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β受体阻滞剂与神经精神不良事件风险:基于美国食品药品监督管理局不良事件报告系统(FAERS)的活性对照限制不成比例性分析

β-blockers and risk of neuropsychiatric adverse events: An active-comparator restricted disproportionality on the FAERS.

作者信息

Ez Eddin Lujain, Omrani Mohammad Ali, Chalabianloo Niaz, Muanda Flory T

机构信息

ICES Western, London, ON, Canada.

Department of Physiology and Pharmacology, Western University, London, ON, Canada.

出版信息

J Psychopharmacol. 2025 Jul 24:2698811251349190. doi: 10.1177/02698811251349190.

DOI:10.1177/02698811251349190
PMID:40704576
Abstract

BACKGROUND

β-blockers (β-adrenoceptor antagonists), commonly used for cardiovascular conditions, may be linked to neuropsychiatric adverse events (AEs). However, many prevalent ones, including delirium and hallucinations, remain insufficiently studied.

AIMS

To compare the neuropsychiatric risks of β-blockers with other antihypertensive drugs using data from the FDA Adverse Event Reporting System (FAERS) and differences between lipophilic and hydrophilic β-blockers.

METHOD

An active-comparator restricted disproportionality analysis was conducted using data from the FAERS (2004Q1-2023Q4). Neuropsychiatric AEs were analyzed using Preferred Terms and the System Organ Classes from the Medical Dictionary for Regulatory Activities for β-blockers compared to lisinopril and losartan. Adjusted Reporting Odds Ratios (aRORs) were calculated using logistic regression to account for potential confounders.

RESULTS

β-blockers were linked to a significantly higher risk of nervous and psychiatric disorders, compared to lisinopril and losartan. Among the nine types of neuropsychiatric events studied, six-dizziness, nightmares, insomnia, hallucinations, somnolence, and disorientation-showed higher aRORs with β-blockers. Propranolol, a lipophilic β-blocker, exhibited the highest aRORs for psychiatric disorders and six types of neuropsychiatric events, including nightmares, delirium, hallucinations, disorientation, altered mental status, and somnolence, compared to lisinopril and losartan. Compared to atenolol, propranolol remained significantly associated with delirium, hallucinations, and disorientation.

CONCLUSION

β-blockers, especially propranolol, may be associated with a higher risk of neuropsychiatric AEs compared to lisinopril and losartan. These findings highlight the importance of considering the specific β-blocker prescribed, particularly in patients at risk for central nervous system side effects. Further population-based studies are warranted to confirm these results.

摘要

背景

β受体阻滞剂(β-肾上腺素能受体拮抗剂)常用于心血管疾病,可能与神经精神不良事件(AE)有关。然而,许多常见的不良事件,包括谵妄和幻觉,仍研究不足。

目的

利用美国食品药品监督管理局不良事件报告系统(FAERS)的数据,比较β受体阻滞剂与其他抗高血压药物的神经精神风险,以及亲脂性和亲水性β受体阻滞剂之间的差异。

方法

使用FAERS(2004年第一季度至2023年第四季度)的数据进行活性对照限制不成比例分析。与赖诺普利和氯沙坦相比,使用医学监管活动词典中的首选术语和系统器官类别对β受体阻滞剂的神经精神不良事件进行分析。使用逻辑回归计算调整后的报告比值比(aROR),以考虑潜在的混杂因素。

结果

与赖诺普利和氯沙坦相比,β受体阻滞剂与神经和精神障碍的风险显著更高相关。在所研究的九种神经精神事件中,六种——头晕、噩梦、失眠、幻觉、嗜睡和定向障碍——显示β受体阻滞剂的aROR更高。与赖诺普利和氯沙坦相比,亲脂性β受体阻滞剂普萘洛尔在精神障碍和六种神经精神事件中表现出最高的aROR,包括噩梦、谵妄、幻觉、定向障碍、精神状态改变和嗜睡。与阿替洛尔相比,普萘洛尔仍与谵妄、幻觉和定向障碍显著相关。

结论

与赖诺普利和氯沙坦相比,β受体阻滞剂,尤其是普萘洛尔,可能与神经精神不良事件的风险更高相关。这些发现凸显了考虑所开具的特定β受体阻滞剂的重要性,特别是在有中枢神经系统副作用风险的患者中。有必要进行进一步的基于人群的研究来证实这些结果。

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