摘要: |
目的 挖掘甲氧氯普胺相关迟发性运动障碍(Tardive dyskinesia,TD)不良事件信息,为临床安全用药提供参考。方法 基于2004年1季度至2022年4季度美国食品和药物管理局不良事件报告系统数据,采用比例失衡法对甲氧氯普胺相关TD信号进行量化,并对可能的诱发风险因素进行Logistic回归分析。结果 以甲氧氯普胺为首要怀疑药物的TD不良事件报告筛选出13842份,信号检测显示甲氧氯普胺与TD诱发具有统计学相关性(ROR 582.56,EBGM 237.89)。报告基本情况显示:女性(63.29%)发病率高于男性(26.91%);除年龄缺失(97.95%)外,18~64岁年龄段的患者比例最大(1.16%);除体重缺失(97.06%)外,小于80kg体重段的患者比例最大(1.60%);严重 ADR/ADE 共 10965 例(79.15%),其中导致残疾的例数较多(74.28%);中位发病时间为1020[四分位数范围(IQR 315-2191)]天。Logistic回归分析显示:甲氧氯普胺发生TD不良事件风险与年龄(OR = 1.029, 95%CI: 1.020 ~ 1.037)显著相关(P < 0.05)。结论 甲氧氯普胺临床使用时应警惕迟发性运动障碍不良反应的诱发,特别关注高龄人群的用药安全。 |
关键词: 甲氧氯普胺 迟发性运动障碍 FAERS 数据挖掘 |
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Risk analysis of Tardive dyskinesia adverse events associated with metoclopramide based on FAERS database |
SHEN Yi1, ZONG Liu-liu2, QI Yuan-chao1, YE Yan-rong3, Li Xiao-yu3, Lv Qian-zhou3
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1.Shanghai Geriatric Medical Center;2.Zhongshan Hospital, Fudan Universit;3.Shanghai Geriatric Medical Center、Zhongshan Hospital, Fudan Universit
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Abstract: |
AIM To provide reference for clinical safe drug use by data mining of the adverse reaction information of metoclopramide-associated Tardive dyskinesia (TD). METHODS Based on data from FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the fourth quarter of 2022, metoclopramide-associated TD signals were quantified using the proportional imbalance method, and logistic regression analyses were performed for possible predisposing risk factors. RESULTS 13842 adverse event reports were screened for TD with metoclopramide as the first suspected drug, and signal detection showed that metoclopramide was statistically correlated with TD induction (ROR 582.56, EBGM 237.89). The basic profile reports showed that the prevalence was higher in females (63.29%) than in males (26.91%); the largest proportion of patients was in the age group of 18-64 years (1.16%), except for missing age (97.95%); the largest proportion of patients was in the weight segment of less than 80 kg (1.60%), except for missing body weight (97.06%); Serious ADRs/ADEs totaled 10,965 (79.15%), with a higher number (74.28%) resulting in disability; and the median time to onset was 1,020 [interquartile range (IQR 315-2,191)] days. Logistic regression analysis showed that the risk of TD adverse events with metoclopramide was significantly associated with age (OR = 1.029, 95%CI: 1.020 ~ 1.037) (p < 0.05). CONCLUSION The clinical use of metoclopramide should be monitored for the induction of Tardive dyskinesia, and special attention should be paid to the drug safety in specific populations such as older age. |
Key words: Metoclopramide Tardive dyskinesia FAERS Signal mining |