RESUMEN
OBJECTIVES: There is a lack of literature regarding the procedure-specific quality of acute postoperative pain management after midfacial fracture repair. The purpose of the presented prospective clinical study was to evaluate postoperative pain management after surgical repair of midfacial fractures. MATERIALS AND METHODS: Eighty-five adults were evaluated on the first postoperative day following midfacial repair using the questionnaire of the Quality Improvement in Postoperative Pain Management (QUIPS) project. The main outcome measures were patients' characteristics and clinical- and patient-reported outcome parameters. RESULTS: Overall, pain on the first postoperative day was moderate. A significant correlation between process and outcome parameters could be shown. Duration of surgery above the calculated median was significantly associated with higher maximum pain intensity (p = 0.017). Patients requiring opioids in the recovery room presented significantly higher pain on activity (p = 0.029) and maximum pain (p = 0.035). Sleeping impairment (p = 0.001) and mood disturbance (p = 0.008) were significantly more prevalent in patients undergoing repair of a centrolateral midfacial fracture. CONCLUSIONS: QUIPS is a simple and qualified tool to evaluate the procedure specific quality of acute postoperative pain management. Pain on the first postoperative day following midfacial fracture repair seems overall to be moderate. Nearly a third of the patients showed inadequate postoperative pain management. To prevent inadequate postoperative pain management, it is necessary to establish a continued procedure-specific outcome measurement.
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Manejo del Dolor/métodos , Dolor Postoperatorio/prevención & control , Fracturas Craneales/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Satisfacción del Paciente , Estudios Prospectivos , Garantía de la Calidad de Atención de Salud , Encuestas y CuestionariosRESUMEN
STATEMENT OF PROBLEM: Little peer-reviewed information is available regarding the accuracy and reproducibility of digitally fabricated casts compared to conventional nondigital methods. PURPOSE: The purpose of this in vitro study was to compare the accuracy and reproducibility of a digital impression and cast fabrication with a conventional impression and cast fabrication. MATERIAL AND METHODS: Conventional impressions were made via a 1-step single viscosity technique with vinyl siloxanether material of a typodont master model, and conventional casts were cast from dental stone. Digital impressions were obtained with a digital scanner, and digital stereolithographic models were printed. The typodont and fabricated casts were digitized with a structured light scanner and saved in surface tessellation language (STL) format. All STL records were superimposed via a best-fit method. The digital impression and cast fabrication method was compared with the conventional impression and cast fabrication method for discrepancy, accuracy, and reproducibility. The Levene test was used to determine equality of variances, and a 1-way ANOVA was conducted to assess the overall statistical significance of differences among the groups (n=5, α=.05). RESULTS: No significant statistical difference was found between the digital cast and conventional casts in the internal area or finish line area (P>.05). In addition, there was no statistically significant difference between these 2 techniques for a fixed dental prosthesis or single crown (P>.05). However, statistically significant differences were observed for overall areas of the casts in terms of accuracy (P<.01) and reproducibility (P<.001). Digital impression and cast fabrication were less accurate and reproducible than conventional impression and cast fabrication methods. CONCLUSIONS: No statistically significant difference was found between the digital cast and conventional cast groups in the internal and finish line areas. However, in terms of the reproducibility and accuracy of the entire cast area, the conventional cast was significantly better than the digital cast.
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Diseño Asistido por Computadora/estadística & datos numéricos , Técnica de Colado Dental/estadística & datos numéricos , Técnica de Impresión Dental/estadística & datos numéricos , Diseño de Prótesis Dental/estadística & datos numéricos , Algoritmos , Sulfato de Calcio/química , Coronas/estadística & datos numéricos , Materiales de Impresión Dental/química , Materiales Dentales/química , Diseño de Dentadura/estadística & datos numéricos , Dentadura Parcial Fija/estadística & datos numéricos , Humanos , Procesamiento de Imagen Asistido por Computador/estadística & datos numéricos , Polivinilos/química , Reproducibilidad de los Resultados , Siloxanos/química , Propiedades de SuperficieRESUMEN
OBJECTIVES: To adequately perform orthognathic surgery procedures, it is from basic interest to understand the morphologic changes caused by orthognathic surgery. Anthropometric analyses of standardized frontal view and profile photographs could help to investigate and understand such changes. STUDY DESIGN: We present a pre- to postoperative evaluation of orthognathic surgery results based on anthropometric indices described by Farkas and cephalometric measurements. 30 Class III patients undergoing maxillary advancement by Le Fort I Osteotomy and mandibular setback by bilateral sagittal split osteotomy were evaluated. Preoperative as well as three and nine months postoperative lateral cephalograms as well as standardized frontal view and profile photographs were taken. On the photographs 21 anthropometric indices given by Farkas were evaluated. In cephalograms SNA and SNB angle as well as Wits appraisal were investigated. RESULTS: The investigated anthropometric indices showed a significant increase of the vertical height of the upper lip without changing the relation of the upper vermilion to the cutaneous upper lip. The lower vermilion height increased relatively to the cutaneous lower lip without vertical changes in the lower lip. Due to maxillary advancement the upper face height increased meanwhile the lower face height decreased due to mandibular setback. SNA and SNB angle and Wits appraisal showed typical changes related to surgery. CONCLUSIONS: The investigated photo-assisted anthropometric measurements presented reproducible results related to bimaxillary surgery.
