Yin Qinan, Han Lizhu, Wang Yin, Kang Fengjiao, Cai Fengqun, Wu Liuyun, Zheng Xingyue, Li Lian, Dong Li E, Dong Limei, Liang Shuhong, Chen Min, Yang Yong, Bian Yuan
Department of Pharmacy, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.
Personalized Drug Therapy Key Laboratory of Sichuan Province, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Front Pharmacol. 2024 Mar 11;15:1352982. doi: 10.3389/fphar.2024.1352982. eCollection 2024.
Thromboembolic disease is associated with a high rate of disability or death and gravely jeopardizes people's health and places considerable financial pressure on society. The primary treatment for thromboembolic illness is anticoagulant medication. Fondaparinux, a parenteral anticoagulant medicine, is still used but is confusing due to its disparate domestic and international indications and lack of knowledge about its usage. Its off-label drug usage in therapeutic settings and irrational drug use are also common. The aim of this guideline is to enhance the judicious clinical application of fondaparinux by consolidating the findings of evidence-based research on the drug and offering superior clinical suggestions. Seventeen clinical questions were developed by 37 clinical pharmacy experts, and recommendations were formulated under the supervision of three methodologists. Through methodical literature searches and the use of recommendation, assessment, development and evaluation grading techniques, we gathered evidence. This guideline culminated in 17 recommendations, including the use of fondaparinux for venous thromboembolism (VTE) prevention and treatment, perioperative surgical prophylaxis, specific diseases, special populations, bleeding and overdose management. For different types of VTE, we recommend first assessing thrombotic risk in hospitalized patients and then administering the drug according to the patient's body mass. In surgical patients in the perioperative period, fondaparinux may be used for VTE prophylaxis, but postoperative use usually requires confirmation that adequate hemostasis has been achieved. Fondaparinux may be used for anticoagulation prophylaxis in patients hospitalized for oncological purposes, in patients with atrial fibrillation (AF) after resuscitation, in patients with cirrhosis combined with portal vein thrombosis (PVT), in patients with antiphospholipid syndrome (APS), and in patients with inflammatory bowel disease (IBD). Fondaparinux should be used with caution in special populations, such as pregnant female patients with a history of heparin-induced thrombocytopenia (HIT) or platelet counts less than 50 × 10/L, pregnant patients with a prethrombotic state (PTS) combined with recurrent spontaneous abortion (RSA), and children. For bleeding caused by fondaparinux, dialysis may partially remove the drug. The purpose of this guideline is to provide all healthcare providers with high-quality recommendations for the clinical use of fondaparinux and to improve the rational use of the drug in clinical practice. Currently, there is a lack of a dedicated antidote for the management of fondaparinux. The clinical investigation of activated prothrombin complex concentrate (APCC) or recombinant activated factor VII (rFⅦa) as potential reversal agents is still pending. This critical gap necessitates heightened scrutiny and research emphasis, potentially constituting a novel avenue for future inquiries into fondaparinux sodium. A meticulous examination of adverse events and safety profiles associated with the utilization of fondaparinux sodium will contribute significantly to a more comprehensive understanding of its inherent risks and benefits within the clinical milieu.
血栓栓塞性疾病与高致残率或死亡率相关,严重危害人们的健康,并给社会带来巨大的经济压力。血栓栓塞性疾病的主要治疗方法是抗凝药物治疗。磺达肝癸钠是一种肠外抗凝药物,仍在使用,但由于其国内外适应症不同以及对其用法缺乏了解,使用起来令人困惑。其在治疗环境中的超说明书用药和不合理用药也很常见。本指南的目的是通过整合基于证据的该药物研究结果并提供更好的临床建议,加强磺达肝癸钠的合理临床应用。37名临床药学专家提出了17个临床问题,并在3名方法学家的指导下制定了建议。通过系统的文献检索和使用推荐、评估、制定和评价分级技术,我们收集了证据。本指南最终形成了17条建议,包括磺达肝癸钠用于静脉血栓栓塞症(VTE)的预防和治疗、围手术期手术预防、特定疾病、特殊人群、出血和过量处理。对于不同类型的VTE,我们建议首先评估住院患者的血栓形成风险,然后根据患者体重给药。在围手术期的手术患者中,磺达肝癸钠可用于VTE预防,但术后使用通常需要确认已实现充分止血。磺达肝癸钠可用于因肿瘤目的住院的患者、复苏后心房颤动(AF)患者、肝硬化合并门静脉血栓形成(PVT)患者、抗磷脂综合征(APS)患者以及炎症性肠病(IBD)患者。在特殊人群中,如患有肝素诱导的血小板减少症(HIT)病史或血小板计数低于50×10⁹/L的妊娠女性患者、患有血栓前状态(PTS)合并复发性自然流产(RSA)的妊娠患者以及儿童,应谨慎使用磺达肝癸钠。对于磺达肝癸钠引起的出血,透析可能会部分清除该药物。本指南的目的是为所有医疗保健提供者提供关于磺达肝癸钠临床使用的高质量建议,并改善该药物在临床实践中的合理使用。目前,缺乏用于管理磺达肝癸钠的专用解毒剂。活化凝血酶原复合物浓缩物(APCC)或重组活化因子VII(rFⅦa)作为潜在逆转剂的临床研究仍在进行中。这一关键差距需要加强审查和研究重点,这可能构成未来对磺达肝癸钠研究的新途径。对与磺达肝癸钠使用相关的不良事件和安全性概况进行细致检查,将有助于更全面地了解其在临床环境中的固有风险和益处。