Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 102
Filtrar
1.
Agric For Meteorol ; 264: 351-362, 2019 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-31007324

RESUMO

Climate change is expected to severely affect cropping systems and food production in many parts of the world unless local adaptation can ameliorate these impacts. Ensembles of crop simulation models can be useful tools for assessing if proposed adaptation options are capable of achieving target yields, whilst also quantifying the share of uncertainty in the simulated crop impact resulting from the crop models themselves. Although some studies have analysed the influence of ensemble size on model outcomes, the effect of ensemble composition has not yet been properly appraised. Moreover, results and derived recommendations typically rely on averaged ensemble simulation results without accounting sufficiently for the spread of model outcomes. Therefore, we developed an Ensemble Outcome Agreement (EOA) index, which analyses the effect of changes in composition and size of a multi-model ensemble (MME) to evaluate the level of agreement between MME outcomes with respect to a given hypothesis (e.g. that adaptation measures result in positive crop responses). We analysed the recommendations of a previous study performed with an ensemble of 17 crop models and testing 54 adaptation options for rainfed winter wheat (Triticum aestivum L.) at Lleida (NE Spain) under perturbed conditions of temperature, precipitation and atmospheric CO2 concentration. Our results confirmed that most adaptations recommended in the previous study have a positive effect. However, we also showed that some options did not remain recommendable in specific conditions if different ensembles were considered. Using EOA, we were able to identify the adaptation options for which there is high confidence in their effectiveness at enhancing yields, even under severe climate perturbations. These include substituting spring wheat for winter wheat combined with earlier sowing dates and standard or longer duration cultivars, or introducing supplementary irrigation, the latter increasing EOA values in all cases. There is low confidence in recovering yields to baseline levels, although this target could be attained for some adaptation options under moderate climate perturbations. Recommendations derived from such robust results may provide crucial information for stakeholders seeking to implement adaptation measures.

3.
Unfallchirurg ; 122(4): 309-322, 2019 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-30847497

RESUMO

Metatarsal and toe fractures are the most frequent injuries of the foot skeleton. Nondislocated fractures can be conservatively treated with good success. Long-term relief and immobilization including the ankle joint are unnecessary. Metatarsal fractures close to the base are nearly always associated with Lisfranc luxation and treatment must also take the instability of the tarsometatarsal joints into consideratíon. Basal fractures of the 5th metatarsal bone require a differentiated consideration. The correct classification is necessary in order to initiate an adequate treatment. In general, intra-articular layer formation, inclination >10° and shortening between 3 mm and 5 mm, taking the position of the head of the metatarsal bone into consideration, are recommended as indications for surgery. Operative treatment of toe fractures is only rarely necessary.


Assuntos
Traumatismos do Pé/cirurgia , Fraturas Ósseas/cirurgia , Ossos do Metatarso/lesões , Dedos do Pé/lesões , Traumatismos do Pé/classificação , Fixação Interna de Fraturas , Fraturas Ósseas/classificação , Humanos , Ossos do Metatarso/cirurgia , Dedos do Pé/cirurgia
4.
Lupus ; 27(8): 1303-1311, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29697013

RESUMO

Kidney transplant for patients with lupus nephritis (LN) has satisfactory outcomes in studies with short-term or mid-term follow up. Nevertheless, information about long-term outcomes is scarce. We performed a retrospective matched-pair cohort study in 74 LN recipients compared with 148 non-LN controls matched by age, sex, immunosuppressive treatment, human leukocyte antigen (HLA) matches, and transplant period in order to evaluate long-term outcomes of kidney transplant in LN recipients. Matched pairs were predominantly females (83%), median age at transplant surgery of 32 years (interquartile range 23-38 years), and 66% received a graft from a living related donor. Among LN recipients, 5-, 10-, 15-, and 20-year graft survival was 81%, 79%, 57% and 51%, respectively, and it was similar to that observed in controls (89%, 78%, 64%, and 56%, respectively). Graft loss (27% vs. 21%, p = 0.24) and overall survival ( p = 0.15) were not different between LN recipients and controls. Also, there was no difference in episodes of immunological rejection, thrombosis, or infection. Only six LN recipients had biopsy-proven lupus recurrence and three of them had graft loss. In a cohort with a long follow up of kidney transplant recipients, LN recipients had similar long-term graft survival and overall outcomes compared with non-lupus recipients when predictors are matched between groups.