Asunto(s)
Cefalometría , Cara/anatomía & histología , Maloclusión de Angle Clase III/cirugía , Maxilar/cirugía , Procedimientos Quirúrgicos Ortognáticos , Adulto , Femenino , Humanos , Masculino , Resultado del TratamientoRESUMEN
OBJECTIVES: Cheek rotation flaps are an established surgical procedure for coverage of facial skin defects especially of the cheek and infraorbital region. A comparison of pre- and postoperative anthropometric measurements may help to objectify intraoperative estimations with regards to postoperative appearance. MATERIALS AND METHODS: We present an evaluation of 31 patients undergoing periorbital reconstruction by a cheek rotation flap on standardized photographs based on reference anthropometric data. Analysis included intercanthal, binocular and eye fissure width, eye fissure, lid sulcus and upper lid height, upper and lower iris coverage, position of cornea to palpebra inferior, scleral show, ectropion, and canthal tilt. Furthermore, it was clearly differentiated whether the defect to cover included eyelid skin or not. RESULTS: Ectropion showed a significant association to surgery (p = 0.03) and time (p = 0.03). If the defect to cover included lower eyelid skin, lower iris coverage values decreased significantly (p = 0.02), meanwhile the rate of scleral show increased significantly (p < 0.01), indicating pre- to postoperative lower eyelid retraction. CONCLUSIONS: In all patients analyzed, indices were reproducible and reliable. An association between surgery and ectropion was detectable. Whenever lower eyelid skin is involved in the defect to be covered, the significantly decreased lower iris coverage and increased rate of scleral show indicate an increased risk of lower lid retraction. CLINICAL RELEVANCE: Whenever eyelid skin is involved in a defect to be covered by a cheek rotation flap, there is an increased risk of postoperative lower lid distortion. Special care has to be taken to perform techniques preventing lower lid retraction.
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Mejilla/cirugía , Procedimientos de Cirugía Plástica , Colgajos Quirúrgicos , HumanosRESUMEN
OBJECTIVES: In the literature, there is an ongoing discussion about the influence of orbital fractures and the surgical approach on the rate of eyelid deformities of the lower eyelid. MATERIALS AND METHODS: We present an evaluation of a series of 221 patients 9 months after zygomaticomaxillary complex fracture repair that underwent implant removal. Reference anthropometric data were measured on standardized pre- and postoperative photographs. Analysis included eye fissure width and height, lid sulcus and upper lid height, upper and lower iris coverage, position of cornea to palpebra inferior, canthal tilt, scleral show, ectropion, and entropion. Both operated and contralateral eyelids were evaluated as well as whether a transconjunctival or a subciliary approach was performed. RESULTS: Time, surgery, and surgical approach presented significant effects on eye fissure index and lower iris coverage. Scleral show was significantly influenced by the surgical procedure itself as well as by the type of incision. The rate of ectropion increased significantly pre- to postoperative. CONCLUSIONS: The subciliary approach included the highest risk of lower lid retraction. The low pre- to postoperative increase of scleral show and ectropion compared to recent studies gives us an idea about the influence of the underlying trauma on the rate of lower lid retraction. The standardized measurements described are accurately and objective to evaluate postoperative results. CLINICAL RELEVANCE: The transconjunctival approach is preferable in orbital fracture repair.
