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1.
Eur Heart J Cardiovasc Pharmacother ; 9(3): 251-261, 2023 04 10.
Artículo en Inglés | MEDLINE | ID: mdl-36640149

RESUMEN

AIMS: As the antithrombotic regimen that may best prevent ischaemic complications along with the lowest bleeding risk offset following transcatheter aortic valve implantation (TAVI) remains unclear, we aimed to compare the safety and efficacy of antithrombotic regimens in patients without having an indication for chronic oral anticoagulation. METHODS AND RESULTS: We conducted a PROSPERO-registered (CRD42021247924) systematic review and network meta-analysis of randomized controlled trials evaluating post-TAVI antithrombotic regimens up to April 2022. We estimated the relative risk (RR) and 95% confidence intervals (95% CIs) using a random-effects model in a frequentist pairwise and network metanalytic approach. We included seven studies comprising 4006 patients with a mean weighted follow-up of 12.9 months. Risk of all-cause death was significantly reduced with dual antiplatelet therapy (DAPT) compared with low-dose rivaroxaban + 3-month single antiplatelet therapy (SAPT) (RR 0.60, 95% CI 0.41-0.88), while no significant reduction was observed with SAPT vs. DAPT (RR 1.02, 95% CI 0.67-1.58) and SAPT and DAPT compared with apixaban or edoxaban (RR 0.60, 95% CI 0.32-1.14 and RR 0.59, 95% CI 0.34-1.02, respectively). SAPT was associated with a significant reduction of life-threatening, disabling, or major bleeding compared with DAPT (RR 0.45, 95% CI 0.29-0.70), apixaban or edoxaban alone (RR 0.45, 95% CI 0.25-0.79), and low-dose rivaroxaban + 3-month SAPT (RR 0.30, 95% CI 0.16-0.57). There were no differences between the various regimens with respect to myocardial infarction, stroke, or systemic embolism. CONCLUSION: Following TAVI in patients without an indication for chronic oral anticoagulant, SAPT more than halved the risk of bleeding compared with DAPT and direct oral anticoagulant-based regimens without significant ischaemic offset.


Asunto(s)
Inhibidores de Agregación Plaquetaria , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Fibrinolíticos/uso terapéutico , Rivaroxabán , Metaanálisis en Red , Quimioterapia Combinada , Ensayos Clínicos Controlados Aleatorios como Asunto , Hemorragia/inducido químicamente , Anticoagulantes/efectos adversos
2.
Thromb Haemost ; 122(4): 646-656, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34535037

RESUMEN

Cancer-associated thrombosis (CT) is associated with a high risk of recurrent venous thromboembolic (VTE) events that require extended anticoagulation in patients with active cancer, putting them at risk of bleeding. The aim of the API-CAT study (NCT03692065) is to assess whether a reduced-dose regimen of apixaban (2.5 mg twice daily [bid]) is noninferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with active cancer who have completed ≥6 months of anticoagulant therapy for a documented index event of proximal deep-vein thrombosis and/or pulmonary embolism. API-CAT is an international, randomized, parallel-group, double-blind, noninferiority trial with blinded adjudication of outcome events. Consecutive patients are randomized to receive apixaban 2.5 or 5 mg bid for 12 months. The primary efficacy outcome is a composite of recurrent symptomatic or incidental VTE during the treatment period. The principal safety endpoint is clinically relevant bleeding, defined as a composite of major bleeding or nonmajor clinically relevant bleeding. Assuming a 12-month incidence of the primary outcome of 4% with apixaban and an upper limit of the two-sided 95% confidence interval of the hazard ratio <2.0, 1,722 patients will be randomized, assuming an up to 10% loss in total patient-years (ß = 80%; α one-sided = 0.025). This trial has the potential to demonstrate that a regimen of extended treatment for patients with CT beyond an initial 6 months, with a reduced apixaban dose, has an acceptable risk of recurrent VTE recurrence and decreases the risk of bleeding.


Asunto(s)
Neoplasias , Tromboembolia Venosa , Anticoagulantes/efectos adversos , Hemorragia/epidemiología , Humanos , Neoplasias/tratamiento farmacológico , Pirazoles , Piridonas/efectos adversos , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/prevención & control
3.
Circ Cardiovasc Interv ; 13(7): e008481, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32674675

RESUMEN

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) exposes to the risk of device thrombosis in patients with atrial fibrillation who frequently have a contraindication to full anticoagulation. Thereby, dual antiplatelet therapy (DAPT) is usually preferred. No randomized study has evaluated nonvitamin K antagonist oral anticoagulant after LAAC, and we decided to evaluate the efficacy and safety of reduced doses of rivaroxaban after LAAC. METHODS: ADRIFT (Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban in Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure) is a multicenter, phase IIb study, which randomized 105 patients after successful LAAC to either rivaroxaban 10 mg (R10, n=37), rivaroxaban 15 mg (R15, n=35), or DAPT with aspirin 75 mg and clopidogrel 75 mg (n=33). The primary end point was thrombin generation (prothrombin fragments 1+2) measured 2 to 4 hours after drug intake, 10 days after treatment initiation. Thrombin-antithrombin complex, D-dimers, rivaroxaban concentrations were also measured at 10 days and 3 months. Clinical end points were evaluated at 3-month follow-up. RESULTS: The primary end point was reduced with R10 (179 pmol/L [interquartile range (IQR), 129-273], P<0.0001) and R15 (163 pmol/L [IQR, 112-231], P<0.0001) as compared with DAPT (322 pmol/L [IQR, 218-528]). We observed no significant reduction of the primary end point between R10 and R15 while rivaroxaban concentrations increased significantly from 184 ng/mL (IQR, 127-290) with R10 to 274 ng/mL (IQR, 192-377) with R15, P<0.0001. Thrombin-antithrombin complex and D-dimers were numerically lower with both rivaroxaban doses than with DAPT. These findings were all confirmed at 3 months. The clinical end points were not different between groups. A device thrombosis was noted in 2 patients assigned to DAPT. CONCLUSIONS: Thrombin generation measured after LAAC was lower in patients treated by reduced rivaroxaban doses than DAPT, supporting an alternative to the antithrombotic regimens currently used after LAAC and deserves further evaluation in larger studies. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03273322.


