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Percutaneous iliosacral screw placement has become the technique of choice for treating injuries to the posterior pelvis. However, the technique requires an understanding of the anatomy surrounding the bone corridors to avoid complications and detect them early if they occur. We present the clinical case of a patient with a U-shaped fracture of the sacrum that evolves with gluteal pain and left foot equine paresis after percutaneous fixation with iliosacral screws. Angio-CT of the pelvis shows active arterial bleeding from the superior gluteal artery associated to extensive hematoma in the thickness of the gluteus medius muscle. Emergency embolization is performed by installing coil and gelatin. Successful control of bleeding is achieved. To avoid this complication, a complete imaging study is recommended in planning the surgery and to avoid multiple repositioning of the guide or screw. Arterial injury should be suspected in case of increasing pain despite analgesia, functional impairment or neurological deficit and the angiographic study and resolution by selective embolization of the bleeding vessels must be performed.
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The management of alcohol withdrawal syndrome is a frequent work in both community medicine and hospital wards. One of the most severe complications of alcohol withdrawal is Delirium Tremens (DT). The purpose of this development is to update knowledge on this complication in terms of diagnosis, evaluation and therapeutic approaches. It also proposes a reflection on the trajectory of care during and after DT.
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Delirio por Abstinencia Alcohólica , Alcoholismo , Síndrome de Abstinencia a Sustancias , Delirio por Abstinencia Alcohólica/diagnóstico , Delirio por Abstinencia Alcohólica/tratamiento farmacológico , Delirio por Abstinencia Alcohólica/epidemiología , Alcoholismo/complicaciones , Alcoholismo/diagnóstico , Alcoholismo/epidemiología , Humanos , Síndrome de Abstinencia a Sustancias/diagnóstico , Síndrome de Abstinencia a Sustancias/terapiaRESUMEN
Poor prognosis factors in surgical treatment of acetabular fracture-dislocations have been well established but there is little information about how morphological abnormalities of the hip may affect the surgical outcome. Hip anatomy has a wide range of variations. Morphological abnormalities of the hip can also be observed in patients with acetabular fractures. We present a case of a complication in a patient with a complex acetabular fracture, acetabular retroversion and femoroacetabular impingement. A 31-year old male patient was transferred to our trauma center following a high speed road traffic accident. Trauma series CT revealed cerebral contusion, subdural hematoma, aortic dissection and a left transverse plus posterior wall acetabular fracture. The left hip was reduced and the acetabular fracture was treated with a Kocher Langenbeck approach in prone position. The pelvic X- ray evidenced an anatomic reduction and signs of acetabular retroversion with positive posterior wall sign and crossover sign. CT scan evidenced increased alpha angle in the femoral head neck junction. During the follow up, 2â¯months after the acetabular fixation, patient suffered a posterior left hip dislocation and a total cementless hip arthroplasty was performed. Patients with acetabular retroversion and femoroacetabular impingement (CAM lesion) may be at risk of posterior dislocation. The influence of acetabular version and impingement may be also closely involved in how challenging the determination of hip stability can be in patients with posterior wall acetabular fractures. Acetabular retroversion and FAI may be related to the dislocation of unstable patterns with small fragments (wall sizes less than 20%). In this case postoperative precautions were not enough. We believe capsular reattachment with anchors and bracing may be useful in these selected cases. As these patients are not candidates for retroPAO (the recommended treatment for acetabular retroversion) maybe arthroscopic anterior wall riming and CAM resection should be performed at an early stage to decrease or avoid fulcrum.
