中国药物警戒 ›› 2026, Vol. 23 ›› Issue (3): 312-317.
DOI: 10.19803/j.1672-8629.20260024

• 安全与合理用药 • 上一篇    下一篇

209例尖吻蝮蛇血凝酶不良反应报告分析

黄丽1,2, 张了云1, 付敏1, 李根1, 杜宇3, 高山3, 兰姗3, 彭丹3, 江永贤1,*   

  1. 1四川省妇幼保健院,四川省妇女儿童医院,成都医学院附属妇女儿童医院药学部,四川 成都 610041;
    2云南省临沧市妇幼保健院药剂科,云南 临沧 677000;
    3四川省药品不良反应监测中心,四川 成都 610093
  • 收稿日期:2026-01-09 出版日期:2026-03-15 发布日期:2026-03-17
  • 通讯作者: *江永贤,女,硕士,副主任药师,药物警戒与药事管理。E-mail: 243609682@qq.com
  • 作者简介:黄丽,女,本科,主管药师,药物警戒。
  • 基金资助:
    国家药监局综合司关于药品监管科学体系建设重点项目（RS2024G001）; 成都医学院2024年第一批临床科学研究基金项目（24LHXX1-07）; 成都市卫生健康委员会医学科研课题项目（2022388）; 成都医学院2025年第三批临床科学研究基金项目（25LHSFY3-08、25LHSFY3-19）; 四川省食品药品审查评价及安全监测中心药物警戒开放课题（YYWJ202504）

Analysis of 209 Cases of Adverse Reactions to Haemocoagulase Agkistrodon

HUANG Li1,2, ZHANG Liaoyun1, FU Min1, LI Gen1, DU Yu3, GAO Shan3, LAN Shan3, PENG Dan3, JIANG Yongxian1,*   

  1. 1Department of Pharmacy, Sichuan Provincial Maternity and Child Health Care Hospital, Sichuan Provincial Women’s and Children’s Hospital, the Affiliated Women's and Children’s Hospital of Chengdu Medical College, Chengdu Sichuan 610041, China;
    2Department of Pharmacy, Lincang Maternity and Child Health Care Hospital, Lincang Yunnan 677000, China;
    3Sichuan Provincial Center for Food and Drug Evaluation and Safety Monitoring, Chengdu Sichuan 610093 China
  • Received:2026-01-09 Online:2026-03-15 Published:2026-03-17

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摘要： 目的 分析注射用尖吻蝮蛇血凝酶不良反应（ADR）发生特点和相关风险因素,为临床安全用药提供参考。方法 收集某省2011年1月1日至2024年12月31日上报怀疑药品为尖吻蝮蛇血凝酶的ADR报告,统计患者的基本情况、用药情况、ADR发生及转归等信息,探讨ADR发生特点。结果 209例ADR报告中,严重ADR的发生与是否超说明书用药差异无统计学意义（P>0.05）,与年龄、合并用药、给药适应证、给药方式的差异具有统计学意义（P<0.05）。ADR多发生于给药30 min内（56.93%）,严重ADR主要集中于给药30 min内（77.42%）,呈速发型过敏反应特征,主要表现为过敏性休克。ADR累及多个系统-器官,主要累及皮肤及皮下组织类、胃肠系统。99.04% ADR转归为痊愈或好转。结论 尖吻蝮蛇血凝酶相关ADR具有明显的速发特征及给药途径相关性,临床用药应侧重于对给药后30 min内严密监护,并做好发生过敏反应的应对抢救措施。

关键词: 尖吻蝮蛇血凝酶, 速发型过敏反应, 皮肤, 皮下组织, 胃肠系统, 药品不良反应, 安全性

Abstract: Objective To analyze the characteristics and related risk factors of adverse drug reactions (ADR) associated with Haemocoagulase Agkistrodon for injection, and to provide evidence for safe clinical use. Methods ADR reports submitted between January 1, 2011 and December 31, 2024, from a certain province, involving Haemocoagulase Agkistrodon as the suspected drug, were collected. Data on patients’ demographics, medication use, ADR occurrence, and clinical outcomes were extracted and analyzed to characterize the features of these ADR. Results Among the 209 ADR reports, the occurrence of serious ADR showed no statistically significant association with off-label use (P>0.05). However, statistically significant differences were observed with respect to age, concomitant medication use, indication for administration, and route of administration (P<0.05). Most ADR occurred within 30 minutes after administration (56.93%), and serious ADR were predominantly concentrated within this period (77.42%), exhibiting characteristics of immediate hypersensitivity reactions, primarily manifesting as anaphylactic shock. ADR involved multiple organ systems, mainly affecting the skin and subcutaneous tissue as well as the gastrointestinal system. A total of 99.04% of the ADR either resolved or showed improvement. Conclusion Adverse reactions associated with Haemocoagulase Agkistrodon for Injection exhibit distinct immediate-onset characteristics and are related to the route of administration. Clinical medication should focus on rigorous monitoring within 30 minutes following administration. Preparedness for emergency rescue measures in response to hypersensitivity reactions is essential.

Key words: Haemocoagulase Agkistrodon, Immediate Hypersensitivity Reaction, Skin, Subcutaneous Tissue, Gastrointestinal System, Adverse Drug Reaction (ADR), Safety

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