基于病例报告文献的妊娠期使用磺达肝癸钠安全性分析  

Safety analysis of fondaparinux in pregnancy based on case report literature

作　　者：王银 蔡凤群 康凤娇 武刘芸 王胡霖 韩丽珠 尹琪楠 杨勇[2] 边原[2] WANG Yin;CAI Fengqun;KANG Fengjiao;WU Liuyun;WANG Hulin;HAN Lizhu;YIN Qinan;YANG Yong;BIAN Yuan(School of Medicine,University of Electronic Science and Technology of China,Chengdu 610054,China;Personalized Drug Therapy Key Laboratory of Sichuan Province/Dept.of Pharmacy,Sichuan Academy of Medical Sciences·Sichuan Provincial People’s Hospital(Affiliated Hospital of University of Electronic Science and Technology of China),Chengdu 610072,China)

机构地区：[1]电子科技大学医学院,成都610054 [2]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)药学部/个体化药物治疗四川省重点实验室,成都610072

出　　处：《中国药房》2025年第9期1099-1104,共6页China Pharmacy

基　　金：四川省科技计划项目(No.2022NSFSC0818);中国药理学会药源性疾病学专委会《2024年药物安全研究项目》(No.ADR2024MS17);国家卫生健康委医院管理研究所医院药学高质量发展研究项目(No.NIHAYS2323);四川省医学会静脉血栓栓塞症防治(恒瑞)专项科研课题(No.2019HR02);四川省药学会“新质药学启航计划”医院药学高质量发展科研资助项目(No.scyxh20240701);四川省药品监督管理局科技计划项目(No.2024012)。

摘　　要：目的评价磺达肝癸钠在妊娠期使用的安全性,为其临床合理应用提供参考。方法检索中国知网、万方数据知识服务平台、PubMed、Embase和Elsevier数据库(检索时间均为从建库起至2024年12月17日),收集磺达肝癸钠在妊娠期使用的病例报告类文献,提取患者基本信息、磺达肝癸钠在妊娠期的使用情况、合并用药情况、临床表现和治疗情况等资料,进行描述性统计分析。结果共收集到妊娠期使用磺达肝癸钠的病例报告17篇,涉及11个国家的42例患者、47次妊娠记录。其中,20次为预防妊娠期静脉血栓栓塞(VTE)而使用磺达肝癸钠,27次因相关疾病接受磺达肝癸钠治疗。有29例次患者因VTE(家族)史而使用磺达肝癸钠;9例次患者经历复杂妊娠;35例患者有合并症/既往病史的相关记录;患者在妊娠期使用磺达肝癸钠出现的不良事件包括产后出血(7例)和不适当剂量所致的过度抗凝(1例);在7例产后出血的病例中,有3例出血量不少于1000 mL(包括2例合并子宫收缩乏力的患者),3例停药时间≤12 h。结论基于现有文献,磺达肝癸钠在妊娠期使用的安全性总体可控,主要不良事件为产后出血。磺达肝癸钠的使用剂量、停药间隔时间、合并症/既往病史和合并用药等问题可能是造成其发生不良事件的主要原因。OBJECTIVE To evaluate the safety of fondaparinux in pregnancy and provide reference for its rational clinical application.METHODS A search was conducted in databases including CNKI,Wanfang,PubMed,Embase,and Elsevier(the search time was from the construction of the database to December 17,2024)to collect case report literature on fondaparinux use during pregnancy.Patient demographic information,fondaparinux use during pregnancy,concomitant medications,clinical manifestations,and treatment details were extracted for descriptive statistical analysis.RESULTS A total of 17 case reports regarding the use of fondaparinux during pregnancy were collected,involving 42 patients from 11 countries and 47 pregnancy records.Among these,20 cases involved the use of fondaparinux for the prevention of pregnancy-related venous thromboembolism(VTE),while 27 cases were fondaparinux treatment due to related conditions.A total of 29 occurrences of the patients were treated with fondaparinux due to a(family)history of VTE.Nine occurrences of complicated pregnancies were reported,and 35 patients had records of comorbidities or relevant medical histories.The adverse events that occurred during pregnancy with the use of fondaparinux include postpartum hemorrhage(7 cases)and excessive anticoagulation caused by inappropriate dosage(1 case).Among the 7 cases of postpartum hemorrhage,3 cases had a blood loss of no less than 1000 mL(including 2 cases with uterine atony),3 cases had a drug discontinuation time of≤12 h.CONCLUSIONS Based on the existing literature,the safety of fondaparinux during pregnancy is generally manageable,with the main adverse event being postpartum hemorrhage.The dosage,interval between discontinuation,comorbidities/medical history,and concomitant medications of fondaparinux may be the main causes of its adverse events.

关 键 词：磺达肝癸钠 妊娠期 安全性评价 抗凝 病例报告 文献分析 

分 类 号：R969.3[医药卫生—药理学] R973[医药卫生—药学]