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Dreuil-lès-Amiens, France

Laharie D.,Bordeaux University Hospital Center | Laharie D.,University of Bordeaux 1 | Bourreille A.,Nantes University Hospital Center | Branche J.,CHRU de Lille | And 28 more authors.
The Lancet | Year: 2012

Background Ciclosporin and infliximab are potential rescue treatments to avoid colectomy in patients with acute severe ulcerative colitis refractory to intravenous corticosteroids. We compared the efficacy and safety of these drugs for this indication. Methods In this parallel, open-label, randomised controlled trial, patients were aged at least 18 years, had an acute severe flare of ulcerative colitis defined by a Lichtiger score greater than 10 points, and had been given an unsuccessful course of high-dose intravenous steroids. None of the patients had previously received ciclosporin or infliximab. Between June 1, 2007, and Aug 31, 2010, patients at 27 European centres were randomly assigned (via computerderived permutation tables; 1:1) to receive either intravenous ciclosporin (2 mg/kg per day for 1 week, followed by oral drug until day 98) or infliximab (5 mg/kg on days 0, 14, and 42). In both groups, azathioprine was started at day 7 in patients with a clinical response. Neither patients nor investigators were masked to study treatment. The primary efficacy outcome was treatment failure defined by absence of a clinical response at day 7, a relapse between day 7 and day 98, absence of steroid-free remission at day 98, a severe adverse event leading to treatment interruption, colectomy, or death. Analysis was by intention to treat. This trial is registered with EudraCT (2006-005299-42) and ClinicalTrials.gov (NCT00542152). Findings 115 patients were randomly assigned; 58 patients were allocated to receive ciclosporin and 57 to receive infliximab. Treatment failure occurred in 35 (60%) patients given ciclosporin and 31 (54%) given infliximab (absolute risk difference 6%; 95% CI -7 to 19; p=0·52). Nine (16%) patients in the ciclosporin group and 14 (25%) in the infliximab group had severe adverse events. Interpretation Ciclosporin was not more effective than infliximab in patients with acute severe ulcerative colitis refractory to intravenous steroids. In clinical practice, treatment choice should be guided by physician and centre experience.

Manfredi S.,University of Rennes 2 - Upper Brittany | Sabbagh C.,CHU Amiens | Vanbiervliet G.,Pole Digestif | Lecomte T.,University of Tours | And 2 more authors.
Endoscopy | Year: 2014

Placement of a colonic stenta) Pre-treatment assessmentb) Time limit for stent placementc) Endoscopic or radiological placement?d) Environment and conditioning of thepatiente Spcific equipment and endoscopef) Stent plaement proceureg) Stentsh) Particular situations and locationsi) Tehnical contraindicationsC. Success and complications ofcolonicstenta) Short-term outcomesb) Long-term outcomes. Surgical treatmentE. Colonic stent with curative intet,as a bridge to surgery F. Colonic stent with palliatve intentG. Colonic stent and anti-angiogenictreatmentTke home messages:? Whatever the situation a medical-suricaldiscussion must take place beforeany treatment deciion.The placement of a stent is not recommendedthe abence of clinical andradiological signs of obstruction, venwhen the endoscope cannot passthrough the tumour.? Iindicated, colonic stenting should beconsidered within12 to 24 hours afteradmission.Stent is contraindicated n cases of perforation,clinical and/or radiologicalsigns of colonic suffering, for cancer ofthe low and middle rectum, and whencolonic obstruction is associated withsmall bowel incarceration.Stent must be placed endoscopicallyand under radiological control.Stent placement must be performed bya trained operator in a suitable medicosurgicalunit.The use of polyethylene glycol (PEG)and other oral preparations is contraindicated.Pre- expansion and passage through thetumour stenosis by a large-caliberendoscope must be avoided.In curative intent (non metastatictumour or resectable metastases),stenting cannot be recommended asfirst-line intervention. It remains atherapeutic option in expert centres,pending validation by a randomizedstudy. In the context of curative intent,the surgical treatment of occlusion ispreferred.In the context of palliative intent(unresectable metastases, unresectablepatient), stenting can be recommendedas a first-line intervention. In thissituation surgery is another treatmentoption. In patients with a colonic stent, usinganti-angiogenic therapy may causemore frequent local complications(relative contraindication), and theplacement of a stent in a patient treatedwith anti-angiogenic treatment is notrecommended.The short-term efficacy data of stentsare generally good. There are few dataabout long-term outcomes or aboutpatients receiving chemotherapy withor without targeted therapy.

