口服抗凝剂和胃肠道出血:来自FDA不良事件报告系统数据库的药监察见解
Jiale Chen1, Guoquan Chen1, Wei Hu2
1Department of Pharmacy, Affiliated Jinhua Hospital, Medical College of Zhejiang University/ Jinhua municipal hospital, Jinhua, China.
International journal of surgery (London, England)
|November 5, 2025
概括
口服抗凝剂 (OAC) 携带胃肠道出血 (GIB) 的风险. 直接口服抗凝剂 (DOACs) 通常比维生素K抗剂 (VKAs) 具有较低的GIB风险,但特定的DOACs如达比加特兰可能会增加较低的GIB风险.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 胃肠病学 胃肠病学
背景情况:
- 关于与口服抗凝剂 (OAC) 相关的胃肠道出血 (GIB) 风险存在争议.
- 对OAC相关的GIB风险进行系统评估对于患者安全至关重要.
研究的目的:
- 系统地使用药监数据评估OAC相关的GIB风险.
- 为了比较各个OAC在GIB的不同地点的GIB风险概况.
主要方法:
- 使用不成比例分析和多变量后勤回归的回顾性药监测研究.
- 从2008年第一季度到2025年第一季度对FDA不良事件报告系统数据的分析1.
- 根据GIB位置 (下部,上部,未指明) 和患者因子进行分层.
主要成果:
- 确定了24000多个与OAC相关的GIB病例.
- 直接口服抗凝剂 (DOAC) 显示GIB风险低于维生素K对抗剂 (VKA).
- 达比加特兰呈现较低GIB的风险较高;特定的OAC对不同的GIB位置具有不同的风险概况,大多数事件发生在治疗3个月内75岁以上的患者中.
结论:
- 与VKAs相比,DOAC与较低的GIB风险有关.
- 不同的OAC对于特定的GIB地点具有独特的风险概况,为抗凝管理提供信息.
- 了解这些细微风险对于优化患者护理和最大限度地减少不良事件至关重要.
相关概念视频
Pharmacovigilance
1.6K
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...
1.6K
Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants
2.1K
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...
2.1K
Anticoagulant Drugs: Low-Molecular-Weight Heparins
1.6K
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...
1.6K
Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors
1.1K
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...
1.1K
Venous Thrombosis III: Interprofessional Care
273
Venous thrombosis requires effective prevention and treatment strategies to improve patient outcomes and reduce potential complications.Prevention StrategiesHealthcare providers must prioritize preventing venous thromboembolism (VTE) for all adult patients upon admission. Interventions depend on bleeding and thrombosis risk, medical history, current medications, diagnoses, planned procedures, and patient preferences. Patients on bed rest should change positions every two hours and, if not...
273
Venous Thrombosis IV: Nursing Management
191
Nursing management begins with a thorough assessment of the patient's health history. Key factors include trauma to veins, peripherally inserted central catheters, varicose veins, recent pregnancy or childbirth, surgery, bacteremia, prolonged bed rest, atrial fibrillation, COPD, heart failure, cancer, coagulation disorders, myocardial infarction, spinal cord injury, stroke, prolonged travel, recent bone fractures, and dehydration. Review medication intake, particularly oral contraceptives,...
191

