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1.
Ann Hematol ; 103(7): 2347-2354, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38771499

ABSTRACT

Ropeginterferon-alfa2b (ropegIFNα2b) is a long-acting IFN formulation with broad FDA/EMA approval as a therapy of polycythemia vera (PV) with no symptomatic splenomegaly. There is currently lack of information on the real-world patient selection, including the impact of local reimbursement policies, and drug management, particularly: type/timing of screening and follow-up tests; absolute/relative contraindications to therapy; ropegIFNα2b dose and combinations with hydroxyurea. As a sub-analysis of the PV-ARC retrospective study (NCT06134102), we here report our monocenter experience with ropegIFNα2b in the period from January 2021, corresponding to drug availability outside clinical trial, and December 2023. Among the 149 patients with EMA/FDA indication, only 55 (36.9%) met the local reimbursement criteria and 18 (12.1%) received ropegIFNα2b. Thanks to appropriate screening, relative/absolute contraindications to ropegIFNα2b were detected and managed in a multidisciplinary manner. Efficacy and safety of ropegIFNα2b was confirmed, with 3 cases of early molecular response. General use of low ropegIFNα2b dose, with frequent need for hydroxyurea combinations, was noted. This real-world experience suggests a significant impact of local regulations on drug prescription and the need for greater real-world data collection on ropegIFNα2b in PV patients. Also, it describes appropriate multidisciplinary screening and monitoring procedures during ropegIFNα2b therapy.


Subject(s)
Interferon alpha-2 , Interferon-alpha , Polycythemia Vera , Polyethylene Glycols , Recombinant Proteins , Humans , Polycythemia Vera/drug therapy , Interferon-alpha/therapeutic use , Interferon-alpha/administration & dosage , Polyethylene Glycols/therapeutic use , Polyethylene Glycols/administration & dosage , Recombinant Proteins/therapeutic use , Interferon alpha-2/therapeutic use , Male , Middle Aged , Retrospective Studies , Female , Aged , Patient Selection , Treatment Outcome , Adult , Hydroxyurea/therapeutic use , Hydroxyurea/administration & dosage
2.
J Dairy Sci ; 102(6): 5005-5018, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31005329

ABSTRACT

Thermization is a sub-pasteurization heat treatment of cheese milk (at 57-68°C for 15-30 s) aimed to reduce the number of undesirable microbial contaminants with reduced heat damage to the indigenous milk enzymes. In this work, the effects of milk thermization on the compositional parameters, proteolysis indices, free fatty acid levels, and low molecular weight metabolite profiles of ovine cheese were studied. Cheese samples at different ripening stages and produced in 2 different periods of the year were analyzed. While the effects of milk thermization on cheese macro-compositional parameters and free fatty acid levels were not evident due to the predominant effects of milk seasonality and cheese ripening stage, the gas chromatography-mass spectrometry based metabolomics approach of ovine cheese produced from raw and thermized milk highlighted strong differences at the metabolite level. Discriminant analysis applied to gas chromatography-mass spectrometry data provided an excellent classification model where cheese samples were correctly classified as produced from raw or thermized milk. The metabolites that mostly changed due to the thermization process belonged to the classes of free amino acids and saccharides. Gas chromatography-mass spectrometry-based metabolomics has proven to be a valid tool to study the effect of mild heat treatments on the polar metabolite profile in ovine cheese.


Subject(s)
Cheese , Milk/chemistry , Pasteurization , Amino Acids/chemistry , Animals , Female , Gas Chromatography-Mass Spectrometry/veterinary , Metabolomics , Sheep
3.
J Biol Regul Homeost Agents ; 32(2): 425-431, 2018.
Article in English | MEDLINE | ID: mdl-29577710

ABSTRACT

Cytokine proteins may have important roles during different human physiological and pathological processes. In the oral cavity, the bone loss and periodontal tissue pathology was related to inflammatory process activation. The aim of the present study was to assess the effects of etiological periodontal therapy with and without the use of Low Level Laser Therapy (LLLT) on clinical periodontal parameters and interleukin (IL)-1ß level in gingival crevicular fluid (GCF) from chronic periodontitis (CP) patients. Thirty non-smoker CP patients were selected from the Foggia University Dental Clinic and other 2 private dental clinics. All patients were divided into two homogeneous randomized groups: 15 patients were treated with only scaling and root planing (group 1) and 15 patients with scaling and root planing etiological treatment and LLLT (group 2). In all sites, at baseline before treatment, the periodontal pocket depth (PPD) and bleeding on probing (BOP) were measured. In the PPD sites, the GCF samples were collected from 30 deep (≥5 mm) and shallow (≤3 mm) sites and IL-1ß were evaluated at baseline, after 10 days and 1 month. In all the samples at baseline, the IL-1ß concentration in GCF and BOP rate were significantly higher at deep PPD sites than at the shallow ones. After 10 days in all samples no PPD improvement was observed in the BOP rate but the IL-1 ß level was statistically significantly improved (p<0.005) in group 2 compared to group 1. At 10 days and 1 month, in all deep PPD sites, PPD and BOP improvements were observed. At same time, IL-1ß levels were lower and statistically significantly (p<0.005) improved in group 2 compared to group 1. The results confirmed that the periodontal etiology treatment of deep PPD sites with or with-out associated LLLT promotes periodontal health. Etiological treatment associated with LLLT, improves BOP and inflammation in periodontal disease. Moreover, the IL-1ß concentration changes in GCF suggest these cytokines as a predictable marker of gingival inflammation in chronic periodontitis patients.


Subject(s)
Chronic Periodontitis/radiotherapy , Gingival Crevicular Fluid/chemistry , Interleukin-1beta/metabolism , Adult , Female , Humans , Low-Level Light Therapy/methods , Male , Middle Aged , Pilot Projects
4.
J Biol Regul Homeost Agents ; 32(2): 433-437, 2018.
Article in English | MEDLINE | ID: mdl-29577711

ABSTRACT

Numerous studies have established statistical associations of the IL-1 gene cluster polymorphisms with various inflammatory diseases. Deriving from that, the present study was intended to determine whether single-nucleotide polymorphisms (SNPs) in these gene are also associated with periodontal disease in a Linkage disequilibrium analysis. This investigation also created two haplotype blocks, both consisting of two different SNPs. Recent theoretical analyses indicate that research with an interpretation of periodontal disease as a complex, oligogenic disorder, with IL-1 genetic variation contributes an important but not exclusive influence on disease risk. Further studies are needed to confirm these results and to understand the mechanisms behind the observed association between IL-1 SNPs and periodontal disease.


Subject(s)
Genetic Predisposition to Disease/genetics , Interleukin-1/genetics , Periodontal Diseases/genetics , Adult , Female , Haplotypes , Humans , Male , Middle Aged , Polymorphism, Single Nucleotide
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