillin/sulbactam for treating infections caused by carbapenem-resistant Acinetobacter spp. and to evaluate prognostic factors. Methods: This was a retrospective review of patients from two teaching hospitals who had nosocomial infections caused by carbapenem-resistant Acinetobacter spp. from 1996 to 2004. Diagnosis of infection was based on CDC criteria plus the isolation of Acinetobacter from a usually sterile site or from bronchoalveolar lavage. Urinary tract infections were not included. Data on demographic and clinical features and treatment were collected from medical records. Prognostic factors associated with two outcomes (mortality during treatment and in-hospital mortality) were evaluated. Results: Eighty-two patients received polymyxins and 85 were treated with ampicillin/sulbactam. Multiple logistic regression analysis revealed that independent predictors of mortality during treatment were treatment with polymyxins, higher Acute Physiological and Chronic Health Evaluation II (APACHE II) score, septic shock, delay in starting treatment and renal failure. On multivariate analysis, prognostic factors for in-hospital mortality were older age, septic shock and higher APACHE II score. Conclusions: This is the first study comparing current therapeutic options for infections due to carbapenem-resistant Acinetobacter. The most important finding of the present study is that ampicillin/sulbactam appears to be more efficacious than polymyxins, which was an independent factor associated with mortality during treatment.

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Purpose: The objective of this pilot study was to evaluate the efficacy and safety of 5% imiquimod cream in the treatment of periocular basal cell carcinoma (BCC) through the analysis of a case series. Methods: Eight subjects with primary nodular BCC of the eyelid were recruited. Treatment lasted 10 to 16 weeks. The average follow-up time was 11.7 months. Results: Of a total of 10 lesions, 80% resolved clinically and histologically and have remained asymptomatic since. Conclusion: Imiquimod cream 5% was shown to be an attractive alternative to surgical treatment of periocular BCC. Future studies with larger samples and longer follow-up periods are expected to provide more accurate information on the efficacy and safety of the drug.

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Objective To evaluate the effectiveness and safety of cinnarizine in the treatment of menopausal symptoms. Design A total of 100 climacteric and symptomatic women participated in a double-blind, placebo-controlled study. They were divided into two groups of the same size: Gcin, intake of 25 mg of cinnarizine every 12 h for 6 months (n = 50); and Gpla, placebo intake every 12 hours for 6 months (n = 50). Menopausal symptoms were evaluated according to the Kupperman menopausal index on the first visit and at 6 months of treatment. A total of 62 women completed the study: 27 from the Gcin group and 35 from the Gpla group. Results Based on the Kupperman menopausal index, there were no statistically significant differences between the two groups before and after the treatment. Conclusion Our data suggest cinnarizine is not effective on menopausal symptoms because it had no more efficacy than placebo.

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Background: Drug-drug interactions (DDIs) are one of the main causes of adverse reactions related to medications, being responsible for up to 23% of hospital admissions. However, only a few studies have evaluated this problem in elderly Brazilians. Objectives: To determine the prevalence of potential DDIs (PDDIs) in community-dwelling elderly people in Brazil, analyse these interactions with regard to severity and clinical implications, and identify associated factors. Methods: A population-based cross-sectional study was carried out involving 2143 elderly (aged 60 years) residents of the metropolitan area of Sao Paulo, Brazil. Data were obtained from the SABE (Saude, Bem estar e Envelhecimento [Health, Well-Being, and Aging]) survey, which is a multicentre study carried out in seven countries of Latin America and the Caribbean, coordinated by the Pan-American Health Organization. PDDIs were analysed using a computerized program and categorized according to level of severity, onset, mechanism and documentation in the literature. The STATA software statistical package was used for data analysis, and logistic regression was conducted to determine whether variables were associated with PDDIs. Results: Analysis revealed that 568 (26.5%) of the elderly population included in the study were taking medications that could lead to a DDI. Almost two-thirds (64.4%) of the elderly population exposed to PDDIs were women, 50.7% were aged >= 75 years, 71.7% reported having fair or poor health and 65.8% took 2-5 medications. A total of 125 different PDDIs were identified; the treatment combination of an ACE inhibitor with a thiazide or loop diuretic (associated with hypotension) was the most frequent cause of PDDIs (n=322 patients; 56.7% of individuals with PDDIs). Analysis of the PDDIs revealed that 70.4% were of moderate severity, 64.8% were supported by good quality evidence and 56.8% were considered of delayed onset. The multivariate analysis showed that the risk of a PDDI was significantly increased among elderly individuals using six or more medications (odds ratio [OR] 3.37) and in patients with hypertension (OR 2.56), diabetes mellitus (OR 1.73) or heart problems (OR 3.36). Conclusions: Approximately one-quarter of the elderly population living in Sao Paulo could be taking two or more potentially interacting medicines. Polypharmacy predisposes elderly individuals to PDDIs. More than half of these drug combinations (57.6%, n = 72) were part of commonly employed treatment regimens and may be responsible for adverse reactions that compromise the safety of elderly individuals, especially at home. Educational initiatives are needed to avoid unnecessary risks.