胃肠外直接凝血酶抑制剂在特殊人群中的临床应用专家共识
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篇名: 胃肠外直接凝血酶抑制剂在特殊人群中的临床应用专家共识
TITLE: Expert consensus on the clinical application of parenteral direct thrombin inhibitors in special populations
摘要: 目的 针对胃肠外直接凝血酶抑制剂(DTIs)在特殊人群中使用的临床问题,形成专家共识。方法由四川省医学科学院·四川省人民医院(电子科技大学附属医院)牵头,组建涵盖临床药学、心脏外科、产科、儿科、循证医学等多领域专家的共识制订工作组。通过文献调研与德尔菲法,筛选聚焦特殊人群胃肠外DTIs使用有效性、安全性的相关临床问题;采用“人群-干预-对照-结局”框架进行结构化设计;系统检索中国期刊全文数据库、PubMed、Embase等数据库,纳入随机对照研究、队列研究、系统评价等相关文献并进行整合。依据推荐意见分级的评估、制订及评价(GRADE)系统评估证据质量,通过3轮德尔菲调研及专家共识会议形成推荐意见。结果与结论最终筛选出7个临床问题(共识率超过90%),形成了7项关于特殊人群(包括儿童、妊娠期、肝肾功能异常、肠系膜静脉血栓、易栓症患者等)用药的推荐意见,明确以上特殊人群中胃肠外DTIs的首选药物、剂量范围、监测指标及安全管理策略。本共识基于现有最佳证据制定,可为特殊人群胃肠外DTIs的临床应用提供循证指导。
ABSTRACT: OBJECTIVE To form an expert consensus addressing clinical issues regarding the use of parenteral direct thrombin inhibitors (DTIs) in special populations. METHODS Led by the Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital(the Affiliated Hospital of UESTC), a multidisciplinary working group was formed comprising experts from multiple fields, including clinical pharmacy, cardiac surgery, obstetrics, pediatrics and evidence-based medicine. Through literature review and the Delphi method, clinical questions regarding the efficacy and safety of parenteral DTIs used in special populations were identified. A structured design was adopted using the “Population-Intervention-Comparison-Outcome” (PICO) framework;systematic searches were conducted in CJFD, PubMed, Embase and other databases. Relevant evidence from randomized controlled trials,cohort studies and systematic reviews were included and synthesized. Evidence quality was assessed using the Grading of Recommendations Assessment,Development and Evaluation (GRADE) approach, and recommendations were formulated through three rounds of Delphi surveys and expert consensus meetings. RESULTS &CONCLUSIONS Seven clinical questions were ultimately selected (with a consensus rate exceeding 90%), resulting in the formulation of seven recommendations on the use of parenteral DTIs in special populations, including children, pregnant women, patients with hepatic or renal impairment, patients with mesenteric venous thrombosis, and individuals with thrombophilia. These recommendations clarify the preferred agents, dosing ranges, monitoring parameters, and safety management strategies for parenteral DTIs in these special populations. 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 special populations.
期刊: 2026年第37卷第08期
作者: 姚芯;边原;韩丽珠;尹琪楠;雷洋;万子梦;黄璐瑶;赵丹洁;严郁;李芹;胡宝荣
AUTHORS: YAO Xin,BIAN Yuan,HAN Lizhu, YIN Qinan,LEI Yang,WAN Zimeng,HUANG Luyao,ZHAO Danjie,YAN Yu,LI Qin,HU Baorong
关键字: 胃肠外直接凝血酶抑制剂;特殊人群;血栓栓塞;抗凝治疗;止血策略;专家共识
KEYWORDS: parenteral direct thrombin inhibitors; special populations; thromboembolism; anticoagulation therapy; hemostatic
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