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.
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
Key words
haemocoagulase agkistrodon/injection/children/safety/real world data/automatic monitoring/model/adverse drug reactions
维普
万方数据