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Salles M.,Rheumatoloy | Minguez S.,Rheumatoloy | Ros S.,Pneumology | Tuneu R.,Rheumatoloy | Gelman S.M.,Rheumatoloy
Clinical and experimental rheumatology | Year: 2017


Herth F.J.F.,University of Heidelberg | Noppen M.,University Hospital Brussels | Valipour A.,Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology | Leroy S.,Lille University Hospital Center | And 7 more authors.
European Respiratory Journal | Year: 2012

The Endobronchial Valve for Emphysema Palliation Trial (VENT) was a multi-centre, prospective, randomised, controlled trial conducted to evaluate the safety and effectiveness of unilateral endobronchial valve (EBV) treatment. The purpose of this analysis was to assess outcomes in the previously unreported European VENT study cohort. Patients with advanced emphysema were randomly assigned (2:1) to receive Zephyr1 (Pulmonx Inc., Redwood City, CA, USA) EBV treatment (n=111) or medical management (n=60). At 6 months, EBV patients demonstrated a significant improvement compared with the controls for mean±SD change in forced expiratory volume in 1 s (7±20% versus 0.5±19%; p=0.067), cycle ergometry (2±14 W versus -3±10 W; p=0.04) and St George's Respiratory Questionnaire (-5±14 points versus 0.3±13 points; p=0.047). At 12 months, the magnitude of the difference between groups for change from baseline was of similar magnitude to the differences seen at 6 months. Rates for complications did not differ significantly. EBV patients with computed tomography (CT) scans suggestive of complete fissure and lobar occlusion had a mean±SD lobar volume reduction of -80±30% and >50% met minimal clinical difference thresholds. The degree of emphysema heterogeneity did not preclude excellent outcomes. Unilateral lobar volume reduction using EBV treatment is safe and superior clinical results correlated with CT suggestive of complete fissures and successful lobar occlusion. Emphysema heterogeneity was not critical for determining positive outcomes. Copyright©ERS 2012.

Berghaus T.M.,Pneumology | Behr W.,Institute of Laboratory Medicine | Von Scheidt W.,Pneumology | Schwaiblmair M.,Pneumology
Thrombosis Research | Year: 2010

Background: Right heart dysfunction is a crucial factor in risk stratification of normotensive patients with pulmonary embolism. Apart from biomarkers, determinants of right heart dysfunction in this group of patients are not yet well established. Aim and method: In order to identify such determinants, we analysed data of 252 patients with acute pulmonary embolism admitted to our hospital in 2008. Results: 69 out of 140 patients showed right heart dysfunction by echocardiography within 24 hours after diagnosis, 71 did not. Right ventricular dysfunction was significantly more frequent in patients with central clots on computed tomography (p = 0.004), a history of syncope (p < 0.001) and among women on oral contraceptives (p = 0.003). In multiple regression analysis, only central thromboembolism (p < 0.001) was identified as individual predictor of right ventricular dysfunction. Age, gender, body mass index, idiopathic or recurrent thromboembolism, duration of symptoms, preceding surgery, room air oxygen saturation, carcinoma, hypertension, diabetes, renal disease, congestive left heart failure and concomitant lung disease were equally distributed. In comparison with NT-pro brain natriuretic peptide (PPV 67%, NPV 75%, p = 0.782) and troponin I (PPV 76%, NPV 62%, p = 0.336), central thromboembolism has shown to have a greater statistical power in predicting right heart dysfunction in normotensive patients with pulmonary embolism (PPV 78%, NPV 88%, p < 0.001). Conclusion: Among normotensive patients with acute pulmonary embolism, those with central clots seem to be at greater risk for echocardiographically evaluated right ventricular dysfunction. © 2010 Elsevier Ltd All rights reserved.