Assuntos
Sobrevivência de Enxerto , Imunossupressores/uso terapêutico , Transplante de Rim , Nefrite Lúpica/mortalidade , Nefrite Lúpica/terapia , Adulto , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , México , Estudos Retrospectivos , Centros de Atenção Terciária , Fatores de Tempo , Adulto Jovem
5.
Radiologe ; 58(11): 976-984, 2018 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-30194639

RESUMO

Diagnosis and treatment of injuries to the elbow joint place high demands on the treating physicians. The complex anatomy of the elbow joint enables a wide range of movement and complex functions in everyday and professional life. These must be restored in the event of injury.Clinical and imaging-based diagnostic procedures serve to classify typical injuries of this joint according to a large variety of different pathologies. These include fractures of the distal humerus, the proximal ulna, and the radial head, as well as dislocations and dislocation fractures.The following article gives an overview of the most common of these injuries.


Assuntos
Articulação do Cotovelo , Luxações Articulares , Fraturas do Rádio , Articulação do Cotovelo/diagnóstico por imagem , Humanos , Luxações Articulares/diagnóstico por imagem , Resultado do Tratamento , Ulna
6.
Lupus ; 26(10): 1042-1050, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28178879

RESUMO

We performed a retrospective cohort analysis to define the prognostic significance of vascular lesions documented in renal biopsies of lupus nephritis patients. A total of 429 patients were segregated into five groups: (1) no vascular lesions (NVL), (2) arterial sclerosis (AS), (3) non-inflammatory necrotizing vasculitis (NNV), (4) thrombotic microangiopathy (TMA), and (5) true renal vasculitis (TRV). Renal outcomes were analyzed by Cox regression models, and correlations between vascular lesions and activity/chronicity scores were determined by Spearman's coefficients. A total of 200 (46.6%) had NVL, 189 (44.0%) AS, six NNV (1.4%), 23 (5.4%) TMA, and 11 (2.6%) TRV. Patients with NVL were younger, with higher renal function; patients with TMA and TRV had lower renal function and higher arterial pressure at baseline. Antiphospholipid syndrome and positive lupus anticoagulant were more frequently observed in the TMA group. Five-year renal survival was 83% for NVL, 63% for AS, 67% for NNV, 31% for TMA, and 33% for TRV. NNV and TRV were significantly correlated with activity scores, while AS and chronic TMA were correlated with chronicity scores. Renal vascular lesions are associated with renal outcomes but do not behave as independent factors. The addition of vascular lesions to currently used scores should be further explored.


Assuntos
Síndrome Antifosfolipídica/epidemiologia , Nefrite Lúpica/fisiopatologia , Microangiopatias Trombóticas/epidemiologia , Vasculite/epidemiologia , Adulto , Fatores Etários , Síndrome Antifosfolipídica/etiologia , Biópsia , Estudos de Coortes , Feminino , Humanos , Testes de Função Renal , Inibidor de Coagulação do Lúpus/sangue , Masculino , Pessoa de Meia-Idade , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Estatísticas não Paramétricas , Microangiopatias Trombóticas/etiologia , Vasculite/etiologia , Adulto Jovem
7.
Unfallchirurg ; 120(8): 652-657, 2017 Aug.
Artigo em Alemão | MEDLINE | ID: mdl-28638931

RESUMO

BACKGROUND: The anatomical reconstruction of tibial pilon fractures is a major challenge with respect to preoperative planning, time management and the intraoperative procedure. OBJECTIVE: Presentation of the various surgical procedures available and the clinical outcome. MATERIAL AND METHODS: The established open reduction and internal plate fixation procedures form the basis for new minimally invasive treatment concepts. The current results of comparative studies and basic literature are discussed. RESULTS: The treatment result depends on the severity of the initial fracture and accompanying soft tissue damage. Essential is an anatomical reduction with an articular displacement of less than 2 mm. Overall, only approximately half of all patients return to work within 1 year. The fixation procedure used is not relevant for this purpose. Both plate fixation and the combination of external fixator plus minimally invasive articular reconstruction with and without arthroscopy achieve equivalent results. CONCLUSION: Good clinical results can be achieved by an accurate preoperative planning with respect to the surgical procedure, time of surgery and the surgical steps. In cases of disregarding these points and inadequate surgical expertise, loss of function and reduced quality of life are impending.


