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一项基于美国食品药品监督管理局不良事件报告系统数据库的劳拉西泮真实世界药物警戒研究。

A real-world pharmacovigilance study of lorazepam based on the FDA adverse event reporting system database.

作者信息

Fang Chunyue, Xu Xiaoyan, Li Jianyi, Zhong Yuanyuan, Dai Wei, Wen Jin, Yang Qionghui, Chen Ruixiang

机构信息

Department of Pharmacy, The Third People's Hospital of Yunnan Province, Kunming, 650011, Yunnan, China.

College of Pharmacy, Dali University, Dali, 671003, Yunnan, China.

出版信息

Sci Rep. 2025 Jun 24;15(1):20272. doi: 10.1038/s41598-025-05680-z.

Abstract

Lorazepam is extensively used to treat anxiety disorders and anxiety associated with depression. This study evaluates the safety of lorazepam based on real-world data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Data were collected from January 2004 to June 2024. After standardizing the data, we quantified signals using four algorithms, including the Reporting Odds Ratio (ROR), the Proportional Reporting Ratio (PRR), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-Item Gamma Poisson Shrinker (MGPS) to quantize the signal by Bayesian analysis and disproportionation analysis. AE signals were predominantly involved psychiatric disorders, nervous system disorders, injury, poisoning and procedural complications, and cardiac disorders. Notably, new potential AE signals of clinical value were identified in this study, including tachycardia, rhabdomyolysis, neologism, phagophobia, pancreatic fibrosis, and pneumonia. Sex-stratified analysis showed that the risk of poisoning was more pronounced in females and the AEs of sedation were more pronounced in males. Age-stratified analysis demonstrated variations in AEs across different age groups.The findings of this study were consistent with clinical trials, and identified several new potential AE signals. In addition, there are gender and age differences in some AEs. These findings provide valuable insights into lorazepam in clinical practice.

摘要

劳拉西泮被广泛用于治疗焦虑症以及与抑郁症相关的焦虑。本研究基于美国食品药品监督管理局不良事件报告系统(FAERS)的真实世界数据评估劳拉西泮的安全性。数据收集时间为2004年1月至2024年6月。在对数据进行标准化处理后,我们使用四种算法对信号进行量化,包括报告比值比(ROR)、比例报告比值比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项目伽马泊松收缩器(MGPS),通过贝叶斯分析和不成比例分析对信号进行量化。不良事件信号主要涉及精神障碍、神经系统疾病、损伤、中毒及操作并发症和心脏疾病。值得注意的是,本研究发现了具有临床价值的新的潜在不良事件信号,包括心动过速、横纹肌溶解、新语症、恐食症、胰腺纤维化和肺炎。性别分层分析表明,中毒风险在女性中更为明显,而镇静相关不良事件在男性中更为明显。年龄分层分析显示不同年龄组的不良事件存在差异。本研究结果与临床试验一致,并确定了几个新的潜在不良事件信号。此外,一些不良事件存在性别和年龄差异。这些发现为劳拉西泮在临床实践中的应用提供了有价值的见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15be/12187914/8276c5b20f05/41598_2025_5680_Fig1_HTML.jpg

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