Marie I.,CHU Rouen |
Menard J.-F.,CHU Rouen |
Hachulla E.,Lille University Hospital Center |
Cherin P.,CHU Pitie Salpetriere |
And 3 more authors.
Seminars in Arthritis and Rheumatism | Year: 2011
Objectives: To assess the prevalence and characteristics of severe pyogenic, nonpyogenic, and opportunistic infections in polymyositis and dermatomyositis (PM/DM) patients and to evaluate the predictive values for infections on clinical presentation and biochemical findings of PM/DM to detect patients at risk for such infections. Methods: The medical records of 279 consecutive PM/DM patients in 3 medical centers were reviewed. Results: One hundred four severe infections occurred in our patients (37.3%), ie, pyogenic (n = 71) and nonpyogenic/opportunistic infections (n = 33). Pyogenic infections were mainly due to aspiration pneumonia (n = 46) and calcinosis cutis infection. Thirty-three PM/DM patients developed nonpyogenic/opportunistic infections that were due to the following: Candida albicans, Pneumocystis jiroveci, Aspergillus fumigatus, Geotrichum capitatum, Mycobacterium (avium-intracellulare complex, xenopi, marinum, peregrinum, tuberculosis), Helicobacter heilmanii, cytomegalovirus, herpes simplex and zoster virus, hepatitis B and C, JC virus, Leishmania major, Strongyloides stercoralis. Esophageal dysfunction, ventilatory insufficiency, malignancy, and lymphopenia were significantly more frequent in the group of PM/DM patients with infections. Conclusion: Our study underscores the high frequency of infections in PM/DM, resulting in an increased mortality rate. Our results suggest that prophylaxis against pyogenic infections should be routinely recommended for patients with PM/DM, including regular physical examination of lungs to depict aspiration pneumonia as well as risk factors of aspiration pneumonia. Finally, because a great variety of micro-organisms may be responsible for opportunistic infections, it seems difficult to initiate primary prophylaxis in PM/DM patients exhibiting risk factors for opportunistic infections. © 2011 Elsevier Inc.
PubMed | CHU Pitie Salpetriere, Institute Gustave Roussy, CRLCC Alexis Vautrin, Center Eugene Marquis and 5 more.
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2017
53 Background: Tools are needed to predict toxicity after prostate cancer treatment. The objective of the study was to analyze late urinary toxicity after prostate cancer radiotherapy (RT) by symptom description and identification of patient characteristics or treatment parameters allowing for the generation of nomograms.965 patient received a median total dose of 70 Gy (range, 65-80 Gy) for localized prostate cancer, using different fractionations (2 or 2.5 Gy/day) and RT techniques. Medical history was recorded. Late urinary toxicity was assessed, prospectively in half of the patients, using the CTCAE v3 classification: urinary frequency, incontinence, bleeding and retention (dysuria). Patients or treatment related predictors of late urinary toxicity (> grade 2) were identified by Univariate and multivariate Cox regression models. Nomograms were built up and their performance were assessed.The median follow-up was 61 months. The 5-year (grade 2) global urinary toxicity, urinary frequency, hematuria, urinary retention and urinary incontinence rates were: 15%, 10%, 5%, 3% and 1%, respectively. The 5-year ( grade 3) urinary toxicity rate was 3%. The following parameters significantly increased the 5 year risk of global urinary toxicity ( grade 2): anticoagulant treatment (RR=2.35), total dose (RR=1.09), age (RR=1.06), bladder D25 (RR=1.03) and maximum dose (RR=1.1). Urinary frequency was increased by the total dose (RR=1.07) and diabetes (RR=4). Hematuria was increased by anticoagulant treatment (RR=2.9). Urinary retention (dysuria) was increased by the total dose (RR=1.1). Corresponding nomograms and their calibration plots were generated.The first nomograms to predict late urinary toxicity but also specific urinary symptoms after prostate RT were generated, contributing to prostate cancer treatment decision.
Deuschl G.,University of Kiel |
Schupbach M.,University Pierre and Marie Curie |
Knudsen K.,University of Kiel |
Pinsker M.O.,University of Kiel |
And 4 more authors.