Asunto(s)
Apéndice Atrial/fisiopatología , Fibrilación Atrial/terapia , Función del Atrio Izquierdo , Cateterismo Cardíaco , Terapia Antiplaquetaria Doble , Inhibidores del Factor Xa/administración & dosificación , Fibrinolíticos/administración & dosificación , Inhibidores de Agregación Plaquetaria/administración & dosificación , Rivaroxabán/administración & dosificación , Trombosis/prevención & control , Anciano , Anciano de 80 o más Años , Antitrombina III , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Biomarcadores/sangre , Coagulación Sanguínea/efectos de los fármacos , Cateterismo Cardíaco/efectos adversos , Terapia Antiplaquetaria Doble/efectos adversos , Inhibidores del Factor Xa/efectos adversos , Femenino , Productos de Degradación de Fibrina-Fibrinógeno/metabolismo , Fibrinolíticos/efectos adversos , Francia , Frecuencia Cardíaca , Humanos , Masculino , Fragmentos de Péptidos/sangre , Péptido Hidrolasas/sangre , Proyectos Piloto , Inhibidores de Agregación Plaquetaria/efectos adversos , Protrombina , Rivaroxabán/efectos adversos , Trombosis/sangre , Trombosis/diagnóstico , Trombosis/etiología , Factores de Tiempo , Resultado del Tratamiento
4.
BMC Cancer ; 20(1): 485, 2020 May 29.
Artículo en Inglés | MEDLINE | ID: mdl-32471382

RESUMEN

BACKGROUND: Preoperative radiochemotherapy (RCT) is recommended in France prior to total mesorectal excision in patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N+) because it has been shown to improve local control. Preoperative RCT has also disadvantages including the absence of proven impact on metastatic recurrence and the risk of late side effects on bowel and genitourinary function. In patients with primarily resectable LARC, preoperative systemic chemotherapy without pelvic irradiation could be used as an alternative to RCT. METHODS: This study is a multicenter, open-label randomized, 2-arm phase III non-inferiority trial. Patients with mid or low resectable LARC (cT3N0 or cT1-T3N+ with circumferential resection margin [CRM] > 2 mm on pretreatment MRI) will be randomized to either modified FOLFIRINOX for 3 months or RCT (Cap50 intensified-modulated radiotherapy). All patients have restaging MRI after preoperative treatment. The primary endpoint is 3-year progression-free survival (PFS) from the time to randomization including progression during preoperative treatment. Secondary endpoints are treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response after preoperative treatment. The number of patients required is 574. DISCUSSION: The choice of modified FOLFIRINOX for preoperative chemotherapy is supported by recent and consistent data on safety and efficacy of this regimen on rectal cancer. The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors. However and first of all, the non-inferiority of preoperative chemotherapy compared to RCT on oncologic outcome has to be validated. If this study demonstrates the non-inferiority of chemotherapy compared to RCT, this can lead to a crucial change in clinical practice in a large subset of rectal cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03875781 (March 15, 2019). Version 1.1.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Terapia Neoadyuvante/efectos adversos , Recurrencia Local de Neoplasia/epidemiología , Complicaciones Posoperatorias/epidemiología , Neoplasias del Recto/terapia , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Quimioradioterapia Adyuvante/efectos adversos , Quimioradioterapia Adyuvante/métodos , Quimioradioterapia Adyuvante/estadística & datos numéricos , Quimioterapia Adyuvante/efectos adversos , Quimioterapia Adyuvante/métodos , Quimioterapia Adyuvante/estadística & datos numéricos , Ensayos Clínicos Fase III como Asunto , Supervivencia sin Enfermedad , Esquema de Medicación , Estudios de Equivalencia como Asunto , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/efectos adversos , Estudios de Seguimiento , Humanos , Irinotecán/administración & dosificación , Irinotecán/efectos adversos , Leucovorina/administración & dosificación , Leucovorina/efectos adversos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Terapia Neoadyuvante/métodos , Terapia Neoadyuvante/estadística & datos numéricos , Recurrencia Local de Neoplasia/prevención & control , Estadificación de Neoplasias , Oxaliplatino/administración & dosificación , Oxaliplatino/efectos adversos , Cooperación del Paciente/estadística & datos numéricos , Complicaciones Posoperatorias/etiología , Periodo Preoperatorio , Proctectomía/efectos adversos , Supervivencia sin Progresión , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias del Recto/mortalidad , Neoplasias del Recto/patología , Recto/efectos de los fármacos , Recto/patología , Recto/efectos de la radiación , Recto/cirugía
5.
Trials ; 17(1): 225, 2016 Apr 30.
Artículo en Inglés | MEDLINE | ID: mdl-27140403

