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是否存在“洛哌丁胺”类药物？对欧洲药品管理局（EMA）药物警戒数据库中与洛哌丁胺相关报告的分析。

Is there such a thing as a 'lope' dope? Analysis of loperamide-related European Medicines Agency (EMA) pharmacovigilance database reports.

机构信息

Psychopharmacology, Drug Misuse, and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, United Kingdom.

Casa di Cura Villa Rosa, Viterbo (VT), Italy.

出版信息

PLoS One. 2018 Oct 4;13(10):e0204443. doi: 10.1371/journal.pone.0204443. eCollection 2018.

DOI:10.1371/journal.pone.0204443
PMID:30286103
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6171858/
Abstract

BACKGROUND

Among over-the-counter (OTC) drugs, loperamide has recently emerged for its potential of misuse and cardiotoxicity issues. Hence, we aimed here at assessing the loperamide-related cases being reported to the EMA's EudraVigilance (EV) database.

METHODS

All spontaneous EV reports relating to loperamide misuse/abuse/dependence/withdrawal and cardiotoxicity issues were here retrieved, performing a descriptive analysis.

FINDINGS

During the years 2005-2017, EV collected a number of 1,983 (out of a total of 7,895; 25.11%) loperamide-related misuse/abuse/dependence/withdrawal adverse drug reaction (ADR) reports, with a progressively increasing trend since 2014. Most cases were classified as drug use disorder (37.4%) or intentional overdose (25.4%). Loperamide was used on its own in 41.9% of cases; remaining, polydrug, cases included antidepressants; benzodiazepines; and other OTCs. Some 1,085 (1,085/7,895 = 13.7%) cardiovascular ADRs were reported, being conduction abnormalities and EKG alterations the most frequently identified.

CONCLUSIONS

EV data may support the levels of concern relating to loperamide potential of abuse and associated cardiotoxicity issues.

摘要

背景

在非处方 (OTC) 药物中，洛哌丁胺最近因其潜在的滥用和心脏毒性问题而受到关注。因此，我们旨在评估向欧洲药品管理局的 EudraVigilance (EV) 数据库报告的与洛哌丁胺相关的病例。

方法

所有与洛哌丁胺滥用/滥用/依赖/戒断和心脏毒性问题相关的自发 EV 报告均在此处检索，进行描述性分析。

结果

在 2005 年至 2017 年期间，EV 共收集了 1983 份（共 7895 份；25.11%）与洛哌丁胺相关的滥用/滥用/依赖/戒断不良药物反应 (ADR) 报告，自 2014 年以来呈逐渐上升趋势。大多数病例被归类为药物使用障碍（37.4%）或故意过量（25.4%）。洛哌丁胺在 41.9%的病例中单独使用；其余的多药，包括抗抑郁药；苯二氮䓬类药物；和其他 OTC 药物。共报告了 1085 例（1085/7895=13.7%）心血管 ADR，最常见的是传导异常和心电图改变。

结论

EV 数据可能支持与洛哌丁胺潜在滥用和相关心脏毒性问题相关的关注程度。