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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术后镇痛患者头晕不良事件信号挖掘与分析

Mining and analysis of dizziness adverse event signals in postoperative analgesia patients based on the FDA adverse event reporting system database.

作者信息

Zhou Fengqi, He Haiou, Gao Jing, Zhang Zhen

机构信息

Department of Anesthesiology, Xiangyang No. 1 People's Hospital, Hubei University of Medicine, Xiangyang, Hubei, China.

Department of Anesthesiology, Suizhou Hospital, Hubei University of Medicine, Suizhou, Hubei, China.

出版信息

Front Pharmacol. 2025 Feb 13;16:1488469. doi: 10.3389/fphar.2025.1488469. eCollection 2025.

DOI:10.3389/fphar.2025.1488469
PMID:40017599
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11865249/
Abstract

OBJECTIVE

This study aimed to explore the association between drugs used in postoperative anesthesia patients and postoperative dizziness using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database, along with other risk factors for dizziness.

METHODS

Using the FAERS database, we retrospectively analyzed dizziness cases reported between 2004 and the third quarter of 2023. We analyzed the relationship between drugs during postoperative anesthesia and the risk of postoperative dizziness, and conducted subgroup analysis according to age, sex and other factors. Signal detection was further performed using the reported odds ratio (ROR) method to identify medications significantly associated with an increased risk of postoperative dizziness.

RESULTS

A total of 166,292 dizziness case reports were obtained, with 128 cases specifically related to postoperative analgesia. The number of dizziness reports has been increasing yearly, with a higher concentration of cases among individuals aged 18-85 years, predominantly in female patients. The analysis identified that amitriptyline, clonazepam, and ketamine were significantly associated with an increased risk of dizziness, with RORs of 34.91, 17.39, and 7.37, respectively. Subgroup analyses revealed variations in the relative risk of dizziness based on sex and age groups. Ketamine may be associated with higher risk of dizziness in the adult male subgroup.

CONCLUSION

The results of this study suggest that specific medications used by patients with postoperative analgesia are associated with an increased risk of postoperative dizziness. Future studies should further validate this finding and explore other potential risk factors.

摘要

目的

本研究旨在利用美国食品药品监督管理局不良事件报告系统(FAERS)数据库,探讨术后麻醉患者使用的药物与术后头晕之间的关联,以及头晕的其他风险因素。

方法

利用FAERS数据库,我们回顾性分析了2004年至2023年第三季度报告的头晕病例。我们分析了术后麻醉期间使用的药物与术后头晕风险之间的关系,并根据年龄、性别和其他因素进行了亚组分析。进一步使用报告比值比(ROR)方法进行信号检测,以确定与术后头晕风险增加显著相关的药物。

结果

共获得166,292份头晕病例报告,其中128例与术后镇痛具体相关。头晕报告数量逐年增加,18 - 85岁个体中的病例集中度较高,主要为女性患者。分析确定阿米替林、氯硝西泮和氯胺酮与头晕风险增加显著相关,ROR分别为34.91、17.39和7.37。亚组分析揭示了基于性别和年龄组的头晕相对风险存在差异。氯胺酮在成年男性亚组中可能与较高的头晕风险相关。

结论

本研究结果表明,术后镇痛患者使用的特定药物与术后头晕风险增加相关。未来研究应进一步验证这一发现,并探索其他潜在风险因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/3a2d13dc72fd/fphar-16-1488469-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/4f3bb42f0a89/fphar-16-1488469-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/9b725ab7b51f/fphar-16-1488469-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/7f386b393fb6/fphar-16-1488469-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/7c1675459752/fphar-16-1488469-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/3a2d13dc72fd/fphar-16-1488469-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/4f3bb42f0a89/fphar-16-1488469-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/9b725ab7b51f/fphar-16-1488469-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/7f386b393fb6/fphar-16-1488469-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/7c1675459752/fphar-16-1488469-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7309/11865249/3a2d13dc72fd/fphar-16-1488469-g005.jpg

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