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Conjuntiva/cirugía , Párpados/cirugía , Procedimientos Quirúrgicos Oftalmológicos/métodos , Fracturas Orbitales/cirugía , Adulto , Análisis de Varianza , Placas Óseas , Remoción de Dispositivos , Ectropión , Ojo/anatomía & histología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Órbita/anatomía & histología , Implantes Orbitales , Fotograbar , Complicaciones Posoperatorias , Estadísticas no Paramétricas , Adulto JovenRESUMEN
OBJECTIVES: There is an ongoing discussion in the literature about preoperative planning and postoperative evaluation of orthognathic surgery and its impact on facial appearance and aesthetics. MATERIALS AND METHODS: We present an anthropometric and cephalometric evaluation of orthognathic surgery results based on reference anthropometric data. In 171 Class II patients, mandibular advancement by bilateral sagittal split osteotomy was performed. Preoperative as well as 3 and 9 months postoperative standardized frontal view and profile photographs and lateral cephalograms were evaluated in a standardized manner by use of 21 anthropometric indices. In cephalograms, SNA and SNB angle as well as Wits appraisal were investigated. Results of anthropometric and cephalometric measurements were correlated. RESULTS: Lower vermilion contour, vermilion and cutaneous total lower lip height, nose-lower face height, nose-face height, upper face-face height, upper lip- and chin-mandible height index showed significant pre- to postoperative changes as well as SNB angle and Wits appraisal. Furthermore, medial-lateral cutaneous upper lip height, vermilion and cutaneous total lower lip height and philtrum-mouth width index presented significant correlations to cephalometric measurements. CONCLUSIONS: The investigated anthropometric indices and cephalometric measurements presented reproducible results related to surgery. The correlation of cephalometric to anthropometric measurements has been proven useful for preoperative planning and postoperative evaluation of orthognathic surgery patients. CLINICAL RELEVANCE: The presented anthropometric measurements and their observed correlation to cephalometric measurements could lead to a better prediction and optimized planning of the soft tissue result in orthognathic surgery patients and thereby improve the aesthetic outcome.
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Estética Dental , Cara/anatomía & histología , Maloclusión Clase II de Angle/cirugía , Avance Mandibular , Osteotomía Sagital de Rama Mandibular , Adolescente , Adulto , Análisis de Varianza , Puntos Anatómicos de Referencia , Antropometría , Cefalometría , Femenino , Humanos , Masculino , Avance Mandibular/métodos , Fotograbar , Valores de Referencia , Reproducibilidad de los Resultados , Estadísticas no Paramétricas , Resultado del Tratamiento , Adulto JovenRESUMEN
STATEMENT OF PROBLEM: The accuracy of impressions has been described in 1 or 2 dimensions, whereas it is most desirable to evaluate the accuracy of impressions spatially, in 3 dimensions. PURPOSE: The purpose of this study was to demonstrate the accuracy and reproducibility of a 3-dimensional (3-D) approach to assessing impression preciseness and to quantitatively comparing the occlusal correctness of gypsum dies made with different impression materials. MATERIAL AND METHODS: By using an aluminum replica of a maxillary molar, single-step dual viscosity impressions were made with 1 polyether/vinyl polysiloxane hybrid material (Identium), 1 vinyl polysiloxane (Panasil), and 1 polyether (Impregum) (n=5). Corresponding dies were made of Type IV gypsum and were optically digitized and aligned to the virtual reference of the aluminum tooth. Accuracy was analyzed by computing mean quadratic deviations between the virtual reference and the gypsum dies, while deviations of the dies among one another determined the reproducibility of the method. The virtual reference was adapted to create 15 occlusal contact points. The percentage of contact points deviating within a ±10 µm tolerance limit (PDP(10) = Percentage of Deviating Points within ±10 µm Tolerance) was set as the index for assessing occlusal accuracy. Visual results for the difference from the reference tooth were displayed with colors, whereas mean deviation values as well as mean PDP(10) differences were analyzed with a 1-way ANOVA and Scheffé post hoc comparisons (α=.05). RESULTS: Objective characterization of accuracy showed smooth axial surfaces to be undersized, whereas occlusal surfaces were accurate or enlarged when compared to the original tooth. The accuracy of the gypsum replicas ranged between 3 and 6 µm, while reproducibility results varied from 2 to 4 µm. Mean (SD) PDP(10)-values were: Panasil 91% (±11), Identium 77% (±4) and Impregum 29% (±3). One-way ANOVA detected significant differences among the subjected impression materials (P<.001). CONCLUSIONS: The accuracy and reproducibility of impressions were determined by 3-D analysis. Results were presented as color images and the newly developed PDP(10)-index was successfully used to quantify spatial dimensions for complex occlusal anatomy. Impression materials with high PDP(10)-values were shown to reproduce occlusal dimensions the most accurately.
