含右美沙芬成分药品说明书的成瘾性提示分析  

Reminders of Addiction in Drug Labels of Dextromethorphan

作　　者：刘小会 周莉[3] 赵一鸣 李英[2] 吴喜蓉[1,4] 王晓玲 徐保平[1,4] LIU Xiaohui;ZHOU Li;ZHAO Yiming;LI Ying;WU Xirong;WANG Xiaoling;XU Baoping(China National Clinical Research Center for Respiratory Diseases,National Center for Children’s Health,Beijing 100045,China;Department of Pharmacy,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China;Department of Pharmaceutics,PLA Rocket Force Charateristic Medical Center,Beijing 100088,China;Department of Respiratory Diseases,Beijing Children’s Hospital,National Center for Children’s Health,Beijing 100045,China)

机构地区：[1]国家儿童医学中心,国家呼吸系统疾病临床医学研究中心,北京100045 [2]首都医科大学附属北京儿童医院药学部,北京100045 [3]火箭军特色医学中心药剂科,北京100088 [4]首都医科大学附属北京儿童医院呼吸中心,北京100045

出　　处：《中国药物警戒》2024年第11期1299-1302,共4页Chinese Journal of Pharmacovigilance

基　　金：北京市高层次公共卫生技术人才培养计划项目(2022-2-023);北京市研究型病房建设示范单位项目(BCRW 202101)。

摘　　要：目的分析我国上市含有右美沙芬成分的药品说明书关于成瘾性提示、国内外关于右美沙芬成瘾性病例文献报道,为右美沙芬临床规范使用提供参考。方法检索含有右美沙芬成分的说明书,对中国知网、万方数据、P ubMed数据库中右美沙芬引起成瘾性的病例报告进行统计分析。结果2021年12月16日国家药品监督管理局(简称“国家药监局”)将氢溴酸右美沙芬口服单方制剂由非处方药转换为处方药管理,同时对11个品名为右美沙芬药品进行了说明书修订,删除“长期服用无成瘾性和耐受性”相关表述。2024年4月30日国家药监局、公安部、国家卫生健康委联合发布调整右美沙芬单方制剂列为第二类精神药品目录。但部分含右美沙芬复方制剂说明书药理作用项下仍标注右美沙芬长期使用无成瘾性。右美沙芬长期服用成瘾性报告共检索到21篇文献,其中国内文献11篇、国外文献10篇,均包含未成年人,多为同伴怂恿诱导,包括明显的戒断症状、欣快感甚至自杀的情况。结论含右美沙芬成分的说明书需要进一步规范,同时需要加强右美沙芬的培训,提高大众对右美沙芬的认知,尤其是对未成年人的教育。Objective To investigate both the reminders of addiction in the instructions of Chinese listed drugs containing dextromethorphan and the reports of addiction cases at home and abroad so as to provide evidence for standardized use.Methods Labels of drugs containing dextromethorphan were retrieved while case reports of addiction induced by dextromethorphan in CNKI,Wan Fang and PUBMED database were searched for before statistical analysis.Results On December 16,2021,the National Medical Products Administration changed dextromethorphan hydrobromide oral monotherapy from an over-the-counter drug to a prescription one,and revised the instructions of 11 dextromethorphan products by deleting such descriptions as“no addiction or tolerance after long-term use”.On April 30,2024,the National Medical Products Administration,Ministry of Public Security and the National Health Commission jointly issued an announcement adjusting dextromethorphan monotherapy as the second category of psychotropic drugs.However,some dextromethorphan-containing compound preparations were still labeled as non-addictive after long-term use under the item of pharmacological actions in the instructions.A total of 21 reports about addiction to dextromethorphan after long-term use were retrieved,including 11 domestic ones and 10 foreign ones,all of which involved minors who were enticed by their peers.Obvious symptoms of withdrawal,feelings of euphoria,and even suicide were reported.Conclusion Labels of drugs containing dextromethorphan should be standardized,and clinicians ought to be better informed of the drug dependence caused by dextromethorphan to improve the public knowledge of dextromethorphan,especially among minors.

关 键 词：右美沙芬 说明书 成瘾 滥用 耐受 未成年 

分 类 号：R994.11[医药卫生—毒理学] R971[医药卫生—药学]