234份化妆品接触性荨麻疹不良反应报告回顾性分析  

Retrospective Analysis of 234 Adverse Reaction Reports of Cosmetic Contact Urticaria

作　　者：庄程元 ZHUANG Cheng-yuan(Fujian Drug Evaluation and Monitoring Center)

机构地区：[1]福建省药品审评与监测评价中心

出　　处：《中国食品药品监管》2024年第12期94-101,共8页China Food & Drug Administration Magazine

摘　　要：目的:为贯彻落实《化妆品监督管理条例》,保障公众用妆安全,本文按照《化妆品不良反应监测管理办法》要求,收集、分析评价福建省内发生的化妆品接触性荨麻疹不良反应情况,以期为化妆品科学监管提供数据支撑。方法:对福建省收集的234份化妆品接触性荨麻疹不良反应报告从报告来源、产品来源、性别年龄分布、不良反应表现、不良反应初步诊断及治疗情况等方面进行分析。结果:234份化妆品接触性荨麻疹不良反应报告中的产品主要来源网购和商场,护肤类和美容修饰类产品居多,20~50岁女性消费者为不良反应发生主要人群,不良反应发生时间间隔均不超过1天,患者症状明显主要表现为红斑、水肿或风团,伴瘙痒或灼感等自觉症状。结论:为控制风险,减少化妆品接触性荨麻疹发生,建议加强化妆品科普宣传工作,提示消费者正确购买合理使用化妆品。督促企业落实主体责任,拓宽化妆品不良反应收集途径。加强化妆品接触性荨麻疹风险信号处置,化妆品抽检可关注相关信号选取品种等。Objective:To implement the Regulations on the Supervision and Administration of Cosmetics and ensure public safety in cosmetic use,this article collects,analyzes,and evaluates adverse reactions of contact urticaria caused by cosmetics in Fujian Province,in accordance with the Measures for Monitoring and Management of Adverse Reactions to Cosmetics,to provide data support for the scientific regulation of cosmetics.Method:A total of 234 adverse reaction reports of cosmetic contact urticaria collected in Fujian Province were analyzed from various aspects,including product source,case occurrence trends,time interval between adverse reactions,manifestations of adverse reactions,outcomes,and treatment methods.Result:Among the 234 reports of adverse reactions to cosmetic contact urticaria,the majority of products originated from online shopping and shopping malls,with skincare and beauty-enhancing products being the most common.Female consumers aged 20 to 50 were the primary users,and the adverse reactions occurred within one day of product use.Symptoms mainly included erythema,edema,or wheals,accompanied by sensations of itching or burning.Conclusion:In order to mitigate risks and reduce the incidence of cosmetic contact urticaria,it is recommended to strengthen public education and awareness about cosmetics,encouraging consumers to purchase and use products correctly and responsibly.Enterprises should be urged to fulfill their main responsibilities and expand channels for collecting adverse reaction reports.Risk signal handling for contact urticaria in cosmetics should be enhanced,with relevant products prioritized for sampling inspections.Additionally,the promotion of product efficacy by online operators should be standardized.

关 键 词：化妆品 接触性荨麻疹 不良反应 过敏 

分 类 号：TQ658[化学工程—精细化工]