288例山东省牙膏不良反应监测数据回顾分析

Review and analysis of 288 cases of adverse reaction monitoring data of toothpaste in Shandong province

分析山东省牙膏不良反应监测现状和不良反应特征,为牙膏安全监管和不良反应监测提供数据支持,保障公众牙膏使用安全。采用回顾性研究法,对2017年-2023年山东省药品不良反应监测中心收集的288例牙膏不良反应报告进行统计和分析。与化妆品不良反应监测总体数据相比,牙膏不良反应报告男女性别比例差异不明显,儿童占比较高。牙膏不良反应除疼痛、瘙痒、红斑、水肿等常见的化妆品不良反应自觉症状和皮损形态外,还有口腔发麻、发涩、恶心、牙龈或口腔黏膜充血、出血、肿胀、溃疡等特异性表现。牙膏不良反应报告并用牙膏(或化妆品)的比例较低,产品来源主要为网购。建议进一步加强牙膏不良反应收集力度,完善牙膏不良反应监测技术体系,做好牙膏不良反应科普宣传,重点关注儿童牙膏不良反应。

This paper analyzes the monitoring status and adverse reaction characteristics of toothpaste in Shandong Province and aims to provide data support for toothpaste safety supervision and adverse reaction monitoring,and to ensure the safety of toothpaste use by the public.By retrospective study,288 cases of toothpaste adverse reactions of toothpaste collected by Shandong Center for Adverse Drug Reaction Monitoring from 2017 to 2023 were statistically analyzed.Compared with the overall data of ADR monitoring of cosmetics,there was no significant difference between male and female ADR reports of toothpaste,and children accounted for a relatively high proportion.In addition to pain,itching,erythema,edema and other common cosmetic adverse reaction symptoms and skin lesions,there were also oral tingling,astringency,nausea,gingival or oral mucosal congestion,bleeding,swelling,ulcer and other specific manifestations.The proportion of use toothpaste or cosmetics simultaneously in the ADR reports of toothpaste,was low,and the product source was mainly online shopping.It is suggested to strengthen the collection of adverse reaction of toothpasteand,improve the technical system of adverse reaction monitoring of toothpaste.Do a good job of popularization of toothpaste adverse reactions,and focusing on the adverse reactions of children's toothpaste.