Darai E.,Ho pital Tenon | Darai E.,French Institute of Health and Medical Research | Darai E.,University Pierre and Marie Curie | Fauvet R.L.,CHU Amiens | And 8 more authors.
Human Reproduction Update | Year: 2013

background: The aim of this systematic review was to evaluate the fertility outcome after borderline ovarian tumor (BOT) management and the results of conservative management, risk of recurrence and alternative options.methods: The search strategy was based on relevant terms concerning BOT using Medline and the Central Cochrane Library. Both early and advanced stages of serous and mucinous BOT were included, but not rare entities such as endometrioid, Brenner or clear-cell BOT because of their low incidence. We considered all articles-case reports, original studies, meta-analyses and reviews-in English and French.results: Overall, 230 articles were screened of which 120 were retained for review. Most pregnancies were spontaneous but some data were obtained from studies analyzing the contribution of assisted reproductive technology (ART). However, not all studies differentiated spontaneous pregnancy from those obtained after fertility treatment including ovulation induction, intrauterine insemination and IVF. Conservative management of early stage BOT resulted in a pooled estimate for spontaneous pregnancy rate of 54% with a low risk of lethal recurrence (pooled estimate: 0.5%). In patients with advanced stage BOT, the spontaneous pregnancy rates was lower (34% in the single series reporting pregnancy rate in this context) and the risk of lethal recurrence increased (pooled estimate: 2%).conclusions: This systematic review underlines that fertility subsequent to treatment of BOT depends mainly on histology and initial staging to distinguish early from advanced stages. In patients with advanced stage BOT, several alternative options to conservative management are available to allow patients to conceive without compromising their prognosis. © The Author 2012. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.

Gossec L.,University of Paris Descartes | Dernis E.,Le Mans Hospital | Boumier P.,CHU Amiens | Sacchi A.,F Quesnay Hospital | And 3 more authors.
Arthritis Care and Research | Year: 2013

Objective An annual assessment of cardiovascular (CV) risk factors in rheumatoid arthritis (RA) is recommended, but its practical modalities have not been determined. The objective was to assess the feasibility and usefulness of a standardized CV risk assessment in RA, performed by rheumatologists during outpatient clinics. Methods We used a cross-sectional design within a network of rheumatologists. Each rheumatologist included 5 consecutive unselected patients with definite RA. Data collection included standardized assessment of CV risk factors: blood pressure, interpretation of glycemia and of lipid levels, and calculation of the Framingham CV risk score. Outcome criteria included feasibility (missing data and time taken to assess the patients) and usefulness (the CV risk assessment was considered useful if at least 1 modifiable and previously unknown CV risk factor was evidenced). Results Twenty-two rheumatologists (77% in office-based practice) assessed 110 RA patients. The mean ± SD age was 57 ± 10 years, and the mean ± SD RA duration was 11 ± 9 years; 50 patients (45%) were treated with biologic agents, and 76% were women. Regarding feasibility, missing data were most frequent for glycemia (27% of patients) and cholesterolemia (14% of patients). The mean ± SD duration of the CV risk assessment was 15 ± 5 minutes. The CV risk assessment was considered useful in 33 patients (30%), evidencing dyslipidemia (15% of patients) or high blood pressure (9% of patients) as the most frequently previously unknown CV risk factor. Conclusion The assessment of CV risk factors is feasible, but labor intensive, during an outpatient rheumatology clinic. This assessment identified modifiable CV risk factors in 30% of the patients. These results suggest that RA patients are not sufficiently assessed and treated for CV risk factors. Copyright © 2013 by the American College of Rheumatology.

Rat A.-C.,University of Paris Descartes | Pouchot J.,University of Paris Descartes | Fautrel B.,University Paris - Sud | Boumier P.,CHU Amiens | And 2 more authors.
Arthritis Care and Research | Year: 2012

Objective. Fatigue frequently occurs in patients with early arthritis (EA). Determinants of its severity are unknown. We aimed to identify the factors associated with fatigue in EA and changes in fatigue after 1 year of followup. Methods. The Evaluation et Suivi de Polyarthrites Indifférenciées Récentes (Assessment and Followup of Early Undifferentiated Arthritis) cohort study is a multicenter, prospective, national cohort of patients with EA. At baseline and every 6 months up to 1 year, we recorded sociodemographic, clinical, and treatment characteristics, Arthritis Impact Measurement Scales 2 Short Form (AIMS2-SF) and Short Form 36 (SF-36) scores for health-related quality of life (HRQOL), and fatigue severity by a visual analog scale (f-VAS) and the SF-36 vitality score (fatigue-SF36). Results. We included 813 patients (77% women, mean ± SD age 48 ± 13 years). At baseline, fatigue as assessed by the f-VAS or fatigue-SF36 was independently associated with young age, female sex, low education level, smoking, increased Disease Activity Score in 28 joints (DAS28), waking up at night, Sjögren's syndrome, and worse AIMS2-SF physical, affect, and symptom scores. At 1-year followup, a favorable change in fatigue scores was associated with increased baseline AIMS2-SF physical and affect scores (better quality of life), high baseline fatigue scores, and improved 1-year AIMS2-SF affect scores. Age, sex, and change in AIMS2-SF physical score, DAS28, and hemoglobin or C-reactive protein level were inconsistently associated with change in fatigue scores. The AIMS2-SF affect score explained most of the variance in baseline fatigue score and was an important factor in 1-year change in fatigue score. Conclusion. Fatigue in EA is multifactorial. Its level and its course are strongly associated with HRQOL, notably the affect dimension. These results should help professionals inform patients about fatigue, explore its causes, and develop tailored interventions. © 2012, American College of Rheumatology.

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