PubMed | Malteser Krankenhaus St Hildegardis, Airway Research Center North, Krankenhaus Barmherzige Bruder Regensburg, Universitatsmedizin Gottingen and 11 more.
Type: Clinical Trial, Phase II | Journal: The European respiratory journal | Year: 2015

Erlotinib with bevacizumab showed promising activity in recurrent nonsquamous (NS) nonsmall cell lung cancer (NSCLC). The INNOVATIONS study was designed to assess in first-line treatment of unselected cisplatin-eligible patients this combination compared to cisplatin, gemcitabine and bevacizumab. Stage IIIB/IV patients with NS-NSCLC were randomised on erlotinib (150mg daily) and bevacizumab (15mgkg(-1) on day 1, every 3weeks) (EB) until progression, or cisplatin (80mgm(-2) on day 1, every 3weeks) and gemcitabine (1250mgm(-2) on days 1 and 8, every 3weeks) up to six cycles and bevacizumab (15mgkg(-1) on day 1, every 3weeks) (PGB) until progression. 224 patients were randomised (EB n=111, PGB n=113). The response rate (12% versus 36%; p<0.0001), progression-free survival (median 3.5 versus 6.9months; hazard ratio (HR) 1.85, 95% CI 1.39-2.45; p<0.0001) and overall survival (median 12.6 versus 17.8months; HR 1.41, 95% CI 1.01-1.97; p=0.04) clearly favoured PGB. In patients with epidermal growth factor receptor mutations (n=32), response rate, progression-free survival and overall survival were not superior with EB. Platinum-based combination chemotherapy remains the standard of care in first-line treatment of unselected NS-NSCLC. Molecular targeted approaches strongly mandate appropriate testing and patient selection.

PubMed | Materials Misericordiae University Hospital, Comprehensive Pneumology Center Munich, Imperial College London, AK and 9 more.
Type: Journal Article | Journal: The Lancet. Respiratory medicine | Year: 2016

Lung volume reduction of emphysematous lobes results in clinical improvement for patients with severe emphysema. However, some segments within a lobe are often substantially more diseased than others, thereby warranting a more targeted approach of the emphysematous parts of a lobe. We therefore did a study to assess whether or not selective sequential treatment of the more diseased upper lobe segments with bronchoscopic vapour ablation led to clinical improvement.For the multicentre, parallel-group, randomised, controlled, open-label Sequential Staged Treatment of Emphysema with Upper Lobe Predominance (STEP-UP) trial, adult patients aged 45-75 years with severe, upper lobe-predominant emphysema with a forced expiratory volume in 1 s (FEV1) between 20% and 45%, substantial hyperinflation, and post-rehabilitation 6-min walk test (6MWT) greater than 140 m were enrolled from 13 hospital sites in Europe (ten sites) and Australia (three sites). A computer-generated blocked randomisation scheme (block size three per site based on a random table from an independent biostatistician) stratified by site was used to randomly assign enrolled patients 2:1 to segmental vapour ablation (treatment group) or standard medical management (control group). Patients and investigators were not masked to group assignment. The primary efficacy endpoints were statistically significant changes in FEV1 and St Georges Respiratory Questionnaire (SGRQ-C) scores between trial groups at 6 months, analysed by intention to treat. This study is registered with, number NCT01719263.Between June 30, 2013, and Oct 1, 2014, 134 patients were screened and 70 were enrolled and randomly assigned: 46 to the treatment group and 24 to the control group. One patient in the treatment group did not receive treatment because of physician decision post-randomisation; this patient is excluded from all analyses. The mean relative improvement in FEV1 between the treatment group versus the control group was 147% (95% CI 78-215%; p<00001) and in SGRQ-C was -97 points (95% CI -157 to -37; p=00021). COPD exacerbation was the most common serious adverse event, occurring in 11 (24%) of 45 patients in the treatment group and one (4%) of 24 in the control group. One exacerbation resulted in a patient death 84 days after treatment; this was judged by the data and safety monitoring board to be possibly related to treatment. No pneumothorax occurred within 30 days of treatment.Compared with standard medical management, targeted thermal vapour ablation of more diseased segments and preservation of less diseased segments resulted in clinically meaningful and statistically significant improvements in lung function and quality of life at 6 months, with an acceptable safety profile.Uptake Medical.