Parkinsonism and Related Disorders | Year: 2013
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an established treatment for advanced Parkinson's disease (PD) with disabling motor complications. However, stimulation may be beneficial at an earlier stage of PD when motor fluctuations and dyskinesia are only mild and psychosocial competence is still maintained. The EARLYSTIM trial was conducted in patients with recent onset of levodopa-induced motor complications (≤3 years) whose social and occupational functioning remained preserved. This is called 'early' here. The study was a randomized, multicenter, bi-national pivotal trial with a 2 year observation period. Quality of life was the main outcome measure, and a video-based motor score was a blinded secondary outcome of the study. Motor, neuropsychological, psychiatric and psychosocial aspects were captured by established scales and questionnaires. The patient group randomized here is the earliest in the disease course and the youngest recruited in controlled DBS trials so far. The methodological innovation for DBS-studies of this study lies in novel procedures developed and used for monitoring best medical treatment, neurosurgical consistency, best management of stimulation programming, blinded video assessment of motor disability, and prevention of suicidal behaviors. © 2012 Elsevier Ltd.
Lucon A.,Service de Cardiologie |
Oger E.,Service de Cardiologie |
Oger E.,French Institute of Health and Medical Research |
Bedossa M.,University of Rennes 1 |
And 13 more authors.
Circulation: Cardiovascular Interventions | Year: 2014
Background-Pulmonary hypertension (PH) is associated with poor prognosis in patients with severe aortic stenosis. The aim of this multicenter study was to describe clinical outcome after transcatheter aortic valve implantation. Methods and Results-The FRANCE 2 Registry included all patients undergoing transcatheter aortic valve implantation in France in 2010 and 2011. Patients were divided into 3 groups depending on systolic pulmonary artery pressure (sPAP) estimated in transthoracic echocardiography: group I, sPAP <40 mm Hg (no PH); group II, sPAP 40 to 59 mm Hg (mildto- moderate PH); and group III, sPAP =60 mm Hg (severe PH). Patients were followed up for 1 year. A total of 2435 patients whose pre-transcatheter aortic valve implantation sPAP was reported were included. A total of 845 were in group I (34.7%), 1112 in group II (45.7%), and 478 in group III (19.6%). Procedural success, early complications, and 30-day mortality were statistically similar across sPAP groups. One-year mortality was higher in groups II and III (group I, 22%; group II, 28%; and group III, 28%; P=0.032). Mild-to-moderate and severe PH were identified as an independent factor of all-cause mortality. The major adverse cardiovascular event rates did not differ according to sPAP. New York Health Association functional class improved significantly in all groups. Conclusions-PH (sPAP =40 mm Hg) in patients with aortic stenosis undergoing transcatheter aortic valve implantation was associated with increased 1-year mortality especially when severe (sPAP =60 mm Hg) but not with increased 30-day mortality, and functional status was significantly improved regardless of PAP level. © 2014 American Heart Association, Inc.
Langeron O.,CHU Pitie Salpetriere |
Cuvillon P.,Nimes University Hospital Center |
Ibanez-Esteve C.,CHU Pitie Salpetriere |
Lenfant F.,CH de Beaune |
And 2 more authors.
Anesthesiology | Year: 2012
Background: It has been suggested that predicting difficult tracheal intubation is useless because of the poor predictive capacity of individual signs and scores. The authors tested the hypothesis that an accurate prediction of difficult tracheal intubation using simple clinical signs is possible using a computer-assist model. Methods: In a cohort of 1,655 patients, the authors analyzed the predictive properties of each of the main signs (Mallampati score, mouth opening, thyromental distance, and body mass index) to predict difficult tracheal intubation. They built the best score possible using a simple logistic model (SCOREClinic) and compared it with the more recently described score in the literature (SCORENaguib). Then they used a boosted tree analysis to build the best score possible using computer-assisted calculation (SCOREComputer). Results : Difficult tracheal intubation occurred in 101 patients (6.1%). The predictive properties of each sign remain low (maximum area under the receiver operating characteristic curve 0.70). Using receiver operating characteristic curve, the global prediction of the SCORE Clinic (0.74, 95% CI: 0.72-0.76) was greater than that of the SCORENaguib (0.66, 95% CI: 0.60-0.72, P < 0.001) but significantly lower than that of the SCOREComputer (0.86, 95% CI: 0.84-0.91, P < 0.001). The proportion of patients in the inconclusive zone was 71% using SCORENaguib, 56% using SCOREClinic, and only 32 % using SCOREComputer (all P < 0.001). Conclusion: Computer-assisted models using complex interaction between variables enable an accurate prediction of difficult tracheal intubation with a low proportion of patients in the inconclusive zone. An external validation of the model is now required. © 2012, the American Society of Anesthesiologists, Inc.
