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Fifth People’s Hospital of Sichuan Province， Chengdu 611130， China；11. Dept. of Pharmacy， the First
Affiliated Hospital of Zhengzhou University， Zhengzhou 450052， China；12. Dept. of Pharmacy， 363 Hospital，
Chengdu 610097， China；13. Dept. of Pharmacy， West China Hospital， Sichuan University， Chengdu 610041，
China；14. Dept. of Pharmacy， West China Tianfu Hospital， Sichuan University， Chengdu 610213， China]

ABSTRACT OBJECTIVE To form an expert consensus on the clinical application of parenteral direct thrombin inhibitors
（DTIs） in patients during the perioperative period. METHODS Led by Sichuan Academy of Medical Sciences & Sichuan
Provincial People’s Hospital （the Affiliated Hospital of UESTC）， a multidisciplinary working group was established. Through
literature review and the Delphi method， clinical questions related to the rational perioperative use of parenteral DTIs were
identified. A structured design was adopted using the “Population-Intervention-Comparison-Outcome” framework； systematic
searches were conducted in CNKI， Medline， Embase and other databases. Relevant evidence from randomized controlled trials and
cohort studies was included and synthesized. Evidence quality was assessed using the Grades of Recommendations Assessment，
Development and Evaluation （GRADE） approach， and recommendations were formulated through multiple rounds of Delphi
surveys and expert consensus meetings. RESULTS & CONCLUSIONS Seven recommendations （each with an expert consensus
rate exceeding 90%） on the use of parenteral DTIs in perioperative patients were developed. These recommendations specify drug
selection， dosing ranges， key monitoring points， and safety management strategies for parenteral DTIs in various scenarios，
including the perioperative period of ventricular assist device implantation， the perioperative period of cardiac surgery， perioperative
patients with lower-extremity atherosclerotic disease， the perioperative period of percutaneous coronary intervention in patients with
acute coronary syndrome， the perioperative period of carotid artery stenting in patients with carotid stenosis， the perioperative
period of patients with right heart thrombosis， and patients who develop related thrombosis and dysfunction after a central venous
catheter insertion. In addition， warning and management pathways for perioperative bleeding and thrombotic events were proposed.
This expert consensus， which is formulated based on the best available evidence， provides evidence-based guidance for
standardized and individualized use of parenteral DTIs in perioperative period.
KEYWORDS parenteral direct thrombin inhibitors； perioperative period； anticoagulation； thromboembolism； rational drug use；
expert consensus

几百年来，从肝素和维生素K拮抗剂等传统抗凝药床实践仍存在药物选择缺乏精准依据、围手术期停药及
物，再到直接凝血酶抑制剂（direct thrombin inhibitors，重启方案不统一、不良反应应对措施不规范等问题，严
DTIs）和直接Ⅹa因子抑制剂等新型抗凝药物，抗凝治疗重影响了患者的用药安全。基于此，本共识制订工作组
及相关药物的研究取得了重大进展。阿加曲班和比伐基于对现有最佳证据的系统性检索与评价，制定了《围
芦定是目前我国临床常用的主要胃肠外DTIs，通过与凝手术期应用胃肠外直接凝血酶抑制剂的专家共识》。
血酶直接结合、阻断其与底物的相互作用而发挥抗凝效 1 共识目的与适用范围
应，为降低肝素诱导的血小板减少症（heparin-induced 本共识聚焦于需接受抗凝治疗的围手术期患者，旨
thrombocytopenia，HIT）发生风险及规范成人择期经皮在为使用胃肠外DTIs进行围手术期抗凝治疗的临床医
冠脉介入术（percutaneous coronary intervention，PCI）等师和药师提供标准化的指导，以提升胃肠外DTIs使用的
的抗凝管理提供了重要的治疗选择。与传统抗凝药物规范性、有效性与安全性。
相比，DTIs 作用直接、高效，无需辅助因子，且与凝血酶 2 共识的制订单位与注册
的结合可逆，表现出显著的临床有效性和安全性 [1―2] 。本共识由四川省医学科学院·四川省人民医院（电
随着胃肠外DTIs在临床应用中的日益普及，其治疗子科技大学附属医院）药学部发起，由中国心胸血管麻
场景持续延伸。在此背景下，围手术期这一特殊阶段的醉学会心血管药学分会和成都药学会血栓与止血专委
用药管理所面临的挑战，逐渐成为临床关注的焦点问会委员组成的专家组提供方法学与证据支持。共识的
题。由于DTIs具有使用过程高度依赖凝血指标监测、抗制订严格遵照《世界卫生组织指南制订手册（第 2
[8]
[7]
凝效应受患者围手术期生理指标波动影响显著等特性，版）》、《临床实践指南的制订方法与步骤》、《STAR 指
加之手术可能引起炎症、应激、器官灌注及代谢抑制、内南评级提高检验医学指南与共识的科学性、透明性和适
[10]
[9]
皮-凝血轴失衡、胃肠活动停滞等生理性改变进而系统用性》以及其他相关指南的要求与格式。本共识在
性改变药物的药动学和药效学特征 [3―6] ，故当前围手术制订初期撰写了计划书，并已在国际实践指南注册与透
期患者应用胃肠外DTIs仍面临诸多问题。目前，国内临明化平台（http：//www.guidelines-registry.cn）进行了注册

· 690 · China Pharmacy 2026 Vol. 37 No. 6 中国药房 2026年第37卷第6期

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