真实世界数据在儿童药物性肾损伤监测中的应用进展与策略  

Application of Real-World Data in the Monitoring of Drug-Induced Renal Injury in Children:Progress and Strategies

作　　者：尉耘翠 彭晓霞[3] 聂晓璐[3] 贾露露 曹旺[1,2] 赵一鸣 王晓玲[1,2] YU Yun-cui;PENG Xiao-xia;NIE Xiao-lu;JIA Lu-lu;CAO Wang;ZHAO Yi-ming;WANG Xiao-ling(Clinical Research Center,National Center for Children's Health,Beijing Children’s Hospital,Capital Medical University;Department of Pharmacy,National Center for Children's Health,Beijing Children’s Hospital,Capital Medical University;Center for Clinical Epidemiology and Evidence-based Medicine,National Center for Children's Health,Beijing Children’s Hospital,Capital Medical University)

机构地区：[1]国家儿童医学中心/首都医科大学附属北京儿童医院临床研究中心 [2]国家儿童医学中心/首都医科大学附属北京儿童医院药学部 [3]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

出　　处：《中国食品药品监管》2021年第11期83-87,共5页China Food & Drug Administration Magazine

基　　金：国家自然科学基金面上项目(72174128);中国毒理协会临床毒理专项(CST2020CT108);首都医科大学附属北京儿童医院儿童用药专项(YZYB202006)。

摘　　要：药物性肾损伤(DIKI)是常见的药品不良反应,可导致急性肾衰竭、少尿、无尿等临床症状。儿童由于肝肾功能发育不完全,比成人更易发生DIKI,且预后风险更大。真实世界研究的迅速发展为儿童DIKI监测与评价带来更多机遇与挑战。当前自发报告系统与电子健康数据均在儿童DIKI监测中取得一定应用进展,为儿童DIKI的防治提供更多参考依据。未来还应持续推动建立儿童药品不良反应监测哨点联盟,同时深入探索多中心真实世界数据分析与共享机制,完善儿科药品安全智能监管体系,提升儿童药物警戒水平,促进儿科合理用药。Drug-induced kidney injury(DIKI)is a common adverse drug reaction(ADR)that can lead to acute renal failure,oliguria and anuria with severe clinical symptoms.Due to the lack of premarketing data and immaturity of liver and kidney function,children are more likely to develop DIKI than adults and are at greater prognostic risk.The rapid development of real-world studies brings more opportunities and challenges for the monitoring and evaluation of DIKI in children.Currently the application of spontaneous reporting systems and electronic health data has made some progress in pediatric DIKI surveillance,providing more evidence for the prevention and treatment of pediatric DIKI.In the future,we should continue to promote the establishment of a sentinel alliance for pediatric adverse drug reaction monitoring,and at the same time,explore multi-center real-world data analysis and sharing mechanisms,improve the intelligent regulatory system for pediatric drug safety,enhance pediatric pharmacovigilance,and promote the rational use of pediatric drugs.

关 键 词：药物性肾损伤 安全性评价 真实世界数据 主动监测 儿童 合理用药 

分 类 号：R95[医药卫生—药学]