Real-World Safety of Vedolizumab in Inflammatory Bowel Disease: A Retrospective Cohort Study Supported by FAERS Signal Analysis.

: Vedolizumab is a gut-selective anti-integrin monoclonal antibody approved for the treatment of inflammatory bowel disease (IBD). While clinical trials have demonstrated a favorable safety profile, real-world studies are essential for identifying rare adverse events (AEs) and evaluating post-marketing safety. This study assessed vedolizumab's safety in a real-world cohort and supported the detection of potential safety signals.

Reversible Inhibition of Cysteine Proteases Using S-Methyl Methanethiosulfonate.

Cysteine proteases find applications in diverse fields, but their susceptibility to autolysis poses storage challenges. Unlike irreversible inhibitors, S-methyl methanethiosulfonate (MMTS) enables enzyme reactivation, offering an ideal solution for preventing autolysis during storage and allowing subsequent protein activation when required. Here, we describe effective methods for inhibiting and reactivating papain, providing valuable insights for enhancing the storage and usability of cysteine proteases in various scientific, medical, and industrial applications.

Review and External Evaluation of Population Pharmacokinetic Models for Vedolizumab in Patients with Inflammatory Bowel Disease: Assessing Predictive Performance and Clinical Applicability.

Background/objectives: Several population pharmacokinetic models of vedolizumab (VDZ) are available for inflammatory bowel disease (IBD) patients. However, their predictive performance in real-world clinical settings remains unknown. This study aims to externally evaluate the published VDZ pharmacokinetic models, focusing on their predictive performance and simulation-based clinical applicability.

Vedolizumab Clearance as a Surrogate Marker for Remission in Inflammatory Bowel Disease Patients: Insights from Real-World Pharmacokinetics.

Vedolizumab (VDZ) is approved in the treatment of patients with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). VDZ exhibits considerable variability in its pharmacokinetic (PK) profile, and its exposure-response relationship is not yet fully understood. The aim was to investigate the variability in VDZ trough levels and PK parameters, to assess the relationship between VDZ PK and biochemical response, as well as clinical and endoscopic outcomes.

Insights into treatment of complex Crohn's perianal fistulas.

Complex perianal fistula is a common complication of Crohn's disease (CD) which leads to negative impact on patient's quality of life. Successful management of the disease requires a multidisciplinary approach, including a gastroenterologist and a colorectal surgeon, applying combined surgical and medical therapy. One of frequently practiced surgical procedures is seton placement in the fistula tract, which is used to control perianal sepsis and drain the fistula, while preventing recurrent abscess formation.

Remodeling of extracellular matrix of the lamina propria in the uninvolved human rectal mucosa 10 and 20 cm away from the malignant tumor.

In recent years, it has been demonstrated that malignancy arises and advances through the molecular interplay between tumor cells and non-malignant elements of the tumor stroma, that is, fibroblasts and extracellular matrix. However, in contrast to the mounting evidence about the role of tumor stroma in the genesis and progression of the malignant disease, there are very few data regarding the uninvolved stromal tissue in the remote surrounding of the tumor. Using the objective morphometric approach in patients with adenocarcinoma, we demonstrate the remodeling of extracellular matrix of the lamina propria in the uninvolved rectal mucosa 10 and 20 cm away from the neoplasm.

[Awareness detection in anaesthesia during otorhino-maxillofacial surgery using bispectral index-monitoring technology].

Introduction: Awareness is characterized by intraoperative presence of consciousness and recollecting of the events occurring during general anaesthesia. The study was aimed at detecting awareness during general anaesthesia in otorhino-maxillofacial procedure.

Methods: The study is a part of a prospective, phase IV academic study carried out at the Department for Otorhinolaringology, Clinical Centre of Serbia, and Maxillofacial Surgery.

[Anesthetic dose correction in hospital pharmacology using bispectral index monitoring technology].

Introduction: Modern hospital pharmacology insists on assessing each patient's individual characteristics because of their influence on drug pharmacokinetics and pharmacodynamic effect. The study was aimed at evaluating anesthetic doses in patients with benign larynx tumors treated by general endotracheal anesthesia during endoscopic surgery procedures.

Material And Methods: The study is a part of a prospective, phase IV, academic study carried out at the Clinical Center of Serbia.

[Costs of anesthetics and other drugs in anesthesia].

Introduction: Drugs are real and transparent costs of treatment, which are subject to constant monitoring and changes. The study was aimed at measuring and analyzing consumption of anesthetics and other drugs in anesthesia in the Clinical Centre of Serbia.

Material And Methods: This paper is part of a five-year (2005-2009), academic, pharmacoeconomic retrospective-prospective study (the 4th phase).

[Radiotherapeutical chromosomal aberrations in laryngeal cancer patients].

Introduction: The authors present the results of cytogenetic analysis of 21 patients with laryngeal carcinomas diagnosed and treated in the period 1995-2000 at the Institute of Otorhinolaryngology and Maxillofacial Surgery, Clinical Center of Serbia and Clinical Center of Novi Sad.

Material And Methods: The patients were specially monitored and the material was analyzed at the Institute of Human Genetics of the School of Medicine in Belgrade as well as in the Laboratory for Radiological Protection of the Institute of Occupational and Radiological Health "Dr Dragomir Karajovic" in Belgrade.

Results: The incidence of chromosomal aberrations and incidence of exchange of material between sister chromatids were observed in the preparation of the metaphasic lymphocyte chromosomes of the peripheral blood obtained in the culture.

Antibiotic consumption monitoring at the Institute of Otorhinolaryngology and Maxillofacial Surgery--Clinical Center of Serbia in 2001-2003.

Background: At the Clinical Center of Serbia (CCS), which includes 21 Institutes and 6 Centers, approximately 10% of the total annual budgetary funds is spent on the drugs. During the studied period, it was estimated that 0.5% of the above amount has been spent at the Institute for Otorhinolaryngology and Maxillofacial surgery (Institute for ORL and MFS), Clinical Center of Serbia.