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This paper addresses the methodological conditions -particularly experimental design and statistical inference- ensuring the identifiability of sorption parameters from breakthrough curves measured during stirred flow-through reactor experiments also known as continuous flow stirred-tank reactor (CSTR) experiments. The equilibrium-kinetic (EK) sorption model was selected as nonequilibrium parameterization embedding the Kd approach. Parameter identifiability was studied formally on the equations governing outlet concentrations. It was also studied numerically on 6 simulated CSTR experiments on a soil with known equilibrium-kinetic sorption parameters. EK sorption parameters can not be identified from a single breakthrough curve of a CSTR experiment, because Kd,1 and k- were diagnosed collinear. For pairs of CSTR experiments, Bayesian inference allowed to select the correct models of sorption and error among sorption alternatives. Bayesian inference was conducted with SAMCAT software (Sensitivity Analysis and Markov Chain simulations Applied to Transfer models) which launched the simulations through the embedded simulation engine GNU-MCSim, and automated their configuration and post-processing. Experimental designs consisting in varying flow rates between experiments reaching equilibrium at contamination stage were found optimal, because they simultaneously gave accurate sorption parameters and predictions. Bayesian results were comparable to maximum likehood method but they avoided convergence problems, the marginal likelihood allowed to compare all models, and credible interval gave directly the uncertainty of sorption parameters θ. Although these findings are limited to the specific conditions studied here, in particular the considered sorption model, the chosen parameter values and error structure, they help in the conception and analysis of future CSTR experiments with radionuclides whose kinetic behaviour is suspected.
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Teorema de Bayes , Cinética , Modelos TeóricosRESUMEN
AIM: To analyze the indications and outcomes of open neurosurgical approaches (ONA) and endoscopic transnasal approaches (ETA) in the surgical management of pediatric sinogenic subdural and epidural empyema. MATERIAL AND METHODS: Retrospective single-center study design within a tertiary care referral center setting. Children less than 18 years of age consecutively operated on between January 2012 and February 2014 for drainage of a sinogenic subdural empyema (SE) or epidural (EE) empyema were included. MAIN OUTCOME MEASURES: success of first surgical procedure, persistent symptoms and sequelae at the end of the follow-up period. RESULTS: Nine SE (53%) and 8 EE (47%) were observed. Neurological symptoms, especially seizures, were more frequent in the SE group. Perioperative pus samples were positive in 67% of the SE group and in 75% of the EE group. The most frequently isolated bacteria belonged to the Streptococcus anginosus group. CT or MR imaging showed that most empyema probably originated from the frontal sinus. However, two cases resulted from an ethmoiditis and one case from a Pott's puffy tumor, without any direct contact with the paranasal sinus. In cases of SE, the most effective surgical technique was ONA with craniotomy. Associated endoscopic sinus drainage was useful for the purpose of bacteriological diagnosis. In cases of EE, effectiveness was noted in both ONA and ETA techniques. In two cases of EE, the ETA procedure encompassed direct drainage of the empyema through the posterior wall of the frontal sinus (Draf III approach). The number of patients successfully treated after a single surgical procedure was higher in the EE group (p=0.05). Regarding outcomes, no mortalities were observed. Persistent disorders at the end of the follow-up period, especially headaches, cognitive, concentration or schooling problems, tended to be more frequent in the SE group than in the EE group (67% vs 29%), and were more commonly observed in cases requiring several surgical procedures (75% vs 12.5%) (p=0.05). DISCUSSION: Endoscopic sinus surgery plays a critical role in the surgical management of pediatric sinogenic SE and EE. In cases of small volume EE, the endoscopic approach associated with antibiotherapy may be sufficient to treat the infectious process.
