[关键词]
[摘要]
目的 基于美国食品药品监督管理局(FDA)公共数据开放项目(openFDA)中丁苯那嗪和氘丁苯那嗪不良事件的数据,分析2个药物的安全性,为临床用药提供参考。方法 收集2017年1月1日—2022年12月31日FDA不良事件报告系统(FAERS)中丁苯那嗪与氘丁苯那嗪相关的不良事件报告,提取报告数排名前50位不良事件报告,采用报告比值比法(ROR)挖掘不良反应风险信号。结果 共得到丁苯那嗪相关的不良事件报告1 468例,氘丁苯那嗪相关的不良事件报告3 097例,对报告数排名前50位不良事件进行药物不良反应风险信号分析,分别检测出丁苯那嗪39个不良反应风险信号,氘丁苯那嗪35个不良反应信号。按照不良事件报告数进行排名,丁苯那嗪前5位的不良事件依次为超说明书使用、死亡、药物无效、抑郁、治疗不服从;氘丁苯那嗪前5位的不良事件依次为药物无效、运动障碍、抑郁、嗜睡、失眠。结论 氘丁苯那嗪通过结构改造,优化了药动学参数,减少了给药剂量和频次,从而明显提高了患者的用药依从性,检测到的不良反应风险信号与原型药物相比有所减少,但需注意其自杀风险,提示临床予以进一步的安全性评价。
[Key word]
[Abstract]
Objective To analyze the safety of tetrabenazine and deutetrabenazine based on openFDA to provide a reference for clinical use. Methods To collect the adverse event reports related to tetrabenazine and deutetrabenazine in the FDA Adverse Events Reporting System (FAERS) from January 1, 2017 to December 31, 2022, extract the top 50 adverse event reports, and the report odds ratio (ROR) was utilized for signal detection. Results A total of 1 468 cases of tetrabenazine-related adverse events and 3 097 cases of deutetrabenazine-related adverse events were reported to FAERS, and the top 50 adverse events were analyzed for adverse drug reaction risk signals, 39 adverse event risk signals were detected for tetrabenazine and 35 adverse event signals for deutetrabenazine, respectively. Top 5 adverse event reports for tetrabenazine were off label use, death, drug ineffective, depression, and treatment noncompliance. Top 5 adverse event reports for deutetrabenazine were drug ineffective, dyskinesia, depression, somnolence, and insomnia. Conclusion Deutetrabenazine significantly improved medication compliance by modifying and optimizing pharmacokinetic parameters to reduce the dose and frequency of administration, and the adverse reaction risk signals detected was reduced compared with tetrabenazine, but attention needs to be paid to its suicide risk, prompting further clinical safety evaluation.
[中图分类号]
R971
[基金项目]
中国毒理学会临床毒理专项(CST2020CT301);北京市研究型病房建设示范单位项目(BCRW202010)