RESUMEN

BACKGROUND: Despite the availability of guidelines for the specific treatment of hereditary angioedema (HAE) attacks, HAE morbidity and mortality rates remain substantial. HAE attacks are a major medical issue requiring specific treatment as well as a considerable socio-economic burden. We report a protocol designed to test whether a dedicated call centre is more effective than usual practice in the management of patients experiencing an HAE attack. METHODS/DESIGN: This prospective, cluster-randomised, single-blind, parallel-group, multicentre trial evaluates the morbidity and consequent socio-economic costs of the management of patients experiencing an HAE attack by a dedicated call centre as compared to usual practice. The trial aims to recruit 200 patients. Patients in the intervention arm are provided with an SOS-HAE card with the call centre's freephone number that they can access in the case of an attack. The centre's mission is to provide recommended expert advice on early home treatment. The centre can route the call to a local emergency medical service with competency in HAE management or even arrange for the drugs needed for the specific treatment of an HAE attack to be sent to the emergency department of the local hospital. The primary outcome measure is the number of hospital admissions for an HAE attack. Each patient will be followed up every 2 months for 2 years. The study has been approved by the ethics committee (Comité de Protection des Personnes d'Ile de France 10; registration number: 2012-A00044-39; date of approval: 19 January 2012). DISCUSSION: The SOS-HAE protocol has been designed to address the handling of attacks experienced by patients with HAE in the home. The proposed trial will determine whether the setting up of a dedicated call centre is more effective than usual practice in terms of reducing morbidity as given by the numbers of hospital admissions. The results are also anticipated to have important implications in terms of socio-economic costs for both healthcare services and patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT01679912 .


Asunto(s)
Angioedemas Hereditarios/terapia , Centrales de Llamados , Prestación Integrada de Atención de Salud , Accesibilidad a los Servicios de Salud , Angioedemas Hereditarios/diagnóstico , Angioedemas Hereditarios/economía , Centrales de Llamados/economía , Costo de Enfermedad , Prestación Integrada de Atención de Salud/economía , Servicios Médicos de Urgencia , Francia , Costos de la Atención en Salud , Gastos en Salud , Accesibilidad a los Servicios de Salud/economía , Servicios de Atención de Salud a Domicilio , Humanos , Admisión del Paciente , Estudios Prospectivos , Calidad de Vida , Proyectos de Investigación , Método Simple Ciego , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento
6.
Radiology ; 280(3): 837-47, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27077380

RESUMEN

Purpose To evaluate the performance of three imaging methods (radiography, dual-energy x-ray absorptiometry [DXA], and quantitative computed tomography [CT]) and that of a numerical analysis with finite element modeling (FEM) in the prediction of failure load of the proximal femur and to identify the best densitometric or geometric predictors of hip failure load. Materials and Methods Institutional review board approval was obtained. A total of 40 pairs of excised cadaver femurs (mean patient age at time of death, 82 years ± 12 [standard deviation]) were examined with (a) radiography to measure geometric parameters (lengths, angles, and cortical thicknesses), (b) DXA (reference standard) to determine areal bone mineral densities (BMDs), and (c) quantitative CT with dedicated three-dimensional analysis software to determine volumetric BMDs and geometric parameters (neck axis length, cortical thicknesses, volumes, and moments of inertia), and (d) quantitative CT-based FEM to calculate a numerical value of failure load. The 80 femurs were fractured via mechanical testing, with random assignment of one femur from each pair to the single-limb stance configuration (hereafter, stance configuration) and assignment of the paired femur to the sideways fall configuration (hereafter, side configuration). Descriptive statistics, univariate correlations, and stepwise regression models were obtained for each imaging method and for FEM to enable us to predict failure load in both configurations. Results Statistics reported are for stance and side configurations, respectively. For radiography, the strongest correlation with mechanical failure load was obtained by using a geometric parameter combined with a cortical thickness (r(2) = 0.66, P < .001; r(2) = 0.65, P < .001). For DXA, the strongest correlation with mechanical failure load was obtained by using total BMD (r(2) = 0.73, P < .001) and trochanteric BMD (r(2) = 0.80, P < .001). For quantitative CT, in both configurations, the best model combined volumetric BMD and a moment of inertia (r(2) = 0.78, P < .001; r(2) = 0.85, P < .001). FEM explained 87% (P < .001) and 83% (P < .001) of bone strength, respectively. By combining (a) radiography and DXA and (b) quantitative CT and DXA, correlations with mechanical failure load increased to 0.82 (P < .001) and 0.84 (P < .001), respectively, for radiography and DXA and to 0.80 (P < .001) and 0.86 (P < .001) , respectively, for quantitative CT and DXA. Conclusion Quantitative CT-based FEM was the best method with which to predict the experimental failure load; however, combining quantitative CT and DXA yielded a performance as good as that attained with FEM. The quantitative CT DXA combination may be easier to use in fracture prediction, provided standardized software is developed. These findings also highlight the major influence on femoral failure load, particularly in the trochanteric region, of a densitometric parameter combined with a geometric parameter. (©) RSNA, 2016 Online supplemental material is available for this article.


Asunto(s)
Fracturas del Fémur/diagnóstico por imagen , Fracturas de Cadera/diagnóstico por imagen , Absorciometría de Fotón , Anciano , Anciano de 80 o más Años , Densidad Ósea , Cadáver , Femenino , Análisis de Elementos Finitos , Humanos , Imagenología Tridimensional , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Interpretación de Imagen Radiográfica Asistida por Computador , Estrés Mecánico , Tomografía Computarizada por Rayos X/métodos
7.
Arch Cardiovasc Dis ; 109(3): 171-7, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26711545

RESUMEN

BACKGROUND: Trans-oesophageal echocardiography (TOE) is one of the major diagnostic tests in cardiovascular medicine, but the procedure is associated with some discomfort for the patient. AIM: To determine the additive value of hypnosis as a means of improving patient comfort during TOE. METHODS: We randomly assigned 98 patients with non-emergency indications for TOE to a 30-minute hypnosis session combined with topical oropharyngeal anaesthesia (HYP group) or topical oropharyngeal anaesthesia only (CTRL group) before the procedure. The primary efficacy endpoint was the level of patient discomfort assessed using a visual analogue scale (VAS). RESULTS: The VAS score was significantly reduced in the HYP group compared with the CTRL group (6 [5; 8] vs. 7 [5; 9]; P=0.046). No statistically significant differences were observed in terms of procedure failure (HYP group 2.2% vs. CTRL group 3.9%; P=1.00) and procedure length (HYP group 7 [5; 11] minutes vs. CTRL group 8 [7; 11] minutes; P=0.29). However, the patients' subjective estimations of the length of the procedure were significantly shorter in the HYP group than in the CTRL group (8 [5; 10] vs. 10 [10; 20] minutes; P<0.0001). There were no major adverse events in either group. The reported minor events rate was lower in the HYP group (36% vs. 57%; P=0.04). CONCLUSION: Hypnosis is an efficient alternative or complementary method for improving patient comfort during TOE.


