Given the critical role of dextran sulfate sodium (DSS)-induced ulcerative colitis (UC) mouse models in the appraisal of associated therapeutic drugs, the optimization of the administration method and dosages is of paramount importance. Therefore, UC was induced in mice through the gavage administration of a DSS solution instead of free drinking water. The effects of varying daily dosages (2, 4, 6, and 8 g/kg) and frequencies (once or twice) of administration on the body weight and survival rate of the model mice were evaluated. Concurrently, the inflammatory indicators and tissue sections of the model mice were thoroughly evaluated. The results revealed that when the daily dosage reached 8 g/kg, the dosage exhibited a high level of toxicity, resulting in a high mortality rate among the mice. The DSS administration of 6 g/kg*2 not only elicited conspicuous symptoms, significant weight loss, substantial shortening of the colon, and significant changes in various inflammatory indicators, such as myeloperoxidase (MPO), nitric oxide (NO), reactive oxygen species (ROS), and glutathione (GSH), but it also maintained a high survival rate in the UC mice. The findings from this experiment lay a solid experimental foundation for future research on drugs intended for the treatment of UC.

Cyclin-dependent kinase (CDK)-4/6 inhibitors have significantly improved outcomes in several cancers but can also induce various organ system toxicities, including musculoskeletal disorders. This study aimed to comprehensively characterize the musculoskeletal adverse events (MSAEs) associated with CDK4/6 inhibitors based on real-world data. Reports of MSAEs linked to CDK4/6 inhibitors from the first quarter (Q1) of 2015 and 2023 Q4 were extracted from the FAERS. Descriptive analyses evaluated report frequencies over time and patient characteristics. Disproportionality analyses using reporting odds ratios (RORs) identified signals for specific musculoskeletal preferred terms (PTs). Time-to-onset analyses examined the temporal patterns of MSAEs. A total of 10,095 MSAE reports associated with CDK4/6 inhibitors were identified, most involving Palbociclib (n = 7819). The median age of patients was 64 years (IQR: 55–72), predominantly female (97.73%). Most reports were submitted by consumers (47.62%) and the majority of reports were from the United States (71.53%). Disproportionality analyses revealed distinct signals, with Ribociclib showing prominent signals for bone pain and bone lesions, and Abemaciclib for osteonecrosis of the jaw and pathological fractures. Palbociclib demonstrated a consistent but less pronounced signal across musculoskeletal PTs. Time-to-onset analyses demonstrated a significantly longer onset of MSAEs for Palbociclib (median 82 days, IQR[14–311]) compared to Abemaciclib (32.5 days, IQR[12–119]) and Ribociclib (34 days, IQR[8-177]) using the nonparametric Kruskal-Wallis test (P-value = 3.048e-11). Musculoskeletal toxicities is a significant adverse event that affects drug safety. Early identification and proper management of these events are crucial for patients receiving CDK4/6 inhibitors. Further research is warranted to elucidate the underlying mechanisms and improve risk mitigation strategies.

Objective: This study aims to help women recover their gastrointestinal function after a cesarean delivery. We will use a nurse-led, evidence-based approach and evaluate how well it works in a clinical setting. Methods: Using the continuous quality improvement model, evidence was translated into clinical quality audit indicators to develop interventions. These interventions compared the implementation of evidence-based practices before (August - December 2023) and after (March - July 2024) enhancing medical staff’s knowledge. The aim was to improve the execution rate of indicators related to gastrointestinal function recovery. Key variables analyzed included perioperative fasting duration, pain (VAS), anxiety (GAD-7), time to first flatus, and incidences of thirst, hunger, nausea/vomiting, and abdominal distension. Results: The study incorporated sixteen pieces of evidence and established eighteen review criteria. A comparative analysis conducted before and after the implementation of evidence-based practice revealed a significant increase in the evidence-based assessment score for healthcare professionals regarding the promotion of post-caesarean gastrointestinal function recovery, with scores rising from 57.84 ± 7.50 to 90.00 ± 7.07 points (P < 0.01). Additionally, the execution rate of all eighteen review criteria showed significant improvement (P < 0.05). The time to first anal exhaust was reduced from 32.19 ± 20.48 hours to 20.25 ± 8.14 hours (P < 0.01). Furthermore, the incidence of thirst decreased from 56.41% to 23.81% (χ² = 35.97, P < 0.01), hunger from 48.72% to 16.67% (χ² = 38.13, P < 0.01), nausea or vomiting from 35.90% to 11.90% (χ² = 25.93, P < 0.01), and bloating from 27.56% to 14.29% (χ² = 8.70, P = 0.003). Conclusion: The implementation of nurse-led, multidisciplinary evidence-based practice effectively facilitates gastrointestinal recovery and improves postoperative comfort and satisfaction among women following elective caesarean section.

