中国药物警戒 ›› 2024, Vol. 21 ›› Issue (7): 787-790.
DOI: 10.19803/j.1672-8629.20230298

• 基础与临床研究 • 上一篇    下一篇

基于真实世界数据的注射用尖吻蝮蛇血凝酶儿童用药安全性评价

程毅菁1, 李涛1, 刘军廷1, 黄贵民1, 钟旭丽2, 林爱华2, 潘守东3, 李龙4, 白东升5, 占小俊6, 刘振江7, 任韡8, 邰隽6,*   

  1. 1首都儿科研究所儿童健康大数据研究中心,北京 100020;
    2首都儿科研究所附属儿童医院药学部,北京 100020;
    3首都儿科研究所附属儿童医院麻醉科,北京 100020;
    4首都儿科研究所附属儿童医院普通（新生儿）外科,北京 100020;
    5首都儿科研究所附属儿童医院泌尿外科,北京 100020;
    6首都儿科研究所附属儿童医院耳鼻咽喉头颈外科,北京 100020;
    7首都儿科研究所附属儿童医院骨科,北京 100020;
    8清华大学药物警戒信息技术与数据科学创新中心,北京 100084
  • 收稿日期:2023-05-11 出版日期:2024-07-15 发布日期:2024-07-31
  • 通讯作者: * 邰隽,男,博士,教授,儿童咽喉头颈常见及重大疾病。E-mail: trenttj@163.com
  • 作者简介:程毅菁,女,硕士,儿童健康大数据分析。
  • 基金资助:
    北京市属医院科研培育计划（PG20241303）; 国家自然科学基金资助项目（82204149）; 真实世界数据支持儿童用药药物警戒工作开展的方法研究（RS2024G001）。

Safety evaluation of haemocoagulase agkistrodon for injection in children based on real world data

CHENG Yijing1, LI Tao1, LIU Junting1, HUANG Guimin1, ZHONG Xuli2, LIN Aihua2, PAN Shoudong3, LI Long4, BAI Dongsheng5, ZHAN Xiaojun6, LIU Zhenjiang7, REN Wei8, TAI Jun6,*   

  1. 1Child Health Big Data Research Center, Capital Institute of Pediatrics, Beijing 100020, China;
    2Department of Pharmacy, Children’s Hospital Capital Institute of Pediatrics, Beijing 100020, China;
    3Department of Anesthesiology, Children’s Hospital Capital Institute of Pediatrics, Beijing 100020, China;
    4Department of General (Neonatal) Surgery, Children’s Hospital Capital Institute of Pediatrics, Beijing 100020, China;
    5Department of Urology, Children’s Hospital Capital Institute of Pediatrics, Beijing 100020, China;
    6Department of Otorhinolaryngology, Head and Neck Surgery, Children’s Hospital Capital Institute of Pediatrics, Beijing 100020, China;
    7Department of Orthopedics, Children’s Hospital Capital Institute of Pediatrics, Beijing 100020, China;
    8Research Center for Pharmacovigilance IT and Data Science(PVID), Department of Automation, Tsinghua University, Beijing 100084, China
  • Received:2023-05-11 Online:2024-07-15 Published:2024-07-31

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摘要： 目的 基于医疗机构真实世界数据,运用单臂观察性研究的方法评价注射用尖吻蝮蛇血凝酶在儿童中使用的安全性,为该药的安全使用和风险管控提供参考。方法 构建儿童用药真实世界数据库,利用大数据人工智能挖掘技术,建立药品不良反应自动监测模型,监测2014年2月25日至2021年1月28日首都儿科研究所附属儿童医院使用注射用尖吻蝮蛇血凝酶的住院儿童电子病历,系统报警病例经人工评价并汇总统计,获得药品不良反应的发生情况,并分析可能影响用药安全性的因素。结果 纳入研究的患者共35 720例,注射用尖吻蝮蛇血凝酶所致皮疹、呕吐、头痛、过敏性休克的药品不良反应发生率分别为0.008%、0.003%、0.003%、0.003%,未见新的药品不良反应,在临床实践中用药天数、给药方式、单次给药剂量的合理选择有助于降低药品不良反应的发生率。结论 利用计算机辅助药品安全性评价,基于医疗机构真实世界数据获得了注射用尖吻蝮蛇血凝酶的儿童用药安全性情况,各不良反应均较为罕见,药品在整体上具有较好的安全性。

关键词: 尖吻蝮蛇血凝酶, 注射, 儿童, 安全性, 真实世界数据, 自动监测, 模型, 药品不良反应

Abstract: Objective To evaluate the safety of haemocoagulase agkistrodon for injection in children by means of single-arm observational study in order to provide reference for the safe use and risk control of this drug. Methods A real world database on the use of pediatric drugs was constructed, and an automatic monitoring model of ADR was established using the AI mining technology of big data. Electronic medical records of hospitalized children who received haemocoagulase agkistrodon for injection in the Capital Institute of Pediatrics from February 25, 2014 to January 28, 2021 were monitored. Cases alarmed by the system were artificially evaluated and statistically analyzed so as to find out about the adverse drug reactions and analyze the risk factors for drug safety. Results A total of 35 720 patients were included in the study. Among children using haemocoagulase agkistrodon for injection, the incidence of such ADR as rash, vomiting, headache, and anaphylactic shock was 0.008％, 0.003％, 0.003％, 0.003％ in the real world, but no new ADR was observed. Prudent selection of the course of medication, modes of delivery and single administration doses could help reduce the incidence of ADR. Conclusion Haemocoagulase agkistrodon used in pediatric patients is relatively safe, with few ADR. Post-marketing safety evaluation of drugs for children, a special population, is of great significance.

Key words: haemocoagulase agkistrodon, injection, children, safety, real world data, automatic monitoring, model, adverse drug reactions

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