Asunto(s)
Ecocardiografía Transesofágica/efectos adversos , Hipnosis , Dolor/prevención & control , Satisfacción del Paciente , Adulto , Anciano , Anestesia Local , Terapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor/diagnóstico , Dolor/etiología , Dimensión del Dolor , Paris , Valor Predictivo de las Pruebas , Método Simple Ciego , Factores de Tiempo
8.
BJU Int ; 117(3): 495-9, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25781490

RESUMEN

OBJECTIVES: To describe the step-by-step learning curve of the holmium laser enucleation of the prostate (HoLEP) surgical technique. SUBJECTS/PATIENTS AND METHODS: A prospective, multicentre observational study was conducted, involving surgeons experienced in transurethral resection of the prostate and open prostatectomy but never having performed HoLEP. The main judgment criterion was the ability of the surgeon to perform four consecutive successful procedures, defined by the following: complete enucleation and morcellation within <90 min, without any conversion to standard transurethral resection of the prostate (TURP), with acceptable stress, and with acceptable difficulty (evaluated by Likert scales). Each surgeon included 20 consecutive cases. RESULTS: Of nine centres, three abandoned HoLEP before the end of the study due to complications, and one was excluded for treating patients off protocol. Only one centre achieved the main judgment criterion of four consecutive successful HoLEP procedures. Overall, the procedures were successfully performed in 43.6% of cases. Reasons for unsuccessful procedures were mainly operative time >90 min (n = 51), followed by conversion to TURP (n = 14), incomplete morcellation (n = 8), significant stress (n = 9), or difficulty (n = 14) during HoLEP. Ignoring operating time, 64% of procedures were successful and four out of five centres did four consecutive successful cases. Of the five centres that completed the study, four chose to continue HoLEP. CONCLUSION: Even in a prospective training structure, HoLEP has a steep learning curve exceeding 20 cases, with almost half of our centres choosing to abandon or not to continue with the technique. Operating time and difficulty of the enucleation seem the most important problems for a beginner. A more intensely mentored and structured mentorship programme might allow safer adoption of the procedure.


Asunto(s)
Educación Médica Continua , Terapia por Láser , Curva de Aprendizaje , Enfermedades de la Próstata/cirugía , Adulto , Anciano , Humanos , Láseres de Estado Sólido , Masculino , Persona de Mediana Edad , Tempo Operativo , Estudios Prospectivos , Resección Transuretral de la Próstata/educación
9.
Therapie ; 70(1): 57-68, 2015.
Artículo en Inglés, Francés | MEDLINE | ID: mdl-25747839

RESUMEN

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.


Asunto(s)
Equipos y Suministros/normas , Evaluación de la Tecnología Biomédica/normas , Biomarcadores , Análisis Costo-Beneficio , Vías Clínicas , Árboles de Decisión , Equipos y Suministros/efectos adversos , Equipos y Suministros/economía , Francia , Humanos , Reembolso de Seguro de Salud , Invenciones , Legislación de Dispositivos Médicos , Programas Nacionales de Salud , Evaluación de la Tecnología Biomédica/organización & administración
10.
Int J Rehabil Res ; 38(1): 81-3, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25185788

RESUMEN

The aim of this study was to assess the efficacy of dynamic humeral centering (DHC) according to Neer test results. The study was a stratified analysis of a previously reported randomized trial. The patients included had shoulder pain with impingement syndrome. Interventions were DHC or nonspecific mobilization for control. The primary outcome was the Constant score including subscores for pain, activity, mobility, and strength at 3 months. All patients improved at follow-up, with better results after DHC. There was no interaction between Neer test results, treatments, and time. However, a trend toward higher effect sizes was observed after DHC in patients with a positive Neer test in comparison with negative patients. Patients with a positive Neer test showed improvement after DHC for rotator cuff disease compared with nonspecific mobilization.


Asunto(s)
Manipulaciones Musculoesqueléticas/métodos , Síndrome de Abducción Dolorosa del Hombro/rehabilitación , Anciano , Femenino , Humanos , Húmero/fisiopatología , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Síndrome de Abducción Dolorosa del Hombro/complicaciones , Síndrome de Abducción Dolorosa del Hombro/fisiopatología , Dolor de Hombro/etiología , Resultado del Tratamiento
11.
Eur Urol ; 64(3): 493-501, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23465519