Asunto(s)
Materiales de Impresión Dental , Técnica de Impresión Dental , Imagenología Tridimensional , Análisis de Varianza , Materiales de Impresión Dental/normas , Técnica de Impresión Dental/normas , Precisión de la Medición Dimensional , Humanos , Modelos Dentales , Diente Molar/anatomía & histología , Polivinilos , Reproducibilidad de los Resultados , Resinas Sintéticas , Siloxanos , Estadísticas no ParamétricasRESUMEN
OBJECTIVE: The objective of our study was to prospectively investigate the feasibility and image quality of and to calculate the radiation dose estimates for CT angiography (CTA) of the thoracic aorta in patients with atrial fibrillation or accelerated heart rates using prospective ECG-triggered sequential dual-source data acquisition in end-systole. CONCLUSION: Prospective ECG-gated sequential dual-source CTA of the thoracic aorta is feasible despite heart rates>80 beats per minute or atrial fibrillation, making motion-free imaging of the thoracic aorta possible at a considerably low radiation dose.
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Aorta Torácica/diagnóstico por imagen , Fibrilación Atrial/diagnóstico por imagen , Técnicas de Imagen Sincronizada Cardíacas/métodos , Angiografía Coronaria/métodos , Electrocardiografía , Tomografía Computarizada por Rayos X/métodos , Anciano , Fibrilación Atrial/fisiopatología , Medios de Contraste , Estudios de Factibilidad , Femenino , Frecuencia Cardíaca/fisiología , Humanos , Yopamidol/análogos & derivados , Masculino , Estudios Prospectivos , Dosis de RadiaciónRESUMEN
OBJECTIVE: To assess for the first time the morphology of the lymphatic system in patients with posttraumatic edema of the lower extremities by magnetic resonance (MR) imaging using the interstitial lymphangiography technique MATERIALS AND METHODS: Six patients with posttraumatic edema in eight of their 12 lower extremities were examined by MR lymphangiography. Eighteen mL of gadoteridol and one mL of mepivacainhydrochloride 1% were subdivided into 10 portions and injected intracutaneously. MR imaging was performed with a 1.5-T system equipped with high-performance gradients. For MR lymphangiography, a 3D-spoiled gradient-echo sequence was used. RESULTS: In five of the eight (63%) traumatized lower extremities, enlarged lymphatic vessels were detected, with the largest diameter measuring 5 mm. Additionally, a fast lymphatic outflow was observed in seven of the eight (88%) traumatized legs with enhancement of the inguinal lymph nodes already in the first image acquisition 15 minutes after contrast material injection. In two of the eight (25%) traumatized lower extremities, an extensive network of collateral lymphatic vessels was detected at the level of the calf. In both extremities, lymphatic collateralization involved not only the epifascial but also the subfascial lymphatic system. In one patient, who sustained a trauma of the left lower leg with tibial fracture, a small aneurysmatic widening of 7 mm could be detected at the middle level of the calf. CONCLUSION: MR lymphangiography is a safe and accurate minimal-invasive imaging modality for the evaluation of the lymphatic circulation in patients with posttraumatic edema of the lower extremities. If the extent of lymphatic damage is unclear at the initial clinical examination or requires a better definition for optimal therapeutic planning, MR lymphangiography is able to identify the anatomic and physiological derangements and to establish an objective baseline.