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Empiema Subdural/cirugía , Endoscopía , Absceso Epidural/cirugía , Infecciones Estreptocócicas/complicaciones , Streptococcus anginosus , Adolescente , Niño , Trastornos del Conocimiento/etiología , Craneotomía/efectos adversos , Drenaje , Empiema Subdural/complicaciones , Empiema Subdural/microbiología , Endoscopía/efectos adversos , Endoscopía/métodos , Absceso Epidural/complicaciones , Absceso Epidural/microbiología , Sinusitis del Etmoides/diagnóstico por imagen , Sinusitis del Etmoides/microbiología , Femenino , Sinusitis Frontal/diagnóstico por imagen , Sinusitis Frontal/microbiología , Cefalea/etiología , Humanos , Discapacidades para el Aprendizaje/etiología , Masculino , Nariz , Radiografía , Estudios RetrospectivosRESUMEN
This study (i) quantified the kinetics of selenate sorption and (ii) measured the influence of biotic processes in soil selenate stabilisation. Stirred flow-through reactor experiments were conducted on samples of a silty clay soil (pH = 8, Eh = 240-300 mV) from Bure (France) in both non-sterile and sterile conditions. Parameters of the proposed two-site sorption model (EK), adapted from van Genuchten and Wagenet (1989), were estimated by nonlinear regression. Fast selenate sorption on type-1 sites was moderate, with an equilibrium constant of 25.5 and 39.1 L/kg for non-sterile and sterile conditions. Rate-limited sorption on type-2 sites increased with time, and was predominant for longer periods of time in non-sterile conditions. At equilibrium, it would represent over 96% of the sorbed inventory, with mean sorption times of 17 h and 191 h for non-sterile and sterile conditions. Our results showed for Bure soil that (i) selenate sorption in flowing and mildly-oxidising conditions was strongly kinetically controlled, especially in non-sterile conditions, (ii) selenate desorption was much slower than sorption, which suggests its pseudo-irreversible stabilisation, and (iii) microbial activity increased the contribution of rate-limited sorption on type-2 sites, for which it increased sorption rate by a factor 7 but also facilitated its reversibility. This work stresses the limits of the Kd approach to represent selenate sorption in flowing conditions and supports an alternative formulation like the EK model, but also points out that biotic conditions are significant sources of variability for sorption parameters.
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Ácido Selénico/análisis , Radioisótopos de Selenio/análisis , Contaminantes Radiactivos del Suelo/análisis , Adsorción , Francia , Cinética , Monitoreo de Radiación , Ácido Selénico/química , Ácido Selénico/metabolismo , Radioisótopos de Selenio/química , Radioisótopos de Selenio/metabolismo , Contaminantes Radiactivos del Suelo/química , Contaminantes Radiactivos del Suelo/metabolismoRESUMEN
Colorectal cancer (CRC) is the most common tumour type in both sexes combined in Western countries. Although screening programmes including the implementation of faecal occult blood test and colonoscopy might be able to reduce mortality by removing precursor lesions and by making diagnosis at an earlier stage, the burden of disease and mortality is still high. Improvement of diagnostic and treatment options increased staging accuracy, functional outcome for early stages as well as survival. Although high quality surgery is still the mainstay of curative treatment, the management of CRC must be a multi-modal approach performed by an experienced multi-disciplinary expert team. Optimal choice of the individual treatment modality according to disease localization and extent, tumour biology and patient factors is able to maintain quality of life, enables long-term survival and even cure in selected patients by a combination of chemotherapy and surgery. Treatment decisions must be based on the available evidence, which has been the basis for this consensus conference-based guideline delivering a clear proposal for diagnostic and treatment measures in each stage of rectal and colon cancer and the individual clinical situations. This ESMO guideline is recommended to be used as the basis for treatment and management decisions.
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Neoplasias Colorrectales/terapia , Toma de Decisiones , Medicina de Precisión , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/epidemiología , Consejo , Humanos , Grupo de Atención al Paciente , PronósticoRESUMEN
This review highlights major achievements of the Russian oncology in the past decades, such as works of N.N. Petrov, L.A. Zilber, N.N. Blokhin, E.E. Pogosyants. Revolutionary shift in the understanding of the malignization process have become possible after decoding of human genome, as well as genome of several tumors such as breast cancer, acute myeloblastic leukemia, several brain tumors, testicular cancer and other neoplasms. The issue of stem cells being possible ancestors of tumor cells is also discussed in the review. Also the author observes main modern therapeutic approaches towards cancer treatment. It is specially highlighted that XXI century molecular biology achievements made it possible to start personal tumor treatment based on its' specific genotype.