RESUMEN

BACKGROUND: Male lower urinary tract symptoms (LUTS) are one of the most treated diseases, but little is known about patient trajectories in current clinical practice. OBJECTIVE: To describe the dynamic treatment patterns of LUTS presumably due to benign prostatic obstruction (BPO). DESIGN, SETTINGS, AND PARTICIPANTS: All prescriptions of α1-adrenergic receptor blocking agents (α1-blockers), 5α-reductase inhibitors (5-ARIs), and phytotherapy, and all surgeries related to BPO performed in France from 2004 to 2008 were identified using two distinct administrative claim databases maintained by the National Health Insurance system that covers the entire population. After linking the two data sets, all consecutive treatment events were analyzed for each patient. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Drug prescription details were assessed for each year, region, and prescriber qualification. Medical treatment initiation, interruption, evolution, and events after surgical management (hospital stay, reoperation, complication rates, and subsequent medical prescriptions) were also investigated. RESULTS AND LIMITATIONS: Overall, 2 620 269 patients were treated within 5 yr, with important geographic variations. Medical treatment was interrupted for approximately 16% of patients. The α1-blockers were prescribed most frequently, but phytotherapy surprisingly accounted for 27% of all monotherapies and 54% of all combination therapies. General practitioners and urologists (92% and 3.7% of overall prescribers, respectively) exhibited a similar prescription profile. Treatment initiation was medical in 95.4% of cases, consisting primarily of monotherapy using α1-blockers (60.3%), phytotherapy (31.8%), or 5-ARIs (7.9%). Treatment was modified at extremely high rates within 12 mo of initiation (8.7%, 14.6%, and 12.9%, respectively). The median hospital stay for surgical management was far higher than in clinical trials. Long-term surgical complications and reoperation rates favored open prostatectomy. Incidence of pharmacologic treatment after surgery was as high as 13.8% at 12 mo. CONCLUSIONS: This unique dynamic evaluation of clinical practice revealed unexpected results that contrast with previously published evidence from clinical trials. This approach may merit monitored and targeted measures to improve the level of care in the field.


Asunto(s)
Inhibidores de 5-alfa-Reductasa/uso terapéutico , Antagonistas de Receptores Adrenérgicos alfa 1/uso terapéutico , Síntomas del Sistema Urinario Inferior/terapia , Preparaciones de Plantas/uso terapéutico , Pautas de la Práctica en Medicina/tendencias , Hiperplasia Prostática/terapia , Agentes Urológicos/uso terapéutico , Inhibidores de 5-alfa-Reductasa/efectos adversos , Antagonistas de Receptores Adrenérgicos alfa 1/efectos adversos , Anciano , Anciano de 80 o más Años , Minería de Datos , Bases de Datos Factuales , Prescripciones de Medicamentos , Revisión de la Utilización de Medicamentos/tendencias , Francia/epidemiología , Medicina General/tendencias , Hospitalización/tendencias , Humanos , Estimación de Kaplan-Meier , Síntomas del Sistema Urinario Inferior/diagnóstico , Síntomas del Sistema Urinario Inferior/epidemiología , Masculino , Persona de Mediana Edad , Fitoterapia/tendencias , Preparaciones de Plantas/efectos adversos , Hiperplasia Prostática/diagnóstico , Hiperplasia Prostática/epidemiología , Factores de Tiempo , Resultado del Tratamiento , Procedimientos Quirúrgicos Urológicos Masculinos/tendencias , Agentes Urológicos/efectos adversos , Urología/tendencias
12.
J Integr Med ; 11(1): 26-31, 2013 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-23464643

RESUMEN

OBJECTIVE: This study investigated the acceptability and effectiveness of acupuncture for persistent musculoskeletal pain in the elderly and assessed the conditions for a future controlled trial. METHODS: A total of 60 patients, hospitalized in a geriatric hospital were enrolled. The intervention consisted of eight acupuncture sessions. The main outcome was the patient's participation rate. Regarding pain, the evaluation was based on pre- and post-treatment variations. As a high proportion of the patients had cognitive impairment, the behavioral pain scale DOLOPLUS-2 was chosen although self evaluation was used wherever possible. RESULTS: The mean age of the patients was 83 years. The acceptance rate was very high (89.6%) and 90% of the patients completed the entire course of treatment. After five weeks, the mean DOLOPLUS score had decreased significantly (P<0.01). The patients reported improved sleep quality and a reduction in their anxiety symptoms. Furthermore, caregivers noticed a decrease in patient aggressiveness making care easier. CONCLUSION: Our results suggest that acupuncture is highly acceptable and could be very useful in the management of chronic pain when performed in very old frail people with chronic physical and mental disability. TRIAL REGISTRATION IDENTIFIER: NCT01043692 ClinicalTrials.gov.


Asunto(s)
Terapia por Acupuntura , Dolor Crónico/terapia , Anciano , Anciano de 80 o más Años , Dolor Crónico/psicología , Femenino , Geriatría , Humanos , Masculino , Proyectos Piloto , Calidad de Vida
13.
Urol Int ; 89(4): 451-6, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-23108188

RESUMEN

OBJECTIVE: To assess the results of transurethral needle ablation (TUNA) (Prostiva®, Medtronic, France) performed in an ambulatory setting in men with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A multicenter open-label study was conducted. Short-term success was defined by ability to leave the hospital on the evening of the intervention, and absence of rehospitalization due to complications during the first postoperative month. Sexual and urinary functions were evaluated by validated questionnaires. RESULTS: The procedure was successful in 44/49 patients. Sexual and ejaculatory function was not affected or slightly improved in the majority of patients. Urinary parameters improved with a 32% decrease in the International Prostate Symptom Score. At 1 month postoperation, more than 80% of patients were satisfied, and 36/41 patients were prepared to undergo the procedure again if needed. Our study was limited by the short follow-up duration. CONCLUSIONS: TUNA can be successfully performed in an ambulatory setting under local and/or general anesthesia with a high level of patient satisfaction and a low short-term morbidity, especially on sexual function. Thus, the procedure is a suitable mini-invasive option for patients who cannot/do not want to take medical therapy or undergo invasive surgical procedures, or want to preserve their sexual function.


