34 resultados para Safe


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Background: This is the first prospective, randomized, doubleblind, placebo-controlled study showing statistical improvement of an H1-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period. Objective: This randomized, placebo-controlled, parallelgroup,double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis. Methods: This study was conducted at 148 centers in 15 countries. Nine hundred thirty-five children (aged 6-11 years) were randomized and treated with either fexofenadine HCl 30 mg (n = 464) or placebo (n = 471) tablets twice a day for 14 days. Individual symptoms (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, and/or red eyes; and nasal congestion) were assessed at baseline and then daily at 7:00 AM and 7:00 PM (±1 hour) during the double-blind treatment period. Each total symptom score was the sum of all symptoms, excluding nasal congestion. The primary efficacy variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout the double-blind treatment. Safety was evaluated from adverse-event reporting, vital signs, physical examinations, and clinical laboratory data at screening and study end point.

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Introdução: Este estudo teve como objectivo determinar os principais sintomas percepcionados pelos doentes com doença pulmonar obstrutiva crónica (DPOC) numa coorte de doentes que participaram num grande ensaio clínico, que avaliou o tiotrópio e que decorreu em Portugal. População e métodos: A caracterização dos sintomas, no momento de avaliação basal dos doentes foi efectuada através do recurso a um questionário padronizado. Os doentes foram inquiridos quanto aos principais sintomas que tinham levado ao diagnóstico e também quanto ao sintoma actual mais problemático. Resultados: Os resultados foram obtidos de 298 doentes, maioritariamente masculinos (95%), que apresentavam, uma média (desvio padrão) de volume expiratório forçado no primeiro segundo basal de 1,1 (0,4) L (40,6 [13.3] % do valor preditivo), uma duração média da doença de 14,4 (10,1) anos e uma carga tabágica de 55,1 (25,3) unidades maço ano. A dispneia foi o sintoma mais frequentemente reportado, como tendo sido o sintoma que levou ao diagnóstico da doença (55,0% de doentes), seguindo-se-lhe a tosse (33,2%). A dispneia foi também o sintoma actual mais problemático (82,6%), seguindo-se-lhe também a tosse (8,4%). A presença de dispneia ou tosse foi independente da gravidade da DPOC. As comorbilidades mais frequentemente reportadas foram as doenças cardiovasculares (49% dos doentes), gastrointestinais (20%) e metabólicas (16%), principalmente a diabetes mellitus.

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Background: Sexually transmitted infections (STIs) present a major public health concern and a global cause of illness in both industrialized and developing countries. Portugal is no exception, with an increasing incidence of STIs, and one of the highest prevalences of HIV in Europe. Reduced risk perceptions among men who have sex with men (MSM) and a consequent high-risk sexual behaviour have been increasingly reported throughout the world. Objectives: To characterize the population of MSM attending a STI clinic in Lisbon, and to assess practice of condom use among these patients. Methods: Records of all MSM patients who attended the STI clinic from 2008 to 2011 were reviewed to study demographic characteristics, sexual behaviours, and leading diagnoses in this population. Results: Of a total of 389 patients, 108 MSM were identified (27.8%), mostly Portuguese men with high school or above education, aged 17 to 61 years (medium age of 32.4 years). More than half of the patients (52.8%) reported more than one sexual partner in the past 6 months (19.4% more than 5 partners), and only a third consistently used condom. A history of sex with sex workers was mentioned in 9.2%. The most prevalent diagnoses were syphilis (45.6%) and condylomata acuminata (38.9%). The prevalence of HIV infection in this subgroup of patients was significantly higher than in the rest of the population (47.2% vs. 14.9%). Inconsistent condom use increased over the years (36.4% in 2008, 66.7% in 2011), and these patients revealed a greater number of sexual partners than condom users (60.4% vs. 50%). However, 38.9% of condom users presented with early syphilis, suggesting inadequate use of this barrier method. Among HIV patients, almost half of them (49%) had sex with more than one partner in the previous six months, and 47.1% did not use the condom during all sexual practices. Of these, 45.8% were not on antiretroviral therapy. Conclusions: High-risk sexual behaviours (inconsistent use of condom and multiple partners) are increasingly prevalent in this MSM subpopulation, despite previous educational programmes. The high incidence of risk behaviours among HIV infected patients is particularly worrisome, and must be addressed with innovative interventions and population-based prevention strategies.

