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Hennequin C.,Ap Hp Et University Of Paris Vii | Bossard N.,University of Lyon | Bossard N.,French National Center for Scientific Research | Servagi-Vernat S.,Center Hospitalier University Of Besancon | And 13 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2013

Purpose: To evaluate the efficacy of irradiation of internal mammary nodes (IMN) on 10-year overall survival in breast cancer patients after mastectomy. Methods and Patients: This multicenter phase 3 study enrolled patients with positive axillary nodes (pN+) or central/medial tumors with or without pN+. Other inclusion criteria were age <75 and a Karnofsky index ≥70. All patients received postoperative irradiation of the chest wall and supraclavicular nodes and were randomly assigned to receive IMN irradiation or not. Randomization was stratified by tumor location (medial/central or lateral), axillary lymph node status, and adjuvant therapy (chemotherapy vs no chemotherapy). The prescribed dose of irradiation to the target volumes was 50 Gy or equivalent. The first 5 intercostal spaces were included in the IMN target volume, and two-thirds of the dose (31.5 Gy) was given by electrons. The primary outcome was overall survival at 10 years. Disease-free survival and toxicity were secondary outcomes. Results: T total of 1334 patients were analyzed after a median follow-up of 11.3 years among the survivors. No benefit of IMN irradiation on the overall survival could be demonstrated: the 10-year overall survival was 59.3% in the IMN-nonirradiated group versus 62.6% in the IMN-irradiated group (P=.8). According to stratification factors, we defined 6 subgroups (medial/central or lateral tumor, pN0 [only for medial/central] or pN+, and chemotherapy or not). In all these subgroups, IMN irradiation did not significantly improve overall survival. Conclusions: In patients treated with 2-dimensional techniques, we failed to demonstrate a survival benefit for IMN irradiation. This study cannot rule out a moderate benefit, especially with more modern, conformal techniques applied to a higher risk population. © 2013 Elsevier Inc.

Frat J.-P.,University of Poitiers | Thille A.W.,University of Poitiers | Mercat A.,Center Hospitalier Regional dOrleans | Girault C.,University of Rouen | And 30 more authors.
New England Journal of Medicine | Year: 2015

BACKGROUND: Whether noninvasive ventilation should be administered in patients with acute hypoxemic respiratory failure is debated. Therapy with high-flow oxygen through a nasal cannula may offer an alternative in patients with hypoxemia. METHODS: We performed a multicenter, open-label trial in which we randomly assigned patients without hypercapnia who had acute hypoxemic respiratory failure and a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of 300 mm Hg or less to high-flow oxygen therapy, standard oxygen therapy delivered through a face mask, or noninvasive positive-pressure ventilation. The primary outcome was the proportion of patients intubated at day 28; secondary outcomes included all-cause mortality in the intensive care unit and at 90 days and the number of ventilator-free days at day 28. RESULTS: A total of 310 patients were included in the analyses. The intubation rate (primary outcome) was 38% (40 of 106 patients) in the high-flow-oxygen group, 47% (44 of 94) in the standard group, and 50% (55 of 110) in the noninvasive-ventilation group (P = 0.18 for all comparisons). The number of ventilator-free days at day 28 was significantly higher in the high-flow-oxygen group (24±8 days, vs. 22±10 in the standard-oxygen group and 19±12 in the noninvasive-ventilation group; P = 0.02 for all comparisons). The hazard ratio for death at 90 days was 2.01 (95% confidence interval [CI], 1.01 to 3.99) with standard oxygen versus high-flow oxygen (P = 0.046) and 2.50 (95% CI, 1.31 to 4.78) with noninvasive ventilation versus high-flow oxygen (P = 0.006). CONCLUSIONS: In patients with nonhypercapnic acute hypoxemic respiratory failure, treatment with high-flow oxygen, standard oxygen, or noninvasive ventilation did not result in significantly different intubation rates. There was a significant difference in favor of high-flow oxygen in 90-day mortality. (Funded by the Programme Hospitalier de Recherche Clinique Interrégional 2010 of the French Ministry of Health; FLORALI ClinicalTrials.gov number, NCT01320384.) Copyright © 2015 Massachusetts Medical Society. All rights reserved.

Mac-Way F.,French Institute of Health and Medical Research | Mac-Way F.,Laval University | Azzouz L.,Center Hospitalier Of Roanne | Lafage-Proust M.-H.,French Institute of Health and Medical Research
Journal of Bone and Mineral Metabolism | Year: 2014

Vitamin D deficiency/insufficiency is significantly prevalent in chronic kidney disease. Data in the literature are however scarce about the effects of this deficiency on bone metabolism in hemodialysis (HD) patients. Moreover, it is still debated whether low vitamin D levels should be normalized in HD patients. In this paper, we report two cases showing the deleterious consequences of vitamin D deficiency in HD patients which is characterised by hypophosphatemia, hypocalcemia and osteomalacia (OM) leading to bone fractures. As vitamin D repletion is an easy way to treat OM, this report underlines the importance of monitoring and correction of vitamin D deficiency in this population. © 2013 The Japanese Society for Bone and Mineral Research and Springer.

