How LLMs can advance safety case intake-points to consider and insights from a proof of concept [0.03%]
关于如何利用大型语言模型（LLMs）推进安全案例的见解及概念验证成果概述
Hans-Joerg Roemming,Manfred Hauben,Wei Wannhoff et al.
Hans-Joerg Roemming et al.
As per Good Pharmacovigilance Practices, pharmaceutical companies must act on potential adverse reactions to drugs. With significant increases in the number of case reports in recent years, they face pressure to raise the efficiency of thei...
Drug recall, its frequencies and conclusion: a retrospective secondary analysis involving 2-year publicly available data from Nepal [0.03%]
药物召回及其频率和结论：一项为期两年的尼泊尔公开数据的回顾性二次分析
Sachita Barma,Nabin Pathak,Shreya Dhungana et al.
Sachita Barma et al.
Background: Drug recalls safeguard patients from potentially harmful existing pharmaceutical products in the market due to safety concerns or manufacturing issues. ...
Mapping the therapeutic versatility of WHO essential medicines: a systematic analysis of off-label indications [0.03%]
世卫组织基本药物疗效的系统分析：超适应症治疗的广泛性地图集
Ramya Kateel,Shreya Hegde,Sadhana Holla
Ramya Kateel
Background: Off-label prescribing represents an important aspect of clinical practice globally. However, there are limited data on the extent, evidence base and guideline support of off-label indications among the World H...
The real-world safety of lacosamide and perampanel in children: a disproportionality analysis of the FDA Adverse Event Reporting System [0.03%]
来可沙胺和吡仑帕奈在儿童中真实世界的安全性：来自美国食品药品监督管理局不良事件报告系统的信号检测分析
Yani Tan,Cuilin Li,Qin Yi et al.
Yani Tan et al.
Background: Lacosamide and perampanel are two novel antiepileptic drugs with distinct mechanisms of action. However, the real-world evidence of adverse events (AEs) related to these drugs in children is limited. ...
Risk of seizure in patients with prostate cancer treated with enzalutamide in China: a noninterventional study [0.03%]
中国接受恩杂鲁胺治疗的前列腺癌患者的癫痫风险：一项非干预性研究
Yong Wang,Yadong Cui,Yonghong Li et al.
Yong Wang et al.
Background: Enzalutamide, approved in China for the treatment of prostate cancer (PC), has been studied for risk of seizure, but there is limited real-world evidence on this risk in China. Cases of posterior reversible en...
Methotrexate use and risk of abnormal alanine aminotransferase elevation in children with rare inflammatory diseases: a self-controlled case series analysis using a pediatric electronic health record database in Japan [0.03%]
日本儿科电子健康记录数据库中罕见炎症性疾病儿童使用甲氨蝶呤与丙氨酸氨基转移酶异常升高的风险：自身病例对照研究
Masayoshi Nakakuni,Azusa Hara,Kosuke Nakano et al.
Masayoshi Nakakuni et al.
Background: Methotrexate (MTX) is commonly prescribed for pediatric inflammatory diseases. However, clinical data on MTX-induced liver injury in children with rare inflammatory diseases currently remain limited. ...
Pharmacokinetic variability of vancomycin in patients undergoing hematopoietic stem cell transplantation: a retrospective cohort study in Peru [0.03%]
秘鲁造血干细胞移植患者万古霉素的药动学变异：一项回顾性队列研究
Wilder Bolaños-Vargas,Cesar Copaja-Corzo,Alfredo Wong-Chang et al.
Wilder Bolaños-Vargas et al.
Background: Vancomycin exhibits high pharmacokinetic variability, particularly in hematopoietic stem cell transplantation (HSCT) patients, where augmented renal clearance (ARC) may compromise therapeutic exposure. This va...
Real-world pharmacovigilance study on neonatal congenital anomalies associated with maternal drug exposure using the FDA Adverse Event Reporting System [0.03%]
基于美国FDA不良事件报告系统的药物警戒研究及其对新生儿出生缺陷的影响
Jingping Zheng,Zhenpo Zhang,Lin Ma et al.
Jingping Zheng et al.
Background: Congenital anomalies represent a significant public health concern, with maternal drug exposure during pregnancy being a potential modifiable risk factor. While certain medications, such as antiepileptics, are...
Impact of social determinants of health on safety of patients in device clinical trials conducted at a safety-net hospital [0.03%]
社会因素对安全网医院开展的医疗器械临床试验患者安全性的影响研究
Anna C Schneider,Katherine N Cilley,Marina A Malikova
Anna C Schneider
Background: Underrepresentation of various populations in clinical trials limits our understanding of efficacy and safety outcomes, as individuals with diverse backgrounds can respond differently to the same interventions...
Knowledge, attitude, and practice regarding pharmacovigilance among hospital pharmacists in China [0.03%]
中国医院药师关于药物警戒的知识、态度和行为调查
Yinchu Cheng,Tingting Qiu,Xiaole Zhang et al.
Yinchu Cheng et al.
Background: Pharmacovigilance is essential for ensuring patient safety, and hospital pharmacists play a key role in this system. However, their knowledge, attitudes, and practices (KAP) remain understudied in China. ...