Assuntos
Fraturas do Tornozelo/cirurgia , Fixação Interna de Fraturas/métodos , Fraturas da Tíbia/cirurgia , Fraturas do Tornozelo/diagnóstico por imagem , Artroscopia/métodos , Placas Ósseas , Fixadores Externos , Fíbula/diagnóstico por imagem , Fíbula/lesões , Fíbula/cirurgia , Fraturas Fechadas/diagnóstico por imagem , Fraturas Fechadas/cirurgia , Fraturas Expostas/diagnóstico por imagem , Fraturas Expostas/cirurgia , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Avaliação de Processos e Resultados em Cuidados de Saúde , Fraturas da Tíbia/diagnóstico por imagem , Tomografia Computadorizada por Raios X
8.
Lupus ; 25(3): 315-24, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26405028

RESUMO

We performed a retrospective cohort analysis focusing on lupus nephritis renal flare incidence and outcome predictors. One hundred and eighteen patients with biopsy-proven lupus nephritis were segregated by induction/maintenance regimes. The primary outcome was the proportion of patients experiencing renal flare. Secondary assessment included doubling of serum creatinine and development of end-stage renal disease. After a median follow-up of 31 months (interquartile range 21-46) from the date of response to induction therapy, 47 patients (39.8%) developed a renal flare. Azathioprine-maintained patients had a higher risk of renal flare compared with mycophenolate mofetil-maintained patients (hazard ratio 2.53, 95% confidence interval 1.39-4.59, p < 0.01). Age (hazard ratio 0.96, 0.92-0.99, p = 0.03), serum creatinine at presentation (hazard ratio 1.76, 1.13-2.76, p = 0.01), complete remission after induction therapy (hazard ratio 0.28, 0.14-0.56, p < 0.001) and azathioprine maintenance therapy (hazard ratio 4.78, 2.16-10.6, p < 0.001) were associated with renal flare on multivariate analysis. Ten patients progressed to end-stage renal disease (8.5%) by a median 32.5 months. Age (hazard ratio 0.88, 0.77-0.99, p = 0.05), complete remission after induction therapy (hazard ratio 0.08, 0.01-0.94, p = 0.04) and severe nephritic flare (hazard ratio 13.6, 1.72-107.7, p = 0.01) were associated with end-stage renal disease development. Azathioprine maintenance therapy is associated with a higher incidence of relapse in the Mexican-mestizo population. Younger age and nephritic flares predict development of end-stage renal disease.


Assuntos
Azatioprina/uso terapêutico , Imunossupressores/uso terapêutico , Falência Renal Crônica/epidemiologia , Nefrite Lúpica/tratamento farmacológico , Nefrite Lúpica/epidemiologia , Ácido Micofenólico/uso terapêutico , Adolescente , Adulto , Biomarcadores/sangue , Distribuição de Qui-Quadrado , Creatinina/sangue , Progressão da Doença , Intervalo Livre de Doença , Feminino , Humanos , Estimativa de Kaplan-Meier , Falência Renal Crônica/sangue , Falência Renal Crônica/diagnóstico , Nefrite Lúpica/sangue , Nefrite Lúpica/diagnóstico , Masculino , México/epidemiologia , Pessoa de Meia-Idade , Análise Multivariada , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Recidiva , Indução de Remissão , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
9.
J Exp Bot ; 66(12): 3463-76, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25795739

RESUMO

A major challenge of the 21st century is to achieve food supply security under a changing climate and roughly a doubling in food demand by 2050 compared to present, the majority of which needs to be met by the cereals wheat, rice, maize, and barley. Future harvests are expected to be especially threatened through increased frequency and severity of extreme events, such as heat waves and drought, that pose particular challenges to plant breeders and crop scientists. Process-based crop models developed for simulating interactions between genotype, environment, and management are widely applied to assess impacts of environmental change on crop yield potentials, phenology, water use, etc. During the last decades, crop simulation has become important for supporting plant breeding, in particular in designing ideotypes, i.e. 'model plants', for different crops and cultivation environments. In this review we (i) examine the main limitations of crop simulation modelling for supporting ideotype breeding, (ii) describe developments in cultivar traits in response to climate variations, and (iii) present examples of how crop simulation has supported evaluation and design of cereal cultivars for future conditions. An early success story for rice demonstrates the potential of crop simulation modelling for ideotype breeding. Combining conventional crop simulation with new breeding methods and genetic modelling holds promise to accelerate delivery of future cereal cultivars for different environments. Robustness of model-aided ideotype design can further be enhanced through continued improvements of simulation models to better capture effects of extremes and the use of multi-model ensembles.