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Vasos Linfáticos/patología , Linfedema/patología , Linfografía/métodos , Imagen por Resonancia Magnética , Heridas y Lesiones/complicaciones , Adulto , Anciano , Medios de Contraste , Femenino , Gadolinio , Compuestos Heterocíclicos , Humanos , Interpretación de Imagen Asistida por Computador , Imagenología Tridimensional , Extremidad Inferior , Vasos Linfáticos/fisiopatología , Linfedema/etiología , Linfedema/fisiopatología , Masculino , Persona de Mediana Edad , Compuestos Organometálicos , Valor Predictivo de las Pruebas , Heridas y Lesiones/patología , Heridas y Lesiones/fisiopatologíaRESUMEN
OBJECTIVES: Detection of subtle pulmonary nodules on digital radiography is a challenging task for radiologists. The aim of this study was to evaluate the performance of a newly approved computer aided detection (CAD) system. MATERIALS AND METHODS: The sensitivity of 3 radiologists and of a CAD system for the detection of pulmonary nodules from 5 to 15 mm in size on digital chest radiography of 117 patients was compared. The reference standard was established by consensus reading of computed tomography scans by 2 experienced radiologists. Computed tomography scans and chest radiographs were performed within 4 weeks. Sixty-six pulmonary nodules from 42 patients, with a mean nodule diameter of 7.5 mm (standard deviation: 2.2 mm), were included in the statistical analysis. Seventy-five of the 117 patients did not have nodules from 5 to 15 mm of size. RESULTS: Two hundred and eighty-eight false-positive detections of the CAD system were found with an average of 2.5 false-positives per image. Sensitivity of the CAD system was 39.4% (95% confidence interval: 11.8%), when compared with 18.2% to 30.3% (95% confidence interval 9.3% to 11.1%) of the 3 radiologists. Substantial agreement for nodule detection ([kappa]N: 0.64-0.73) was found among the 3 radiologists, whereas only moderate agreement was found between the radiologists and the CAD performance ([kappa]N: 0.45-0.52). CONCLUSIONS: The CAD system's diagnostic sensitivity in detecting pulmonary nodules of 5 to 15 mm of size was superior to the 1 of radiologists. The CAD system may be used for assisting the radiologist in the detection of lung nodules on digital chest radiographs.
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Competencia Clínica , Diagnóstico por Computador , Intensificación de Imagen Radiográfica/métodos , Interpretación de Imagen Radiográfica Asistida por Computador/métodos , Nódulo Pulmonar Solitario/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Reacciones Falso Positivas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Sensibilidad y Especificidad , Estadísticas no ParamétricasRESUMEN
PURPOSE: Detection of pulmonary metastases is still a challenging task for magnetic resonance imaging (MRI). It was the aim of this study to evaluate the potential of a free-breathing move-during-scan turbo inversion recovery magnitude sequence for the detection of pulmonary nodules. MATERIALS AND METHODS: The sensitivities and positive-predictive values of 2 radiologists to detect pulmonary nodules in 41 move-during-scan MRI examinations of 38 patients with different malignancies were calculated and subgroup analyses according to lesion size and localization were performed. Multidetector computed tomography served as the standard of reference. Additionally, 6 radiologists rated the confidence for the presence of nodular lesions in 212 regions-of-interest, which were randomly selected to represent lesions of various sizes as well as negative findings. Receiver-operator-characteristic was performed. RESULTS: Three hundred twenty-one nodules were found in 30 patients by multidetector computed tomography. Sensitivity and specificity of MRI to detect pulmonary nodules larger than 3 mm on a per-patient basis were 81.8% and 94.7%, respectively. On a per-lesion basis, MRI revealed a sensitivity of 79.0% to 80.7% for lesions larger than 3 mm, if high conspicuity ratings were counted as positive, and 84.6%, if medium and high conspicuity ratings were counted as positive. Sensitivity increased uniformly with lesion size, and all lesions larger than 12 mm were detected. Receiver-operator-characteristic analysis revealed a mean accuracy of 0.90 and sensitivities over 90% for lesions larger than 3 mm with a specificity of 96.1%. For lesions larger than 6 mm the accuracy was 0.99. CONCLUSION: Detection of pulmonary nodules with a move-during-scan turbo inversion recovery magnitude sequence is feasible. Excellent detection of lesions larger than 6 mm is achievable with free-breathing moving-table MRI.
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Neoplasias Pulmonares/diagnóstico , Imagen por Resonancia Magnética/métodos , Nódulo Pulmonar Solitario/diagnóstico , Adolescente , Adulto , Anciano , Niño , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Curva ROC , Estudios Retrospectivos , Sensibilidad y Especificidad , Imagen de Cuerpo EnteroRESUMEN
With the use of current multislice techniques for MR cholangiopancreatography various upper abdominal pathologies including pancreatic carcinoma, Klatskin tumor and metastatic spread can be non invasively depicted. Respiratory gating allows free breathing of the patient, which increases patient comfort, while excellent image quality can be achieved. In this concise pictorial report, state of the art MRCP images of various cancer entities including sequence descriptons are presented.
