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Le Touquet – Paris-Plage, France

Daculsi G.,French Institute of Health and Medical Research | Pascal-Moussellard H.,Pitie Salpetriere
Key Engineering Materials | Year: 2013

The objective of the study was to compare clinical efficiency of the fusion after reconstruction with an anatomically shaped PEEK cage associated with a iliac crest autograft or MBCP in the treatment of cervical disc disease in randomized clinical trial. A multicente randomized, comparative and prospective study on 58 patients, with a 12 months follow up are reported. They underwent anterior cervical decompression and fusion being randomized for autologous graft or MBCP. Patients presenting purely degenerative disc disease were implanted with a PEEK cage filled with iliac crest autograft or MBCP. Pain and functionality as well as patient's satisfaction were assessed through VAS, Neck Disability Index (NDI) and Patient Satisfaction index were recorded until 24 month follow-up. Radiological evaluation included plain and dynamic short X-rays at each stage of the follow up. The patient's satisfaction rates was of 82% in the autograft group versus 96% in the MBCP group. Pain at the donor site was significantly more important in the autograft group at 3 weeks, 3 months and 1 year follow-up. No implant failures were recorded. Previously goat preclinical study was performed. Micro CT, light microscopy and shistomorphometry were related to the high performance of the MBCP insert for filling cage fusion, completing the clinical assessment of our clinical study. The use of MBCP insert is safe and avoids potential graft site morbidity and pain in comparison with an autologous graft procedure. © (2013) Trans Tech Publications, Switzerland. Source

Menown I.,Craigavon Cardiac Center | Montalescot G.,Pitie Salpetriere | Pal N.,Craigavon Cardiac Center | Fidler C.,Abacus International | And 2 more authors.
Advances in Therapy | Year: 2010

Introduction: In patients receiving fibrinolytic therapy for ST-elevation myocardial infarction (STEMI), adjunct treatment with enoxaparin has been shown to provide superior net clinical benefit compared with unfractionated heparin (UFH) in the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment - Thrombolysis in Myocardial Infarction (ExTRACT-TIMI) 25 study. The objective of this study was to compare the cost effectiveness of enoxaparin and UFH strategies. Methods: A cost-utility analysis was conducted using a two-stage model: (1) A 30-day decision tree analytical model for the acute treatment phase, and (2) a lifetime Markov model (from 30 days post-STEMI until death) populated using patient survival data. Results: Assuming treatment continuation for 7 days, the mean day 1-30 incremental cost associated with enoxaparin was £49 per patient, and mean lifetime incremental cost was £592 per patient (£91, 091 vs. £90, 499, respectively). Given an additional 0.048 life years gained per patient with enoxaparin, the cost per life year saved was £12, 353, and given an additional 0.038 quality-adjusted life years (QALY) per patient with enoxaparin, the cost per QALY was £15, 413. In an alternative scenario, reflecting contemporary practice assuming early treatment discontinuation at 48 hours, for example following urgent revascularization, the incremental cost per QALY was £13, 556. Conclusions: The use of an enoxaparin versus UFH strategy in patients receiving fibrinolytic therapy for STEMI, whether continued for 7 days or discontinued early, for example following urgent revascularization, is cost effective at a £20, 000 willingness-to-pay threshold. © Springer Healthcare 2010. Source

Annane D.,Raymond Poincare hospital | Siami S.,CH dEtampes | Jaber S.,CHU Montpelier | Martin C.,AP HM Hopital Nord | And 12 more authors.
JAMA - Journal of the American Medical Association | Year: 2013