Assuntos
Cruzamento/métodos , Simulação por Computador , Grão Comestível/crescimento & desenvolvimento , Modelos Teóricos , Mudança Climática , Ecótipo
10.
Unfallchirurg ; 118(3): 245-50, 2015 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-24599028

RESUMO

BACKGROUND: The steady rise in life expectancy of our population leads to an exponential increase in proximal femoral fractures. The growing increase of comorbidities in these patients requires continuous development of modern implant systems for internal fixation of proximal femoral fractures. MATERIALS AND METHODS: In this study we enrolled 116 patients with pertrochanteric femoral fractures who were treated with a proximal femoral nail (Targon PF, Aesculap) over a period of 1 year. The indications for this implant system were set at unstable fracture types. Data of the operative and postoperative course were collected prospectively. RESULTS: The average age of the 116 predominantly female subjects was 77±14 years and the most commonly observed fracture subtype was 31-A1.2. The follow-up rate was 55 %. We observed a decrease in the postoperative modified Harris hip score of 22.7 %. The 1-year mortality was 21.6 %. CONCLUSIONS: The results of this study showed a low rate of perioperative complications and implant loss anda decline in patient mobility was typically observed within 1 year.


Assuntos
Pinos Ortopédicos , Fraturas do Fêmur/diagnóstico por imagem , Fraturas do Fêmur/cirurgia , Fixação Interna de Fraturas/instrumentação , Procedimentos de Cirurgia Plástica/instrumentação , Idoso , Análise de Falha de Equipamento , Feminino , Fixação Interna de Fraturas/métodos , Humanos , Estudos Longitudinais , Masculino , Desenho de Prótese , Radiografia , Resultado do Tratamento
11.
Can J Kidney Health Dis ; 10: 20543581221132748, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36700057

RESUMO

Background: Chronic kidney disease (CKD) is a global health problem. As it progresses to end stages, renal replacement therapy is required but ultimately, the best treatment is transplantation. Decreased renal function has been associated with an inflammatory state associated to primary CKD and in kidney transplant recipients (KTRs). Objective: To establish how the serum concentrations of some cytokines, such as interleukin (IL)-2, IL-8, IL-22, IL-17α, interferon-gamma, IL-4, and transforming growth factor-ß, correlate with various CKD stages. Methods: One hundred and forty-one KTRs between the ages of 18 and 75 years were included in the study. We also included 112 live kidney donors, 37 CKD PGCKD+3, and 76 GPhealthy. Participants were grouped according to their glomerular filtration rate (GFR) and their circulating cytokine levels, previously quantified by ELISA. Results: By linear regression analysis, we established the relation of each cytokine with the GFR. Transforming growth factor-ß correlated positively with the GFR in the study population, except in healthy individuals. A negative correlation of IL-8 and IL-17α and GFR was found in all cases. Conclusions: Whether these cytokines (IL-8 and IL-17α) could be used as inflammatory biomarkers indicating CKD progression, regardless of the type of population, remains to be prospectively determined.


Contexte: L'insuffisance rénale chronique (IRC) est un problème de santé mondial. Une thérapie de remplacement rénal est nécessaire au fur et à mesure que la maladie évolue vers les stades terminaux. Mais, en définitive, le meilleur traitement reste la transplantation. La réduction de la fonction rénale a été associée à un état inflammatoire associé à l'IRC primaire; une association observée aussi chez les receveurs d'une greffe de rein. Objectif: Déterminer la façon dont les concentrations sériques de certaines cytokines, notamment IL-2, IL-8, IL-22, IL-17a, IFN-γ, IL-4 et TGF-ß, corrèlent avec divers stades de l'IRC. Méthodologie: Ont été inclus dans l'étude 141 receveurs d'une greffe rénale âgés de 18 à 75 ans, 112 donneurs vivants de rein, 37 personnes atteintes d'IRC (PGIRC+3) et 76 personnes en bonne santé (PGen santé). Les sujets ont été regroupés en fonction de leur débit de filtration glomérulaire (DFGe) et de leur taux de cytokines en circulation, quantifiés préalablement par ELISA. Résultats: Une analyse de régression linéaire a servi à établir la relation entre chaque cytokine et le DFGe. Dans la population étudiée, une corrélation positive a été observée entre TGF-ß et le DFGe, sauf chez les individus sains. Dans tous les cas, la corrélation s'est avérée négative entre le DFGe et les taux d'IL-8 et d'IL-17a. Conclusion: Il reste à déterminer prospectivement si ces cytokines (IL-8 et IL-17a) pourraient être utilisées comme biomarqueurs inflammatoires pour indiquer la progression de l'IRC, quelle que soit la population.