Kerebel D.,French Army Hospital Sainte Anne |
Joly L.-M.,CHU Rouen |
Honnart D.,CHU Dijon |
Schmidt J.,CHU Clermont Ferrand |
And 4 more authors.
Critical Care | Year: 2013
Introduction: Prothrombin complex concentrates (PCC) are haemostatic blood preparations indicated for urgent anticoagulation reversal, though the optimal dose for effective reversal is still under debate. The latest generation of PCCs include four coagulation factors, the so-called 4-factor PCC. The aim of this study was to compare the efficacy and safety of two doses, 25 and 40 IU/kg, of 4-factor PCC in vitamin K antagonist (VKA) associated intracranial haemorrhage.Methods: We performed a phase III, prospective, randomised, open-label study including patients with objectively diagnosed VKA-associated intracranial haemorrhage between November 2008 and April 2011 in 22 centres in France. Patients were randomised to receive 25 or 40 IU/kg of 4-factor PCC. The primary endpoint was the international normalised ratio (INR) 10 minutes after the end of 4-factor PCC infusion. Secondary endpoints were changes in coagulation factors, global clinical outcomes and incidence of adverse events (AEs).Results: A total of 59 patients were randomised: 29 in the 25 IU/kg and 30 in the 40 IU/kg group. Baseline demographics and clinical characteristics were comparable between the groups. The mean INR was significantly reduced to 1.2 - and ≤1.5 in all patients of both groups - 10 minutes after 4-factor PCC infusion. The INR in the 40 IU/kg group was significantly lower than in the 25 IU/kg group 10 minutes (P = 0.001), 1 hour (P = 0.001) and 3 hours (P = 0.02) after infusion. The 40 IU/kg dose was also effective in replacing coagulation factors such as PT (P = 0.038), FII (P = 0.001), FX (P <0.001), protein C (P = 0.002) and protein S (0.043), 10 minutes after infusion. However, no differences were found in haematoma volume or global clinical outcomes between the groups. Incidence of death and thrombotic events was similar between the groups.Conclusions: Rapid infusion of both doses of 4-factor PCC achieved an INR of 1.5 or less in all patients with a lower INR observed in the 40 IU/kg group. No safety concerns were raised by the 40 IU/kg dose. Further trials are needed to evaluate the impact of the high dose of 4-factor PCC on functional outcomes and mortality.Trial registration: Eudra CT number 2007-000602-73. © 2013 Kerebel et al.; licensee BioMed Central Ltd.
Salmon R.,Hopital des Peupliers |
Rey J.B.,University of Reims Champagne Ardenne |
Launay-Vacher V.,CHU Pitie Salpetriere
Cancer Chemotherapy and Pharmacology | Year: 2015
A significant proportion of post-menopausal, patients treated with AI reports side-effects, especially bone pain. In such patients, the difficulties to treat pain and to clearly identify its causes may lead to treatment discontinuation. Ageing is associated with physiological modifications that may impair drug pharmacokinetics (PKs). The elimination can be altered, with decreased drug clearance (CL), resulting in an increased exposure to the drug, reflected by increased AUCs. The reported increases in AI exposure being around 50 %, an intermittent dosing schedule of 1 administration every other day could result in a similar drug exposure as compared to the usual daily schedule. © 2015 Springer-Verlag Berlin Heidelberg.
Le Manach Y.,Center Hospitalo University Pitie |
Ibanez Esteves C.,Center Hospitalo University Pitie |
Bertrand M.,Center Hospitalo University Pitie |
Goarin J.P.,Center Hospitalo University Pitie |
And 5 more authors.