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INTRODUCTION: Chylothorax is a rare but serious postoperative condition in children with congenital heart disease. Conventional medical treatment consists of specific long-term dietary modification, and surgical reintervention, such as lymphatic duct ligation, may be indicated in refractory cases. In recent years, an additional conservative treatment, octreotide, a synthetic analog of somatostatin, has been used in management of congenital and postoperative chylothorax. METHODS: The objective of this work was to analyze the efficacy and safety of this treatment for chylothorax after congenital heart surgery. We reviewed the records of sixteen patients with chylothorax after surgery for congenital heart disease between January 1999 and December 2007, and collected the following data: demographic information; type of surgical procedure; onset, duration and management of chylothorax and treatment; and duration of hospital stay. To analyze efficacy we compared these parameters in children receiving conventional treatment only with those receiving octreotide. To analyze safety we compared the adverse effects of both treatments. Octreotide was administered at a dose of 4 to 10 microg/kg/hour, with monitoring of side effects. RESULTS: The incidence of chylothorax in our population was 1.6%. It occurred more often after Glenn and Fontan procedures (8 patients). Octreotide was begun three days after diagnosis of chylothorax and continued for a median of seventeen days (ranging from 4 to 26 days), until complete resolution. Side effects were frequent (in 3 of the 8 patients) but of no clinical relevance. All patients responded to the therapy and there was no indication for further surgical intervention. DISCUSSION AND CONCLUSIONS: Octreotide is safe and effective in the treatment of postoperative chylothorax in children with congenital heart disease. It is a useful adjunctive therapy to the conventional treatment of this complication.

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BACKGROUND: Surgery for congenital heart disease (CHD) has changed considerably during the last three decades. The results of primary repair have steadily improved, to allow treating almost all patients within the pediatric age; nonetheless an increasing population of adult patients requires surgical treatment. The objective of this study is to present the early surgical results of patients who require surgery for CHD in the adult population within a multicentered European study population. METHODS: Data relative to the hospital course of 2,012 adult patients (age > or = 18 years) who required surgical treatment for CHD from January 1, 1997 through December 31, 2004 were reviewed. Nineteen cardiothoracic centers from 13 European countries contributed to the data collection. RESULTS: Mean age at surgery was 34.4 +/- 14.53 years. Most of the operations were corrective procedures (1,509 patients, 75%), followed by reoperations (464 patients, 23.1%) and palliative procedures (39 patients, 1.9%). Six hundred forty-nine patients (32.2%) required surgical closure of an isolated ostium secundum atrial septal defect. Overall hospital mortality was 2%. Preoperative cyanosis, arrhythmias, and NYHA class III-IV, proved significant risk factors for hospital mortality. Follow-up data were available in 1,342 of 1,972 patients (68%) who were discharged home. Late deaths occurred in 6 patients (0.5%). Overall survival probability was 97% at 60 months, which is higher for corrective procedures (98.2%) if compared with reoperations (94.1%) and palliations (86.1%). CONCLUSIONS: Surgical treatment of CHD in adult patients, in specialized cardiac units, proved quite safe, beneficial, and low-risk.

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The introduction of new procedures in surgery usually implies the costs of the so called learning curve. However patients should not suffer the negative effects of surgeon's learning curves. We report our results with the first 15 Ross procedures, a single surgeon and institution experience, and how it was possible to build a safe learning curve without major consequences for the patients. We emphasize the need for a continuous program of surgical performance assessment throughout the learning curve period, as was demonstrated in our series.

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The authors report two cases in which stent grafts were used to treat visceral artery aneurysms. Case number 1 was a 42-year old woman with a history of renal colic who was found to have a right renal artery aneurysm. Two 6-mm x 20-mm Wallgraft endoprosthesis (Boston Scientific, Watertown, Mass) were placed across the aneurysm neck. Case number 2 was a 72 year-old woman with a past medical history significant for hepatic angioma and hypothyroidism. She was found to have a superior mesenteric artery aneurysm that was treated with a 6-mm x 17-mm Jostent stent graft (Jomed, GmbH, Ra). In both cases the aneurysm was completely excluded and distal end-organ flow preserved. Stent graft placement is a safe and effective treatment for visceral artery aneurysms. If this approach proves durable and reproducible, it can become the method of choice for the management of visceral artery aneurysms in selected patients.

