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检测食品和药物管理局不良事件数据库中行为成瘾与多巴胺激动剂之间的关联。

Detecting associations between behavioral addictions and dopamine agonists in the Food & Drug Administration's Adverse Event database.

机构信息

Yale University School of Medicine, New Haven, CT, USA.

出版信息

J Behav Addict. 2014 Mar;3(1):21-6. doi: 10.1556/JBA.3.2014.1.3. Epub 2014 Mar 24.

Abstract

BACKGROUND/AIMS: Studies have reported higher prevalences of four behavioral addictions (binge eating, compulsive shopping, hypersexuality, and pathological gambling) in dopamine agonist-treated Parkinson's disease relative to non-dopamine agonist-treated Parkinson's. However, recent case-control and epidemiological studies suggest that prevalences of behavioral addictions in dopamine agonist-treated Parkinson's may be similar to background population rates. This study tests that hypothesis by examining the FDA Adverse Event Reporting System (FAERS) for evidence of these associations, taking into account the potential impact of publicity on reporting rates.

METHODS

FAERS reports in 2004 (pre-publicity for all but pathological gambling) and 2007 (post-publicity for all four behaviors) were analyzed. A threshold consisting of ≥3 cases, proportional reporting ratio ≥2, and χ (2) with Yates' correction ≥4 was used to detect signals (drug-associated adverse reactions) involving any of five dopamine agonists and any of four behavioral addictions.

RESULTS

No reports containing compulsive shopping and no signal for binge eating and dopamine agonists were found in either year. A weak signal was found for hypersexuality in 2004, with a stronger signal in 2007. A robust signal was found for pathological gambling in 2004, with a more robust signal in 2007.

DISCUSSION/CONCLUSIONS: These results suggest that publicity may increase reporting rates in the FAERS. Findings for binge eating, compulsive shopping, and hypersexuality suggest that prevalences of these behaviors among those treated with dopamine agonists may be similar to background population rates and thus may not reflect an adverse safety signal. Further investigation of the relationship between dopamine agonists and behavioral addictions is warranted.

摘要

背景/目的:研究报告称,与未使用多巴胺激动剂治疗的帕金森病患者相比,接受多巴胺激动剂治疗的帕金森病患者中,四种行为成瘾(暴食、强迫性购物、性欲亢进和病理性赌博)的患病率更高。然而,最近的病例对照和流行病学研究表明,接受多巴胺激动剂治疗的帕金森病患者中行为成瘾的患病率可能与背景人群的发病率相似。本研究通过检查 FDA 不良事件报告系统(FAERS)中是否存在这些关联的证据来检验这一假设,同时考虑到宣传对报告率的潜在影响。

方法

分析了 2004 年(除病理性赌博外,所有行为均有宣传)和 2007 年(所有四种行为均有宣传)的 FAERS 报告。使用≥3 例、比例报告比≥2 和 χ(2)与 Yates 校正≥4 的阈值来检测涉及五种多巴胺激动剂和四种行为成瘾症中的任何一种的信号(与药物相关的不良反应)。

结果

在这两年中,均未发现包含强迫性购物的报告,也未发现暴食和多巴胺激动剂的信号。2004 年发现性欲亢进的信号较弱,2007 年则较强。2004 年发现病理性赌博的信号较强,2007 年则更强。

讨论/结论:这些结果表明,宣传可能会增加 FAERS 中的报告率。暴食、强迫性购物和性欲亢进的发现表明,接受多巴胺激动剂治疗的这些行为的患病率可能与背景人群的发病率相似,因此可能不会反映出不良的安全信号。有必要进一步调查多巴胺激动剂与行为成瘾之间的关系。

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Web-scale pharmacovigilance: listening to signals from the crowd.网络规模药物警戒:从人群中聆听信号。
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