Development and validation of a MedDRA-based signal detection construct for drug-induced neurobehavioral impairment [0.03%]
一种基于MedDRA的药物所致神经行为障碍信号检测模型的构建及验证
Christopher D Breder
Christopher D Breder
Background: The FDA's Guidance for an industry evaluating drug effects on the ability to operate a motor vehicle describes the need to evaluate drug-induced neurobehavioral impairment. However, the guidance does not provi...
Disproportionality analysis of off-label intravitreal bevacizumab in the FDA Adverse Event Reporting System database [0.03%]
基于FDA不良事件数据库进行贝伐单抗超说明书使用的 disproportionality 分析
Homero Contreras-Salinas,Janet Cristina Vázquez-Beltrán,Gisela García-Sánchez et al.
Homero Contreras-Salinas et al.
Background: Bevacizumab, an anti-vascular endothelial growth factor agent initially approved for cancer treatment, is widely used off-label in retinal vascular diseases; however, this use may carry safety risks, particula...
Development and prospective validation of a machine learning model for risk stratification of drug-induced liver injury using real-world clinical data [0.03%]
基于真实世界临床数据的机器学习模型的开发及前瞻性验证用于药物性肝损伤的风险分层
Ngan Thi Tran,Tung My Pham,Mai Thi Quynh Ngo et al.
Ngan Thi Tran et al.
Background: Drug-induced liver injury (DILI) is difficult to diagnose and manage in routine care because it lacks pathognomonic biomarkers and is often recognized only after clinically meaningful injury has occurred. Exis...
Sex-specific risk factors for genital infections associated with SGLT2 inhibitors in type 2 diabetes: a retrospective cohort study and disproportionality analysis using JADER [0.03%]
2型糖尿病患者使用SGLT2抑制剂关联的生殖器感染的性别特异性风险因素：基于JADER的回顾性队列研究和不良事件信号强度分析
Ayami Kajiwara-Morita,Sawa Kugimoto,Kentaro Oniki et al.
Ayami Kajiwara-Morita et al.
Background: Genital infections are notable adverse events that may lead to nonadherence to or discontinuation of sodium-glucose cotransporter 2 (SGLT2) inhibitors, essential agents in the management of type 2 diabetes (T2...
Prolonged neonatal phosphate retention and transient hypercalcemia following antenatal Burosumab exposure: a pharmacovigilance alert [0.03%]
抗妊娠期布舒硫酸盐暴露的新生儿长时间磷酸盐滞留和短暂高钙血症：药物警戒警示
Guido Filler,Funmbi Babalola,Andrea Cowan et al.
Guido Filler et al.
Burosumab is a monoclonal antibody targeting fibroblast growth factor 23 (FGF23) and is approved for the treatment of X-linked hypophosphatemia. Its use during pregnancy has not been studied, and fetal exposure may affect neonatal mineral m...
Team approach to polypharmacy evaluation and reduction for general practice patients with dementia: the Australian TAPERDem study [0.03%]
澳大利亚TAPERDem研究：初级保健痴呆症患者多药治疗的团队评估和减少方法
Christopher Etherton-Beer,Amy Theresa Page,Hui Wen Quek et al.
Christopher Etherton-Beer et al.
Background: Polypharmacy is common in people with dementia but may be insufficiently tailored to personal preferences and goals, particularly in the presence of a life-limiting condition. ...
Sequential analysis for post-marketing drug safety surveillance using routinely collected electronic healthcare data: a scoping review [0.03%]
基于常规收集的电子医疗数据的药品上市后安全性监测序列分析：系统评价
Yixin Sun,Qian Ding,Hongting Nie et al.
Yixin Sun et al.
Background: Routinely collected electronic healthcare data have created new opportunities for active, near real-time post-marketing drug safety surveillance. Sequential analysis offers a natural framework for periodic sig...
Muscle relaxant use and the associated risk of Sjögren's syndrome and dry eye disease (including keratoconjunctivitis sicca) in patients with ankylosing spondylitis: a population-based cohort study [0.03%]
肌肉松弛剂的使用与强直性脊柱炎患者的Sjögren综合征和干眼病（包括keratoconjunctivitis sicca）相关风险：一项基于人群的队列研究
Weijie Wang,Jingyang Huang,Shujun Xia et al.
Weijie Wang et al.
Background: Muscle relaxants are widely used for the treatment of ankylosing spondylitis (AS) and inevitably have many adverse reactions. Individuals with AS frequently present with ocular symptoms. However, the associati...
Safety of belimumab during pregnancy: associations with maternal and fetal or newborn adverse outcomes based on FAERS data [0.03%]
贝利木单抗孕期使用的安全性：基于FAERS数据的母体及胎儿或新生儿不良结局分析
Yujie Lin,Jing Yao
Yujie Lin
Background: Belimumab is a biologic agent used in the treatment of systemic lupus erythematosus (SLE). However, its safety profile during pregnancy has not been fully established, and real-world evidence regarding its ass...
Detection of clinically significant drug-drug interactions in serotonin syndrome: a multisource real-world data and pharmacovigilance study [0.03%]
基于多源真实世界数据和药物警戒的临床显著药物相互作用所致血清素综合征检测研究
Shanshan Xu,Zhihui Song,Dong Wang et al.
Shanshan Xu et al.
Background: Serotonin syndrome (SS) is a potentially life-threatening condition increasingly driven by complex drug-drug interactions (DDIs) as serotonergic agents expand beyond psychiatry into pain management and infecti...