RESUMO
Background: On 15 June 2020, the United States Food and Drug Administration (FDA) approved lurbinectedin for treating adult patients with metastatic small-cell lung cancer whose disease has progressed despite prior platinum-based chemotherapy. Following its market approval, safety data on lurbinectedin in large populations is currently lacking. Therefore, this study aims to evaluate adverse events (AEs) associated with lurbinectedin using the FDA's Adverse Event Reporting System (FAERS)database. Methods: Data concerning lurbinectedin from the FAERS database were extracted for the period from June 2020 to September 2023. Four disproportionality analysis algorithms were utilized to assess potential AEs linked to lurbinectedin: reporting odds ratio (ROR), proportional reporting ratio, disproportionate multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network. These algorithms were applied to quantify signals of lurbinectedin-related AEs. Result: A total of 5,801,535 AE reports were retrieved from the FAERS database, with 511 related to lurbinectedin. These lurbinectedin-induced AEs were observed in 23 system organ classes (SOCs). After simultaneously applying the four algorithms, 47 lurbinectedin-induced AE signals were detected in 23 SOCs. At the SOC level, blood and lymphatic system disorders (ROR, 6.70; 95% confidence interval [CI]: 5.47-8.22) were the only SOC that met all four algorithms. Lurbinectedin's most frequent adverse event was death (ROR: 6.11%, 95% CI: 4.86-7.68), while extravasation exhibited the strongest signal intensity in the ROR algorithm (ROR: 326.37%, 95% CI: 191.66-555.75). Notably, we identified a novel signals: tumor lysis syndrome (ROR: 63.22%, 95% CI: 33.87-117.99). The mean time of onset of AEs was 66 days, the median time of onset was 25 days (interquartile range: 8-64 days), and most AEs occurred within the first month of lurbinectedin treatment. Conclusion: Our study provided a comprehensive evaluation of lurbinectedin's safety profile in the post-marketing setting. In addition to the adverse events consistent with the existing clinical trials and labeling information, we have also identified an unreported signal related to tumor lysis syndrome. This finding will better guide the clinical practice of lurbinectedin and provide valuable evidence for future research.
RESUMO
Despite considerable interest in medical and pharmaceutical fields, there remains a notable absence of functional textiles that concurrently exhibit antibacterial and antioxidant properties. Herein, a new composite fabric constructed using nanostructured bacterial cellulose (BC) covalently-linked with cerium oxide nanoparticles (BC@CeO2NPs) is introduced. The synthesis of CeO2NPs on the BC is performed via a microwave-assisted, in situ chemical deposition technique, resulting in the formation of mixed valence Ce3+/Ce4+ CeO2NPs. This approach ensures the durability of the composite fabric subjected to multiple washing cycles. The Reactive oxygen species (ROS) scavenging activity of CeO2NPs and their rapid and efficient eradication of >99% model microbes, such as Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus remain unaltered in the composite. To demonstrate the feasibility of incorporating the fabric in marketable products, antimicrobial face masks are fabricated with filter layers made of BC@CeO2NPs cross-linked with propylene or cotton fibers. These masks exhibit complete inhibition of bacterial growth in the three bacterial strains, improved breathability compared to respirator masks and enhanced filtration efficiency compared to single-use surgical face masks. This study provides valuable insights into the development of functional BC@CeO2NPs biotextiles in which design can be extended to the fabrication of medical dressings and cosmetic products with combined antibiotic, antioxidant and anti-inflammatory activities.