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Pancreatocolangiografía por Resonancia Magnética/métodos , Neoplasias/diagnóstico , Adulto , Anciano , Femenino , Humanos , Imagenología Tridimensional , Masculino , Persona de Mediana EdadRESUMEN
A 12-year-old boy was admitted after recently having had a resection performed of an extraadrenal retroperitoneal paraganglioma and left adrenalectomy for pheochromocytoma. Despite these procedures, the blood pressure and urinary noradrenalin were elevated. Screening with fluorine-18 DOPA PET demonstrated increased tracer uptake in the right adrenal gland, in a second abdominal lesion, which was prevertebral, and 2 cervical hot spots near the carotid bifurcation, one on each side of the neck. The patient carries a mutation of the gene Succinate dehydrogenasis subunits D (SDHD) and is thus classified with the paraganglioma syndrome type 1.
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Neoplasias Abdominales/diagnóstico por imagen , Dihidroxifenilalanina/análogos & derivados , Neoplasias de Cabeza y Cuello/diagnóstico por imagen , Paraganglioma/diagnóstico por imagen , Tomografía de Emisión de Positrones/métodos , Neoplasias Abdominales/genética , Niño , Neoplasias de Cabeza y Cuello/genética , Humanos , Masculino , Paraganglioma/genética , Radiofármacos , Succinato Deshidrogenasa/genética , SíndromeRESUMEN
BACKGROUND: Pelvic magnetic resonance imaging (MRI) is accurate in identifying perianal fistulas. The exact visualization of fistulous tracts and concomitant abscesses determine the type of treatment. To improve the detection of perianal fistulas, we studied digital subtraction MR-fistulography for tissue differentiation based on signal intensity measurements. METHODS: This study included 75 patients with the clinical diagnosis of perianal fistula. All patients were analyzed by a thin-slice, high-resolution, fast low-angle shot 3-dimensional sequence in the axial plane before and after intravenous injection of gadobenate dimeglumine, followed by image subtraction. Operator-defined regions of interest were used to calculate signal intensities of the inflamed fibrous walls of fistulas, the common femoral artery, the internal and external sphincter muscles, and the gluteus muscle. The fistulas were classified according to Parks classification. RESULTS: Based on signal intensity measurements in 75 patients with perianal fistulas, diagnosed by digital subtraction MR-fistulography, a significant differentiation between fistulous tracts and anatomic structures was possible. MRI identified 116 perianal fistulas (34 intersphincteric, 33 transsphincteric, 10 suprasphincteric, and 39 extrasphincteric) and 35 abscesses. CONCLUSIONS: Digital subtraction MR-fistulography is a new, promising, noninvasive imaging technique for the detection of perianal fistulas and abscesses.
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Imagenología Tridimensional , Imagen por Resonancia Magnética/métodos , Meglumina/análogos & derivados , Fístula Rectal/patología , Técnica de Sustracción , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Canal Anal/patología , Nalgas/patología , Niño , Medios de Contraste , Femenino , Arteria Femoral/patología , Humanos , Masculino , Persona de Mediana Edad , Músculo Esquelético/patología , Compuestos OrganometálicosRESUMEN
UNLABELLED: This article describes a four virus panel validation of EMD Millipore's (Bedford, MA) small virus-retentive filter, Viresolve® Pro, using TrueSpike(TM) viruses for a Biogen Idec process intermediate. The study was performed at Charles River Labs in King of Prussia, PA. Greater than 900 L/m(2) filter throughput was achieved with the approximately 8 g/L monoclonal antibody feed. No viruses were detected in any filtrate samples. All virus log reduction values were between ≥3.66 and ≥5.60. The use of TrueSpike(TM) at Charles River Labs allowed Biogen Idec to achieve a more representative scaled-down model and potentially reduce the cost of its virus filtration step and the overall cost of goods. The body of data presented here is an example of the benefits of following the guidance from the PDA Technical Report 47, The Preparation of Virus Spikes Used for Viral Clearance Studies. LAY ABSTRACT: The safety of biopharmaceuticals is assured through the use of multiple steps in the purification process that are capable of virus clearance, including filtration with virus-retentive filters. The amount of virus present at the downstream stages in the process is expected to be and is typically low. The viral clearance capability of the filtration step is assessed in a validation study. The study utilizes a small version of the larger manufacturing size filter, and a large, known amount of virus is added to the feed prior to filtration. Viral assay before and after filtration allows the virus log reduction value to be quantified. The representativeness of the small-scale model is supported by comparing large-scale filter performance to small-scale filter performance. The large-scale and small-scale filtration runs are performed using the same operating conditions. If the filter performance at both scales is comparable, it supports the applicability of the virus log reduction value obtained with the small-scale filter to the large-scale manufacturing process. However, the virus preparation used to spike the feed material often contains impurities that contribute adversely to virus filter performance in the small-scale model. The added impurities from the virus spike, which are not present at manufacturing scale, compromise the scale-down model and put into question the direct applicability of the virus clearance results. Another consequence of decreased filter performance due to virus spike impurities is the unnecessary over-sizing of the manufacturing system to match the low filter capacity observed in the scale-down model. This article describes how improvements in mammalian virus spike purity ensure the validity of the log reduction value obtained with the scale-down model and support economically optimized filter usage.
