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磺达肝癸钠在孕期使用安全吗?当前证据的最新综述。

Is fondaparinux safe for use during pregnancy? A state-of-the-art review of current evidence.

作者信息

Wu Yuexiao, Ji Yurou, Wang Siqi, Hu Yayi, Shan Dan

机构信息

Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, No. 20, Renmin South Road, Section 3, Chengdu, 610041, Sichuan, China.

Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Chengdu, 610041, Sichuan, China.

出版信息

Arch Gynecol Obstet. 2025 Sep 12. doi: 10.1007/s00404-025-08181-6.

DOI:10.1007/s00404-025-08181-6
PMID:40938418
Abstract

Fondaparinux, a synthetic pentasaccharide, represents the smallest heparin-based molecule and functions as a potent selective indirect inhibitor of activated factor Xa. Its high bioavailability, ease of dosing, and favorable tolerability profile render it an ideal antithrombotic agent for pregnant patients who are intolerant to unfractionated heparin (UFH) and low-molecular-weight heparins (LMWHs). Recent studies have highlighted the advancements in the use of fondaparinux in pregnant patients over the past decades. This research provides a comprehensive summary of the safety profiles of fondaparinux, noting that its application in pregnant women may elevate the risk of bleeding events during pregnancy and postpartum. Caution is advised when administering fondaparinux to patients with renal insufficiency. The advantages of fondaparinux include a lower risk of thrombocytopenia, liver injury, allergic reactions, and osteopenia compared with UFH and LMWHs. Although fondaparinux can cross the placental barrier and be detected in the umbilical-cord blood, real-world data have not established a direct association between fondaparinux and teratogenicity or adverse fetal outcomes. Overall, fondaparinux appears to be a viable option for certain groups of pregnant patients requiring anticoagulation. However, further research is warranted to provide deeper insights into the benefits and risks associated with fondaparinux use in this population. The long-term effects of intrauterine exposure to fondaparinux remain an important area for future investigation.

摘要

磺达肝癸钠是一种合成的五糖,是最小的基于肝素的分子,可作为活化因子Xa的强效选择性间接抑制剂发挥作用。其高生物利用度、易于给药以及良好的耐受性使其成为对普通肝素(UFH)和低分子量肝素(LMWH)不耐受的孕妇的理想抗血栓药物。最近的研究突出了过去几十年磺达肝癸钠在孕妇中的应用进展。这项研究全面总结了磺达肝癸钠的安全性概况,指出其在孕妇中的应用可能会增加孕期和产后出血事件的风险。对肾功能不全患者使用磺达肝癸钠时建议谨慎。与UFH和LMWH相比,磺达肝癸钠的优势包括血小板减少、肝损伤、过敏反应和骨质减少的风险较低。尽管磺达肝癸钠可以穿过胎盘屏障并在脐带血中检测到,但实际数据尚未证实磺达肝癸钠与致畸性或不良胎儿结局之间存在直接关联。总体而言,磺达肝癸钠似乎是某些需要抗凝的孕妇群体的可行选择。然而,有必要进行进一步研究,以更深入地了解该人群使用磺达肝癸钠的益处和风险。宫内接触磺达肝癸钠的长期影响仍是未来研究的一个重要领域。

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本文引用的文献

1
Evaluating the impact of continuous venovenous hemodiafiltration on the efficacy of prophylactic fondaparinux doses: a prospective single-center observational study.评估持续静静脉血液透析滤过对预防性磺达肝癸钠剂量疗效的影响:一项前瞻性单中心观察性研究。
Sci Rep. 2025 May 24;15(1):18083. doi: 10.1038/s41598-025-03365-1.
2
Anti-Xa Activity Test Is Needed but Is Not Enough for Monitoring Fondaparinux Therapy Among Critically Ill Patients.抗Xa活性检测对于监测危重症患者的磺达肝癸钠治疗是必要的,但仅靠它并不够。
Arch Pathol Lab Med. 2025 Jan 1;149(1):e11-e18. doi: 10.5858/arpa.2023-0496-OA.
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Pregnancy outcomes and adverse events in patients with recurrent miscarriage receiving fondaparinux versus low molecular-weight heparin: A meta-analysis.
复发性流产患者接受磺达肝素钠与低分子肝素治疗的妊娠结局和不良事件:一项荟萃分析。
Eur J Obstet Gynecol Reprod Biol. 2023 Aug;287:29-35. doi: 10.1016/j.ejogrb.2023.05.031. Epub 2023 May 27.
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Fondaparinux Sodium: Recent Advances in the Management of Thrombosis.磺达肝癸钠:血栓管理的最新进展。
J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484221145010. doi: 10.1177/10742484221145010.
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Safety and effectiveness of fondaparinux as a postpartum thromboprophylaxis during puerperium among muslim women: A single centre prospective study.磺达肝癸钠作为穆斯林妇女产褥期产后血栓预防用药的安全性和有效性:一项单中心前瞻性研究。
Front Pharmacol. 2022 Sep 23;13:887020. doi: 10.3389/fphar.2022.887020. eCollection 2022.
6
Recurrent thrombosis rescued by fondaparinux in high-risk patients: A case series.磺达肝癸钠挽救高危患者复发性血栓形成:病例系列
Res Pract Thromb Haemost. 2022 Jul 29;6(5):e12773. doi: 10.1002/rth2.12773. eCollection 2022 Jul.
7
When Will Fondaparinux Induce Thrombocytopenia?磺达肝癸钠何时会引起血小板减少症?
Bioconjug Chem. 2022 Aug 17;33(8):1574-1583. doi: 10.1021/acs.bioconjchem.2c00316. Epub 2022 Jul 25.
8
Retrospective Analysis of Fondaparinux and Low-Molecular-Weight Heparin in the Treatment of Women With Recurrent Spontaneous Abortion.回顾性分析那屈肝素钙和低分子肝素治疗复发性自然流产的疗效。
Front Endocrinol (Lausanne). 2021 Oct 14;12:717630. doi: 10.3389/fendo.2021.717630. eCollection 2021.
9
Challenging anticoagulation cases: A case of heparin-induced-thrombocytopenia in the first trimester of pregnancy.具有挑战性的抗凝病例:一例妊娠早期肝素诱导的血小板减少症
Thromb Res. 2021 Nov;207:58-61. doi: 10.1016/j.thromres.2021.09.001. Epub 2021 Sep 14.
10
Population pharmacokinetics-pharmacodynamics of fondaparinux in dialysis-dependent chronic kidney disease patients undergoing chronic renal replacement therapy.在接受慢性肾脏替代治疗的透析依赖慢性肾脏病患者中,磺达肝素的群体药代动力学-药效学。
Eur J Clin Pharmacol. 2022 Jan;78(1):89-98. doi: 10.1007/s00228-021-03201-1. Epub 2021 Aug 19.