Cima K.,Pneumology | Vogelsinger H.,Pneumology | Kahler C.M.,Pneumology
Regulatory Peptides | Year: 2010

The sensory neuropeptides secretoneurin (SN) and substance P (SP) are involved in "neurogenic" inflammatory processes as they occur in bronchial asthma or allergic rhinitis. A possible interaction with basophils has not been reported to date. Basophils were isolated from healthy donors by magnetic cell sorting technique and migration was explored using Boyden microchemotaxis chambers. SN [10- 8 M] and SP [10- 6 to 10- 8 M] proved to be chemoattractants equally potent to FMLP [10- 8 M] or LPS [10 pg/ml]. Specific anti-SN antibodies and a trypsinization preparation of SN were used to determine the specificity of the SN effect on basophils. The preincubation of basophils with neurokinin-1 (NK-1) or -2 (NK-2) receptor antagonists revealed the SP effect to act via NK-1 receptors in basophils. In addition, we were able to show phosphodiesterases and phosphoinositide-3 kinases to be engaged in the downstream signalling pathway. Our observations reveal for the first time a link between basophils, which are engaged in allergic processes, and the neuropeptides SN and SP. Furthermore, our data might suggest phosphodiesterases or phosphoinositide-3 kinases to be new therapeutic targets for the treatment of allergic diseases such as asthma or allergic rhinitis. © 2009 Elsevier B.V. All rights reserved.

Senny F.,University of Liège | Maury G.,Pneumology | Cambron L.,University of Liège | Leroux A.,University of Liège | And 2 more authors.
Sleep and Breathing | Year: 2012

Purpose: Estimating the total sleep time in home recording devices is necessary to avoid underestimation of the indices reflecting sleep apnea and hypopnea syndrome severity, e. g., the apnea-hypopnea index (AHI). A new method to distinguish sleep from wake using jaw movement signal processing is assessed. Methods: In this prospective study, jaw movement signal was recorded using the Somnolter (SMN) portable monitoring device synchronously with polysomnography (PSG) in consecutive patients complaining about a lack of recovery sleep. The automated sleep/wake scoring method is based on frequency and complexity analysis of the jaw movement signal. This computed scoring was compared with the PSG hypnogram, the two total sleep times (TSTPSG and TSTSMN) as well. Results: The mean and standard deviation (in minutes) of TST PSG on the whole dataset (n=124) were 407±95.6, while these statistics were 394.2±99.3 for TST SMN. The Bland and Altman analysis of the difference between the two TST was 12.8±57.3 min. The sensitivity and specificity (in percent) were 85.3 and 65.5 globally. The efficiency decreased slightly when AHI lies between 15 and 30, but remained similar for lower or greater AHI. In the 24 patients with insomnia/depression diagnosis, a mean difference in TST of -3.3 min, a standard deviation of 58.2 min, a sensitivity of 86.3%, and a specificity of 66.2% were found. Conclusions: Mandible movement recording and its dedicated signal processing for sleep/wake recognition improve sleep disorder index accuracy by assessing the total sleep time. Such a feature is welcome in home screening methods. © Springer-Verlag 2011.

Hebuterne X.,University of Nice Sophia Antipolis | Lemarie E.,Pneumology | Michallet M.,Lyon University Hospital Center | De Montreuil C.B.,Nantes University Hospital Center | And 2 more authors.
Journal of Parenteral and Enteral Nutrition | Year: 2014

