Safety and efficacy of fondaparinux use in hemodialysis patients with heparin-induced thrombocytopenia: a systematic review.

IF 2.7 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-09-09 DOI:10.1007/s00228-025-03913-8

Milorad Stojadinovic, Slobodan Jankovic, Radica Zivkovic-Zaric, Marko Baralic, Svetlana Jovicic-Pavlovic, Ana Bontic, Nemanja Petrovic, Ana Pejcic

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引用次数: 0

Abstract

Background: Heparin-induced thrombocytopenia (HIT) is a severe primary hypercoagulable disorder, particularly concerning in hemodialysis (HD) patients frequently exposed to heparin. Fondaparinux has emerged as a potential alternative anticoagulant, though supporting evidence is limited. This systematic review aimed to evaluate the safety and efficacy of fondaparinux in HD patients with HIT.

Methods: We searched PubMed/MEDLINE, Web of Science, Scopus, CENTRAL, ClinicalTrials.gov, and SCIndeks up to March 2, 2025. Eligible studies included clinical trials, observational studies, and case reports/series on fondaparinux use in adult HD patients with HIT. Data on demographics, clinical characteristics, diagnostics, dosing, administration routes, and outcomes were extracted and narratively synthesized.

Results: Seventeen studies with 37 patients (aged 38-88 years) were included. Dosing regimens and monitoring strategies varied widely across dialysis modalities, with the most common initial fondaparinux dose being 2.5 mg/day. Platelet recovery was observed in most cases. Bleeding occurred in 10.8% of patients, thrombotic events in 5.4%, and overall mortality was 16.2%. Vascular access thrombosis was reported in two patients (5.4%) following the initiation of fondaparinux. Some clotting of the extracorporeal circuit was reported during select sessions in 7 patients undergoing non-continuous dialysis modalities (18.9%), including five on high-flux HD, one on unspecified intermittent HD, and one on post-dilution hemodiafiltration.

Conclusions: Fondaparinux may be a potential alternative anticoagulant in HD patients with HIT, especially when first-line agents are unavailable. However, its use should be approached with caution and tailored to individual clinical circumstances, pending confirmation of its safety, efficacy, and optimal dosing and monitoring through larger prospective studies.

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fondaparinux用于血液透析患者肝素诱导的血小板减少症的安全性和有效性：一项系统综述。

背景：肝素诱导的血小板减少症（HIT）是一种严重的原发性高凝性疾病，特别是在经常暴露于肝素的血液透析（HD）患者中。Fondaparinux已成为一种潜在的替代抗凝剂，尽管支持证据有限。本系统综述旨在评价fondaparinux在HD合并HIT患者中的安全性和有效性。方法：我们检索了PubMed/MEDLINE、Web of Science、Scopus、CENTRAL、ClinicalTrials.gov和SCIndeks，截止日期为2025年3月2日。符合条件的研究包括临床试验、观察性研究和fondaparinux在成人HD合并HIT患者中的应用的病例报告/系列。对人口统计学、临床特征、诊断、给药、给药途径和结果的数据进行提取和叙述合成。结果：纳入17项研究，37例患者（38-88岁）。不同透析方式的给药方案和监测策略差异很大，最常见的初始剂量为2.5 mg/天。多数病例血小板恢复。10.8%的患者发生出血，5.4%的患者发生血栓形成事件，总死亡率为16.2%。2例（5.4%）患者在开始使用fondaparinux后发生血管通路血栓形成。7例接受非连续性透析方式的患者（18.9%）在选定的疗程中报告了一些体外循环凝血，包括5例高通量HD， 1例未指明的间歇性HD和1例稀释后血液滤过。结论：Fondaparinux可能是HD合并HIT患者的潜在替代抗凝药物，特别是在无法获得一线药物的情况下。然而，在通过更大规模的前瞻性研究确认其安全性、有效性、最佳剂量和监测之前，应谨慎使用并根据个人临床情况量身定制。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.