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INTRODUCTION: Primary angioplasty is accepted as the preferred treatment for acute myocardial infarction in the first 12 hours. However, outcomes depend to a large extent on the volume of activity and experience of the center. Continuous monitoring of methods and results obtained is therefore crucial to quality control. OBJECTIVE: To describe the demographic, clinical and angiographic characteristics as well as in-hospital outcomes of patients undergoing primary PCI in a high-volume Portuguese center. We also aimed to identify variables associated with in-hospital mortality in this population. METHODS: This was a retrospective registry of consecutive primary PCIs performed at Santa Marta Hospital between January 2001 and August 2007. Demographic, clinical, and angiographic characteristics and in-hospital outcomes were analyzed. Independent predictors of in-hospital mortality were identified by multivariate logistic regression analysis. RESULTS: A total of 1157 patients were identified, mean age 61+/-12 years, 76% male. Mean pain-to-balloon time was 7.6 hours and primary angiographic success was 88%. Overall in-hospital mortality was 6.9%, or 5.5% if patients presenting in cardiogenic shock were excluded from the analysis. Previous history of heart failure, cardiogenic shock on admission, invasive ventilatory support, major hemorrhage, and age over 75 years were found to be associated with increased risk of in-hospital death. Conclusions: In this center primary PCI is effective and safe. Angiographic success rates and in-hospital mortality and morbidity are similar to other international registries. Patients at increased risk for adverse outcome can be identified by simple clinical characteristics such as advanced age, cardiogenic shock on admission, mechanical ventilation and major hemorrhage during hospitalization.

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INTRODUCTION: The use of drug-eluting stents in the context of mechanical reperfusion following ST-segment elevation myocardial infarction (MI) was initially viewed with concern. The main fear was that the drugs' action in unstable lesions could increase the risk of thrombotic stent occlusion. Furthermore, there was no evidence that the proven benefit of reduced instent restenosis could be extended to such patients, since they were excluded from the initial clinical trials. OBJECTIVES: To assess the safety and long-term clinical outcomes of the use of drug-eluting stents in primary angioplasty. METHODS: The first 100 consecutive and non-selected patients admitted for MI and treated by primary angioplasty with drug-eluting stent implantation in the target lesion were analyzed retrospectively. The efficacy and safety of the procedure, in-hospital clinical evolution and the occurrence of major adverse cardiac events in the first year were assessed. RESULTS: Patients' mean age was 58.2 +/- 11.5 years, and 78 were male. The success rate of primary angioplasty was 99%. Stents coated with sirolimus were used in 67 patients, paclitaxel in 19 and dexamethasone in 16. In-hospital mortality was 3%. The follow-up rate at 12 months was 98%. During this period, the rate of target vessel revascularization was 1% (with no patient requiring target lesion revascularization), MI 2%, and overall mortality 3.9%. Fourteen patients had clinical indication for repeat coronary angiography, which showed no significant in-stent restenosis. One event was considered to be due to acute stent thrombosis. The incidence of major adverse events was 5.9%. CONCLUSION: The use of drug-eluting stents in MI patients undergoing primary mechanical revascularization is safe and is associated with a reduced incidence of major adverse events, thrombosis and clinical restenosis at one year.

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Background: Performing magnetic resonance imaging (MRI) on women with gynecological devices is a completely accepted practice. The goal of our review is to assess how safe it is to perform MRI on women using contraceptive implants or devices. Study Design: Literature review, searching in PubMed-Medline/Ovid for the following keywords: magnetic resonance imaging, intrauterine devices, Implanon® and Essure®. Results: Though plastic devices do not represent a contraindication to the use of the technique, those including metallic components have been submitted to several tests, after which they were classified as MR Conditional (devices presenting no risks in MR-specific environments) by the Food and Drug Administration. Thus, the use of MRI can be safely advised to women with this type of device as long as the magnetic resonance equipment is ≤3.0 T. Conclusions: Presently, there is no scientific evidence that contraindicates performing MRI on women with any kind of gynecological device. Therefore, this procedure is safe as long as it is performed under previously tested conditions.

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Background: Few studies have been performed in children withs uspected betalactam allergy.We aimed to assess the role of the drug provocation test(DPT)with betalactams in a paediatric setting and to study the association between allergy to betalactam antibiotics and other allergic diseases. Methods:We included all the patients under 15 years old who were consecutively referred to the Immunoallergy Department, Dona Estefânia Hospital,Portugal(January 2002 to April 2008)for a compatible history of allergic reaction to betalactam. All were submitted to a DPT.Children were proposed to performs kintests(ST)to betalactam antibiotics followed by DPT. If they decline ST,a DPT with the culprit drug was performed. Results: We studied 161 children,60%were boys,with a median age of 5years old at the time of the DPT.Thirty-three patients(20.5%)had an immediate reaction and 33(20.5%)a non-immediate reaction. These verity of there porte dreactions was low in most cases. Skin tests to betalactams were performed in 47 children and were positive in 8.DPT was positive inonlyone(3.4%)of the patients skin tested and in 11(13.4%)of those not skin tested. These verity of the DPT reaction was low.Asthma and food allergy were associated with a positive DPT in the later group. Conclusions: DPT seems a safe procedure even in the absence of ST in non-severe cases. This could be a practical optionin infants and pre-school children,where ST are painful and difficult to perform.Additional caution should be taken in children with asthma and food allergy.