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Oncología Médica/historia , Neoplasias/historia , Antineoplásicos/historia , Antineoplásicos/uso terapéutico , Quimioterapia/historia , Quimioterapia/métodos , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Mutación , Neoplasias/genética , Neoplasias/terapia , Federación de Rusia , Células Madre/patologíaRESUMEN
OBJECTIVES: To evaluate paclitaxel, bleomycin, etoposide, and cisplatin (T-BEP) in patients with poor-prognosis nonseminomatous germ cell tumor (NSGCT). Paclitaxel is an active treatment of nonseminomatous germ cell tumors. METHODS: The present study was an open-label, single-center, Phase II study. Chemotherapy-naive patients received T-BEP (paclitaxel 175 mg/m2 [day 2], cisplatin 20 mg/m2 [days 1-5], etoposide 100 mg/m2 [days 1-5], bleomycin 30 IU [days 1, 3, and 5]), and granulocyte colony-stimulating factor 300 µg (days 6-10). The number of cycles (range 4-6) was dependent on the normalization of tumor markers. Secondary resection was planned for patients with tumor marker-negative partial remission. Assessments included radiologic response, tumor markers, and safety. The primary endpoint was progression-free survival (PFS) 1 year after chemotherapy. RESULTS: Of 51 patients, 49 completed chemotherapy and were evaluable for response: 12 (25%) had a complete response, 29 (59%) were marker-negative (tumor marker normalization) and 3 (6%) were marker-positive (tumor marker decrease for ≥1 month) incomplete responders, and 5 (10%) had progressive disease. A total of 37 patients underwent secondary resection. After the treatment of 27 patients, an unplanned analysis showed inappropriate toxicity at cycle 1 (grade 3-4 infection [6 patients] resulting in 2 toxic deaths), which led to treatment modification (BEP [cycle 1], T-BEP [subsequent cycles]), with no further toxic deaths observed. Grade 3-4 adverse events included neutropenia (71%), febrile neutropenia (33%), and infection (14%). During the first year after chemotherapy, 1 patient was lost to follow-up, and 21 patients relapsed. The PFS rate at 1 year after chemotherapy was 58% (29 of 50 patients). CONCLUSIONS: T-BEP did not improve PFS in patients with poor-prognosis NSGCT. The administration of T-BEP from cycle 1 resulted in excessive toxicity but was administered safely from cycle 2.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias del Mediastino/tratamiento farmacológico , Neoplasias de Células Germinales y Embrionarias/tratamiento farmacológico , Neoplasias Testiculares/tratamiento farmacológico , Adolescente , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bleomicina/administración & dosificación , Bleomicina/efectos adversos , Cisplatino/administración & dosificación , Cisplatino/efectos adversos , Supervivencia sin Enfermedad , Etopósido/administración & dosificación , Etopósido/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Neoplasias de Células Germinales y Embrionarias/secundario , Pronóstico , Adulto JovenRESUMEN
BACKGROUND: This retrospective study was carried out to evaluate the prognostic significance of clinical factors in patients treated for metastatic gastric cancer with second-line chemotherapy. PATIENTS AND METHODS: We evaluated the prognostic significance of various clinical factors in 126 patients, who were treated with second-line chemotherapy. RESULTS: Median progression-free and overall survival (OS) for second-line chemotherapy were 3.3 and 5.3 months, respectively, with an overall response rate of 11.1%. Multivariate analysis identified three independent prognostic factors: performance status: Eastern Cooperative Oncology Group zero to one [hazard ratio (HR) 2.3, 95% confidence interval (CI) 1.7-5.4], hemoglobin (Hb) level: >/=10 g/dl (HR 2.2, 95% CI 2.1-2.4) and time-to-progression (TTP) under first-line therapy: >/=5 months (HR 0.5, 95% CI 0.3-0.8). From the obtained data, a prognostic index was constructed, dividing the patients into three risk groups: good (n = 40), intermediate (n = 36) and poor risk group (n = 56). The median survival for good, intermediate and poor risk groups were 13.5, 6.0 and 2.9 months, respectively, whereas the 1-year OS rates were 50.2%, 14.2% and 2.6%, respectively (P = 0.00001). CONCLUSIONS: With inadequate data from randomized controlled trials at the moment, our report indicates that second-line chemotherapy is effective and beneficial in patients with good performance status, higher Hb level along with higher TTP under first-line therapy.