Background and Aims: The aim of this study was to evaluate on 1 day the prevalence of malnutrition in different types of cancer and the use of nutrition support in patients with cancer. Methods: A 1-day prevalence survey was carried out in 154 French hospital wards. Malnutrition was defined as a body mass index (BMI) <18.5 in patients <75 years old or <21 in patients ≥75 years old and/or body weight loss >10% since disease onset. Oral food intake was measured using a visual analog scale. Results: Nutrition status was collected for 1903 patients (1109 men and 794 women, 59.3 ± 13.2 years). Cancer was local in 25%, regional in 31%, and metastatic in 44% of patients. Performance status was 0 or 1 in 49.8%, 2 in 23.7%, 3 or 4 in 19.6% and not available in 6.5% of patients. Overall, 39% of patients were malnourished. The prevalence of malnutrition by disease site was as follows: head and neck, 48.9%; leukemia/lymphoma, 34.0%; lung, 45.3%; colon/rectum, 39.3%; esophagus and/or stomach, 60.2%; pancreas, 66.7%; breast, 20.5%; ovaries/uterus, 44.8%; and prostate, 13.9%. Regional cancer (odds ratio, 1.96; 95% confidence interval, 1.42-2.70), metastatic cancer (2.97; 2.14-4.12), previous chemotherapy (1.41; 1.05-1.89), and previous radiotherapy (1.53; 1.21-1.92) were associated with malnutrition. Only 28.4% of non-malnourished patients and 57.6% of malnourished patients received nutrition support. In all, 55% of patients stated that they were eating less than before the cancer, while 41.4% of patients stated that they had received nutrition counseling. Conclusions: The prevalence of malnutrition is high in patients with cancer, and systematic screening for and treatment of malnutrition is necessary. © 2013 American Society for Parenteral and Enteral Nutrition.

Ritz C.,Copenhagen University | Baty F.,Pneumology | Streibig J.C.,Copenhagen University | Gerhard D.,University of Canterbury
PLoS ONE | Year: 2015

Dose-response analysis can be carried out using multi-purpose commercial statistical software, but except for a few special cases the analysis easily becomes cumbersome as relevant, non-standard output requires manual programming. The extension package drc for the statistical environment R provides a flexible and versatile infrastructure for dose-response analyses in general. The present version of the package, reflecting extensions and modifications over the last decade, provides a user-friendly interface to specify the model assumptions about the dose-response relationship and comes with a number of extractors for summarizing fitted models and carrying out inference on derived parameters. The aim of the present paper is to provide an overview of state-of-the-art dose-response analysis, both in terms of general concepts that have evolved and matured over the years and by means of concrete examples. © 2015 Ritz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

PubMed | Institute for Pulmonary Diseases, Autonomous University of Barcelona, University of Thessaly, Pneumology and 6 more.
Type: | Journal: Chest | Year: 2016

Extracellular matrix remodeling (ECM) of the lung tissue releases protein fragments into the blood, where they may be detected as serological surrogate markers of disease activity in chronic obstructive pulmonary disease (COPD). We aimed to assess the association of ECM turnover with severity and outcome of COPD.In a prospective, observational, multicenter study including 506 patients with COPD, GOLD grades II-IV, we analyzed serum samples at stable state, exacerbation and 4 weeks after exacerbation, for a panel of 5 novel neo-epitopes including fragments of collagen type-III (C3M) and type-VI (C6M), pro-forms of collagen type-III (Pro-C3) and type-VI (Pro-C6) and neutrophil elastase-generated fragments of elastin (EL-NE) by ELISA. These neo-epitopes were also measured at stable state in a derivation cohort including 100 COPD patients.Serum levels of C3M, C6M, Pro-C3, Pro-C6 and EL-NE were associated with lung function. Patients with the lowest levels of Pro-C3 and Pro-C6 had more severe airflow limitation, hyperinflation, air trapping, and emphysema. Degradation of collagen type-III and -VI was associated with dyspnea. All ECM biomarkers, except Pro-C6, were increased at exacerbation as compared to stable state but, except EL-NE, did not differ between stable state and exacerbation follow-up in the crude and adjusted analyses. In Cox regression adjusted analyses, Pro-C3 was associated with a shorter time to exacerbation (HR 0.72[0.59-0.89] p=0.002) and Pro-C6 with survival (HR 2.09[1.18-3.71], p=0.011).Serum biomarkers of ECM turnover are significantly associated with disease severity and clinically relevant outcomes in COPD.

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