12.
Nephron Clin Pract ; 117(3): c184-97, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-20805691

RESUMO

The response of the nephrological community to the Haiti and Chile earthquakes which occurred in the first months of 2010 is described. In Haiti, renal support was organized by the Renal Disaster Relief Task Force (RDRTF) of the International Society of Nephrology (ISN) in close collaboration with Médecins Sans Frontières (MSF), and covered both patients with acute kidney injury (AKI) and patients with chronic kidney disease (CKD). The majority of AKI patients (19/27) suffered from crush syndrome and recovered their kidney function. The remaining 8 patients with AKI showed acute-to-chronic renal failure with very low recovery rates. The intervention of the RDRTF-ISN involved 25 volunteers of 9 nationalities, lasted exactly 2 months, and was characterized by major organizational difficulties and problems to create awareness among other rescue teams regarding the availability of dialysis possibilities. Part of the Haitian patients with AKI reached the Dominican Republic (DR) and received their therapy there. The nephrological community in the DR was able to cope with this extra patient load. In both Haiti and the DR, dialysis treatment was able to be prevented in at least 40 patients by screening and adequate fluid administration. Since laboratory facilities were destroyed in Port-au-Prince and were thus lacking during the first weeks of the intervention, the use from the very beginning on of a point-of-care device (i-STAT®) was very efficient for the detection of aberrant kidney function and electrolyte parameters. In Chile, nephrological problems were essentially related to difficulties delivering dialysis treatment to CKD patients, due to the damage to several units. This necessitated the reallocation of patients and the adaptation of their schedules. The problems could be handled by the local nephrologists. These observations illustrate that local and international preparedness might be life-saving if renal problems occur in earthquake circumstances.


Assuntos
Injúria Renal Aguda/terapia , Desastres , Terremotos , Serviço Hospitalar de Emergência , Socorro em Desastres , Diálise Renal/métodos , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/etiologia , Chile/epidemiologia , Serviço Hospitalar de Emergência/tendências , Haiti/epidemiologia , Humanos , Mapas como Assunto , Diálise Renal/tendências
13.
Nutr Metab Cardiovasc Dis ; 21(9): 617-9, 2011 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-21907903

RESUMO

This paper is a Position Statement from an 'ad hoc' Scientific Review Subcommittee of the PAHO/WHO Regional Expert Group on Cardiovascular Disease Prevention through Dietary Salt Reduction. It is produced in response to requests from representatives of countries of the Pan-American Region of WHO needing clarification on two recent publications casting doubts on the appropriateness of population wide policies to reduce salt intake for the prevention of cardiovascular disease. The paper provides a brief background, a critical appraisal of the recent reports and explanations as why the implications have been mis-interpreted. The paper concludes that the benefits of salt reduction are clear and consistent, and reinforces the recommendations outlined by PAHO/WHO and other organizations worldwide for a population reduction in salt intake to prevent strokes, heart attacks and other cardiovascular events.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Cloreto de Sódio na Dieta/administração & dosagem , Pressão Sanguínea/efeitos dos fármacos , Doenças Cardiovasculares/induzido quimicamente , Medicina Baseada em Evidências , Promoção da Saúde , Humanos , Hipertensão/induzido quimicamente , Hipertensão/prevenção & controle , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Acidente Vascular Cerebral/prevenção & controle
14.
Clin Nephrol ; 73(4): 300-8, 2010 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-20353738