Anesthesiology | Year: 2011
Background: Chronic statin therapy is associated with reduced postoperative mortality. Renal and cardiovascular benefits have been described, but the effect of chronic statin therapy on postoperative adverse events has not yet been explored. Methods: In this observational study involving 1,674 patients undergoing aortic reconstruction, we prospectively assessed chronic statin therapy compared with no statin therapy, with regard to serious outcomes, by propensity score and multivariable methods. Results: In propensity-adjusted multivariable logistic regression (c-index: 0.83), statins were associated with an almost threefold reduction in the risk of death in patients undergoing major vascular surgery (odds ratio: 0.40; 95% CI: 0.28-0.59) and an almost twofold reduction in the risk of postoperative myocardial infarction (odds ratio: 0.52; 95% CI: 0.38-0.71). Likewise, the use of chronic statin therapy was associated with a reduced risk of postoperative stroke and renal failure. Statins did not significantly reduce the risk of pneumonia, multiple organ dysfunction syndrome, and surgical complications; however, in the case of postoperative multiple organ dysfunction syndrome (odds ratio: 0.34; 95% CI: 0.12-0.94) and surgical complications (odds ratio: 0.39; 95% CI: 0.17-0.86), reduced mortality was observed. Conclusions: Chronic statin therapy was associated with a reduction in all cardiac and vascular outcomes after major vascular surgery. Furthermore, in major adverse events, such as multiple organ dysfunction syndrome and surgical complications, statins were also associated with decreased mortality. © 2010, the American Society of Anesthesiologists, Inc. Lippincott Williams & Wilkins.
Fellahi J.-L.,Caen University Hospital Center |
Le Manach Y.,CHU Pitie Salpetriere |
Daccache G.,CHP Saint Martin |
Riou B.,CHU Pitie Salpetriere |
And 2 more authors.
Anesthesiology | Year: 2011
Background: Reclassification tables have never been used to compare concentrations of cardiac troponin I (cTnI) with predictive models of risk in the perioperative setting. The current study aimed to evaluate the prognostic value of pre- and/or postoperative serum cTnI when combined with The European System for Cardiac Operative Risk Evaluation (EuroSCORE) in predicting adverse outcome after cardiac surgery. Methods: Nine hundred five consecutive patients were included. Standard EuroSCORE as well as preoperative and 24-h postoperative cTnI were measured in all patients. Major adverse cardiac events and in-hospital mortality were chosen as study endpoints. The performance of EuroSCORE with and without pre- and/or postoperative cTnI were assessed by means of receiver operating characteristic curves, net reclassification index, and integrated discrimination improvement analyses. Data are expressed as ±SD. Results: Death occurred in 28 of 905 (3%) patients and major adverse cardiac events in 202/905 (22%) patients. Models including EuroSCORE alone were characterized by a low discriminative power (c-index = 0.60 ± 0.05) in predicting major adverse cardiac events. The c-index increased to 0.61 ± 0.05 (P = 0.46), 0.70 ± 0.04 (P < 0.001), and 0.71 ± 0.04 (P < 0.001) when preoperative, postoperative, and pre/postoperative cTnI were included, respectively. The better predictive ability was confirmed by net reclassification index (0.41 ± 0.08, P < 0.001; 0.67 ± 0.08, P < 0.001; and 0.68 ± 0.08, P < 0.001, respectively) and integrated discrimination improvement (0.003 ± 0.002, P = 0.12; 0.099 ± 0.015, P < 0.001; and 0.094 ± 0.016, P < 0.001, respectively). Similar results were observed for in-hospital mortality. Conclusions: The combination of EuroSCORE and postoperative cTnI provides the best discriminative power and performance in predicting adverse outcome after cardiac surgery and is suggested as being an effective model that improves early identification of high-risk patients. © 2011, the American Society of Anesthesiologists, Inc. Lippincott Williams & Wilkins. Anesthesiology.
Jacqueminet S.,CHU Pitie Salpetriere
Diabetes & metabolism | Year: 2010
Maternal and perinatal complications linked to gestational diabetes mellitus could be decreased with an intensive management approach. To assess the effect of various treatments, glycaemic targets and procedures for self-monitoring of blood glucose on the foetal and maternal prognosis. Systematic review of literature studying the efficacy of the treatment of gestational diabetes in order to decrease maternal-foetal morbidity-mortality. Analysis based on bibliographic search in PubMed using the following keywords: " therapeutic" , " treatment" and " gestational diabetes" . Specific treatment of gestational diabetes (dietary, adapted physical activity, self-monitoring of blood glucose, insulin-therapy if appropriate) reduces severe perinatal complications (composite criterion), foetal macrosomia and preeclampsia compared to the absence of therapy, with however an increase in the number of labour inductions, and without any increase in the number of caesarean sections. Regarding oral antidiabetic agents (glibenclamide or metformin), despite the absence of difference found on foetal or maternal prognosis compared to insulin, they should not be prescribed during pregnancy at this time. The treatment of " severe or moderate" gestational diabetes is recommended. Additional studies, in particular long-term studies in children, are warranted before oral antidiabetic agents can be used.