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Anticuerpos Monoclonales/química , Filtración , Filtros Microporos , Parvovirus/aislamiento & purificación , Productos Biológicos/normas , Contaminación de Medicamentos/prevención & control , Modelos TeóricosRESUMEN
RATIONALE AND OBJECTIVES: To evaluate the detection rate of fine details of a new thin-film transistor (TFT) grayscale monitor designed for radiologic diagnosis, compared with a type of cathode ray tube (CRT) screen used routinely for diagnostic radiology. METHODS: Fifteen radiographs of a statistical phantom presenting low- and high-contrast details were obtained and read out with an Agfa ADC compact storage phosphor system. Each radiograph presented 60 high-density (high-contrast) and 60 low-density (low-contrast) test bodies. Approximately half the test bodies contained holes with different diameters. Observers were asked to detect the presence or absence of a hole in the test body on a 5-point confidence range. The total of 1800 test bodies was reviewed by 5 radiologists on the TFT monitor (20.8 inches; 1536 x 2048 pixels; maximum luminance, 650 cd/m2; contrast, 600:1) and the CRT monitor (21 inches; P45 Phosphor; 2048 x 2560 pixels operated at 1728 x 2304 pixels; maximum luminance, 600 cd/m2; contrast, 300:1). The data were analyzed by receiver-operator characteristic analysis. RESULTS: For high-contrast details, the mean area under the curve rated 0.9336 for the TFT monitor and 0.9312 for the CRT monitor. For low-contrast details, the mean area under the curve rated 0.9189 for the TFT monitor and 0.9224 for the CRT monitor. At P Asunto(s)
Intensificación de Imagen Radiográfica/instrumentación
, Pantallas Intensificadoras de Rayos X
, Fantasmas de Imagen
, Curva ROC
RESUMEN
INTRODUCTION/OBJECTIVES: Contrast-enhanced MRA (ce-MRA) has been claimed by many authors as a replacement of conventional angiography evaluating peripheral arterial occlusive disease. However, reliable detection of relevant stenoses (>70%) has to be provided for planning vascular interventions. Only few data in the literature focuses on this crucial problem. The purpose of this study was to evaluate this topic using a two-step body-coil-based MRA protocol. METHODS AND PATIENTS: Forty three patients presenting with 82 stenoses >/=50% and 61 stenoses >70% on conventional catheter angiogram received fast Gadolinium-DTPA-enhanced high resolution 3D MR angiography at 1.5 T covering the pelvic and peripheral vascular tree in two examination steps using the body-coil. The data were evaluated double-blinded by three readers distinguishing moderate (50-70%) from severe stenoses (>70%). RESULTS: Overall sensitivity/specificity/accuracy was 84/60/70% evaluating 143 segments. Specificity was rather poor in the iliac (58%) and crural (50%) region and moderate in the femoral and popliteal level (73%). The negative predictive value ranged between 78 and 91%. The grade of stenosis tend to be overestimated rather than underestimated in all levels with positive predictive values between 55 and 78%. DISCUSSIONS AND CONCLUSIONS: Body-coil-based contrast-enhanced MRA has limited potential in distinguishing moderate from severe stenoses in peripheral occlusive disease. Overestimations are more common than underestimations. Both occur mainly in small-sized crural arteries but also in larger iliac arteries where vessel course in partition direction may cause inadequacy between voxel size and lumen diameter in severe stenosis.
