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1.
J Am Coll Cardiol ; 74(16): 2032-2043, 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31623760

RESUMO

BACKGROUND: Major disparities between women and men in the diagnosis, management, and outcomes of acute coronary syndrome are well recognized. OBJECTIVES: The aim of this study was to evaluate the impact of implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds for myocardial infarction in women and men with suspected acute coronary syndrome. METHODS: Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge, cluster-randomized controlled trial across 10 hospitals. Myocardial injury was defined as high-sensitivity cardiac troponin I concentration >99th centile of 16 ng/l in women and 34 ng/l in men. The primary outcome was recurrent myocardial infarction or cardiovascular death at 1 year. RESULTS: A total of 48,282 patients (47% women) were included. Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%. Following implementation, women with myocardial injury remained less likely than men to undergo coronary revascularization (15% vs. 34%) and to receive dual antiplatelet (26% vs. 43%), statin (16% vs. 26%), or other preventive therapies (p < 0.001 for all). The primary outcome occurred in 18% (369 of 2,072) and 17% (488 of 2,919) of women with myocardial injury before and after implementation, respectively (adjusted hazard ratio: 1.11; 95% confidence interval: 0.92 to 1.33), compared with 18% (370 of 2,044) and 15% (513 of 3,325) of men (adjusted hazard ratio: 0.85; 95% confidence interval: 0.71 to 1.01). CONCLUSIONS: Use of sex-specific thresholds identified 5 times more additional women than men with myocardial injury. Despite this increase, women received approximately one-half the number of treatments for coronary artery disease as men, and outcomes were not improved. (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome [High-STEACS]; NCT01852123).

2.
Int J Pharm ; 564: 359-368, 2019 Jun 10.
Artigo em Inglês | MEDLINE | ID: mdl-30978485

RESUMO

Inkjet printing is a form of additive manufacturing where liquid droplets are selectively deposited onto a substrate followed by solidification. The process provides significant potential advantages for producing solid oral dosage forms or tablets, including a reduction in the number of manufacturing steps as well as the ability to tailor a unique dosage regime to an individual patient. This study utilises solvent inkjet printing to print tablets through the use of a Fujifilm Dimatix printer. Using polyvinylpyrrolidone and thiamine hydrochloride (a model excipient and drug, respectively), a water-based ink formulation was developed to exhibit reliable and effective jetting properties. Tablets were printed on polyethylene terephthalate films where solvent evaporation in the ambient environment was the solidification mechanism. The tablets were shown to contain a drug loading commensurate with the composition of the ink, in its preferred polymorphic phase of a non-stoichiometric hydrate distributed homogenously. The printed tablets displayed rapid drug release. This paper illustrates solvent inkjet printing's ability to print entire free-standing tablets without an edible substrate being part of the tablet and the use of additional printing methods. Common problems with solvent-based inkjet printing, such as the use toxic solvents, are avoided. The strategy developed here for tablet manufacturing from a suitable ink is general and provides a framework for the formulation for any drug that is soluble in water.


Assuntos
Impressão Tridimensional , Tecnologia Farmacêutica/métodos , Administração Oral , Liberação Controlada de Fármacos , Excipientes/química , Tinta , Polietilenotereftalatos/química , Povidona/química , Solubilidade , Comprimidos , Tiamina/química , Água/química
3.
Carbohydr Polym ; 200: 229-238, 2018 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-30177161

RESUMO

Binder jetting is an additive manufacturing technique in which powdered material is sequentially laid down and printed on by an ink binder, in a selective manner, to form a 3D object. Unfortunately work in this area relevant to food materials is largely unpublished, however a typical application of this technique is sugar powder bound by a water and alcohol based ink with optional colour or flavour demonstrated by commercial ventures. In this work we demonstrate the use of a small scale powder layering device under an ink jet printer to test prototype powders prior to producing quantities typically used in commercially available binder jetting machines. Powders comprising predominantly of ball milled, amorphous cellulose were successfully used to create 3D structures when interacting polysaccharides were present in the ink (xanthan gum) and as a proportion of the powder component (glucomannan) by inducing selective recrystallization. These ingredients are categorized as dietary fibre, thus such formulations can be used to create low-calorie 3D printed food designs to be used within food products.

