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P0867 Long-term effectiveness, safety, acceptability, and progression of bowel damage of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases treated with intensified doses: The REMSWITCH-VLT study
No full textInternational audienceBackground In the REMSWITCH-VLT (Very-Long Term), we assessed the very long-term effectiveness (including endoscopic and transmural data), safety, acceptability, and progression of bowel damage after switching from IV to SC infliximab in IBD patients initially treated with standard or intensified IV regimens. Methods This multicenter prospective study enrolled consecutive IBD patients in clinical remission (partial Mayo score ≤ 2 or Harvey–Bradshaw Index ≤ 4) on IV infliximab. Patient follow-up was standardized, with data collected on the day of the switch to SC infliximab (corresponding to the theoretical date of the next IV infusion) (= V0), and for long-term follow-up visits at 6, 18, and 42 months (±3 months). Relapse was defined as a partial Mayo score > 2 or Harvey–Bradshaw Index > 4, or an increase in fecal calprotectin ≥ 150 mg/g from baseline (V0). Acceptability was assessed using a numerical scale from 0 to 10. Results A total of 133 patients were included (Table 1). Risk of relapse according to initial IV dose and interval is illustrated in Figure 1. Dose escalation to 240 mg every two weeks or 120 mg weekly recaptured clinical remission in 83.8% (31/37). No significant difference existed between the two intensification strategies (84.2% [16/19] vs 83.3% [15/18], p = ns). Serum infliximab levels increased after switching (p < 0.0001), except in patients previously receiving 10 mg/kg every 4 weeks. At last follow-up, only 3/133 patients (2.2%) had developed anti-infliximab antibodies ( >10 ng/mL). In multivariate analysis, patients previously treated with 10 mg/kg every 4 weeks (OR = 28.4 [5.5–144.2], p < 0.001) and 10 mg/kg every 6 weeks (OR = 5.4 [1.7–17.0], p = 0.003) had an increased risk of relapse at 42 months after switching to standard-dose SC infliximab (120 mg every 2 weeks). Overall, only 22/133 patients (16.5%) discontinued infliximab due to loss of response or intolerance at 42 months. No significant differences were observed according to prior IV dosing regimen. Rates of endoscopic remission and transmural healing under SC infliximab at 42 months were 72.9% (97/133) and 65.4% (87/133), respectively, and 92.4% (97/105) and 82.8% (87/105) among those still receiving SC infliximab at month 42. Only 3/133 patients (2.2%) showed progression of bowel damage, and none required surgery. Acceptability improved significantly after switching to SC infliximab (6.9 ± 1.6 for IV vs 8.6 ± 1.4 at 6 months; p < 0.0001) and remained stable over time (9.0 ± 1.5 at 42 months). No serious adverse events were reported. Conclusion Switching from IV to SC infliximab is safe and well accepted in the very long term, resulting in low rates of clinical, endoscopic, and transmural relapse in IBD patients. Conflict of interest: Prof. Dr. Buisson, Anthony: Consulting fees from: Abbvie, AlfaSigma, Amgen, Arena, Biogen, Celltrion, CTMA, Ferring, Galapagos, Guty Care, Janssen, Hikma, Lilly, Mylan, Nexbiome, Pfizer, Roche, Takeda, Tillotts Lecture fees from: Abbvie, Alfa Sigma, Amgen, Biogen, Celltrion, Ferring, Galapagos, Hikma, Janssen, Lilly, Mayoli-Spindler, MSD, Pfizer, Roche, Sanofi-Aventis, Takeda, Tillotts, Vifor-Pharma Research fundings from: Abbvie, Alfa Sigma, Celltrion, Janssen, Lessaffre, Lilly, Pfizer, Takeda Nachury, Maria: Abbvie, Alfa Sigma, Biosynex, Celltrion, Galapagos, Janssen, Lilly, MSD, Pfizer, Takeda Bazoge, Maëva: No conflict of interest Yzet, Clara: No conflict of interest Wils, Pauline: No conflict of interest Dodel, Marie: No conflict of interest Banana Hamadidi, Amira: No conflict of interest Pereira, Bruno: No conflict of interest Fumery, Mathurin: Grant: Pfizer Personal Fees: Abbvie, Janssen, Takeda, MSD, Biogen, Amgen, Sandoz, Fresenius, Gilead, Celgene, Galapagos, Mylan, Tillots, Ferring, Pfizer, Hospira, CTMA, Boehringer, Lilly, Arena Non-financial Support: Abbvie, Janssen, Takeda, MSD, Galapagos, Ferring, Pfize
Guidelines on Antibiotic Prophylaxis in Surgery 2024
