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中国临床药理学与治疗学 ›› 2023, Vol. 28 ›› Issue (10): 1109-1120.doi: 10.12092/j.issn.1009-2501.2023.10.004

• 临床药理学 • 上一篇    下一篇

基于FAERS的老年患者药源性吞咽障碍信号挖掘研究

贾博颖1,周  双2,万里燕1,周  颖2,崔一民2   

  1. 1清华大学第一附属医院药学部,北京  100016;2北京大学第一医院药学部,北京  100034
  • 收稿日期:2023-05-15 修回日期:2023-07-11 出版日期:2023-10-26 发布日期:2023-10-26
  • 通讯作者: 周颖,女,主任药师,硕士生导师,研究方向:临床药学与临床药理学。 Tel: (010) 66110802 E-mail: zhouying0321@126. com
  • 作者简介:贾博颖,女,硕士研究生,主管药师,研究方向:临床药学。 E-mail: jby9075@163.com
  • 基金资助:
    中央高水平医院临床科研业务费资助(北京大学第一医院科研种子基金项目No.2022SF87);北京药学会临床药学研究项目资助(LCYX-2022-10)

Drug-induced dysphagia risk in elder people——A pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) database

JIA Boying1, ZHOU Shuang2, WAN Liyan1, ZHOU Ying2, CUI Yimin2    

  1. 1 Department of Pharmacy ,The First Hospital of Tsinghua University, Beijing 100016, China; 2 Department of Pharmacy, Peking University First Hospital, Beijing 100034, China 
  • Received:2023-05-15 Revised:2023-07-11 Online:2023-10-26 Published:2023-10-26

摘要:

目的:挖掘与分析美国食品药品监督管理局不良事件报告系统(FDA adverse event reporting system,FAERS)数据库中导致老年人吞咽障碍的药品不良反应风险信号,为临床用药安全提供参考。方法:使用Open Vigil 2.1数据平台,收集2004年第1季度至2022年第2季度老年患者(年龄≥65岁)吞咽障碍事件相关报告。采用比例失衡法中报告比值比法(ROR)和比例报告比值法(PRR)检测药品导致老年人吞咽障碍的不良反应信号。设定阈值为报告数≥3且ROR值的95%置信区间下限>1与PRR≥2且c2≥4,信号须同时满足上述两种阈值判定标准,则为导致老年人群吞咽障碍高风险的药源性信号。结果:检索获得共计51 590条报告,经数据清洗,共计13 197例次吞咽障碍事件,1 395个药品品种被纳入分析。纳入分析患者年龄中位数为75岁,女性占比略高于男性。经药源性吞咽障碍信号检测,共计检测到阳性信号药品350个。按照生理系统和药理作用机制分类,阳性信号药物主要集中于神经系统[n=99,ROR 2.17(1.97-2.39)]、消化道及代谢系统[n=47,ROR 1.44(1.25-1.66)]、心血管系统[n=42,ROR 1.30(1.22-1.39)]、抗感染系统[n=27,ROR 1.44(1.29-1.61)]。结论:吞咽障碍是FAERS数据库中老年人不良事件报告的较常见原因,致吞咽障碍风险增加的药物广泛存在。建议多学科团队在选择药物时,评估患者吞咽功能对于吞咽障碍高风险老年患者优先选择吞咽障碍阴性信号药品,在优选药品不能满足临床需求时,建议选择风险更低的药品,并在应用过程中加强用药安全监护,预防吞咽障碍事件的发生。

关键词: 老年患者, 药源性吞咽障碍, 不良事件报告系统, 药物警戒, 用药安全

Abstract:

AIM: To evaluate the risk of drug-related dysphagia in elder people based on the FDA Adverse Event Reporting System (FAERS). METHODS: We collected the reports of dysphagia in elder people (Age≥65) from 2004 quarter 1 through 2022 quarter 2 of FAERS by Open Vigil 2.1 database. The reported odds ratio (ROR) and the proportional reported ratio (PRR) were calculated to detect the adverse reaction signal of drug-induced dysphagia in elder people. Signal generation standard of ROR: number of reports≥3 with the lower limit of 95% confidence interval (CI) of the ROR value>1, PRR≥2 and c2≥4, which indicates positive signal. RESULTS: A total of 51, 590 reports (including 13,197 dysphagia events and 1,395 drug) were considered, and 350 positive signal drugs were detected. The Median age of the included patients was 75 years,and there were more females than males. Positive signal drugs are mainly concentrated on nervous system [n=99, ROR 2.17(1.97-2.39)] , alimentary tract and metabolism [n=47, ROR 1.44(1.25-1.66)], cardiovascular system [n=42, ROR 1.30(1.22-1.39)], anti-infectives for systemic use [n=27, ROR 1.44(1.29-1.61)]. CONCLUSION: Drug-induced dysphagia risk are widespread according to the FAERS. It is recommended that multidisciplinary teams should assess the swallowing status of potients when selecting drugs. For elderly patients with high risk of swallowing, priority should be given to drugs with negative signals of dysphgia. When the preferred  drugs fail to meet the clinical need, it is recommended to select drug with lowe risk.Simultaneous clinical need to supervise the application of drugs in the process to prevent the occurrence of dysphagia events.

Key words: elder patients, drug-induced dysphagia, FARES, pharmacovigilance, drug safety

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