RESUMO
BACKGROUND: The use of certain chemotherapy agents is associated with the development of a condition called "chemotherapy-associated neutropenic enterocolitis" (CANE). OBJECTIVE: To determine the risk of CANE associated with the use of each antineoplastic agent. METHODS: The FDA FAERS database of spontaneous adverse reactions was searched for the occurrence of the MedDRA preferred term "neutropenic colitis." RESULTS: The search resulted in 1134 records of patients (535 [47.3%] females, 479 [42.2%] males, sex not specified in 120 [10.6%]) with neutropenic colitis receiving immunosuppressive chemotherapy. The mean age of patients was 47 (SD 22). 22 antineoplastic agents were found to have a strong association (reported odds ratio [ROR] > 100) with the occurrence of CANE; 9 had ROR < 2. CONCLUSION: Drug databases have several limitations in providing updated information about newly approved pharmaceutical adverse events. Signal detection is a diagnostic method recognized as practical in pharmacovigilance. It may be utilized in the FDA's adverse event reporting database and has demonstrated a reasonable predictive performance in signaling adverse events. Our study emphasized the substantial knowledge gap between what we know about the potential risk of CANE caused by antineoplastic agents and the reports of the FDA on their new approved products.
RESUMO
Background: In the current era of monitoring healthcare costs for patients with inflammatory bowel disease (IBD), there has been a shift in the pattern of such costs. In this cross-sectional study conducted in three hospitals in Iran from 2015 to 2021, we aimed to assess the in-hospital costs of IBD and identify predictors of higher total hospital costs in hospitalized patients with IBD. Methods: This cross-sectional study was conducted at three hospitals in Iran. For the purpose of this study, we collected demographic and clinical information, as well as cost data for patients with IBD. Two non-parametric statistical procedures, classification and regression trees (CARTs) and quantile regression forests (QRFs), were employed to identify the main factors related to hospital costs of IBD, which served as the dependent variable in our analysis. Results: During 7 years, 930 admissions occurred in these three hospitals. 22.3% of patients (138 of 619) were readmitted, and 306 (49.4%) were male. The mean age of the patients was 33 (SD=18.9) years. A total of 454 patients (73.3%) had ulcerative colitis (UC), and 165 patients (26.7%) had Crohn's disease (CD). Hotelling and medication costs accounted for the largest share of the total hospital costs, with percentages of 30.61% and 23.40%, respectively. Length of stay (LOS) was found to be the most important variable related to hospital costs of IBD in both QRF and CART models, followed by age and year of hospital admission in QRF. Additionally, in the CART model, hospital type and year of hospital admission were also significant predictors of hospital costs for patients with IBD. Conclusion: The present study showed that LOS, age, year of admission, and the hospital where the patient is admitted are all important factors that determine hospital costs for patients with IBD. Patients admitted for 20.5 days or longer had the highest hospital costs. These findings can be used as thresholds for future DRG policies.
