64 resultados para Adverse Events


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This study aimed to assess knowledge of nursing professionals (nurses, technicians and nursing assistants) on the Project Sentinel Hospitals in a state hospital in the interior of and identify the occurrence of under-reporting of hospital products and the reasons that prevented the team to notify them. This is a study of a descriptive and exploratory, held in a public hospital in the interior of which serves only patients of the Unified Health System (SUS). The study sample consisted of 245 nurses. Data analysis revealed that the majority of nurses and nursing assistants refers knowledge about Project Sentinel Hospitals. In relation to the Practical nurses less than half know Hospitals Project Sentry. Knowledge of the four spheres of Hospitals Project Sentinel is higher among nurses. Among the practical nurses and nursing assistants prevailing knowledge in the area of Pharmacovigilance. The nurses have more knowledge about the process of notification and are major notifiers. Technicians and nursing assistants are those who have greater interest in learning content as a whole Hospitals Project Sentry. The nurses were the professionals who witnessed the most under-and under-reporting associated with the fear, lack of knowledge on the subject, insecurity and lack of time. It can be concluded that the study identified the knowledge of nurses on Project Sentinel Hospitals and the procedure for notification of technical defects and adverse events related to health products as well as identify the presence of under-reporting among professionals. In addition, the study shows the importance and need for greater disclosure of the activities developed by Project Sentinel Hospitals among nursing professionals through meetings, lectures, brochures, among other outlets

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Pós-graduação em Enfermagem - FMB

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Pós-graduação em Cirurgia Veterinária - FCAV

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

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BackgroundDiabetes is associated with long-term damage, dysfunction and failure of various organs, especially the eyes, kidneys, nerves, heart and blood vessels. The risk of developing type 2 diabetes increases with age, obesity and lack of physical activity. Insulin resistance is a fundamental aspect of the aetiology of type 2 diabetes. Insulin resistance has been shown to be associated with atherosclerosis, dyslipidaemia, glucose intolerance, hyperuricaemia, hypertension and polycystic ovary syndrome. The mineral zinc plays a key role in the synthesis and action of insulin, both physiologically and in diabetes mellitus. Zinc seems to stimulate insulin action and insulin receptor tyrosine kinase activity.ObjectivesTo assess the effects of zinc supplementation for the prevention of type 2 diabetes mellitus in adults with insulin resistance.Search methodsThis review is an update of a previous Cochrane systematic review published in 2007. We searched the Cochrane Library (2015, Issue 3), MEDLINE, EMBASE, LILACS and the ICTRP trial register (frominception toMarch 2015). There were no language restrictions. We conducted citation searches and screened reference lists of included studies.Selection criteriaWe included studies if they had a randomised or quasi-randomised design and if they investigated zinc supplementation compared with placebo or no intervention in adults with insulin resistance living in the community.Data collection and analysisTwo review authors selected relevant trials, assessed risk of bias and extracted data.Main resultsWe included three trials with a total of 128 participants in this review. The duration of zinc supplementation ranged between four and 12 weeks. Risk of bias was unclear for most studies regarding selection bias (random sequence generation, allocation concealment) and detection bias (blinding of outcome assessment). No study reported on our key outcome measures (incidence of type 2 diabetes mellitus, adverse events, health-related quality of life, all-cause mortality, diabetic complications, socioeconomic effects). Evaluation of insulin resistance as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) showed neutral effects when comparing zinc supplementation with control (two trials; 114 participants). There were neutral effects for trials comparing zinc supplementation with placebo for total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol and triglycerides (2 studies, 70 participants). The one trial comparing zinc supplementation with exercise also showed neutral effects for total cholesterol, HDL and LDL cholesterol, and a mean difference in triglycerides of -30 mg/dL (95% confidence interval (CI) -49 to -10) in favour of zinc supplementation (53 participants). Various surrogate laboratory parameters were also analysed in the included trials.Authors'conclusionsThere is currently no evidence on which to base the use of zinc supplementation for the prevention of type 2 diabetes mellitus. Future trials should investigate patient-important outcome measures such as incidence of type 2 diabetes mellitus, health-related quality of life, diabetic complications, all-cause mortality and socioeconomic effects.