PubMed | University of California at Irvine, University of Lyon, University Claude Bernard Lyon 1, Center Hospitalier Of Roanne and 2 more.
Type: | Journal: Critical care research and practice | Year: 2016

Pulse pressure variation can predict fluid responsiveness in strict applicability conditions. The purpose of this study was to describe the clinical applicability of pulse pressure variation during episodes of patient hemodynamic instability in the intensive care unit. We conducted a five-day, seven-center prospective study that included patients presenting with an unstable hemodynamic event. The six predefined inclusion criteria for pulse pressure variation applicability were as follows: mechanical ventilation, tidal volume >7mL/kg, sinus rhythm, no spontaneous breath, heart rate/respiratory rate ratio >3.6, absence of right ventricular dysfunction, or severe valvulopathy. Seventy-three patients presented at least one unstable hemodynamic event, with a total of 163 unstable hemodynamic events. The six predefined criteria for the applicability of pulse pressure variation were completely present in only 7% of these. This data indicates that PPV should only be used alongside a strong understanding of the relevant physiology and applicability criteria. Although these exclusion criteria appear to be profound, they likely represent an absolute contraindication of use for only a minority of critical care patients.

PubMed | Hospices Civils de Lyon, University Claude Bernard Lyon 1, Center Leon Berard, Groupement Hospitalier Est and 2 more.
Type: Journal Article | Journal: Journal of clinical pharmacy and therapeutics | Year: 2016

Trends in the care of glioblastoma in actual practice settings are poorly described. In a previous pharmacoepidemiologic study, we highlighted changes in the management of patients with glioblastoma (GBM) newly diagnosed between 2004 and 2008. Our aim was to complete and to extend the previous report with a study of a cohort of patients diagnosed in 2011 to emphasize the trends in the pharmacotherapy of GBM over the last decade.A single-centre study was undertaken of three historic cohorts of GBM patients newly diagnosed during years 2004, 2008 and 2011 (corresponding to groups 1, 2 and 3, respectively) but limited to patients eligible for radiotherapy after initial diagnosis. The type of medical management was described and compared, as well as overall survival and total cost from diagnosis to death or the last follow-up date. Cost analysis was performed from the French sickness fund perspective using tariffs from 2014.Two hundred and seventeen patients (49 in Group 1, 73 in Group 2, 95 in Group 3) were selected with similar baseline characteristics. Fluorescence-guided surgery using 5-ALA was increasingly used over the three periods. There was a strong trend towards broader use of temozolomide radiochemotherapy (39%, 73% and 83% of patients, respectively) as first-line treatment as well as bevacizumab regimen at recurrence (6%, 48% and 58% of patients, respectively). The increase in overall survival between Group 2 and Group 1 was confirmed for patients in Group 3 (175 months vs. 10 months in Group 1). The mean total cost per patient was 53368 in Group 1, 70 201 in Group 2 and 78355 in Group 3. Hospital care represented the largest expenditure (75%, 59% and 60% in groups 1, 2 and 3, respectively) followed by chemotherapy drug costs (11%, 30% and 29%, respectively).This is the first study to report on changes in the management of GBM in real-life practice. The ten-year study indicates an improvement in overall survival but also an increase in total cost of care. The data should be useful for informing the care of GBM patients in settings similar to ours.

PubMed | CHU de Saint Etienne, Center Hospitalier Of Roanne and MPR Societe
Type: | Journal: Annals of physical and rehabilitation medicine | Year: 2016

The replacement of a mechanical knee with prosthetic class I foot fitting by an electronic knee with prosthetic class II foot was proposed to a 54-years-old schizophrenic patient, active, with right femoral and left tibial traumatic amputation. This fitting evolution was assessed both quantitatively and qualitatively.Compared evaluation of electronic knee with prosthetic class II foot versus mechanical polycentric knee with prosthetic class I foot (fitting unchanged moreover) in: -functional abilities and quality of life using standardized scores (Functional Ambulation Classification, Houghton, Functional Independence Measurement, B.A-BA, MOS-SF36), satisfaction VAS, walking perimeter, stair climbing abilities, crutches use; -walking and balance analysis using GAITRITE system, stabilometric platform, Get up and Go test.Functional abilities: walking perimeter was increased by approximately 2km; walking outdoors was now performed with a single crutch; walking indoors without crutches was made possible on short perimeter, leaving both hands free for everyday or leisure tasks; walking downstairs was realized in a continuous sequence of steps. Quantified analysis of gait and balance: spatiotemporal parameters recorded on GAITRITE with 1 single crutch improved (speed, cadence, step length and support time), no improvement with 2 crutches. No improvement in static balance recorded on stabilometric platform. Get up and Go test improved (14.85 s vs. 19.77 s with mechanical knee). Standardized scores: improvement of Houghtons score (10/12 vs. 6/12), of FAC score (7/8 vs. 6/8), of B.A-BA (15/20 vs. 13.6/20). Slightly modified FIM score (123/126 vs. 120/126), yet there is an improvement of the SF36-MOS for physical scores (55.8/100 vs. 43.1/100) as well as mental scores (64.3/100 vs. 47.1/100). Global satisfaction improved (90/100mm vs. 32/100mm) using the VAS.This new fitting allowed an objective improvement of walk and quality of life. Compliance for the new femoral prosthesis is total although this schizophrenic patient was not spontaneously asking for prosthetic improvement initially. This is pleading for a systematic information of active patients, even non-demanding ones but regularly followed and evaluated, on fitting techniques evolution that might improve their daily lives.