No full textInternational audienceObjectiveTo provide guidelines for antibiotic prophylaxis in surgery and interventional medicine.DesignA consensus committee of 167 experts from the French Society of Anaesthesia and Intensive Care Medicine (Société française d'anesthésie et de réanimation, SFAR) and 28 surgery and interventional medicine learned societies was convened. A formal conflict-of-interest (COI) policy was developed at the beginning of the process and enforced throughout. The entire guideline construction process was conducted independently of any industrial funding (i.e., pharmaceutical, medical devices). The authors were required to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasised.MethodsThe latest SFAR guidelines on antibiotic prophylaxis in surgery and interventional medicine were published in 2018. The literature is now sufficient for an update. The aim of this expert panel guidelines is to evaluate antibiotic prophylaxis in surgery and interventional medicine. The experts studied questions within 2 fields and 9 domains. Each question was formulated according to the PICO (Patients Intervention Comparison Outcome) model and the evidence profiles were produced. An extensive literature review and recommendations were carried out and analysed according to the GRADE® methodology.ResultsThe experts' synthesis work and the application of the GRADE® method resulted in 9 tables of recommendations dealing, by specialty, on antibiotic prophylaxis in surgery and interventional medicine. Among the formalised recommendations, several have high levels of evidence (GRADE 1+) and low levels of evidence (GRADE 2+). For many recommendations, the GRADE method could not be applied, resulting in expert opinions. After 2 rounds of scoring and amendment, strong agreement was reached for all the recommendations.ConclusionsThere was strong agreement among experts for all the recommendations to improve practices for antibiotic prophylaxis in surgery and interventional medicine
French Society for Biological Psychiatry and Neuropsychopharmacology (AFPBN) guidelines for the management of patients with partially responsive depression and treatment-resistant depression: Update 2024
No full textInternational audienceIntroduction: The purpose of this update is to add newly approved nomenclatures and treatments as well as treatments yet to be approved in major depressive disorder, thus expanding the discussions on the integration of resistance factors into the clinical approach.Methods: Unlike the first consensus guidelines based on the RAND/UCLA Appropriateness Method, the French Association for Biological Psychiatry and Neuropsychopharmacology (AFPBN) developed an update of these guidelines for the management of partially responsive depression (PRD) and treatment-resistant depression (TRD). The expert guidelines combine scientific evidence and expert clinicians' opinions to produce recommendations for PRD and TRD.Results: The recommendations addressed three areas judged as essential for updating the previous 2019 AFPBN guidelines for the management of patients with TRD: (1) the identification of risk factors associated with TRD, (2) the therapeutic management of patients with PRD and TRD, and (3) the indications, the modalities of use and the monitoring of recent glutamate receptor modulating agents (esketamine and ketamine).Conclusion: These consensus-based guidelines make it possible to build bridges between the available empirical literature and clinical practice, with a highlight on the 'real world' of the clinical practice, supported by a pragmatic approach centred on the experience of specialised prescribers in TRD
A sham-controlled randomised trial of Tecar therapy for painful caesarean scars: the NOCEPAIN study protocol
No full textInternational audienceIntroduction: Caesarean section is a frequent procedure in obstetrics, accounting for 21.4% of deliveries in France in 2021. Three months after delivery, 15.4% of these women report they still have pain, which can be associated with psychological disorders (including anxiety and depression). Although the only treatment currently recommended is self-massage of the scar, capacitive and resistive electric transfer (Tecar) therapy could improve healing and reduce pain associated with caesarean scars and, therefore, improve women's health-related quality of life (QoL). We aim to evaluate the analgesic efficacy of Tecar therapy for postoperative scar pain and/or