Asunto(s)
Procedimientos Quirúrgicos Ambulatorios , Síntomas del Sistema Urinario Inferior/cirugía , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/métodos , Anciano , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Hiperplasia Prostática/complicaciones , Factores de Tiempo
14.
Eur Urol ; 61(6): 1165-73, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22341632

RESUMEN

BACKGROUND: Evidence supporting the widespread use of GreenLight High Performance System (HPS) 120-W photoselective vaporization of the prostate (PVP) is lacking. OBJECTIVE: To assess the noninferiority of PVP compared with transurethral resection of the prostate (TURP) on urinary symptoms and the superiority of PVP over TURP on length of hospital stay. DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized controlled trial was conducted. INTERVENTION: Patients underwent monopolar TURP or PVP with the GreenLight HPS 120-W laser. MEASUREMENTS: International Prostate Symptom Score (IPSS), Euro-QOL questionnaire, uroflowmetry, Danish Prostate Symptom Score Sexual Function Questionnaire, sexual satisfaction, and adverse events were collected at 1, 3, 6, and 12 mo. The two groups were compared using the 95% confidence interval (CI) of median difference for testing noninferiority of the IPSS at 12 mo and the student t test for testing the difference in length of hospital stay. RESULTS AND LIMITATIONS: A total of 139 patients (70 vs 69 men in each group) were randomized. Median IPSS scores at 12-mo follow-up were 5 (interquartile range [IQR]: 3-8) for TURP versus 6 (IQR: 3-9) for PVP, and the 95% CI of the difference of the median was equal to -2 to 3. Because the upper limit of the 95% CI was >2 (the noninferiority margin), the hypothesis of noninferiority could not be considered demonstrated. Median length of stay was significantly shorter in the PVP group than in the TURP group, with a median of 1 (IQR: 1-2) versus 2.5 (IQR: 2-3.5), respectively (p<0.0001). Uroflowmetry parameters and complications were comparable in both groups. Sexual outcomes were slightly better in the PVP group without reaching statistical significance. CONCLUSIONS: The present study failed to demonstrate the noninferiority of 120-W GreenLight PVP versus TURP on prostate symptoms at 1 yr but showed that PVP was associated with a shorter length of stay in the hospital. TRIAL REGISTRATION: NCT01043588.


Asunto(s)
Terapia por Láser/instrumentación , Rayos Láser , Síntomas del Sistema Urinario Inferior/cirugía , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata , Anciano , Anciano de 80 o más Años , Distribución de Chi-Cuadrado , Diseño de Equipo , Francia , Humanos , Terapia por Láser/efectos adversos , Tiempo de Internación , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/patología , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/patología , Disfunciones Sexuales Fisiológicas/diagnóstico , Disfunciones Sexuales Fisiológicas/etiología , Encuestas y Cuestionarios , Factores de Tiempo , Resección Transuretral de la Próstata/efectos adversos , Resultado del Tratamiento , Trastornos Urinarios/diagnóstico , Trastornos Urinarios/etiología , Urodinámica
15.
BMC Musculoskelet Disord ; 12: 224, 2011 Oct 07.
Artículo en Inglés | MEDLINE | ID: mdl-21981821

RESUMEN

BACKGROUND: Fibromyalgia is a common disease, but little is known on its real prevalence in France. This epidemiological study aimed to assess fibromyalgia (FM) prevalence in the French metropolitan population, based on a multi-step sampling analysis, combining national screening and clinical confirmation by trained specialists. METHODS: a sampling method on the entire national territory was used: patients over 18 years of age accepting to take part in the study were contacted by telephone using the LFES Questionnaire, a screening test for FM. The, for patients detected by the LFESQ, a visit with a FM-trained rheumatologist was proposed to confirm FM, based on 1990 ACR criteria. Each detected patient completed the following self-questionnaires: SF36, HADS, stress VAS, Co-morbidities and Regional pain score. RESULTS: 3081 patients were contacted in 5 representative French regions, of which 232 patients were screened for FM. A fibromyalgia diagnosis was then confirmed by rheumatologist in 20 cases (17 female and 3 male, 56.9 ± 13.2 years). The final estimated FM prevalence was 1.6 (CI95: 1.2%; 2.0%). No significant difference was detected between the patients accepting (CS+) and refusing (CS-) rheumatologist visit for the SF36 score, regional pain score, stress VAS scale and co-morbidities. In patients detected for FM by the LFESQ, we found a statistically significant decrease in quality of life and a statistically significant increase in stress level in patients with a confirmed diagnosis (FM+) (6.3 ± 1.9) compared to patients with an invalidated diagnosis (FM-) (4.4 ± 2.8; p = 0.007). The study also demonstrated a significant association, independently of ACR criteria, between the diagnosis of FM and several factors such as regional pain score > 10, elevated stress level, low SF36 scale score and presence of gastro-intestinal disorder co-morbidities. CONCLUSION: Fibromyalgia is a common condition; the 1.6% prevalence calculated in the French population in our study corroborates the figures published in the European literature. Our results also suggest that criteria such as regional pain score, stress level or SF36 quality of life, could represent useful tools in fibromyalgia diagnosis.


