| 杨其亮,朱峰,周双,等.基于美国食品药品监督管理局不良事件报告系统数据库的药源性睡眠障碍信号挖掘研究[J].中国临床保健杂志,2025,28(6):780-791. |
| 基于美国食品药品监督管理局不良事件报告系统数据库的药源性睡眠障碍信号挖掘研究 |
| Signal mining of drug-induced sleep disorder based on FAERS database |
| 投稿时间：2025-09-20 |
| DOI：10.3969/J.issn.1672-6790.2025.06.011 |
| 中文关键词: 睡眠异常 药物警戒性 药物相关性副作用和不良反应 数据挖掘 |
| 英文关键词: Dyssomnias Pharmacovigilance Drug-related side effects and adverse reactions Data mining 〖FL |
| 基金项目:中央保健科研项目(2024YB04) |
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| 中文摘要: |
| 目的 基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库,系统挖掘与分析药物相关的睡眠障碍风险信号,识别潜在药源性睡眠障碍的高风险药物,为临床用药安全提供依据。方法 提取2004年1月至2024年12月FAERS数据库中睡眠障碍不良事件报告数据,采用比例失衡法中报告比值比(ROR)和贝叶斯可信传播神经网络检测与药源性睡眠障碍相关的药品不良反应信号。结果 经数据清洗,共纳入131 174份与睡眠障碍相关药物不良事件报告,检测出阳性信号药物233种,其中32种药物说明书中未记载睡眠障碍风险。报告频数前3位的阳性信号药物为度普利尤单抗(ROR=3.48)、羟丁酸钠(ROR=10.36)和伐尼克兰(ROR=4.42)。结论 多种药物(尤其是神经系统药物)具有导致睡眠障碍的潜在风险。临床实践中,应考虑药物诱发睡眠障碍风险水平,以优化治疗方案。 |
| 英文摘要: |
| Objective To identify drugs associated with increased risk of sleep disorders through mining and analyzing the FDA Adverse Event Reporting System (FAERS) database,thereby mitigating drug-induced sleep disturbances and improving clinical medication safety.Methods Reports of sleep disorder from the FAERS database between January 2004 to December 2024 were collected.Two disproportionality analysis methods,the Reporting Odds Ratio (ROR) and the Bayesian Confidence Propagation Neural Network,were employed to detect adverse reaction signals associated with drug-induced sleep disorders.Results A total of 131 174 sleep disorder-related reports were analyzed,identifying 233 drugs with positive signals.Among these,32 medications had sleep disorder risks not documented in their prescribing information.The top three most frequently reported drugs with positive signals were dupilumab (ROR=3.48),sodium oxybate (ROR=10.36),and varenicline (ROR=4.42).Conclusions Some medications are associated with drug-induced sleep disorders,particularly nervous system drugs.Various pharmacological agents,especially neuroactive drugs,correlate with medication-induced sleep disturbances.Clinical practitioners should evaluate drug-related somnolence/insomnia risks to optimize treatment strategies. |
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