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Adenocarcinoma/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Células en Anillo de Sello/tratamiento farmacológico , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Peritoneales/tratamiento farmacológico , Neoplasias Gástricas/tratamiento farmacológico , Adenocarcinoma/patología , Adulto , Anciano , Carcinoma de Células en Anillo de Sello/patología , Cisplatino/administración & dosificación , Docetaxel , Etopósido/administración & dosificación , Femenino , Fluorouracilo/administración & dosificación , Estudios de Seguimiento , Humanos , Neoplasias Hepáticas/secundario , Metástasis Linfática , Masculino , Persona de Mediana Edad , Mitomicina/administración & dosificación , Estadificación de Neoplasias , Neoplasias Ováricas/secundario , Neoplasias Peritoneales/secundario , Pronóstico , Estudios Retrospectivos , Neoplasias Gástricas/patología , Tasa de Supervivencia , Taxoides/administración & dosificaciónAsunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Médula Ósea/efectos de los fármacos , Hematínicos/uso terapéutico , Imidazoles/uso terapéutico , Neoplasias Ováricas/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Caproatos , Ciclofosfamida/efectos adversos , Desoxicitidina/efectos adversos , Desoxicitidina/análogos & derivados , Doxorrubicina/efectos adversos , Femenino , Humanos , Leucopenia/inducido químicamente , Leucopenia/tratamiento farmacológico , Persona de Mediana Edad , Neutropenia/inducido químicamente , Neutropenia/tratamiento farmacológico , Neoplasias Ováricas/patología , Resultado del Tratamiento , GemcitabinaRESUMEN
5-Fluorouramcil has been the medicine of choice for systemic treatment of metastatic colonic cancer for the last 35 years. Objective positive results of this therapy were documented in 30% of the cases, it delayed the development of active disease by 4 months, and ensured a 6 month survival. Introduction of irinotecan, oxaliplatin, capecitabine, S = 1, and other drugs into clinical practice improved overall efficiency of therapy to 40-50%, increased time till progression of the disease to 6 months and survival to 15 months. Targeted drugs (bevacizumab, cetuximab) combined with the known chemotherapeutic programs (FOLFOX, FOLFIRI, XELIRI, XELFOX, etc.) showed even higher therapeutic effect, i.e. overall efficiency 50-60%, time to progression 10 months and survival of more than 1.5 years. Panitumumab is an active agent to be used in the third-line therapy.
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Inhibidores de la Angiogénesis/uso terapéutico , Antineoplásicos/uso terapéutico , Neoplasias del Colon/tratamiento farmacológico , Neoplasias del Colon/secundario , Humanos , Resultado del TratamientoRESUMEN
Since the late 1990s, docetaxel (Dtx), an antitubular drug, has been studied as a tool for the treatment of GC. Maximum effectiveness of docetaxel as monotherapy amounted to 24%, with a median survival of 7 months. Two-drug combinations were developed containing docetaxel with 5-fluorouracil (DF) and docetaxel with cisplatin (DC). They proved effective in 43 and 33% of the cases respectively and ensured a similar median survival of 9-10 months. Clinical studies of a three-component combination containing docetaxel, 5-fluorouracil and cisplatin (DCF) as first-line therapy of metastatic GC were carried out in the XXIst century and showed its efficacy in 50% of the cases with a median survival of 10-12 months. The DCF regimen may be considered as a new standard for the treatment of patients with metastatic GC and satisfactory health status (ECOG 0-1). The combination is being modified to improve its toxicity profile by substituting oxaliplatin for cisplatin and oral fluoropyrimidines for i.v. 5-fluorouracil.
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Antineoplásicos/uso terapéutico , Neoplasias Gástricas/tratamiento farmacológico , Neoplasias Gástricas/secundario , Taxoides/uso terapéutico , Docetaxel , Humanos , Fármacos Sensibilizantes a Radiaciones , Resultado del TratamientoRESUMEN
The aim of this study was to investigate the role of microorganisms on the behaviour of selenium in natural soil maintained under strictly aerobic conditions. Six-day batch experiments were performed with soils constrained to different microbiological states, either by sterilisation or by adding organic substrates. Selenium was added to the soil as selenite. The distribution of selenium in the gaseous, liquid and solid phases of the batch was measured. Selenium partitioning between the various solid phases was investigated by chemical sequential extractions. Active microorganisms played major effects on the distribution of selenium within the soil. On the one hand, microorganisms could promote selenium volatilisation (in relatively small amounts), leading to the spreading of selenium compounds outside the soil. On the other hand, microbial activities increased both amount of selenium retained by the soil and the strength of its retention (less exchangeable selenium), making selenium less susceptible to remobilisation.