RESUMO

BACKGROUND: Protein-energy malnutrition and hypervolemia are major causes of morbidity and mortality in patients on chronic hemodialysis (CHD). The methods used to evaluate nutritional status and volume status remain controversial. Vector bioelectric impedance analysis (vector- BIA) has recently been developed to assess both nutritional status and tissue hydration. The purpose of the study was to assess the nutritional status and volume status of patients on CHD with conventional nutritional assessment methods and with vector-BIA and then to compare the resulting findings. METHODS: 76 Mexican patients on CHD were studied. Nutritional status and body composition were assessed with anthropometry, biochemical variables, and the modified Bilbrey nutritional index (mBNI), the results were compared with both conventional BIA and vector-BIA. RESULTS: The BNI was used to determine the number of patients with normal nutritional status (n = 27, 35.5%), and mild (n = 31, 40.8%), moderate (n = 10, 13.2%) and severe malnutrition (n = 8, 10.5%). Patients displayed shorter vectors with smaller phase angles or with an overhydration vectorial pattern before the initiation of their hemodialysis session. There was general improvement to normal hydration status post-dialysis (p < 0.05); however, 28% remained overhydrated as assessed by vector-BIA. The vector-BIA results showed that worse malnutrition status was associated with greater volume overload (p < 0.05). Diabetes mellitus (DM) was associated with shorter vectors with smaller phase angles (a vectorial pattern of overhydration and cachexia) (p < 0.05). Patients with lower serum creatinine presented with shorter vectors and smaller phase angles (vectorial patterns of malnutrition and/or overhydration) (p < 0.05). In women, lower serum albumin (< 3.4 g/dl) correlated with greater overhydration and malnutrition (p < 0.05). CONCLUSIONS: In this population, the vector-BIA showed that 28% of the population remained overhydrated after their hemodialysis session. Diabetics and those with moderate or severe malnutrition were more overhydrated, which is a condition that may be associated with increased cardiovascular morbidity. Because nutritional and volume status are important factors associated with morbidity and mortality in CHD patients, we focused on optimizing the use of existing methods. Our studies suggest that vector-BIA offers a comprehensive and reliable reproducible means of assessing both volume and masses at the bedside and can complement the traditional methods.


Assuntos
Estado Nutricional/fisiologia , Desnutrição Proteico-Calórica/diagnóstico , Desnutrição Proteico-Calórica/etiologia , Diálise Renal/efeitos adversos , Adulto , Idoso , Antropometria , Composição Corporal/fisiologia , Água Corporal/fisiologia , Impedância Elétrica , Feminino , Humanos , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Avaliação Nutricional , Fatores Sexuais
15.
Artigo em Alemão | MEDLINE | ID: mdl-19418030

RESUMO

With the move towards globalized international commerce and trade, a call for harmonization of medical device regulatory requirements and practices has evolved. The purpose of the Global Harmonization Task Force (GHTF) is to encourage convergence of regulatory requirements and practices at a global level through consensus to achieve four principle goals: promote safety, quality and performance/effectiveness of medical devices; encourage technological innovation; foster international trade; and serve as a forum of information exchange - all in the interests of protecting and promoting public health. The GHTF is governed by a Steering Committee, and the principle development of the GHTF regulatory model has been, and continues to be, done through five working groups known as Study Groups and supplemented recently by the creation of several Ad Hoc Working Groups. Since its creation in 1992, the members of the GHTF have worked collaboratively to develop what is now ready to be called a global model for the regulation of medical devices.


Assuntos
Comitês Consultivos/organização & administração , Segurança de Equipamentos/normas , Equipamentos e Provisões/normas , Internacionalidade , Vigilância de Produtos Comercializados/normas , Gestão da Segurança/legislação & jurisprudência , Alemanha
16.
Oper Orthop Traumatol ; 31(2): 149-164, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30413845

RESUMO

OBJECTIVE: A minimally invasive technique to prevent soft tissue problems using a calcaneal nail (Calcanail®, FH Orthopedics, Heimsbrunn, France) for calcaneal fractures or in subtalar joint arthrodesis is described. INDICATIONS: Displaced extra-articular calcaneal fractures involving the tuberosity fragment and in displaced intra-articular calcaneal fractures with impression and/or displacement of the subtalar joint surface. Subtalar joint arthrodesis for posttraumatic subtalar osteoarthritis. CONTRAINDICATIONS: Severely displaced fractures type Sanders IV with the purpose of internal fixation; peripheral calcaneal fractures; general contraindications for operative treatment. SURGICAL TECHNIQUE: Minimally invasive reduction of calcaneal fractures using a special distractor and a graft pusher through a calcaneal working channel. Fixation performed via the insertion of the Calcanail® and the two locking screws, optional additional screws. Subtalar joint arthrodesis with a Calcanail® used with optional three locking screws to fix the talus and calcaneus creating an angular stable construct. POSTOPERATIVE MANAGEMENT: Mobilization and restricted weight-bearing for 6 weeks in the patient's own shoes after fracture fixation or in a walker after arthrodesis. RESULTS: Preliminary results of 69 cases from three surgical centers have already been published. From 2013-2017, the technique was used in 48 of our own patients (42 calcaneal fracture reduction and fixation; 6 for subtalar joint arthrodesis). Mean postoperative hospital stay was 7 days for fracture reduction without any need of additional operations. During follow-up, 6 implant removals and 2 secondary subtalar fusions were noticed. All 6 cases of subtalar joint arthrodesis were planned in posttraumatic subtalar osteoarthritis.


