中国药物警戒 ›› 2026, Vol. 23 ›› Issue (4): 456-459.
DOI: 10.19803/j.1672-8629.20250819

• 安全与合理用药 • 上一篇    下一篇

二羟丙茶碱注射剂安全性风险分析

朱会卷1, 王芳2, 王丹1, 任经天1   

  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河北省药物警戒中心,河北 石家庄 050000
  • 收稿日期:2025-11-17 出版日期:2026-04-15 发布日期:2026-04-15
  • 作者简介:朱会卷,女,硕士,副研究员,药物警戒。
  • 基金资助:
    药品监管科学全国重点实验室(2025SKLDRS0334)

Safety Risks of Diprophylline Injection Preparations

ZHU Huijuan1, WANG Fang2, WANG Dan1, REN Jingtian1   

  1. 1Center for Drug Reevaluation, NMPA/NMPA Center for Innovation and Research in Regulatory Science, Beijing 100163, China;
    2The Pharmacovigilance Center of Hebei, Shijiazhuang Hebei 050000, China
  • Received:2025-11-17 Online:2026-04-15 Published:2026-04-15

摘要: 目的 分析二羟丙茶碱注射剂安全性信息,为临床用药安全提供参考。方法 检索国家药品不良反应监测数据库(2004年1月1日至2023年9月30日)、国外数据库(建库至2026年1月25日)、国内外文献报道(建库至2025年10月31日)以及药品监管部门已采取的风险控制措施,对二羟丙茶碱注射剂不良反应报告的病例基本情况、累及系统-器官及临床表现等进行分析。结果 二羟丙茶碱注射剂不良反应累及多个系统-器官,临床表现主要为恶心、呕吐、心悸、胸部不适、呼吸困难、瘙痒等。注射用二羟丙茶碱严重报告构成比高于其他二羟丙茶碱注射剂。年龄≥65岁占比最高。结论 医务人员应关注二羟丙茶碱注射剂的不良反应,在用药前详细询问过敏史,尤其是对右旋糖酐类辅料的过敏情况,监测患者发生过敏性休克等严重不良反应的症状和体征,及时采取对症处理措施。

关键词: 二羟丙茶碱注射剂, 右旋糖酐40, 过敏性休克, 呼吸困难, 药品不良反应

Abstract: Objective To analyze reports of adverse reactions of diprophylline injection preparations so as to provide a reference for rational clinical use of the drug. Methods Related reports were retrieved from the National Adverse Drug Reaction Monitoring Database that were collected between January 1, 2004 and September 30, 2023 and from overseas databases that were collected from the inception to January 25, 2026. Related articles were retrieved from literature databases that were published from the inception to October 31, 2025. Risk control measures taken by drug regulatory authorities were summarized. The basic information of cases, organs or systems involved and clinical manifestations of adverse reactions related to diprophylline injection preparations were analyzed. Results Adverse drug reactions of diprophylline injection preparations involved multiple systems or organs. Nausea, vomiting, palpitations, chest discomfort, dyspnoea and pruritus were common manifestations. Diprophylline for injection was involved in a larger proportion of reports about severe adverse reactions than other diprophylline injection preparations. Most of the patients were aged 65 and older. Conclusion Clinicians should be alert to the adverse reactions caused by diprophylline injection preparations, inquire about the allergic history of patients before medication, especially hypersensitivity to dextran-based excipients, monitor the symptoms and signs of severe adverse reactions such as anaphylactic shock so as to offer immediate symptomatic treatment.

Key words: Diprophylline Injection, Dextran 40, Anaphylactic Shock, Dyspnoea, Adverse Drug Reaction

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