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Background: Pulmonary embolism (PE) is a common life-threatening cardiovascular condition, with an incidence of 23 to 69 new cases per 100,000 people per year. Outpatient treatment instead of traditional inpatient treatment in selected non-high-risk patients with acute PE might provide several advantages, such as reduction of hospitalizations, substantial cost saving and an improvement in health-related quality of life. Objectives: To compare the efficacy and safety of outpatient versus inpatient treatment for acute PE for the outcomes of all-cause and PE-related mortality; bleeding; and adverse events such as hemodynamic instability, recurrence of PE and patients'satisfaction.Search methodsThe Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched October 2014) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 9). The TSC also searched clinical trials databases. The review authors searched LILACS (last searched November 2014). Selection criteria: Randomized controlled trials of outpatient versus inpatient treatment in people diagnosed with acute PE. Data collection and analysis: Two review authors selected relevant trials, assessed methodological quality, and extracted and analyzed data. Main results: We included one study, involving 339 participants. We ranked the quality of the evidence as very low due to not blinding the outcome assessors, the small number of events with imprecision in the confidential interval (CI), the small sample size and it was not possible to verify publication bias. For all outcomes, the CIs were wide and included clinically significant treatment effects in both directions: short-term mortality (30 days) (RR 0.33, 95% CI 0.01 to 7.98, P = 0.49), long-term mortality (90 days) (RR 0.98, 95% CI 0.06 to 15.58, P = 0.99), major bleeding at 14 days (RR 4.91, 95% CI 0.24 to 101.57, P = 0.30) and 90 days (RR 6.88, 95% CI 0.36 to 134.14, P = 0.20), recurrent PE within 90 days (RR 2.95, 95% CI 0.12 to 71.85, P = 0.51) and participant satisfaction (RR 0.97, 95% CI 0.92 to 1.03, P = 0.30). PE-related mortality, minor bleeding, and adverse course such as hemodynamic instability and compliance were not assessed by the single included study. Authors' conclusions: Current very low quality evidence from one published randomized controlled trial did not provide sufficient evidence to assess the efficacy and safety of outpatient versus inpatient treatment for acute PE in overall mortality, bleeding and recurrence of PE adequately. Further well-conducted research is required before informed practice decisions can be made.

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

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This is a qualitative-quantitative study based on hospital records of female patients of reproductive age, presenting sexual dysfunction, and treated with 250 mg Tribulus terrestris extract (1 tablet thrice daily for 90 days). Safety monitoring included vital signs, physical examination, laboratory tests, and occurrence of adverse events. Efficacy analysis included results of the Female Sexual Function Index (FSFI), dehydroepiandrosterone (DHEA) levels together with total and free testosterone, and the patient and physician assessments. There was a statistically significant improvement in total FSFI scores (P < 0.0001) post-treatment, with improvement among 106 (88.33%) subjects. There was a statistically significant (P < 0.0001) increase in the level of DHEA, while the levels of both serum testosterone (P = 0.284) and free testosterone decreased (P < 0.0001). Most adverse events recorded were related to the gastrointestinal tract. Physical examination showed no significant changes post-treatment. Based on the results, it is concluded that the T. terrestris extract is safe and effective in the treatment of female sexual dysfunction.

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To assess the intraocular pressure (IOP)-lowering effect of travoprost 0.004%/timolol 0.5% fixed-dose combination (TRAV/TIM-FC) in patients not achieving the target IOP of ≤18 mmHg while on timolol 0.5% (TIM) monotherapy. A multicenter, prospective, open-label study (NCT01336569) was conducted in patients with open-angle glaucoma or ocular hypertension. Eligible patients were receiving TIM monotherapy with a screening/baseline IOP of 19-35 mmHg in ≥1 eye. TIM was discontinued on the baseline visit day (no washout period) and TRAV/TIM-FC was initiated and administered once daily at 8 pm for 4-6 weeks. The primary efficacy variable was mean change in IOP from TIM-treated baseline to study end, measured by Goldmann applanation tonometry. Results were analyzed by analysis of variance and paired samples t-test (5% significance). A total of 49 patients were enrolled (mean age, 63 [range, 42-82] years; 55.1% White; 73.5% women), and 45 were included in the intent-to-treat (ITT) population. Mean duration of treatment with TRAV/TIM-FC was 31 days. Mean ± standard deviation IOP reduction from baseline (TIM) to the follow-up visit (TRAV/TIM-FC) was -5.0±3.6 mmHg. IOP decreased significantly (P<0.0001) from baseline (22.1±2.6 mmHg) to study end (17.1±3.9 mmHg) in the ITT population, with a mean IOP reduction of 22.3%. Most patients (n=33/45; 73.3%) achieved IOP ≤18 mmHg. Two patients experienced a total of four adverse events (AEs), including a patient who reported one serious AE (enterorrhagia) that was considered unrelated to treatment, and a patient who reported one event each of drug-related redness, pruritus, and foreign body sensation. Most patients (n=47/49; 95.9%) reported no AEs. TRAV/TIM-FC lowered IOP in patients who were not at target IOP while receiving TIM monotherapy, with most patients achieving an IOP ≤18 mmHg with TRAV/TIM-FC. TRAV/TIM-FC was well tolerated in this population.