IMPORTANCE: Evidence supporting the choice of intravenous colloid vs crystalloid solutions for management of hypovolemic shock remains unclear. OBJECTIVE: To test whether use of colloids compared with crystalloids for fluid resuscitation alters mortality in patients admitted to the intensive care unit (ICU) with hypovolemic shock. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, randomized clinical trial stratified by case mix (sepsis, trauma, or hypovolemic shock without sepsis or trauma). Therapy in the Colloids Versus Crystalloids for the Resuscitation of the Critically Ill (CRISTAL) trial was open label but outcome assessment was blinded to treatment assignment. Recruitment began in February 2003 and ended in August 2012 of 2857 sequential ICU patients treated at 57 ICUs in France, Belgium, North Africa, and Canada; follow-up ended in November 2012. INTERVENTIONS: Colloids (n = 1414; gelatins, dextrans, hydroxyethyl starches, or 4% or 20% of albumin) or crystalloids (n = 1443; isotonic or hypertonic saline or Ringer lactate solution) for all fluid interventions other than fluid maintenance throughout the ICU stay. MAIN OUTCOMES AND MEASURES: The primary outcomewas death within 28 days. Secondary outcomes included 90-day mortality; and days alive and not receiving renal replacement therapy, mechanical ventilation, or vasopressor therapy. RESULTS: Within 28 days, there were 359 deaths (25.4%) in colloids group vs 390 deaths (27.0%) in crystalloids group (relative risk [RR], 0.96 [95% CI, 0.88 to 1.04]; P = .26). Within 90 days, there were 434 deaths (30.7%) in colloids group vs 493 deaths (34.2%) in crystalloids group (RR, 0.92 [95% CI, 0.86 to 0.99]; P = .03). Renal replacement therapy was used in 156 (11.0%) in colloids group vs 181 (12.5%) in crystalloids group (RR, 0.93 [95% CI, 0.83 to 1.03]; P = .19). There were more days alive without mechanical ventilation in the colloids group vs the crystalloids group by 7 days (mean: 2.1 vs 1.8 days, respectively; mean difference, 0.30 [95% CI, 0.09 to 0.48] days; P = .01) and by 28 days (mean: 14.6 vs 13.5 days; mean difference, 1.10 [95% CI, 0.14 to 2.06] days; P = .01) and alive without vasopressor therapy by 7 days (mean: 5.0 vs 4.7 days; mean difference, 0.30 [95% CI, -0.03 to 0.50] days; P = .04) and by 28 days (mean: 16.2 vs 15.2 days; mean difference, 1.04 [95% CI, -0.04 to 2.10] days; P = .03). CONCLUSIONS AND RELEVANCE: Among ICU patients with hypovolemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality. Although 90-day mortality was lower among patients receiving colloids, this finding should be considered exploratory and requires further study before reaching conclusions about efficacy. Source

Luporsi E.,Nancy University Hospital Center | Andre F.,Institute Gustave Roussy | Spyratos F.,Institute Curie HOpital Rene Huguenin | Martin P.-M.,Translational Laboratory Biological Oncology | And 21 more authors.
Breast Cancer Research and Treatment | Year: 2012

Clinicians can use biomarkers to guide therapeutic decisions in estrogen receptor positive (ER?) breast cancer. One such biomarker is cellular proliferation as evaluated by Ki-67. This biomarker has been extensively studied and is easily assayed by histopathologists but it is not currently accepted as a standard. This review focuses on its prognostic and predictive value, and on methodological considerations for its measurement and the cutpoints used for treatment decision. Data describing study design, patients' characteristics, methods used and results were extracted from papers published between January 1990 and July 2010. In addition, the studies were assessed using the REMARK tool. Ki-67 is an independent prognostic factor for disease-free survival (HR 1.05-1.72) in multivariate analyses studies using samples from randomized clinical trials with secondary central analysis of the biomarker. The level of evidence (LOE) was judged to be I-B with the recently revised definition of Simon. However, standardization of the techniques and scoring methods are needed for the integration of this biomarker in everyday practice. Ki-67 was not found to be predictive for longterm follow-up after chemotherapy. Nevertheless, high KI-67 was found to be associated with immediate pathological complete response in the neoadjuvant setting, with an LOE of II-B. The REMARK score improved over time (with a range of 6-13/20 vs. 10-18/20, before and after 2005, respectively). KI-67 could be considered as a prognostic biomarker for therapeutic decision. It is assessed with a simple assay that could be standardized. However, international guidelines are needed for routine clinical use. © Springer Science+Business Media, LLC. 2011. Source

Izzedine H.,Pitie Salpetriere | Gueutin V.,Pitie Salpetriere | Gharbi C.,Pitie Salpetriere | Mateus C.,French Institute of Health and Medical Research | And 5 more authors.
Investigational New Drugs | Year: 2014

Monoclonal antibodies directed against the immune checkpoint protein cytotoxic T-lymphocyte antigen-4 (CTLA-4; CD152) have been investigated in metastatic melanoma and other cancers and have shown promising results. Inhibition of CTLA-4 characteristically induces well-known side effects called "immune-related adverse events" (irAEs). IrAEs mainly include colitis, dermatitis, hepatitis, endocrinopathies; uveitis, iridocyclitis, neuropathies, and inflammatory myopathy have occasionally been reported. Kidney involvement is rare. We report 2 cases of acute granulomatous interstitial nephritis and present, based on literature review, renal disorders related to Ipilimumab therapy. Autoimmune symptoms have to be carefully checked for patients treated with CTLA-4 inhibitors. In order to reduce the risk of sequelae, early recognition of irAEs and treatment initiation are crucial. © 2014 Springer Science+Business Media. Source

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