我国牙膏不良反应监测面临的挑战与对策探析  

The Challenges and Countermeasures of Monitoring of Adverse Reaction of Toothpaste in China

作　　者：张琳[1] 华红[2] 徐明明[3] 单艳华[1] 林红[4] 魏攀[2] 刘洋[2] 韩建民[4] 王婉 何汶秀 Zhang Lin;HUA Hong;XU Ming-ming;SHAN Yan-hua;LIN Hong;WEI Pan;LIU Yang;HAN Jian-min;WANG Wan;HE Wen-xiu(Department of Scientific Research,Peking University School and Hospital of Stomatology,National Center of Stomatology,National Clinical Research Center for Oral Diseases,National Engineering Laboratory for Digital and Material Technology of Stomatology;Department of Oral Medicine,Peking University School and Hospital of Stomatology,National Center of Stomatology,National Clinical Research Center for Oral Diseases,National Engineering Laboratory for Digital and Material Technology of Stomatology;Department of VIP Dental Service,Peking University School and Hospital of Stomatology,National Center of Stomatology,National Clinical Research Center for Oral Diseases,National Engineering Laboratory for Digital and Material Technology of Stomatology;Dental Medical Devices Testing Center of Peking University School of Stomatology,National Center of Stomatology,National Clinical Research Center for Oral Diseases,National Engineering Laboratory for Digital and Material Technology of Stomatology)

机构地区：[1]北京大学口腔医院科研处,国家口腔医学中心,国家口腔疾病临床医学研究中心,口腔生物材料和数字诊疗装备国家工程研究中心 [2]北京大学口腔医院口腔黏膜科,国家口腔医学中心,国家口腔疾病临床医学研究中心,口腔生物材料和数字诊疗装备国家工程研究中心 [3]北京大学口腔医院特诊科,国家口腔医学中心,国家口腔疾病临床医学研究中心,口腔生物材料和数字诊疗装备国家工程研究中心 [4]北京大学口腔医学院口腔医疗器械检验中心,国家口腔医学中心,国家口腔疾病临床医学研究中心,口腔生物材料和数字诊疗装备国家工程研究中心

出　　处：《中国食品药品监管》2023年第3期58-63,共6页China Food & Drug Administration Magazine

摘　　要：目的:对牙膏不良反应监测面临的挑战进行全面的分析,并提出相应对策与建议,以期为牙膏不良反应监测体系的建设提供借鉴与参考。方法:分析我国牙膏不良反应上报工作中面临的挑战及原因。结果:我国牙膏不良反应监测面临的挑战包括:监管层面需完善管理体系建设、医疗机构层面重视不够或经验不足、生产经营层面重功效宣传轻不良反应监测、社会公众层面对不良反应的认知不足,针对上述挑战提出了对策与建议。结论:各级监管部门应强化不良反应监测理念,完善监测体系建设,鼓励公众、监测机构、牙膏生产企业、医疗机构、消费者协会、媒体等多方共同参与,保障公众口腔健康。Objective:This paper aims to comprehensively analyze the challenges faced by the adverse reaction monitoring of toothpastes and put forward corresponding countermeasures and suggestions,thus providing reference for the construction of the adverse reaction monitoring system of toothpastes.Methods:This paper analyzed the challenges and reasons faced in the reporting of adverse drug reactions of toothpastes in China.Results:The challenges faced by the adverse reaction monitoring of toothpaste in China include:the need to improve the construction of the management system at the regulatory level,the lack of attention or experience at the level of medical institutions,the stress on efficacy publicity rather than the adverse reaction monitoring at the production and operation level,and the lack of awareness of adverse reactions at the social public level.Countermeasures and suggestions were put forward to address the above challenges.Conclusion:The regulatory authorities at all levels should strengthen the concept of adverse reaction monitoring,improve the construction of the monitoring system.The public,monitoring institutions,toothpaste manufacturers,medical institutions,consumer associations,media and other parties are encouraged to participate together and create a good atmosphere for safe social governance of toothpaste.

关 键 词：牙膏 不良反应 监测 对策 

分 类 号：TQ658[化学工程—精细化工]