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Conscious sedation has become established as an important alternative to general anesthesia (GA) in dental treatment of patients with intellectual disability (ID). Aim: to investigate dental patients undergoing sedation using a mean dose of 0.6 mg/kg intravenous midazolam and the adverse events of sedation in patients with ID. Methods: This study analyzed the records of 163 dental patients with ID aged between 2 and 76 years who had undergone conscious intravenous sedation (CIV) using a mean dose of 0.61 mg/kg of midazolam at Araçatuba Dental School, São Paulo State University, Brazil. The efficacy and complications induced by CIV were evaluated in each subject. Results: CIV was effective for dental treatment in 80% of the cases. A total of 626 dental procedures were performed. The mean treatment time was 33.9 minutes. There was statistically significant difference (p<0.05) between absence and presence of adverse reactions. Adverse reactions were observed in 21.47% of the cases. Conclusions: The results of this study showed that CIV is a useful method for dental treatment of patients with ID and these patients can need higher doses of sedative to reach an adequate level of sedation.

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Mouth lymphoepithelial cyst is rare, with few cases reported in literature. The aim of this article is to describe a clinical case, focusing on clinical and diagnostic aspects, treatment and prognosis. The lesion was one year old and had developed as a fibrous nodule in the jugal mucosa of a 71-year-old leucoderma patient. Considering focal inflammatory fibrous hyperplasia, fibroma and mucocele as differential diagnosis, excisional biopsy was carried out. A cystic cavity limited by pseudostratified epithelium without projections into the conjunctive tissue, with lymphoid tissue within, was microscopically identified. Without postoperative adverse events, the one-year clinical followup confirmed the favorable prognosis of this kind of lesion.

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Pós-graduação em Enfermagem (mestrado profissional) - FMB

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Objective: to evaluate the standardization of vaccination rooms in the Municipality of Marília, State of São Paulo, Brazil. Methods: descriptive and exploratory study, realized in 2008-2009; the instrument used was the Supervision in Vaccination Rooms, of the Ministry of Health; variables analyzed were general aspects of the vaccination room, technical procedures, cold chain, information system, post-vaccination adverse events, special immunobiologicals, epidemiological surveillance and health education; the score achieved classifies the room (90.0-100.0% = ideal; 76.0-89.0% = good; 50.0-75.0% = fair; <50.0% = insufficient); overall index for each point was calculated as the average score of all rooms. Results: technical procedures, information system, post-vaccination adverse events and special immunobiologicals were scored as ideal; cold chain, epidemiological surveillance and health education were scored as good; and to general aspects of the vaccination room, the evaluation was fair. Conclusion: general index for vaccination rooms in the municipality was considered ideal.

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The annual vaccination campaign against rabies is the most effective prevention procedure for this disease in dogs and cats and hence for human protection also. However, in 2010 and 2011, this activity was interrupted in Brazil due to the occurrence of adverse events associated with vaccination. Even though cases of canine rabies have been decreasing in the last two decades, vigilance must be strengthened in order to maintain pet owners trust in the vaccines provided in public services. This study aimed to determine pet owners participation in the annual vaccination campaign carried out in Botucatu. During March and April 2012, the period before the 42nd campaign, 312 pet owners, dogs and cats, were interviewed. The homes were randomly drawn in blocks from different sectors of the city; all houses on the same block over the 120 km² of urban area participated in the sampling process. Statistical analysis was performed descriptively. The results showed that the owners main motivation to vaccinate their pets during the campaigns is rabies prevention (36%), followed by the proximity of the vaccination station to the house (20.7%), zero cost (10.9%), and the combination of all three factors (16.1%). When asked if they would take their animals back to be vaccinated in another campaign, 60.1% answered yes, 13.5% would go to a private clinic, 2.2% would not take because they do not trust the vaccine and 1.6% had not decided yet. We conclude that the respondents have realized how dangerous Rabies is, because even after the break period, they still utilized the vaccination campaign demonstrating confidence in its effectiveness, while knowing the campaign goals facilitates understanding and participation.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)