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  • 1
    Online Resource
    Online Resource
    Immune-mediated colitis associated with ocrelizumab: A new safety risk
    SAGE Publications ; 2023
    In:  Multiple Sclerosis Journal Vol. 29, No. 10 ( 2023-09), p. 1275-1281
    Details
    In: Multiple Sclerosis Journal, SAGE Publications, Vol. 29, No. 10 ( 2023-09), p. 1275-1281
    Abstract: An association between certain immunomodulatory therapies (rituximab, ipilimumab, and other immune checkpoint inhibitors) and inflammatory (non-ischemic and non-infectious) colitis in oncologic and non-oncologic patient populations is well documented in the medical literature. Objective: The purpose of this case series is to describe adverse event reports of new onset, inflammatory colitis in association with ocrelizumab in patients with multiple sclerosis submitted to U.S. Food and Drug Administration (FDA) or published in the medical literature. Methods: The FDA Adverse Event Reporting System (FAERS) and medical literature were searched. Results: A review of postmarketing cases from FAERS and published medical literature identified 38 cases consistent with inflammatory, non-ischemic, and non-infectious colitis in association with ocrelizumab. The median time-to-onset was 8 months. Cases were reported using the following diagnostic terms: Crohn’s disease (13), unspecified colitis (11), microscopic colitis (5), ulcerative colitis (5), medication-induced colitis (3), and autoimmune colitis (2). Conclusions: This case series highlights ocrelizumab induced immune-mediated colitis that can be clinically severe and potentially life-threatening. Based on the findings of this review, the ocrelizumab Prescribing Information was amended to include immune-mediated colitis in the Warnings and Precautions section.
    Type of Medium: Online Resource
    ISSN: 1352-4585 , 1477-0970
    URL: Article
    DOI: 10.1177/13524585231195854
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2008225-3
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  • 2
    Online Resource
    Online Resource
    Polypropylene Degradation on Co-Rotating Twin-Screw Extruders
    MDPI AG ; 2023
    In:  Polymers Vol. 15, No. 9 ( 2023-05-04), p. 2181-
    Details
    In: Polymers, MDPI AG, Vol. 15, No. 9 ( 2023-05-04), p. 2181-
    Abstract: Nowadays, usable plastic materials with defined properties are created by blending additives into the base polymer. This is the main task of compounding on co-rotating twin-screw extruders. The thermal and mechanical stress occurring in the process leads to a mostly irreversible damage to the material. Consequently, the properties of the polymer melt and the subsequent product are affected. The material degradation of polypropylene (PP) on a 28 mm twin-screw extruder has already been studied and modeled at Kunststofftechnik Paderborn. In this work, the transferability of the previous results to other machine sizes and polypropylene compounds were investigated experimentally. Therefore, pure polypropylene was processed with screw diameters of 25 mm and 45 mm. Furthermore, polypropylene compounds with titanium dioxide as well as carbon fibers were considered on a 28 mm extruder. In the course of the evaluation of the pure polypropylene, the melt flow rates of the samples were measured and the molar masses were calculated on this basis. The compounds were analyzed by gel permeation chromatography. As in the previous investigations, high rotational speeds, low throughputs and high melt temperatures lead to a higher material degradation. In addition, it is illustrated that the previously developed model for the calculation of material degradation is generally able to predict the degradation even for different machine sizes by adjusting the process coefficients. In summary, this article shows that compounders can use the recommendations for action and the calculation model for the material degradation of polypropylene, irrespective of the machine size, to design processes that are gentle on the material.
    Type of Medium: Online Resource
    ISSN: 2073-4360
    URL: Article
    DOI: 10.3390/polym15092181
    Language: English
    Publisher: MDPI AG
    Publication Date: 2023
    detail.hit.zdb_id: 2527146-5
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  • 3
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    Online Resource
    Terlipressin therapy is associated with increased risk of colonisation with multidrug‐resistant bacteria in patients with decompensated cirrhosis
    Wiley ; 2024
    In:  Alimentary Pharmacology & Therapeutics Vol. 59, No. 7 ( 2024-04), p. 877-888
    Details
    In: Alimentary Pharmacology & Therapeutics, Wiley, Vol. 59, No. 7 ( 2024-04), p. 877-888
    Abstract: Patients with cirrhosis are susceptible to develop bacterial infections that trigger acute decompensation (AD) and acute‐on‐chronic liver failure (ACLF). Infections with multidrug‐resistant organisms (MDRO) are associated with deleterious outcome. MDRO colonisation frequently proceeds MDRO infections and antibiotic therapy has been associated with MDRO colonisation. Aim The aim of the study was to assess the influence of non‐antibiotic medication contributing to MDRO colonisation. Methods Three hundred twenty‐four patients with AD and ACLF admitted to the ICU of Frankfurt University Hospital with MDRO screening were included. Regression models were performed to identify drugs associated with MDRO colonisation. Another cohort ( n = 129) from Barcelona was included to validate. A third multi‐centre cohort ( n = 203) with metagenomic sequencing data of stool was included to detect antibiotic resistance genes. Results A total of 97 patients (30%) were identified to have MDRO colonisation and 35 of them (11%) developed MDRO infection. Patients with MDRO colonisation had significantly higher risk of MDRO infection than those without ( p = 0.0098). Apart from antibiotic therapy (odds ratio (OR) 2.91, 95%‐confidence interval (CI) 1.82–4.93, p 〈 0.0001), terlipressin therapy in the previous 14 days was the only independent covariate associated with MDRO colonisation in both cohorts, the overall (OR 9.47, 95%‐CI 2.96–30.23, p 〈 0.0001) and after propensity score matching (OR 5.30, 95%‐CI 1.22–23.03, p = 0.011). In the second cohort, prior terlipressin therapy was a risk factor for MDRO colonisation (OR 2.49, 95% CI 0.911–6.823, p = 0.075) and associated with risk of MDRO infection during follow‐up ( p = 0.017). The validation cohort demonstrated that antibiotic inactivation genes were significantly associated with terlipressin administration ( p = 0.001). Conclusions Our study reports an increased risk of MDRO colonisation in patients with AD or ACLF, who recently received terlipressin therapy, while other commonly prescribed non‐antibiotic co‐medications had negligible influence. Future prospective trials are needed to confirm these results.
    Type of Medium: Online Resource
    ISSN: 0269-2813 , 1365-2036
    URL: Issue
    URL: Article
    DOI: 10.1111/apt.v59.7
    DOI: 10.1111/apt.17899
    Language: English
    Publisher: Wiley
    Publication Date: 2024
    detail.hit.zdb_id: 2003094-0
    SSG: 15,3
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