首页|儿童化妆品不良反应风险信号挖掘及应对策略——基于上海监测实践

儿童化妆品不良反应风险信号挖掘及应对策略——基于上海监测实践

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目的:化妆品不良反应监测作为风险监测的重要环节,是识别上市后化妆品风险点的重要抓手,实施儿童化妆品不良反应监测及风险信号挖掘具有积极意义.方法:本文基于国内外儿童化妆品法规制度、监管情况及风险信号等,采用正态近似法、方差分析和报告比值比法对上海地区儿童化妆品不良反应进行风险信号挖掘.结果:儿童化妆品在商场和网购的风险性一致;普通-护肤类-霜在"0~3岁"检出较强信号,特殊-防晒类在"4~12岁"检出较强信号;普通-护肤类-乳液在"治愈"检出信号.结论:儿童化妆品不良反应风险的应对,需从消费环节、生产环节、流通环节、产品固有风险以及警戒监测等场景做出相应策略.
Risk Signal Mining and Coping Strategies of Adverse Reactions in Children's Cosmetics based on Shanghai Cosmetics Monitoring Practice
The cosmetics adverse reaction monitoring,which is a main link of risk monitoring,is identifying the post marketing risk points of cosmetics.It has positive significance to implement the adverse reaction monitoring and risk signal mining.Based on the analysis of the domestic and foreign children's cosmetics regulations,regulatory situation,and risk signals,the author mined the risk signals of adverse reactions to children's cosmetics in Shanghai by using the relative to an identified distribution unit(Ridit),variance analysis,and reporting odds ratio method(ROR).The data shown that the risk consistent between the children's cosmetics in shopping malls and online shopping,detect strong signals among the ordinary skincare creams at the age of 0~3,detect strong signals among the special sunscreen products at the age of 4~12,detecting the signal among the common skin care lotion of"cure",and so on.The risk corresponding strategies to adverse reactions in children's cosmetics need to be made from the consumption,production,and market circulation stages,and several scenarios of risk product and alert monitoring.

children's cosmeticsadverse reactionrisk signaldata miningcoping

王颍

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上海市药品和医疗器械不良反应监测中心

儿童化妆品 不良反应 风险信号 数据挖掘 应对

2022年度上海市药品监督管理局研究课题

ZX-2022-07

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(3)
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