Asunto(s)
Fibromialgia/diagnóstico , Fibromialgia/epidemiología , Tamizaje Masivo , Vigilancia de la Población , Adulto , Dolor de Espalda/epidemiología , Dolor de Espalda/fisiopatología , Femenino , Fibromialgia/fisiopatología , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Música , Programas Nacionales de Salud , Dolor de Cuello/epidemiología , Dolor de Cuello/fisiopatología , Dimensión del Dolor , Prevalencia , Calidad de Vida , Estrés Psicológico , Encuestas y Cuestionarios , Extremidad Superior/fisiopatología
16.
J Bone Joint Surg Am ; 93(20): 1897-905, 2011 Oct 19.
Artículo en Inglés | MEDLINE | ID: mdl-22012527

RESUMEN

BACKGROUND: Despite the importance of the hip muscles in protecting against hip fracture and in the outcome of hip arthroplasty, the variability in their fat content has not been previously studied. Our objectives were to evaluate the variability in the fat content of the hip muscles in a population without myopathy or a need for hip surgery with the use of computed tomography (CT), to study the relationship between hip muscle fat content and physical performance, and to identify medical conditions and lifestyle habits associated with an increase in hip muscle fat content. METHODS: Ten normal subjects without a relevant medical history and ninety-nine consecutive nonsurgical patients without myopathy (age, twenty-one to ninety-four years) underwent a nonenhanced CT scan of the pelvis. Patients were asked to perform physical tests (six-meter walk, repeated chair stands, and Trendelenburg test), and their level of physical activity and medical history were recorded. Evaluation of the fat content of the hip muscles was based on the analysis of four reproducible and representative CT slices with use of custom software. RESULTS: The fat content varied among the muscles, with an anteroposterior gradient from the hip flexors (mean, 2%) to the hip extensors (mean, 10%). This gradient increased after fifty years of age. Fat content also varied considerably among patients. Higher fat content was associated with poorer performance on physical tests, even after adjustment for the cross-sectional area of the muscle (p < 0.05). Higher fat content was also associated with greater age, higher body-mass index, and lower physical activity (p < 0.001). CONCLUSIONS: The observed variability in the fat content of individuals without myopathy or a need for hip surgery should be useful for comparison with future studies of specific populations of patients, such as those with muscle weakness secondary to hip fracture or hip surgery. Simple lifestyle changes such as dietary restriction, increased physical activity, and vitamin D supplementation may decrease muscle fat content and improve physical performance in the elderly.


Asunto(s)
Tejido Adiposo/diagnóstico por imagen , Composición Corporal/fisiología , Índice de Masa Corporal , Cadera/diagnóstico por imagen , Músculo Esquelético/fisiología , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Músculo Esquelético/diagnóstico por imagen , Músculos Psoas/diagnóstico por imagen , Músculos Psoas/fisiología , Valores de Referencia , Reproducibilidad de los Resultados , Tomografía Computarizada por Rayos X/métodos , Adulto Joven
17.
Ann Rheum Dis ; 70(9): 1613-8, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21623001

RESUMEN

OBJECTIVES: Treatment for degenerative rotator cuff disease of the shoulder includes physiotherapy. Dynamic humeral centering (DHC) aims at preventing subacromial impingement, which contributes to the disease. The goal of this study was to assess the effectiveness of DHC. METHOD: 69 patients with shoulder pain and impingement syndrome were prospectively included in a single-centre randomised trial with a 12-month follow-up. Patients and assessor were blinded to the study hypothesis and treatment, respectively. DHC and non-specific mobilisation as control were performed for 6 weeks, in 15 supervised individual outpatient sessions, and patients performed daily home exercises. The planned primary outcome was the Constant score including subscores for pain, activity, mobility and strength at 3 months. Secondary outcomes were the Constant score and subscores at 12 months, and medication use for pain at 3 and 12 months. RESULTS: The DHC group did not differ from the control group in the total Constant score at 3 months. However, the DHC group showed a higher Constant subscore for pain (12.2 (SD 2.8) vs 9.9 (2.9), least square means difference 2.1, 95% CI 0.7 to 3.5, p=0.004). At 3 months, the DHC group also showed a higher rate of no medication use (96.7% vs 71%, proportional difference 25.7, 95% CI 3.7 to 51.9, p=0.012). There was no other intergroup difference. CONCLUSIONS: There was no difference in the total Constant score between DHC and controls. However, pain was improved at 3 months after DHC. The differences found in subscores for pain should be explored in future studies. Trial registration clinicaltrials.gov Identifier: NCT 01022775.


Asunto(s)
Húmero/fisiopatología , Manipulaciones Musculoesqueléticas/métodos , Síndrome de Abducción Dolorosa del Hombro/rehabilitación , Dolor de Hombro/rehabilitación , Adulto , Anciano , Métodos Epidemiológicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Síndrome de Abducción Dolorosa del Hombro/complicaciones , Dolor de Hombro/etiología , Resultado del Tratamiento
18.
Epilepsia ; 51(12): 2412-22, 2010 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-21121909

RESUMEN

PURPOSE: Recently we reported that intrathalamic microinjection of carbachol triggers generalized convulsive seizures (GCS) followed by severe inflammatory response including edema, microhemorrhages, and subsequent degeneration of amygdaloallocortical area. Our further observations of increased expression of tumor necrosis factor alpha (TNF-α) and interleukin (IL)-1ß immunoreactivity (IR) confirmed the inflammatory nature of the brain damage following GCS. In the presented experiments, we addressed possible effects of a nonspecific cyclooxygenase (COX) inhibitor (ibuprofen), in the development of inflammatory response following thalamic-induced GCS. METHODS: In male Wistar rats, intrathalamic microinjection of carbachol (55 nm, 100 nl) within 2 h induced three to four episodes of GCS of an average duration of 57 s, each which led to the development of edema associated with microhemorrhages at 72 h and changes in expression of TNF-α/IL-1ß IR in the amygdaloallocortical area as revealed by immunohistochemistry at 24 h. RESULTS: Ibuprofen when administered intraperitoneally 30 min after the episode of GCS dramatically increased edema and microhemorrhages. It also increased expression of TNF-α/IL-1ß in microvessels and decreased IL-1ß IR in microglia/macrophages. CONCLUSIONS: Experiments suggest that in our model, inhibition of COX pathway early after GCS may increase rather than reduce the inflammatory consequences of GCS, suggesting that COX products may have a negative feedback effect on the development of edema by modifying the expression of "proinflammatory" cytokines. There is also a possibility that ibuprofen may exert its action through other than COX-associated pathways.


