氟哌啶醇制剂心血管系统安全性风险的分析及思考

Cardiovascular safety of haloperidol preparations

目的了解氟哌啶醇制剂的安全性风险,为临床合理用药提供参考。方法对国家药品不良反应监测数据库2004年1月1日至2019年12月31日和国内外数据库建库至2020年5月31日中涉及氟哌啶醇的相关不良反应数据及国内外药品监管机构发布的关于氟哌啶醇相关风险控制措施等资料进行整理与分析。结果我国药品不良反应监测数据库共收到怀疑和并用药品涉及氟哌啶醇制剂的药品不良反应报告共13936例,其中涉及心血管系统624例次,严重不良反应111例次;国内外文献报道等均提示了氟哌啶醇制剂的心血管相关不良反应风险。结论建议督促药品上市许可持有人加强氟哌啶醇制剂的不良反应监测和评价工作,及时修订产品说明书,密切监测用药风险,促进广大医护人员及患者合理用药。

Objective To analyze the risk of haloperidol preparations so as to provide reference for clinical rational drug use.Methods The reports about adverse drug reactions(ADR)induced by haloperidol that were collected in China adverse drug reaction database from,January 1,2004 to December 31,2019 as well as those collected in domestic and foreign database from inception to May 31,2020,and the relevant risk control measures for haloperidol issued by domestic and foreign drug regulatory agencies were retrieved and analyzed.Results A total of 13936 reports of adverse drug reactions involving haloperidol preparations were received the China Adverse Drug Reaction Monitoring Database for suspected and concurrent use of drugs including 624 cases involving the cardiovascular system and 111 cases of serious adverse reactions.The risk of cardiovascular-related adverse reactions of haloperidol preparations was suggested by domestic and foreign literature reports.Conclusion It is recommended that regulatory authorities urge the drug marketing authorization holders to strengthen the monitoring and evaluation of adverse reactions of haloperidol preparations,revise product instructions in a timely manner,and promote the rational use of drugs by medical staff and patients.