达比加群酯药物利用评价标准的建立与回顾性分析

目的:建立达比加群酯药物利用评价标准(drug use evaluation, DUE),为临床合理应用达比加群酯提供参考。方法:以达比加群酯药品说明书为基础,参考相关指南和文献,通过专家咨询法制订达比加群酯药物利用评价标准,并采用回顾性研究方法,对湖北省某大型三甲医院2021年1-6月使用达比加群酯的住院患者用药进行合理性评价,具体包括适应证、用法用量、联合用药、禁忌证、不良反应监测及药物转换等。结果:共纳入501份病例,完全符合评价标准的合理率为91.42%,不合理应用常见于适应证不适宜(2.2%)和用法用量不适宜(2.0%),同时存在30.3%的联合用药的高风险。结论:建立的达比加群酯的DUE具有较强的科学性、实用性和可行性,该院达比加群酯临床应用中尚存在一些问题,应进一步加强干预,促进临床合理用药。     

住院患者达比加群酯的临床应用调查与分析

目的:调查并分析苏州大学附属第一医院(以下称“我院”)达比加群酯的使用现状,为规范其临床应用提供依据。方法:汇总国内外达比加群酯的相关指南和专家共识及建议并结合药品说明书形成其临床应用合理性评价标准(以下简称“标准”),同时回顾性收集2020年度入住我院并使用达比加群酯的患者资料,对其适应证、禁忌证、用法用量、药物相互作用、桥接转换及围手术期使用等情况进行统计分析。结果:共检索到文献978篇,最终纳入11篇形成“标准”。213例使用达比加群的患者中有56例(26.29%)存在用药不合理现象,其中无适应证用药3例(1.41%),禁忌证用药1例(0.47%),用法用量不合理19例(8.92%),桥接转换不合理4例(1.88%),存在不良药物相互作用1例(1.08%),围手术期用药不合理28例(13.15%)。结论:我院住院患者达比加群酯的临床应用与“标准”仍存在一定差距,且不同科室间存在明显的差异,尤以给药频次和围手术期用药不合理最为突出。药师应及时关注达比加群酯及血栓栓塞性疾病相关循证医学证据的更新,同时积极参与全院患者的抗凝药物管理,进一步规范达比加群酯的临床应用。     

Atrial fibrillation: an epidemic in the elderly

Atrial fibrillation is the most common cardiac arrhythmia that increases in prevalence with age. As the general population grows older, general practitioners will more frequently see this disease in their clinic population. In order to most effectively treat these patients, physicians need to understand key issues, including the use of rhythm control versus ventricular rate control and how to reduce the risk of ischemic stroke. This article will review recent advancements in the understanding of the pathophysiology, management, stroke risk stratification and prevention of thromboembolic complications in atrial fibrillation.     

Novel anticoagulants for stroke prevention in atrial fibrillation: safety issues in the elderly

Vitamin K antagonists (VKAs) are the most widely used anticoagulants for stroke prevention in patients with atrial fibrillation (AF). Recently, the US FDA approved three novel anticoagulants that work through inhibition of coagulation cascade independent of Vitamin K-dependent enzymatic reactions and, therefore, should have less food–drug interactions. Since AF is a disease of the aging heart, it is important to assess safety and efficacy of these new anticoagulants in elderly patients. We reviewed age-related changes in pharmacokinetics and pharmacodynamics observed with senescence and the effects of these changes on novel anticoagulants, known and anticipated drug and food interactions, and challenges related to bleeding complications and temporary discontinuation prior to surgery or interventional procedure. Although advantageous to VKA in age groups represented in trials, there are lack of data on VKA usage in older–elderly patients; additional research and post-marketing analysis in older–elderly patients are needed.     

达比加群酯预防非瓣膜性房颤患者血栓栓塞的有效性和安全性

目的 比较达比加群酯和调整剂量的华法林预防非瓣膜性房颤患者血栓栓塞的有效性和安全性.方法 选取2013年9月至2014年6月收治的166例非瓣膜性房颤患者进行回顾性分析,分为达比加群酯组(110 mg/次,2次/d)和华法林组(初始剂量为2.5 mg/d),国际标准化比值(INR)在2.0~3.0之间.随访6个月,比较两组血栓栓塞事件及出血事件的发生情况.结果 有效性终点指标:达比加群酯组无血栓栓塞事件的发生,华法林组发生缺血性脑卒中1例,两组患者血栓栓塞事件发生率差异无统计学意义(0.0% vs 1.2%, P>0.05);安全性终点指标:两组均无重要出血事件发生,达比加群酯组发生轻微出血事件4例,华法林组发生轻微出血事件5例,两组患者出血事件发生率差异无统计学意义(P>0.05).结论 达比加群酯预防非瓣膜性房颤患者血栓栓塞的有效性和安全性与华法林相当.     

利伐沙班、达比加群与肝素在全髋或全膝置换后的抗凝治疗

背景：目前临床上主要使用依诺肝素预防全髋或全膝置换后静脉血栓形成,但其并非百分之百的有效与安全。 目的：系统评价新型口服抗凝药利伐沙班和达比加群与依诺肝素在临床随机对照试验中预防全髋或全膝置换后静脉血栓形成的有效性和安全性。 方法：计算机检索Pubed、ScienceDirect、Cochrane Library、CBM、CNKI,收集有关利伐沙班、达比加群与依诺肝素在全髋或全膝置换后抗凝治疗有效性和安全性的临床随机对照试验,并评价纳入研究的方法学质量,统计软件用RevMan5.1.0。 结果与结论：共纳入14个临床随机对照试验,共17 212例患者。Meta分析显示,利伐沙班组总静脉血栓发生率、大静脉血栓及有症状静脉血栓发生率均低于依诺肝素组;利伐沙班和达比加群组深静脉血栓发生率低于依诺肝素组;利伐沙班和达比加群与依诺肝素在出血率方面差异无显著性意义。提示新型口服抗凝药对全髋或全膝置换后深静脉血栓的预防效果优于依诺肝素,且利伐沙班优于达比加群。     

New oral anticoagulants to revolutionise venous thromboembolism (VTE) management

Warfarin, a vitamin K antagonist has been the mainstay of venous thromboembolism treatment for over 60 years. However, it has significant limitations in relation to achieving a safe and therapeutic efficacy. Evolution in the development of oral anticoagulants to offset the drawbacks of warfarin, has led to the introduction of two new oral anticoagulants, namely dabigatran, a direct thrombin inhibitor and rivaroxaban, a direct factor Xa inhibitor. This paper examines the potential of the two new oral anticoagulants to offer a safer therapeutic alternative to warfarin, as well as their clinical efficacy in relation to the prevention of venous thromboembolism in patients undergoing hip and knee replacement surgery. In seven randomized clinical trials, dabigatran has demonstrated noninferior efficacy to enoxaparin, with a similar safety profile. Following a single technology appraisal of dabigatran, The National Institute of Clinical Excellence (NICE) have now endorsed its clinical efficacy as a serious alternative to low molecular weight heparin and fondaparinux.Three randomized clinical trials have also concluded that rivaroxaban is as efficacious and safe as enoxaparin in the prevention of venous thromboembolism for patients undergoing major orthopaedic surgery of the lower limbs. In a single technology appraisal, rivaroxaban within its marketing authorisation was recommended by NICE in April 2009, as an option for the prevention of venous thromboembolism in adults having elective hip or knee replacement surgery.