Asunto(s)
Inhibidores de la Ciclooxigenasa/efectos adversos , Inhibidores de la Ciclooxigenasa/farmacología , Ibuprofeno/efectos adversos , Ibuprofeno/farmacología , Inflamación/patología , Microvasos/patología , Convulsiones/inducido químicamente , Convulsiones/patología , Tálamo/efectos de los fármacos , Animales , Encéfalo/irrigación sanguínea , Encéfalo/efectos de los fármacos , Encéfalo/patología , Edema Encefálico/inducido químicamente , Edema Encefálico/patología , Carbacol/farmacología , Modelos Animales de Enfermedad , Inmunohistoquímica , Inflamación/inducido químicamente , Interleucina-1/metabolismo , Masculino , Microinyecciones , Microvasos/efectos de los fármacos , Ratas , Ratas Wistar , Convulsiones/metabolismo , Tálamo/patología , Factor de Necrosis Tumoral alfa/metabolismo
19.
Ann Surg ; 252(5): 863-8, 2010 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-21037443

RESUMEN

OBJECTIVE: To assess with a single-blinded, multicenter, randomized trial, the postoperative results in patients undergoing sphincter-saving rectal resection for cancer without preoperative mechanical bowel preparation (MBP). BACKGROUND: The collective evidence from literature strongly suggests that MBP, before elective colonic surgery, is of no benefit in terms of postoperative morbidity. Very few data and no randomized study are available for rectal surgery and preliminary results conclude toward the safety of rectal resection without MBP. METHODS: From October 2007 to January 2009, patients scheduled for elective rectal cancer sphincter-saving resection were randomized to receive preoperative MBP (ie, retrograde enema and oral laxatives) or not. Primary endpoint was the overall 30-day morbidity rate. Secondary endpoints included mortality rate, anastomotic leakage rate, major morbidity rate (Dindo III or more), degree of discomfort for the patient, and hospital stay. RESULTS: A total of 178 patients (103 men), including 89 in both groups (no-MBP and MBP groups), were included in the study. The overall and infectious morbidity rates were significantly higher in no-MBP versus MBP group, 44% versus 27%, P = 0.018, and 34% versus 16%, P = 0.005, respectively. Regarding both anastomotic leakage and major morbidity rates, there was no significant difference between no-MBP and MBP group: 19% versus 10% (P = 0.09) and 18% versus 11% (P = 0.69), respectively. Moderate or severe discomfort was reported by 40% of prepared patients. Mortality rate (1.1% vs 3.4%) and mean hospital stay (16 vs 14 days) did not differ significantly between both groups. CONCLUSIONS: This first randomized trial demonstrated that rectal cancer surgery without MBP was associated with higher risk of overall and infectious morbidity rates without any significant increase of anastomotic leakage rate. Thus, it suggests continuing to perform MBP before elective rectal resection for cancer.


Asunto(s)
Neoplasias del Recto/cirugía , Anciano , Distribución de Chi-Cuadrado , Enema , Femenino , Francia/epidemiología , Mortalidad Hospitalaria , Humanos , Laxativos/administración & dosificación , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Neoplasias del Recto/mortalidad , Método Simple Ciego , Infección de la Herida Quirúrgica/epidemiología , Resultado del Tratamiento
20.
Stroke ; 40(5): 1721-8, 2009 May.
Artículo en Inglés | MEDLINE | ID: mdl-19286582

RESUMEN

BACKGROUND AND PURPOSE: Uncontrolled studies have shown that statins can improve cerebral vasoreactivity (CVR) in patients with mild small vessel disease. We sought to determine whether high-dose atorvastatin increases CVR compared with placebo in patients with severe small vessel disease. METHODS: Ninety-four adults with recent lacunar stroke were randomly allocated in a double-blind manner to 80 mg of atorvastatin daily or matching placebo after stratification for hypertensive and diabetic status. The primary end point was change in CVR after 3 months of treatment. Secondary outcomes were changes in brachial and carotid artery endothelial-dependent vasodilations. RESULTS: At baseline, all patients had a severely impaired CVR (mean, 12.1%; 95% CI, 9.5-14.7) and carotid (mean, -0.25%; 95% CI, -1.17-0.67) and brachial artery (mean, 2.72%; 95% CI, 1.39-4.05) endothelial function. Despite reductions of 55% in low-density lipoprotein cholesterol and of 30% in high-sensitivity C-reactive protein in the active arm compared to placebo, atorvastatin 80 mg per day did not improve CVR or endothelial dysfunction of carotid and brachial arteries. CONCLUSIONS: We found no positive effect of 3-month treatment with atorvastatin on severe cerebral microvasculature endothelial dysfunction in patients with lacunar stroke.


Asunto(s)
Trastornos Cerebrovasculares/tratamiento farmacológico , Ácidos Heptanoicos/uso terapéutico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Pirroles/uso terapéutico , Accidente Cerebrovascular/tratamiento farmacológico , Anciano , Atorvastatina , Presión Sanguínea/efectos de los fármacos , Arteria Braquial/fisiología , Proteína C-Reactiva/metabolismo , Arterias Carótidas/efectos de los fármacos , Arterias Carótidas/fisiología , Circulación Cerebrovascular/fisiología , Trastornos Cerebrovasculares/patología , Bases de Datos Factuales , Método Doble Ciego , Endotelio Vascular/efectos de los fármacos , Endotelio Vascular/fisiología , Femenino , Ácidos Heptanoicos/administración & dosificación , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Lípidos/sangre , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Pirroles/administración & dosificación , Factores de Riesgo , Accidente Cerebrovascular/patología , Resultado del Tratamiento , Vasodilatación/fisiología
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