Analysis of adverse drug reactions of Denosumab (Prolia) in osteoporosis based on FDA adverse event reporting system (FAERS).

Objective: To comprehensively analyze the ADRs associated with Denosumab (Prolia) in the treatment of osteoporosis using data from the FAERS database, and gain a better understanding of the potential risks and side effects of Denosumab (Prolia) therapy. Methods: Data of Denosumab (Prolia) were collected from the FAERS database covering the period from first quarter of 2010 to the third quarter of 2023. Disproportionality analysis was performed by calculating the reporting odds ratios (ROR), proportional reporting ratio (PRR), and Bayesian analysis confidence propagation neural network (BCPNN) to detect positive signals. Results: Totally, 17,985,365 reports were collected from the FAERS database, 1,97,807 reports of Denosumab (Prolia) were identified as the "primary suspected (PS)" ADRs. Denosumab (Prolia) induced ADRs occurred in 27 organ systems. 38 significant disproportionality PTs satisfying with the three algorithms were retained at the same time. Unexpected significant ADRs such as bone density abnormal and immobile also occur. The majority of the ADRs occurred within the first 30 days after Denosumab (Prolia) initiation. Conclusion: Based on the American FAERS database, the high frequency ADRs of Denosumab (Prolia) were hypocalcaemia, bone density abnormal, eczema, rebound effect, spinal deformity, etc. Clinical use of this drug should focus on this part of ADRs. Attention should also be paid to newly discovered ADRs, such as immobile, menopausal symptoms, etc., to avoid more serious consequences. Cohort studies, more detailed and comprehensive case information, and long-term clinical investigations are needed to confirm these results and to further understand the safety profile of Denosumab (Prolia).

Global burden of rheumatoid arthritis among adolescents and young adults aged 10-24 years: A trend analysis study from 1990 to 2019.

BACKGROUND: In recent decades, there has been a global increase in the burden of rheumatoid arthritis (RA) among adolescents and young adults (AYAs), making it a significant public health issue. However, our understanding of the disease burden, harm, and influencing factors of RA in this population remains insufficient. This study aimed to assess the trends in RA burden among AYAs aged 10-24 years from 1990 to 2019 at the global, regional, and national levels. METHODS: Incidence, prevalence, and disability-adjusted life years (DALYs) rate per 100,000 population, as well as average annual percentage changes (AAPCs), of RA among individuals aged 10-24 years were reported globally, regionally, and nationally based on the Global Burden of Diseases, Injuries, and Risk Factors Study 2019 (GBD 2019). These global trends were further analyzed by age, sex, and Sociodemographic index (SDI). Joinpoint regression analysis was used to determine the year in which the most significant changes in global trends occurred. RESULTS: Globally, the incidence of RA among AYAs increased from 4.98 per 100,000 population in 1990 to 5.41 per 100,000 population in 2019, with an AAPCs of 0.29 (95%CI: 0.26, 0.32, p < 0.001). The most significant increase occurred in 2000, while the most significant decrease occurred in 2014. The prevalence increased from 34.11 per 100,000 population in 1990 to 36.34 per 100,000 population in 2019, with an AAPCs of 0.22 (95%CI: 0.19, 0.24, p<0.001); The most significant increase was observed in 2000, and the most significant decrease occurred in 2014. DALYs rate with RA were 5.96 per 100,000 population in 1990 and 5.79 per 100,000 population in 2019 for AYAs, with an average decrease of 0.1 years per year (AAPCs = -0.1, 95%CI: -0.2, -0.01, p = 0.04). In terms of gender, the incidence, prevalence, and DALYs rate were higher for females compared to males during the same period. Regarding age, the incidence, prevalence, and DALYs rate increased with increasing age. Based on the SDI quintile, the incidence, prevalence, and DALYs rate of RA were highest in countries with high SDI and lowest in countries with low SDI from 1990 to 2019. However, the relationship between incidence and SDI is non-linear. In terms of regions, Tropical Latin America exhibited the highest incidence, prevalence, and DALYs rate, while Andean Latin America experienced the most rapid increase in incidence and prevalence. Southern Latin America saw the fastest growth in DALYs rate, whereas Southern Sub-Saharan Africa witnessed the most significant decline. CONCLUSION: In conclusion, the study revealed an overall increase in the incidence and prevalence of RA among adolescents and young adults (AYAs) over the past three decades, while DALYs rate remained relatively stable. Furthermore, the incidence, prevalence, and DALYs rate of RA were found to increase with age. Fortunately, recent proactive preventive measures and treatment methods have shown promising results. Moving forward, it is crucial to prioritize the female population and AYAs patients in order to further alleviate the global burden of RA.

