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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(FAERS)的孕激素与抑郁症关联的药物警戒研究

Pharmacovigilance study of the association between progestogen and depression based on the FDA adverse event reporting System (FAERS).

作者信息

Gao Hui, Zhai Xiaohan, Hu Yan, Wu Hang

机构信息

Heze Medical College, Heze, 274000, Shandong Province, China.

Department of Pharmacy, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, Liaoning Province, China.

出版信息

Sci Rep. 2025 Jan 8;15(1):1302. doi: 10.1038/s41598-025-85826-1.

DOI:10.1038/s41598-025-85826-1
PMID:39779872
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11711629/
Abstract

Progestogens commonly used in the clinic include levonorgestrel, etonogestrel, medroxyprogesterone, hydroxyprogesterone, progesterone, desogestrel, and megestrol. Progestogens are widely used for contraception and the treatment of endometriosis, threatened abortion and other diseases. However, the correlation between progestogen use and depression is not clear. Therefore, this study used data from the FDA Adverse Event Reporting System (FAERS) database to assess the relationship between progestogen levels and depression. In this study, all data from the first quarter of 2004 to the third quarter of 2024 were extracted and imported into SAS 9.4 software for data cleaning and analysis. The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MGPS) were used for Bayesian analysis and disproportionation analysis. Levonorgestrel, medroxyprogesterone, etonogestrel and desogestrel presented positive signals for depression, and medroxyprogesterone also presented positive signals for major depression. Although none of the progestogens presented positive signals for suicide or self-harm, medroxyprogesterone presented a positive signal for suicidal ideation. Conclusion Analysis of data from the FAERS database revealed that levonorgestrel, medroxyprogesterone, etonogestrel, and desogestrel were correlated with depression. These findings provide real-world evidence of the potential risk of progestogen-related depression.

摘要

临床上常用的孕激素包括左炔诺孕酮、依托孕烯、甲羟孕酮、羟孕酮、孕酮、去氧孕烯和甲地孕酮。孕激素广泛用于避孕以及治疗子宫内膜异位症、先兆流产等疾病。然而,使用孕激素与抑郁症之间的相关性尚不清楚。因此,本研究使用美国食品药品监督管理局不良事件报告系统(FAERS)数据库中的数据来评估孕激素水平与抑郁症之间的关系。在本研究中,提取了2004年第一季度至2024年第三季度的所有数据,并导入SAS 9.4软件进行数据清理和分析。采用报告比值比(ROR)、比例报告比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项目伽马泊松收缩器(MGPS)进行贝叶斯分析和不成比例分析。左炔诺孕酮、甲羟孕酮、依托孕烯和去氧孕烯呈现出与抑郁症相关的阳性信号,甲羟孕酮还呈现出与重度抑郁症相关的阳性信号。虽然没有一种孕激素呈现出自杀或自我伤害相关的阳性信号,但甲羟孕酮呈现出自杀意念相关的阳性信号。结论对FAERS数据库数据的分析表明,左炔诺孕酮、甲羟孕酮、依托孕烯和去氧孕烯与抑郁症相关。这些发现为孕激素相关抑郁症的潜在风险提供了真实世界的证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cec9/11711629/1aa2b5b54d44/41598_2025_85826_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cec9/11711629/1aa2b5b54d44/41598_2025_85826_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cec9/11711629/1aa2b5b54d44/41598_2025_85826_Fig1_HTML.jpg

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本文引用的文献

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