4.
Food Biophys ; 13(2): 175-185, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29755301

RESUMO

Suspensions of gel particles which are pourable or spoonable at room temperature can be created by shearing a gelling biopolymer through its gelation (thermal or ion mediated) rather than allowing quiescent cooling - thus the term 'fluid gel' may be used to describe the resulting material. As agar gelation is thermoreversible this type of fluid gel is able to be heated again to melt agar gel particles to varying degrees then re-form a network quiescently upon cooling, whose strength depends on the temperature of re-heating, determining the amount of agar solubilised and subsequently able to partake in re-gelation. Using this principle, for the first time fluid gels have been applied to a high viscosity 3D printing process wherein the printing temperature (at the nozzle) is controllable. This allows the use of ambient temperature feedstocks and by altering the nozzle temperature, the internal nature (presence or absence of gel particles) and gel strength of printed droplets differs. If the nozzle prints at different temperatures for each layer a structure with modulated texture could be created.

5.
Int J Pharm ; 529(1-2): 523-530, 2017 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-28673860

RESUMO

Additive manufacturing (AM) offers significant potential benefits in the field of drug delivery and pharmaceutical/medical device manufacture. Of AM processes, 3D inkjet printing enables precise deposition of a formulation, whilst offering the potential for significant scale up or scale out as a manufacturing platform. This work hypothesizes that suitable solvent based ink formulations can be developed that allow the production of solid dosage forms that meet the standards required for pharmaceutical tablets, whilst offering a platform for flexible and personalized manufacture. We demonstrate this using piezo-activated inkjetting to 3D print ropinirole hydrochloride. The tablets produced consist of a cross-linked poly(ethylene glycol diacrylate) (PEGDA) hydrogel matrix containing the drug, photoinitiated in a low oxygen environment using an aqueous solution of Irgacure 2959. At a Ropinirole HCl loading of 0.41mg, drug release from the tablet is shown to be Fickian. Raman and IR spectroscopy indicate a high degree of cross-linking and formation of an amorphous solid dispersion. This is the first publication of a UV inkjet 3D printed tablet. Consequently, this work opens the possibility for the translation of scalable, high precision and bespoke ink-jet based additive manufacturing to the pharmaceutical sector.


Assuntos
Impressão Tridimensional , Comprimidos , Tecnologia Farmacêutica , Liberação Controlada de Fármacos , Hidrogel de Polietilenoglicol-Dimetacrilato/química , Indóis/química
6.
Sci Rep ; 6: 20852, 2016 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-26868530

RESUMO

An initial study of processing bioresorbable polycaprolactone (PCL) through material jetting was conducted using a Fujifilm Dimatix DMP-2830 material printer. The aim of this work was to investigate a potential solvent based method of jetting polycaprolactone. Several solvents were used to prepare a PCL solvent based ink and 1, 4-dioxane was chosen with the consideration of both solubility and safety. The morphology of PCL formed under different substrate temperatures, droplet spacings were investigated. Multi-layer PCL structures were printed and characterized. This work shows that biodegradable polycaprolactone can be processed through material jetting.

7.
Trials ; 15: 44, 2014 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-24484541

RESUMO

BACKGROUND: Approximately 20% of patients are not satisfied with the outcome of total knee replacement, great volumes of which are carried out yearly. Physiotherapy is often provided by the NHS to address dysfunction following knee replacement; however the efficacy of this is unknown. Although clinically it is accepted that therapy is useful, provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year. No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes. We are also investigating whether the structure of the physiotherapy provision itself influences outcomes. METHODS/DESIGN: The study is a multi-centre prospective randomised controlled trial (RCT) of patients undergoing primary total knee replacement, with treatment targeted at those deemed most susceptible to gain from it. Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review, and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy. The intervention will be either 'intensive' involving both hospital and home-based functional exercise rehabilitation, or 'standard of care' consisting of home exercises. Patients will be randomised to either group using a web-based system. Both groups will receive pre and post-intervention physiotherapy review. Patients will be followed-up to one year post-operation. The primary outcome measure is the Oxford Knee Score. Secondary outcomes are patient satisfaction, functional ability, pain scores and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN23357609. ClinicalTrials.gov NCT01849445.


Assuntos
Artroplastia do Joelho/reabilitação , Articulação do Joelho/cirurgia , Modalidades de Fisioterapia , Projetos de Pesquisa , Artroplastia do Joelho/economia , Fenômenos Biomecânicos , Protocolos Clínicos , Análise Custo-Benefício , Avaliação da Deficiência , Custos de Cuidados de Saúde , Humanos , Articulação do Joelho/fisiopatologia , Medição da Dor , Satisfação do Paciente , Seleção de Pacientes , Modalidades de Fisioterapia/economia , Estudos Prospectivos , Recuperação de Função Fisiológica , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Reino Unido
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