Association between systemic immune-inflammation index and risk of lower extremity deep venous thrombosis in hospitalized patients: a 10-year retrospective analysis.

Background: The systemic immune-inflammation index (SII), as a novel inflammatory biomarker, has recently attracted attention in cardiovascular disease research. However, the relationship between SII and risk of lower extremity deep venous thrombosis (LEDVT) remains unclear to date. Thus, this study aimed to explore the association in a large sample over a 10-year period (2012-2022). Methods: All hospitalized patients undergoing lower extremity compression ultrasonography (CUS) examination were consecutively screened by searching our hospital information system database. The receiver operating characteristic (ROC) curve analysis was used to identify the optimal cut-off value for high and low SII group. Multivariate logistic regression analyses were performed to investigate the relationship between SII and LEDVT risk. Propensity score matching (PSM), subgroup and sensitivity analyses were also conducted. Moreover, restricted cubic spline (RCS) regression and two-piecewise linear regression models were used to assess the dose-response relationship between natural log transformed SII [ln(SII)] and risk of LEDVT. Results: A total of 16,725 consecutive hospitalized patients were included, and 1,962 LEDVT events occurred. After adjusting for confounding factors, patients in the high SII group (≥ 574.2 × 109/L) showed a 1.740-fold risk of LEDVT (95% CI: 1.546-1.959, P < 0.001), and elevated ln(SII) was associated with a 36.1% increased risk of LEDVT (95% CI: 1.278-1.449, P < 0.001). PSM, subgroup and sensitivity analyses confirmed the robustness of the association. A non-linear relationship was observed (P non-linear < 0.001), with a threshold value of 5.6 × 109/L for all LEDVT events. Above the threshold, each unit increase in ln(SII) had a 1.369-fold higher risk of LEDVT (95% CI: 1.271-1.475, P < 0.001). The association also existed in both distal and proximal LEDVT. Conclusion: Elevated SII is significantly associated with an increased risk of LEDVT in hospitalized patients. Additionally, the association is non-linear and exhibit a threshold effect.

Frailty is associated with an increased risk of postoperative pneumonia in elderly patients following surgical treatment for lower-extremity fractures: A cross-sectional study.

Elderly patients with lower-extremity fractures are at high risk of postoperative pneumonia (POP) after surgery due to longtime bed rest. This study aimed to explore whether preoperative frailty is an independent risk factor for POP in elderly patients undergoing surgical treatment for lower-extremity fractures. The study adopted a cross sectional design with 568 patients (≥60 years) admitted to a tertiary hospital in China from January 1, 2021 to June 30, 2022, for surgical intervention of a significant lower-extremity fracture. Preoperative frailty was assessed using the CFS (Clinical Frailty Scale). POP was assessed based on the classic diagnostic criteria reported in previous studies. Univariate and multiple logistic regression analyses were conducted to determine the impacts of preoperative frailty on POP. Of the 568 elderly patients, 65 (11.4%) developed pneumonia during postoperative hospitalization. There were significant differences among gender, hypoproteinemia, type of anesthesia, history of chronic obstructive pulmonary disease (COPD), and CFS scores. Multiple regression analysis revealed that the risk of POP in vulnerable, mildly frail, and severely frail patients increased by 2.38 times (P = .01, 95% CI [1.22-1.91]), 3.32 (P = .00, 95% CI [2.39-5.61]), and 5.36 (P = .00, 95% CI [3.95-6.52]), significantly. 12.8% of patients with hip fractures and 8.9% of patients with other main types of lower-extremity fractures developed POP. However, the difference between hip and non-hip fractures was not statistically significant (P > .05). Preoperative frailty increases the risk of POP in elderly patients after surgical treatment of main lower-extremity fractures. The severer the preoperative frailty is, the higher the risk of preoperative pneumonia is in elderly patients with lower-extremity fractures. CFS is simple and feasible for the assessment of frailty in elderly patients with lower-extremity fractures. Preoperative frailty assessment and appropriate management strategies should be considered in the perioperative management of elderly patients with lower-extremity fractures.