Assuntos
Calcâneo , Fixação Interna de Fraturas/métodos , Fraturas Ósseas , Articulação Talocalcânea , Artrodese , Calcâneo/lesões , Calcâneo/cirurgia , Fraturas Ósseas/cirurgia , Humanos , Fraturas Intra-Articulares/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos , Articulação Talocalcânea/cirurgia , Resultado do Tratamento
17.
Curr Opin Plant Biol ; 45(Pt B): 255-261, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29866444

RESUMO

Modelling is a key tool to explore agricultural impacts of and adaptations to climate change. Here we report recent progress made especially referring to the large project initiatives MACSUR and AgMIP; in particular, in modelling potential crop impacts from field to global using multi-model ensembles. We identify two main fields where further progress is necessary: a more mechanistic understanding of climate impacts and management options for adaptation and mitigation; and focusing on cropping systems and integrative multi-scale assessments instead of single season and crops, especially in complex tropical and neglected but important cropping systems. Stronger linking of experimentation with statistical and eco-physiological crop modelling could facilitate the necessary methodological advances.


Assuntos
Mudança Climática , Produtos Agrícolas/fisiologia , Adaptação Fisiológica/fisiologia , Agricultura
18.
Clin Nephrol ; 67(5): 306-17, 2007 May.
Artigo em Inglês | MEDLINE | ID: mdl-17542340

RESUMO

AIM: This study was designed to assess the potential of the continuous erythropoietin receptor activator (C.E.R.A.) to correct anemia at extended administration intervals in erythropoiesis-stimulating agent-naive patients with chronic kidney disease (CKD) not on dialysis and to determine its optimal starting dose. METHODS: Patients were assigned to subcutaneous C.E.R.A. at 3 doses: 0.15, 0.30 and 0.60 microg/kg/wk. During the first 6 weeks, dose adjustments for efficacy were not permitted in order to assess dose response. Within each of the 3 dose groups, patients were randomized to receive C.E.R.A. QW, Q2W or Q3W; the total dose during the first 6 weeks was the same for a particular dose group across the frequency subgroups. During the next 12 weeks, dose was adjusted according to predefined hemoglobin (Hb) criteria. The primary efficacy parameter was change in Hb over 6 weeks, estimated from regression analysis between baseline and the point at which the patient received a dose change or blood transfusion. It therefore provided an estimate of Hb increase based on starting dose. Other endpoints included Hb response rate (proportion of patients with a Hb increase > 1.0 g/dl on 2 consecutive occasions). A 1-year extension period investigated long term tolerability and efficacy. RESULTS: A dose-dependent relationship was noted in the mean change in Hb from baseline over 6 weeks (p < 0.0001), independent of administration schedule (p = 0.9201). There was also a significant relationship between Hb change and median serum C.E.R.A. concentration (p < 0.0001). Erythropoietic responses were sustained in all groups with mean changes from baseline in Hb > 1.2 g/dl observed at doses > or = 0.30 microg/kg/wk. Hb response rate increased with increasing dose: 67, 72 and 90% with C.E.R.A. 0.15, 0.30 and 0.60 microg/kg/wk, respectively. Generally, the median Hb response time was faster with increasing dose (89, 43 and 31 days, respectively). Response was unrelated to administration frequency. Stable Hb concentrations were maintained throughout the 1-year extension period. C.E.R.A. was generally well tolerated, and the most common adverse events were hypertension, urinary tract infection and renal failure. CONCLUSIONS: C.E.R.A. corrected anemia and maintained sustained and stable control of Hb over 1 year. These results suggest that 0.60 microg/kg subcutaneous C.E.R.A. given twice monthly is a suitable starting dose for further investigation in Phase III studies in patients with CKD not on dialysis.