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Selenio/química , Selenio/metabolismo , Microbiología del Suelo , Biodegradación Ambiental , Contaminantes del Suelo/química , Contaminantes del Suelo/metabolismo , VolatilizaciónRESUMEN
The ability to predict the consequences of an accidental release of radionuclides relies mainly on the level of understanding of the mechanisms involved in radionuclide interactions with different components of agricultural and natural ecosystems and their formalisation into predictive models. Numerous studies and databases on contaminated agricultural and natural areas have been obtained, but their use to enhance our prediction ability has been largely limited by their unresolved variability. Such variability seems to stem from incomplete knowledge about radionuclide interactions with the soil matrix, soil moisture, and biological elements in the soil and additional pollutants, which may be found in such soils. In the 5th European Framework Programme entitled Bioavailability of Radionuclides in Soils (BORIS), we investigated the role of the abiotic (soil components and soil structure) and biological elements (organic compounds, plants, mycorrhiza, and microbes) in radionuclide sorption/desorption in soils and radionuclide uptake/release by plants. Because of the importance of their radioisotopes, the bioavailability of three elements, caesium, strontium, and technetium has been followed. The role of one additional non-radioactive pollutant (copper) has been scrutinised in some cases. Role of microorganisms (e.g., K(d) for caesium and strontium in organic soils is much greater in the presence of microorganisms than in their absence), plant physiology (e.g., changes in plant physiology affect radionuclide uptake by plants), and the presence of mycorrhizal fungi (e.g., interferes with the uptake of radionuclides by plants) have been demonstrated. Knowledge acquired from these experiments has been incorporated into two mechanistic models CHEMFAST and BIORUR, specifically modelling radionuclide sorption/desorption from soil matrices and radionuclide uptake by/release from plants. These mechanistic models have been incorporated into an assessment model to enhance its prediction ability by introducing the concept of bioavailability factor for radionuclides.
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Radioisótopos/metabolismo , Contaminantes Radiactivos del Suelo/metabolismo , Adsorción , Disponibilidad Biológica , Micorrizas/metabolismo , Plantas/metabolismo , Microbiología del SueloRESUMEN
This study aimed to (i) evaluate whether the K(d) value of selenium is dependent upon the soil microbial activity and (ii) define the limitation of the use of the K(d) concept to describe selenium behaviour in soils when assessing the long-term radiological waste disposal risk. K(d) coefficients, as well as information on selenite speciation in the soil-solution, were derived from short- and long-term batch experiments with a calcareous silty clay soil in various microbial states. Soil microbial activity induced (i) an increase of the K(d) value from 16 l kg(-1) in sterile conditions to 130 l kg(-1) when the soil was amended with glucose and nitrate, and (ii) changes in selenium speciation both in the solution (presence of seleno-species other than free Se(IV)) and in the solid phase (Se linked to microorganisms). Although the K(d) coefficient adequately reflects the initial fractionation between soil-solid and soil-solution, it does not allow for speciation and microbial processes, which could affect reversibility, mobility and the long-term accumulation and uptake into crops.
