Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (7): 787-790.
DOI: 10.19803/j.1672-8629.20230298

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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, NIE Xiaolu9,10, 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;
    9Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    10Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100091, China
  • Received:2023-05-11 Online:2024-07-15 Published:2024-07-31

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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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