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To evaluate the short and mid-term results of prostatic artery embolization in patients with benign prostatic embolization. Retrospective study between March 2009 and June 2011 with 103 patients (mean age 66.8 years, 50-85) that met our inclusion criteria with symptomatic benign prostatic hyperplasia. The clinical outcome was evaluated by the International Prostate Symptom Score (IPSS), quality of life (QoL), International Index of Erectile Function, prostate volume (PV), prostate-specific antigen (PSA), peak urinary flow (Q(max)), and post-void residual volume (PVR) measurements at 3 and 6 months, 1 year, 18 months, and 2 years after PAE and comparison with baseline values was made. Technical and clinical successes, as well as poor clinical outcome definitions, were previously defined. In this review, we evaluate the short and mid-term clinical outcomes and morbidity of patients treated only with non-spherical polyvinyl alcohol. Six months after the procedure, the PV decreased about 23%, IPSS changed to a mean value of 11.95 (almost 50% reduction), the QoL improved slightly more than 2 points, the Q(max) changed to a mean value of 12.63mL/s, the PVR underwent a change of almost half of the baseline value, and the PSA decreased about 2.3ng/mL. In the mid-term follow-up and comparing to the baseline values, we still assisted to a reduction in PV, IPSS, QoL, PVR, and PSA, and an increase in Q(max). Prostatic Artery Embolization is a safe procedure with low morbidity that shows good short- and mid-term clinical outcome in our institution.

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OBJECTIVE: Long-term follow-up after endovascular aneurysm repair (EVAR) is very scarce, and doubt remains regarding the durability of these procedures. We designed a retrospective cohort study to assess long-term clinical outcome and morphologic changes in patients with abdominal aortic aneurysms (AAAs) treated by EVAR using the Excluder endoprosthesis (W. L. Gore and Associates, Flagstaff, Ariz). METHODS: From 2000 to 2007, 179 patients underwent EVAR in a tertiary institution. Clinical data were retrieved from a prospective database. All patients treated with the Excluder endoprosthesis were included. Computed tomography angiography (CTA) scans were retrospectively analyzed preoperatively, at 30 days, and at the last follow-up using dedicated tridimensional reconstruction software. For patients with complications, all remaining CTAs were also analyzed. The primary end point was clinical success. Secondary end points were freedom from reintervention, sac growth, types I and III endoleak, migration, conversion to open repair, and AAA-related death or rupture. Neck dilatation, renal function, and overall survival were also analyzed. RESULTS: Included were 144 patients (88.2% men; mean age, 71.6 years). Aneurysms were ruptured in 4.9%. American Society of Anesthesiologists classification was III/IV in 61.8%. No patients were lost during a median follow-up of 5.0 years (interquartile range, 3.1-6.4; maximum, 11.2 years). Two patients died of medical complications ≤ 30 days after EVAR. The estimated primary clinical success rates at 5 and 10 years were 63.5% and 41.1%, and secondary clinical success rates were 78.3% and 58.3%, respectively. Sac growth was observed in 37 of 142 patients (26.1%). Cox regression showed type I endoleak during follow-up (hazard ratio, 3.74; P = .008), original design model (hazard ratio, 3.85; P = .001), and preoperative neck diameter (1.27 per mm increase, P = .006) were determinants of sac growth. Secondary interventions were required in 32 patients (22.5%). The estimated 10-year rate of AAA-related death or rupture was 2.1%. Overall life expectancy after AAA repair was 6.8 years. CONCLUSIONS: EVAR using the Excluder endoprosthesis provides a safe and lasting treatment for AAA, despite the need for maintained surveillance and secondary interventions. At up to 11 years, the risk of AAA-related death or postimplantation rupture is remarkably low. The incidences of postimplantation sac growth and secondary intervention were greatly reduced after the introduction of the low-permeability design in 2004.