使用FDA不良事件报告系统对静脉血栓栓塞的不同皮下抗凝剂的安全性比较
Bo-Wen Lu1, Jia-Cheng Li1,2, Ming-Tao Wen2
1The First Clinical Medical School, Shandong University of Traditional Chinese Medicine, Jinan, 250014, Shandong, China.
Scientific reports
|May 16, 2025
概括
这项研究比较了老年人中的 fondaparinux ,enoxaparin 和dalteparin 的不良药物事件. 芬达巴努克斯对特定出血的风险较高,而埃诺沙巴林和达尔特巴林对氨酸诱导的血小板缩有显著的信号.
科学领域:
- 药物监督 药物监督 药物监督
- 血液学 血液学 血液学
- 临床药理学 临床药理学
背景情况:
- 静脉血栓塞栓症 (VTE) 是一个主要的全球健康问题,特别是在老年人中.
- 芬达巴林克斯,埃诺沙巴林和达尔特巴林是广泛使用的抗凝剂.
- 评估这些抗凝固剂的安全性概况和不良药物事件 (ADEs) 对患者护理至关重要.
研究的目的:
- 为了比较 fondaparinux ,enoxaparin 和dalteparin 的安全性.
- 识别和分析与每个抗凝剂相关的特定不良药物事件 (ADEs).
- 为个人风险评估和抗凝治疗患者监测策略提供信息.
主要方法:
- 使用FDA不良事件报告系统 (FAERS) 数据 (2004年第一季度 - 2024年第二季度) 的回顾性药监测研究.
- 提取关于作为主要可疑药物的芬达巴素,埃诺沙巴和达尔特巴的报告.
- 使用ROR,PRR,BCPNN和MGPS进行不成比例性分析,使用MedDRA (v23.0) 分类的ADE.
主要成果:
- FAERS数据包括470份关于芬达巴林克斯的报告,1375份关于埃诺沙巴林的报告,以及344份关于达尔特巴林的报告.
- 大多数病例涉及60岁以上的患者,住院治疗是最常见的结果.
- 芬达巴努克斯显示出强烈的信号,用于腹内,肌肉和逆皮质血瘤; 埃诺沙巴林和达尔特巴林显示出信号,用于肝素诱导的血小板缩 (HIT) 和逆皮质出血.
结论:
- 对于 fondaparinux सोडियम, enoxaparin सोडियम和 dalteparin सोडियम,存在不同的不良药物事件概况.
- 个性化风险评估对于优化抗凝治疗至关重要.
- 密切监测患者至关重要,特别是在高风险人群中,以确保安全.
相关概念视频
Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants
1.1K
Oral anticoagulants are vital tools in preventing and treating blood clotting disorders. This diverse class of medications can be categorized as vitamin K antagonists, exemplified by warfarin, and direct thrombin inhibitors (DTIs), such as dabigatran, as well as factor Xa inhibitors, including rivaroxaban.
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...
1.1K
Anticoagulant Drugs: Low-Molecular-Weight Heparins
583
Hemostasis is a crucial process that prevents excessive blood loss from damaged blood vessels. It involves various mechanisms such as vasoconstriction, platelet adhesion and activation, and fibrin formation. The importance of each mechanism depends on the type of vessel injury. In contrast, thrombosis is the abnormal formation of a blood clot within the blood vessels, leading to potential complications if the clot obstructs blood flow. Thrombosis can be caused by increased coagulability of the...
583
Pharmacovigilance
761
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
761
Therapeutic Index
4.0K
The therapeutic index of a drug is a key parameter in pharmacology that quantifies the relative safety of a drug by calculating the ratio between the dose that causes toxicity in half the population (50%) to the dose that proves to be effective for half the population (50%). It provides a spectrum of doses for a particular drug ranging from effective to potentially toxic. To illustrate, consider an anticoagulant agent like warfarin. It possesses a narrow window within its therapeutic index to...
4.0K
Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors
436
Antiplatelet drugs emerge as frontline defenders against the insidious threat of thromboembolic diseases, where abnormal clots obstruct vital blood vessels. These drugs stand as bulwarks, inhibiting platelet aggregation and clot formation, thereby mitigating the risk of life-threatening conditions like myocardial infarction, coronary artery disease, and thrombotic strokes.
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
436
Routes of Drug Administration: Parenteral
1.8K
The administration of drugs via parenteral routes allows for direct drug introduction into the systemic circulation, resulting in high bioavailability because the medication bypasses the harsh conditions of the gastrointestinal tract and hepatic metabolism.
The intravenous route (IV) of drug administration can be further categorized into two types. The bolus injection administers the entire dose rapidly, while an intravenous infusion slowly delivers smaller doses steadily.
The IV route is often...
The intravenous route (IV) of drug administration can be further categorized into two types. The bolus injection administers the entire dose rapidly, while an intravenous infusion slowly delivers smaller doses steadily.
The IV route is often...
1.8K