Assuntos
Anemia/tratamento farmacológico , Anemia/etiologia , Eritropoetina/administração & dosagem , Falência Renal Crônica/complicações , Polietilenoglicóis/administração & dosagem , Diálise Renal , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Área Sob a Curva , Biomarcadores/sangue , Relação Dose-Resposta a Droga , Eritropoese/efeitos dos fármacos , Eritropoetina/efeitos adversos , Eritropoetina/sangue , Feminino , Ferritinas/sangue , Ferritinas/efeitos dos fármacos , Seguimentos , Hemoglobinas/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Polietilenoglicóis/efeitos adversos , Proteínas Recombinantes , Análise de Regressão , Fatores de Tempo , Resultado do Tratamento
19.
Oper Orthop Traumatol ; 29(2): 107-114, 2017 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-28303286

RESUMO

OBJECTIVE: Fractures of the olecranon are the most common fractures of the elbow in adults. Due to the dislocating force of the triceps muscle, internal fixation is the treatment of choice. INDICATIONS: All fractures of the olecranon without contraindications. CONTRAINDICATIONS: Infection and severe soft tissue damage. SURGICAL TECHNIQUE: Dorsal approach to the olecranon with the patient in a prone position. Open reduction and internal fixation with tension band wiring or plate fixation according to fracture pattern. POSTOPERATIVE MANAGEMENT: Treatment goal is early functional mobilization. No load bearing allowed for 6-8 weeks; full load bearing is allowed after fracture healing. RESULTS: The quality of published studies concerning the surgical treatment of olecranon fractures is poor. Published functional results are predominantly good and excellent. Hardware removal was often required.


Assuntos
Fixação Interna de Fraturas/instrumentação , Olécrano/lesões , Olécrano/cirurgia , Redução Aberta/instrumentação , Fraturas da Ulna/reabilitação , Fraturas da Ulna/cirurgia , Terapia Combinada/métodos , Articulação do Cotovelo/cirurgia , Medicina Baseada em Evidências , Fixação Interna de Fraturas/métodos , Fixação Interna de Fraturas/reabilitação , Consolidação da Fratura , Humanos , Redução Aberta/reabilitação , Recuperação de Função Fisiológica , Resultado do Tratamento , Lesões no Cotovelo
20.
Vasa ; 35(2): 96-100, 2006 May.
Artigo em Inglês | MEDLINE | ID: mdl-16796008

RESUMO

BACKGROUND: Antiplatelet therapy is one of the most important modalities for secondary prevention of ischemic events. The aim of this prospective study was to evaluate the current practice of antiplatelet therapy in patients with high grade stenosis of the internal carotid artery (ICA), who were referred by neurologists, stroke physicians and cardiologists for carotid endarterectomy. PATIENTS AND METHODS: Patients referred to our department for carotid endarterectomy with ICA stenosis (> 70% according to NASCET criteria) were prospectively evaluated regarding atherosclerosis risk factors and current antiplatelet therapy. During a 7 month period, 235 patients were scheduled for carotid endarterectomy. Their mean age was 70 years (range 42 years to 95 years), 91 patients were female (39%), 144 male (61%). 122 patients (52%) had a symptomatic ICA stenosis, 113 (48%) an asymptomatic ICA stenosis. RESULTS: Of the 235 patients, 29 were either on low molecular weight heparin or vitamin K antagonists for reasons other than ICA stenosis and were therefore excluded from analysis. Therefore, 206 patients (88%) were evaluated for antiplatelet therapy prescribed by their admitting physicians. Of these patients, 77 (37%) (42 (41%) symptomatic and 35 (34%) asymptomatic patients) did not receive any antithrombotic therapy prior to admission for surgery. The majority of patients received aspirin preoperatively (106 patients, 51.5%) 13 (6%) patients were on clopidogrel and 10 (5%) on dual therapy with Aspirin and clopidogrel. CONCLUSIONS: More than one third of patients awaiting carotid endarterectomy did not receive any antiplatelet therapy, despite high grade ICA stenosis. Since this practice does not meet the current guidelines, campaigns to increase the awareness of this problem are urgently needed.


Assuntos
Artéria Carótida Interna/efeitos dos fármacos , Estenose das Carótidas/tratamento farmacológico , Endarterectomia das Carótidas , Inibidores da Agregação Plaquetária/uso terapêutico , Pré-Medicação , Adulto , Idoso , Idoso de 80 Anos ou mais , Aspirina/farmacologia , Aspirina/uso terapêutico , Áustria , Artéria Carótida Interna/cirurgia , Estenose das Carótidas/complicações , Estenose das Carótidas/cirurgia , Clopidogrel , Uso de Medicamentos , Feminino , Fidelidade a Diretrizes , Pesquisas sobre Atenção à Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/farmacologia , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Ticlopidina/análogos & derivados , Ticlopidina/farmacologia , Ticlopidina/uso terapêutico
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA