非处方药地芬尼多片自杀性滥用风险析及分控制建议  

Risk analysis and control suggestions for suicidal abuse of over-the-counter drug difenidol tablets

作　　者：左丽 吴文宇 吴海强 林怡宏 赖舒坤 吴斌 王茜 ZUO Li;WU Wen-yu;WU Hai-qiang;LIN Yi-hong;LAI Shu-kun;WU Bin;WANG Qian(Shenzhen Institute of Pharmacovigilance and Risk Management,Shenzhen 518024,Guangdong Province,China;School of Pharmacy,Shenzhen University,Shenzhen 518061,Guangdong Province,China)

机构地区：[1]深圳市药物警戒和风险管理研究院,广东深圳518024 [2]深圳大学医学部药学院,广东深圳518061

出　　处：《中国临床药理学杂志》2024年第8期1213-1216,共4页The Chinese Journal of Clinical Pharmacology

基　　金：广东省药品监督管理局科技创新基金资助项目(2021ZDB01)。

摘　　要：目的 通过分析地芬尼多片中毒相关文献,总结中毒特征,为控制地芬尼多片自杀性滥用风险提供参考。方法 对2011-01-01至2022-12-31全球公开发表的与地芬尼多自杀、过量、中毒、休克、死亡相关的文献涉及病例数据包括性别、年龄、服药剂量、心(血药)浓度、中毒症状等进行分析。结果 中毒人群以年轻女性居多,11~30岁年龄段中毒人数占比最高;服药剂量大于3 000 mg的患者死亡风险可能较高;心(血药)浓度大于6μg·mL^(-1)的患者死亡风险可能较高。恶性心律失常、意识障碍、昏迷、呼吸暂停为中毒时多见的严重不良事件。结论 建议药监部门要求地芬尼多上市许可持有人将中毒风险、症状等加入说明书。建议限制单个消费者短期大量购买地芬尼多片。建议取消地芬尼多片大剂量规格销售包装。建议将地芬尼多片转换成处方药进行管理,甚至可考虑取消地芬尼多片注册证。Objective To analyze the literature related to diphenidol tablets poisoning,the characteristics of poisoning were summarized to provide reference for controlling the suicidal abuse risk of diphenidol tablets.Methods The global literature on suicide,overdose,poisoning,shock,and death related to difenidol published from January 1,2011 to December 31,2022 was analyzed,including gender,age,dosage,cardiac(blood)concentration,poisoning symptoms,etc.Results Young women were the majority of people with poisoning.The highest proportion of the age group is 11 to 30 years group.Patients who take medication doses greater than 3000 mg may have a higher risk of death;patients with a heart(blood)concentration greater than6μg·mL^(-1)may have a higher risk of death.Malignant arrhythmia,consciousness disorders,coma,and apnea are common serious adverse events during poisoning.Conclusion It is recommended that the drug regulatory authorities should require the Listing permit holder of difenidol tablets to add the risk and symptoms of poisoning into the instructions.It is suggested that restricting individual consumers from purchasing large amounts of difenidol tablets in the short term.It is recommended that canceling the high-dose sales packaging of difenidol tablets.It is suggested that converting difenidol tablets into prescription drugs,even consider canceling the registration certificate of difenidol tablets.

关 键 词：地芬尼多 非处方药 自杀 风险控制 

分 类 号：R97[医药卫生—药品]