This study aimed to analyze the FAERS database to identify adverse event associated with sunitinib to offer valuable insights for the judicious utilization of medication in clinical settings. Various disproportionality analysis techniques, such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPN), and multi-gamma Poisson shrinkage (MGPS), were employed to analyze adverse drug reaction (ADR) reports pertaining to sunitinib in the FAERS database from its market introduction up to the first quarter of 2023. Subsequently, a secondary screening process was conducted to identify reliable positive signals. The analysis of sunitinib adverse event signals at the system-organ classification level encompassed 27 organ systems, with gastrointestinal and endocrine disorders emerging as the predominant SOCs. A total of 237 significant adverse events meeting all four algorithms were detected. Notably, this study revealed previously unreported adverse events, including pleural effusion and ascites, while potential adrenal toxicity-related adverse events, highlighted in the drug's specification, were not identified in this analysis. The study examined the relationship between the duration of sunitinib dosing and the onset of adverse events, revealing a median onset of 48 days (IQR, 15-160 days). The findings indicated that a majority of adverse events manifested early in the dosing period, with tumor progression, disease progression, and mortality becoming more prevalent after one year of treatment. In the clinical utilization of sunitinib, vigilant monitoring of potential adverse reactions is imperative during the initial phase of drug administration. In addition to the documented adverse reactions outlined in the drug specification, healthcare providers should remain attentive to potential adverse reactions such as pleural effusion, ascites, and tumor development.

Objective: ¹⁷⁷ Lu-DOTA-TATE (LUTATHERA) is a crucial radiopharmaceutical in neuroendocrine tumor therapy, yet real-world long-term safety data across diverse populations remain limited. This study aims to comprehensively assess the postmarketing safety of LUTATHERA using a real-world pharmacovigilance database. Methods: We conducted an observational study using the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) database from the first quarter of 2018 to the third quarter of 2024. Reports were filtered for LUTATHERA as the primary suspect. The characteristics and onset time of LUTATHERA-associated adverse events were analyzed. The disproportionality analysis via reporting odds ratio (ROR) and Bayesian confidence propagation neural network was employed to identify significant adverse event signals associated with LUTATHERA. Results: A total of 4058 reports identified with LUTATHERA as the primary suspected drug. LUTATHERA was linked to increased risks in in general disorders, gastrointestinal, hematological, metabolic, hepatobiliary, and endocrine systems. Common adverse events like nausea, thrombocytopenia, and anemia aligned with clinical trial data. Novel and serious signals such as intestinal obstruction [ROR = 5.62, information component (IC) = 2.49], gastrointestinal hemorrhage (ROR = 2.84, IC = 1.50), carcinoid heart disease (ROR = 571.03, IC = 8.93), and esophageal varices hemorrhage (ROR = 11.92, IC = 3.57) were also identified. LUTATHERA-associated adverse events typically occurred within 2 months, with a median onset of 54 days. Conclusion: This study enhances understanding of LUTATHERA’s safety profile, offers clinicians valuable data, and advocates continuous pharmacovigilance. Continuous pharmacovigilance and potential label updates are recommended.