We compared the results of two methods of measurement of HbA1c before replacing the current method on Integra 800® by the HPLC method on an apparatus recently put on the market, the G8®. The comparative study of the results for 119 patients was carried out. The reproducibility obtained with the G8® method is good with CV = 0 for the control Level 1 at 5.6%, CV = 0.6% for Level 2 at 10.5% and CV = 0.73% for the Bio-Rad control at 5.7%. The comparison of the results of HbA 1c gives the Passing - Bablock equation: Y (G8®) = X (Integra®) + 0.10 with r = 0,996. Systematic bias is of 0.092% and the ratio of the G8®/Integra® averages of 1.014 (7.43 %/7.34 %). Only 8 results out of the 119 are out of limits of more than 0.4% between the two methods. They are only 4 after bringing together the results by correlation. The two methods provide results with exactitude in conformity with the recommendations of the French governmental agency (Afssaps). The G8® method is slightly better regarding accuracy and precision.

Szymanowicz A.,Center Hospitalier Of Roanne
Immuno-Analyse et Biologie Specialisee | Year: 2011

Besides structural and physiological cortisol data, this paper points out the optimal conditions for immunoassay and interpretation of results. © 2011 Elsevier Masson SAS.

Szymanowicz A.,Center Hospitalier Of Roanne
Immuno-Analyse et Biologie Specialisee | Year: 2012

The C-peptide is a polypeptide of connection that is generated during the proteolytic cleavage of proinsulin in pancreatic beta cells. It is secreted in equimolar amounts with insulin. Unlike insulin, C-peptide is not metabolized by the liver but filtered by the kidneys and excreted in the urine. Because of its longer half-life (compared with insulin), the C-peptide value is better suited to control the secretion of β cells. The C-peptide plays an important role in the structural conformation of A and B chains of insulin and the formation of two disulfide bonds present in the proinsulin molecule that are conserved in the active insulin. The main indications of its assay are: evaluating the residual function of β cells in diabetic patients and in case of exogenous insulin substitution, the evaluation of secretory capacity of β cells in the early stage of diabetes mellitus, control of patients with symptoms of hypoglycemia. Less frequently, the assay may be useful in patients suffering from polycystic ovarian syndrome, the diagnosis of insulinoma, the diagnosis of factitious hypoglycemia, the evaluation of β-cell transplantation and monitoring of patients after pancreatectomy. The urinary assay facilitates the monitoring of gestational diabetes and the follow-up of patients with unstable glycemic status. Besides structural and physiological C-peptide data, this paper points out the optimal conditions for immunoassay and interpretation of results. © 2011 Elsevier Masson SAS.

The chest pain (CP) is a motive for frequent admissions in emergency departments requiring an optimal medical care of the patient according to the recommendations of the good professional practices. The objective looked for by the medical teams is to reduce the number of the useless admissions and to improve the quality of the care. It is imperative all the more quickly and exactly in the suspicions of acute coronary syndromes (ACS) received at the emergency departments. We evaluated the practices for this important care for the patients. The guideline used for the study is the one of the HAS of 2007. The reserved method is the clinical audit. The evaluation of files was manually realized by second reading over a period of 1 week from 1st till 7 June 2008 on a sample of 42 files extracted on the motive for " chest pain" The statistical studies on the rate of troponin T positive (TnT+) and the average for turn around time (TAT) were made from the base Infocentre ® of the laboratory. One hundred percent of the physicians answered the survey, the good guideline is quoted in 57% of the cases, the clinical examination+electrocardiogram+TnT are quoted in 100%, and the cardiological opinion is drawn in 50% of the answers. The estimated TAT of the laboratory by the physician (1 hour) is in accordance with the reality at 80%, the notion of decision-making threshold in 99th percentile for the interpretation of the TnT is quoted only by 40%. The patients are 22 men (average age: 67 years) and 20 women (average age: 78 years). The number of suspicions ACS is 18. All are ST-, 13 had an interpreted and formalized electrocardiogram (ECG), five ECG were not formalized, 24 had another motive for CP. Factors of cardiovascular risk (FCVR) were looked for and noted seven times on 13 suspect patients of ACS and only five times on 29 with CP for another motive. Forty-seven percent of the patients were hospitalized. All the 42 patients had prescribed a TnT as the only marker of cardiac damage, 13% had a TnT>0,1μg/L. The average of TnT TAT is 54minutes. In conclusion, no lack of diagnosis of ACS was detected in the second reading of 42 files; the interpretation of ECG and FCVR is not systematically formalized. At the conclusion of this study several actions of improvement were organized and indicators of TnT TAT and rate of TnT+ were positioned. © 2010 Elsevier Masson SAS.

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