中国药物警戒 ›› 2026, Vol. 23 ›› Issue (6): 672-676.
DOI: 10.19803/j.1672-8629.20250815

• 安全与合理用药 • 上一篇    下一篇

右旋糖酐铁注射液不良反应探析

王春婷1, 张瑞芳2, 邓彬3, 邹箴蕾1, 王琨4   

  1. 1国家药品监督管理局药品评价中心,国家药品监督管理局监管科学创新研究基地,北京 100163;
    2山西省药物警戒中心,山西 太原 030000;
    3广东省药品不良反应监测中心,广东 广州 510000;
    4河北省药物警戒中心,河北 石家庄 050091
  • 收稿日期:2025-11-17 出版日期:2026-06-15 发布日期:2026-06-18
  • 作者简介:王春婷,女,主任药师,药品上市后安全性评价。
  • 基金资助:
    药品监管科学全国重点实验室课题项目（2024SKLDRS0232）; 国家药品监督管理局药品监管科学体系建设重点项目（RS2024G001）

Adverse Reactions Induced by Iron Dextran Injection

WANG Chunting1, ZHANG Ruifang2, DENG Bin3, ZOU Zhenlei1, WANG Kun4   

  1. 1Drug Evaluation Center, National Medical Products Administration, NMPA/NMPA Center for Innovation and Research in Regulatory Science, Beijing 100163, China;
    2Shanxi Provincial Pharmacovigilance Center, Taiyuan Shanxi 030000, China;
    3Center for ADR Monitoring of Guangdong, Guangzhou Guangdong 510000, China;
    4The Pharmacovigilance Center of Hebei, Shijiazhuang Hebei 050091, China
  • Received:2025-11-17 Online:2026-06-15 Published:2026-06-18

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摘要： 目的 对右旋糖酐铁注射液上市后不良反应监测数据进行分析,了解其风险因素和风险特征,提出相应的风险控制措施,为临床安全用药提供参考。方法 梳理国家药品不良反应监测系统（2004年1月1日至2024年5月31日）和国外数据库不良反应报告、国内外文献（建库至2025年12月26日）以及药品说明书,从人口学特征、累及系统-器官及临床表现、转归等方面进行分析,提出说明书修订建议。结果 国家药品不良反应监测系统共收到右旋糖酐铁注射液不良反应2 173例,其中严重报告占比21.91%,不良反应中45~64岁患者居首位,多见于女性患者。不良反应主要累及系统-器官为全身性疾病及给药部位各种反应,皮肤及皮下组织,胃肠系统、呼吸系统、胸及纵隔,免疫系统等,其导致的过敏性休克多为速发型。国外数据库与文献报道的不良反应情况与国内基本一致,说明书中【注意事项】【禁忌】【特殊人群】项下安全性信息存在缺失。结论 右旋糖酐铁注射液可导致过敏性休克等严重不良反应,药品上市许可持有人应加强不良反应监测,根据反馈不良反应监测数据及时完善说明书;医务人员用药前询问患者用药史和过敏史,在具备急救复苏专业人员及设备的前提下给予右旋糖酐铁注射液,严格控制给药速度,确保安全用药。

关键词: 右旋糖酐铁注射液, 过敏性休克, 药品不良反应, 风险控制, 说明书修订

Abstract: Objective To analyze the data on monitoring of post-marketing adverse reactions of Iron Dextran injection, explore the risk factors, recommend risk control measures, and provide a reference for clinical safe medication. Methods The adverse reaction reports retrieved from the National Adverse Drug Reaction Monitoring System (from January 1, 2004 to May 31, 2024) and foreign databases, literature (published from the inception to December 26, 2025), as well as drugs’ package inserts were systematically analyzed. Data was analyzed in terms of demographics, systems and organs involved, manifestations and outcomes before the revision of drug instructions was proposed. Results Among the 2 173 reports, Severe cases accounted for 21.91% of the adverse reactions of Iron Dextran injection from the National Adverse Drug Reaction Monitoring System. Adverse reactions were dominating among adults ages 45 to 64, especially in female patients. The systems and organs involved included general disorders and reactions at the sites of administration, the skin and subcutaneous tissues, the gastrointestinal system, respiratory, thoracic and mediastinal disorders, and the immune system. The allergic shocks caused by this drug were mostly immediate. The adverse reaction profiles reported in databases and literature were basically consistent with those in China. There was a lack of information on safety in the sections of precautions, contraindications and special populations in drug instructions. Conclusion Iron Dextran injection can cause severe adverse reactions such as anaphylactic shock. Marketing authorization holders are to monitor adverse reactions and quickly improve drug instructions based on feedback. Health care providers should inquire about patients’ medication history and allergy history before administration, administer Iron Dextran injection with caution, and control the infusion rate to ensure safe medication.

Key words: Iron Dextran Injection, Anaphylactic Shock, Adverse Drug Reaction, Risk Control, Improve Drug Instructions

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