中国麻风皮肤病杂志 ›› 2022, Vol. 38 ›› Issue (2): 89-92.doi: 10.12144/zgmfskin202202089

• 论著 • 上一篇    下一篇

报告比值比法对化妆品不良反应信号的挖掘研究

夏秀娟1,梁津宁1,金外淑1,陈先进1,邵娟1,周素荣1,冯西恩1,尹爱群2   

  1. 1青岛大学附属烟台毓璜顶医院皮肤科，烟台，264000；2山东省烟台市药品不良反应监测中心，烟台，264000
  • 出版日期:2022-02-15 发布日期:2021-12-20
  • 通讯作者: 尹爱群，E-mail: 2843275272@qq.com

Data mining of reporting odds ratio on cosmetic adverse reactions

XIA Xiujuan1, LIANG Jinning1, JIN Waishu1, CHEN Xianjin1, SHAO Juan1, ZHOU Surong1, FENG Xien1, YIN Aiqun2   

  1. 1 Department of Dermatology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai 264000, China; 
    2 Yantai Center for ADR Monitoring, Yantai 264000, China
  • Online:2022-02-15 Published:2021-12-20
  • Contact: YIN Aiqun, E-mail: 2843275272@qq.com

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摘要： 目的：评价报告比值比法对化妆品不良反应的安全警戒信号的作用。方法：收集2019年烟台市化妆品不良反应/事件报告系统中不良反应报告数据，选定疼痛、干燥、瘙痒及灼热感等4种不良反应症状作为不良反应信号，报告比值比法（ROR）计算值 95%可信区间（CI）下限＞1提示出现警戒信号。结果：分析纳入的1429条不良反应上报报告，具有不良反应前五位的化妆品类型分别是霜、乳液、面膜、水、露。经ROR计算，霜（ROR=2.1757）、乳液（ROR=2.0365）具有瘙痒警戒信号；面膜（ROR=3.3815）和乳液（ROR=2.3994），染发类产品（ROR=2.9289）具有灼热感警戒信号。结论：采用报告比值比法对化妆品不良反应警戒信号进行分析，可为化妆品不良反应提供参考。

关键词: 化妆品不良反应, 报告比值比

Abstract: Objective: To assess the the predition effect of reporting odds ratio on cosmetic adverse reactions. Methods: The data of cosmetic adverse reactions of 2019 in Yantai from Adverse Event Reporting System were analyzed. Four symptoms including pain, drying, itching and burning sensation, were selected for adverse reaction signals. The reporting oods ratio (ROR) was used to calculate the ROR scores of signals and the lower limit of 95% CI＞1 was regarded as suggestive of ADR alert signal. Results: 1429 of cosmetic adverse reactions were included in the analysis. The first five of cosmetic with adverse reactions were frost, emulsion, mask, water and dew.  The alert signal of cream (ROR=2.1757) and emulsion (ROR=2.0365) was the pruritus. The alert signal of the facial mask (ROR=3.3815), emulsion (ROR=2.3994) and the hair dye product (ROR=2.9289) was burning sensation. Conclusion: The alert signals from ROR method may be provide reference for cosmetic adverse reactions.

Key words: cosmetic adverse reactions, reporting odds ratio