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Selenio/metabolismo , Microbiología del Suelo , Acetatos/metabolismo , Adsorción , Glucosa/metabolismo , Nitratos/metabolismo , Selenito de Sodio/química , Selenito de Sodio/metabolismoRESUMEN
BACKGROUND: Cancer patients receiving chemotherapy experience thromboembolic complications associated with the use of long-term indwelling central venous catheters (CVCs). This prospective, double-blind, placebo-controlled, multicenter study evaluated whether prophylactic treatment with a low molecular weight heparin could prevent clinically relevant catheter-related thrombosis. PATIENTS AND METHODS: Patients with cancer undergoing chemotherapy for at least 12 weeks (n=439) were randomly assigned, in a 2:1 ratio, to receive either dalteparin (5000 IU) or placebo, by subcutaneous injection, once daily for 16 weeks. Patients underwent upper extremity evaluation with either venography or ultrasound at the time of a suspected catheter-related complication (CRC) or upon completion of study medication. The primary end point, as determined by a blinded adjudication committee, was the occurrence of a CRC, defined as the first occurrence of any one of the following: clinically relevant catheter-related thrombosis that was symptomatic or that required anticoagulant or fibrinolytic therapy; catheter-related clinically relevant pulmonary embolism; or catheter obstruction requiring catheter removal. RESULTS: There was no significant difference in the frequency of CRCs between the dalteparin arm (3.7%) and the placebo arm (3.4%; P=0.88), corresponding to a relative risk of 1.0883 (95% confidence interval 0.37-3.19). No difference in the time to CRC was observed between the two arms (P=0.83). There was no significant difference between the dalteparin and placebo groups in terms of major bleeding (1 versus 0) or overall safety. CONCLUSIONS: Dalteparin prophylaxis did not reduce the frequency of thromboembolic complications after CVC implantation in cancer patients. Dalteparin was demonstrated to be safe over 16 weeks of treatment in these patients.
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Anticoagulantes/uso terapéutico , Cateterismo Venoso Central/efectos adversos , Catéteres de Permanencia/efectos adversos , Dalteparina/uso terapéutico , Tromboembolia/prevención & control , Anticoagulantes/administración & dosificación , Antineoplásicos/administración & dosificación , Antineoplásicos/uso terapéutico , Dalteparina/administración & dosificación , Femenino , Humanos , Infusiones Intravenosas , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Factores de Riesgo , Tromboembolia/etiologíaRESUMEN
The effects of simplified rhizospheric conditions on the leaching of (241)Am from a calcareous soil, freshly contaminated, were investigated in batch and column experiments. Glucose and/or citrate were used as artificial exudate solutions at concentrations ranging from 10(-4) to 10(-2)moldm(-3). Am desorption, expressed in terms of distribution coefficients, varied from K(d)>10(4)dm(3)kg(-1) corresponding to a majority of experimental conditions, to K(d)=10(2)dm(3)kg(-1) when citrate combined or not with glucose was used at >/=10(-2)moldm(-3). Soil columns revealed successive steady states coupled with transitory episodes, the latter represented up to 90% of the total Am release. (241)Am fractions with different behaviours were thus highlighted in columns whereas batch only accounted for highest Am mobile fractions. The implications of the different processes are discussed in terms of modelling approach and risk assessment.
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Americio/análisis , Hongos/metabolismo , Contaminantes Radiactivos del Suelo/análisis , Suelo/análisis , Adsorción , Ácido Cítrico/química , Monitoreo del Ambiente/instrumentación , Monitoreo del Ambiente/métodos , Glucosa/química , Cinética , Porosidad , Reología , Medición de RiesgoRESUMEN
The purpose of this phase II trial was to compare the efficacy, safety and pharmacokinetics of four irinotecan schedules for the treatment of metastatic colorectal cancer. In total, 174 5-fluorouracil pretreated patients were randomised to: arm A (n=41), 350 mg m(-2) irinotecan as a 90-min i.v. infusion q3 weeks; arm B (n=38), 125 mg m(-2) irinotecan as a 90-min i.v. infusion weekly x 4 weeks q6 weeks; arm C (n=46), 250 mg m(-2) irinotecan as a 90-min i.v. infusion q2 weeks; or arm D (n=49), 10 mg m(-2) day(-1) irinotecan as a 14-day continuous infusion q3 weeks. No significant differences in efficacy across the four arms were observed, although a shorter time to treatment failure was noted for arm D (1.7 months; P=0.02). Overall response rates were in the range 5-11%. Secondary end points included median survival (6.4-9.4 months), and time to progression (2.7-3.8 months) and treatment failure (1.7-3.2 months). Similarly, there were no significant differences in the incidence of grade 3-4 toxicities, although the toxicity profile between arms A, B, and C and D did differ. Generally, significantly less haematologic toxicity, alopecia and cholinergic syndrome were observed in arm D; however, there was a trend for increased gastrointestinal toxicity. Irinotecan is an effective and safe second-line treatment for colorectal cancer. The schedules examined yielded equivalent results, indicating that there is no advantage of the prolonged vs short infusion schedules.