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  

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

作　　者：程毅菁 李涛[1] 刘军廷[1] 黄贵民 钟旭丽[2] 林爱华[2] 潘守东[3] 李龙[4] 白东升[5] 占小俊 刘振江 任韡 聂晓璐[9,10] 邰隽 CHENG Yijing;LI Tao;LIU Junting;HUANG Guimin;ZHONG Xuli;LIN Aihua;PAN Shoudong;LI Long;BAIDongsheng;ZHAN Xiaojun;LIU Zhenjiang;REN Wei;NIE Xiaolu;TAI Jun(Child Health Big Data Research Center,Capital Institute of Pediatrics,Beijing 100020,China;Department of Pharmacy,Children’s Hospital Capital Institute of Pediatrics,Beijing 100020,China;Department of Anesthesiology,Children’s Hospital Capital Institute of Pediatrics,Beijing 100020,China;Department of General(Neonatal)Surgery,Children’s Hospital Capital Institute of Pediatrics,Beijing 100020,China;Department of Urology,Children’s Hospital Capital Institute of Pediatrics,Beijing 100020,China;Department of Otorhinolaryngology,Head and Neck Surgery,Children’s Hospital Capital Institute of Pediatrics,Beijing 100020,China;Department of Orthopedics,Children’s Hospital Capital Institute of Pediatrics,Beijing 100020,China;Research Center for Pharmacovigilance IT and Data Science(PVID),Department of Automation,Tsinghua University,Beijing 100084,China;Center for Clinical Epidemiology and Evidence-based Medicine,Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health,Beijing 100045,China;Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100091,China)

机构地区：[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 [9]国家儿童医学中心,首都医科大学附属北京儿童医院临床流行病与循证医学中心,北京100045 [10]北京大学公共卫生学院流行病与卫生统计学系,北京100091

出　　处：《中国药物警戒》2024年第7期787-790,共4页Chinese Journal of Pharmacovigilance

基　　金：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(82104202);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)。

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35720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。Objective To evaluate the safety of haemocoagulase agkistrodon for injection in children by means of singlearm 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 35720 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.Postmarketing 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 

分 类 号：R994.1[医药卫生—毒理学] R973[医药卫生—药学]