Conectar
by Meirong Shan, Qian Guo, Ruofei Li, Ni Li, Yanhua Fu, Huanyu Qi, Ge Zhang, Qian Wang, Xingli Xu, Jinchuan Lai
Hypertension is one of the main causes of cardiovascular diseases worldwide, affecting over one billion people. Although aliskiren offers a valuable option for inhibiting the renin-angiotensin system, its safety profile in the real world remains insufficiently explored, especially for rare or under-recognized adverse events (AEs), which have not been fully clarified. Therefore, leveraging large-scale post-marketing surveillance data is crucial for identifying rare AEs and guiding safer clinical practice. This study aims to elucidate pharmacovigilance signals associated with aliskiren (an antihypertensive drug) by systematically analyzing the characteristics of adverse events (AEs) from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database and WHO-VigiAccess database, which provides a reliable scientific basis for clinical practice and regulatory decision-making. We conducted a retrospective quantitative analysis of aliskiren-related AE reports from the aforementioned two databases, employing the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) algorithms for signal detection. The results indicate that there were 5,596 and 5,549 aliskiren-related reports in the FAERS and WHO-VigiAccess databases, respectively. The median duration of these AEs during the observation period was 62 days, with an interquartile range (IQR) of 7–282 days. In both databases, signals for aliskiren were distributed across 28 System Organ Classes (SOCs), among which investigations, cardiac disorders, renal and urinary disorders, vascular disorders, and metabolism and nutrition disorders exhibited significant signals based on specific criteria applied across the four algorithms. A total of 607 preferred terms (PTs) with significant disproportionality signals were detected using the four algorithms, including potential AEs not previously well-documented, such as palpitations, myalgia, proteinuria, muscular weakness, pulmonary edema, and pollakiuria. This study not only confirms the known adverse reactions of aliskiren but also uncovers new potential risks, highlighting the importance of strengthening drug safety monitoring to enhance therapeutic efficacy and reduce the risk of adverse reactions. It provides valuable safety insights for physicians considering the use of aliskiren in the management of primary hypertension.The study examines the associations between nursing competence, work environment, and health system resilience. It also analyzes how nursing competence and work environment relate to different patterns of health system resilience.
A multiple center cross-sectional study was conducted between December 2023 and January 2024 across 33 hospitals in eastern China, involving 2435 nurses.
Questionnaires measuring nursing competence, work environment resources, nurse disaster resilience, and organizational commitment to resilience were utilised, along with the collection of additional personal demographic data. Structural equation modelling and cluster analysis were performed to explore the underlying mechanisms within the overall model and across multiple groups. Multivariable regression was conducted to identify variables associated with resilience in different subgroups.
Structural equation modelling demonstrated significant influences of nursing competence and work environment support on system resilience. Cluster analysis identified four resilience patterns: strong, marginal, low, and critical vulnerability. Strong resilience correlated with balanced individual-organizational resources, while vulnerable systems relied heavily on environmental support.
Our findings support policymakers and managers in developing systematic strategies with distinct focal points—targeting nurse workforce investment and optimised work environment—to enhance health system resilience across varying levels of public health emergencies.
This study validated the framework connecting individual and organizational resilience, offering evidence-based insights for nurse training and resource allocation to enhance healthcare systems' adaptability during disasters.
The study addressed how nursing competence and work environment significantly influenced resilience during public health emergencies, identified four resilience patterns, and provided insights to guide policymakers and healthcare managers in developing targeted, effective strategies.
Strengthening the Reporting of Observational studies in Epidemiology checklist.
No patient or public contribution.
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