Asunto(s)
Arteriopatías Oclusivas/diagnóstico , Arteria Femoral/patología , Arteria Ilíaca/patología , Angiografía por Resonancia Magnética , Arteria Poplítea/patología , Adulto , Anciano , Anciano de 80 o más Años , Angiografía de Substracción Digital , Medios de Contraste , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sensibilidad y EspecificidadRESUMEN
PURPOSE: To assess pulmonary abnormalities in patients with primary Sjogren's syndrome (PSS) using high-resolution computed tomography (HRCT). MATERIAL AND METHODS: The HRCT scans of 24 patients with the diagnosis PSS were retrospectively reviewed regarding the presence, extension and distribution of 16 pathological findings. RESULTS: Nineteen patients (79.2%) showed pathological findings and in five patients (21.8%) the HRCT scan was judged to be normal. A predominance of abnormalities in the lower lobes and subpleural areas was detected. The following pathologies were found: bronchiectasis, thin-walled cysts and small pulmonary nodules (46.2%), ground-glass attenuation and emphysema (37.8%), interlobular-septal thickening (29.4%), honeycombing (25.2%), bronchial wall thickening, tree-in-bud pattern (21.0%), mosaic perfusion (16.8%), architectural distortion (12.6%). Airspace consolidation, air trapping, large nodules (10-30mm) and masses (>30mm), mediastinal lymph node enlargement (>15mm) and free pleural fluid were seen each in 4.2%. In 7 of the 11 patients with thin-walled cysts areas of ground-glass attenuation were detected. CONCLUSION: HRCT seems is contributive to the characterization of the wide variety of lung abnormalities in PSS. Airway disease alone or in association with the presence of varying degrees of interstitial disease represents the main findings in accordance with earlier reports. Unexpectedly, almost half of the patients had thin-walled cysts on the HRCT scans, which etiology is unclear but could be associated with areas of ground-glass attenuation indicating LIP.
Asunto(s)
Síndrome de Sjögren/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tomografía Computarizada por Rayos X/métodosRESUMEN
An outbreak of meningococcal disease, caused by Neisseria meningitidis, occurred following an international youth football tournament in the summer of 1997, affecting individuals from four European countries. This paper describes the outbreak, focusing on international co-operation in detection, investigation, control and follow-up, identifying weaknesses and exploring opportunities for improved co-operation. Data came from interviews, reports and related documents. The detection and management of the outbreak in each country is analysed. Eleven cases were linked to this outbreak and serotyped as C:2a:P1.5. Control measures varied in each country, reflecting different national guidelines. The outbreak illustrated deficiencies in management of international outbreaks but also demonstrated benefits of international co-operation.
Asunto(s)
Brotes de Enfermedades , Infecciones Meningocócicas/diagnóstico , Neisseria meningitidis/patogenicidad , Guías de Práctica Clínica como Asunto , Fútbol , Adolescente , Adulto , Europa (Continente)/epidemiología , Femenino , Humanos , Cooperación Internacional , Masculino , Infecciones Meningocócicas/epidemiología , Infecciones Meningocócicas/terapia , Neisseria meningitidis/aislamiento & purificación , Vigilancia de la PoblaciónRESUMEN
OBJECTIVES: To investigate the effects, digital impression procedures can have on the three-dimensional fit of ceramic partial crowns in vitro. METHODS: An acrylic model of a mandibular first molar was prepared to receive a partial coverage all-ceramic crown (mesio-occlusal-distal inlay preparation with reduction of all cusps and rounded shoulder finish line of buccal wall). Digital impressions were taken using iTero (ITE), cara TRIOS (TRI), CEREC AC with Bluecam (CBC), and Lava COS (COS) systems, before restorations were designed and machined from lithium disilicate blanks. Both the preparation and the restorations were digitised using an optical reference-scanner. Data were entered into quality inspection software, which superimposed the records (best-fit-algorithm), calculated fit-discrepancies for every pixel, and colour-coded the results to aid visualisation. Furthermore, mean quadratic deviations (RMS) were computed and analysed statistically with a one-way ANOVA. Scheffé's procedure was applied for multiple comparisons (n=5, α=0.05). RESULTS: Mean marginal (internal) discrepancies were: ITE 90 (92) µm, TRI 128 (106) µm, CBC 146 (84) µm, and COS 109 (93) µm. Differences among impression systems were statistically significant at p<0.001 (p=0.039). Qualitatively, partial crowns were undersized especially around cusp tips or the occluso-approximal isthmus. By contrast, potential high-spots could be detected along the preparation finishline and at central occlusal boxes. CONCLUSIONS: Marginal and internal fit of milled lithium disilicate partial crowns depended on the employed digital impression technique. CLINICAL SIGNIFICANCE: The investigated digital impression procedures demonstrated significant fit discrepancies. However, all fabricated restorations showed acceptable marginal and internal gap sizes, when considering clinically relevant thresholds reported in the literature.