discomfort at 3 months postpartum by comparing it with sham Tecar therapy. Methods and analysis: The NOCEPAIN study is a two-centre, single-blind, two-arm, parallel-group, sham-controlled randomised trial currently underway. A total of 120 women with a caesarean scar still painful at 6-8 weeks postpartum, aged 18-50 years, are being randomly allocated in a ratio of 1:1 to either the active Tecar therapy group (active device group) or the sham Tecar therapy group (placebo device group). The women undergo one Tecar or sham session of 20 min per week for 3 weeks. Women in both groups also receive the recommended standard treatment: manual self-massage of the scar.The primary outcome is the caesarean scar pain and/or discomfort at 3 months postpartum, assessed with a Visual Analogue Scale from 0 (no pain and/or discomfort) to 10 (the worst imaginable). Secondary outcomes include validated self-report questionnaires about pain (French adaptations of the McGill Pain Questionnaire and the Brief Pain Inventory, as well as the 'Douleur Neuropathique en 4 Questions' instrument for neuropathic pain), the interference of pain with activities of daily living (Multidimensional Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), health-related QoL (WHO QoL Brief) and sexual functioning (Female Sexual Function Index). The final secondary outcomes are the quality of skin healing (Vancouver Scar Scale), as well as analgesic use and concomitant treatments for analgesia. Ethics and dissemination: The West III Committee for the Protection of Persons (French Institutional Review Board) approved this study and its compliance with French individual data protection laws (number: 2022-A01492-41, 20 March 2023). All participants provide written informed consent before randomisation. The results will be reported in peer-reviewed journals and at scientific meetings.Trial registration number: NCT05696301
Identification of miR136, miR155, and miR183 in Vascular Calcification in Human Peripheral Arteries
No full textInternational audienceVascular calcification (V) is an independent risk factor for all-cause and cardiovascular mortality. Vascular smooth muscle cells (VSMCs) play a major role in VC as they can acquire mineralizing properties when exposed to osteogenic conditions. Despite its clinical impact, there are still no dedicated therapeutic strategies targeting VC. To address this issue, we used human calcified and non-calcified atherosclerotic arteries (ECLAGEN Biocollection) to screen and identify microRNA (miR) associated with VC. We combined non-biased miRNomic (microfluidic arrays) and transcriptomic analysis to select miR candidates and their putative target genes with expression associated with VC and ossification. We further validated miR functional regulation and function in relation to cell mineralization using primary human VSMCs. Our study identified 12 miRs associated with VC in carotid and femoral arteries. Among those, we showed that miR136, miR155, and miR183 expression were regulated during VSMC mineralization and that overexpression of these miRs promoted VSMC mineralization. Cross-analysis of this miRNomic and a transcriptomic analysis led to the identification of CD73 and Smad3 pathways as putative target genes responsible for mediating the miR155 pro-mineralizing function. These results highlight the potential benefit of miR155 inhibition in limiting VC development in peripheral atherosclerotic arteries
Biopharmaceutical evaluation of pentobarbital suppositories using in vitro dissolution tests.
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Development and Characterization Of an Amphotericin B Vaginal Ovule for the Local Treatment of Recurrent Vulvovaginal Candidiasis.
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Rheumatoid purpura and gastrointestinal obstruction
No full textInternational audiencePurpura rheumatoid, also known as Henoch-Sch€ onlein syndrome (HSP) is a small vessels vasculitis associated with immune complex deposits of IgA. Altough it predominantly affects children, it can occur at any age. Gastrointestinal symptoms are frequent, but varying according to clinical series, and may include pain, diarrhea and bleeding. We report the case of a 64-year-old woman who had a relapse of her rheumatoid purpura presenting with terminal ileitis that resulted in an occlusion
