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Predictors of serious adverse drug events from opioids: Results from the Food and Drug Administration Adverse Events Reporting System.阿片类药物严重药物不良事件的预测因素:来自食品和药物管理局不良事件报告系统的结果。
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2
Association Between Benzodiazepine Use With or Without Opioid Use and All-Cause Mortality in the United States, 1999-2015.美国 1999-2015 年苯二氮䓬类药物(无论是否与阿片类药物合用)使用与全因死亡率的关系。
JAMA Netw Open. 2020 Dec 1;3(12):e2028557. doi: 10.1001/jamanetworkopen.2020.28557.
3
US Food and Drug Administration Safety Advisories and Reporting to the Adverse Event Reporting System (FAERS).美国食品和药物管理局安全咨询和向不良事件报告系统(FAERS)报告。
Pharmaceut Med. 2020 Apr;34(2):135-140. doi: 10.1007/s40290-020-00329-w.
4
2018 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 36th Annual Report.2018 年美国毒物控制中心协会国家毒物数据系统(NPDS)年度报告:第 36 次年度报告。
Clin Toxicol (Phila). 2019 Dec;57(12):1220-1413. doi: 10.1080/15563650.2019.1677022. Epub 2019 Nov 21.
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Opioids and frequency counts in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database: a quantitative view of the epidemic.美国食品药品监督管理局不良事件报告系统(FAERS)数据库中的阿片类药物与频数计数:对这一流行情况的定量分析
Drug Healthc Patient Saf. 2019 Aug 19;11:65-70. doi: 10.2147/DHPS.S214771. eCollection 2019.
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2009年至2018年间美国成年人同时使用阿片类药物和苯二氮卓类药物及其相关药物不良事件的描述性分析。

A descriptive analysis of concomitant opioid and benzodiazepine medication use and associated adverse drug events in United States adults between 2009 and 2018.

作者信息

Marwitz Kathryn K, Noureldin Marwa

机构信息

Manchester University College of Pharmacy, Natural & Health Sciences, 10627 Diebold Road, Fort Wayne, IN 46845, United States of America.

出版信息

Explor Res Clin Soc Pharm. 2022 Mar 20;5:100130. doi: 10.1016/j.rcsop.2022.100130. eCollection 2022 Mar.

DOI:10.1016/j.rcsop.2022.100130
PMID:35478505
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9031034/
Abstract

BACKGROUND

In 2016, the Centers for Disease Control and Prevention (CDC) published guidelines for prescribing opioids for chronic pain in response to the opioid epidemic and recommended avoiding concomitant use of opioid and benzodiazepine medications whenever possible. However, based on a recent report, 16% of overdose deaths involving opioids also involved benzodiazepines.

OBJECTIVE

The objectives of this study were to examine 1) trends in concomitant opioid and benzodiazepine usage and factors associated with utilization 2) and related adverse event reporting before and after the publication of CDC chronic pain prescribing guidelines.

METHODS

This study employed a retrospective data analysis of the National Health and Nutrition Examination Survey (NHANES) and FDA Adverse Event Reporting System (FAERS) databases between 2009 and 2018. Descriptive statistics and logistic regression were used to examine characteristics and temporal trends in people taking or reporting adverse events with opioid, benzodiazepine, and both medications.

RESULTS

Among those taking an opioid medication, 19.7% were also taking a benzodiazepine within the same 30 days. Characteristics for those who reported taking both medications together include being female, non-Hispanic White, being middle aged, and having a lower household income. Concomitant medication use rose between 2009 and 2016 and declined in 2017-2018. Among FAERS reports examined with an opioid suspect medication, 17.9% also included a benzodiazepine suspect medication. Over time, there was an increase in identified FAERS reports involving concomitant opioid and benzodiazepine medications.

CONCLUSIONS

Concomitant opioid and benzodiazepine use was detected in a small but notable proportion of NHANES survey participants and FAERS reports between 2009 and 2018. Further research examining causal associations between opioids, benzodiazepines, and identified social risk factors are needed to inform prescribing and to best tailor public health interventions to address physical and mental illness safely and effectively across the population.

摘要

背景

2016年,美国疾病控制与预防中心(CDC)发布了针对慢性疼痛开具阿片类药物的指南,以应对阿片类药物泛滥问题,并建议尽可能避免同时使用阿片类药物和苯二氮䓬类药物。然而,根据最近一份报告,16%的涉及阿片类药物的过量死亡案例也涉及苯二氮䓬类药物。

目的

本研究的目的是调查1)阿片类药物和苯二氮䓬类药物联合使用的趋势以及与使用相关的因素,2)以及CDC慢性疼痛处方指南发布前后相关不良事件的报告情况。

方法

本研究对2009年至2018年期间的美国国家健康与营养检查调查(NHANES)和美国食品药品监督管理局不良事件报告系统(FAERS)数据库进行了回顾性数据分析。描述性统计和逻辑回归用于研究服用或报告使用阿片类药物、苯二氮䓬类药物以及两种药物的不良事件的人群的特征和时间趋势。

结果

在服用阿片类药物的人群中,19.7%的人在同一30天内也服用了苯二氮䓬类药物。报告同时服用这两种药物的人群特征包括女性、非西班牙裔白人、中年以及家庭收入较低。联合用药在2009年至2016年期间有所上升,在2017 - 2018年有所下降。在接受检查的FAERS报告中,涉及阿片类可疑药物的报告中,17.9%也包括苯二氮䓬类可疑药物。随着时间的推移,涉及阿片类药物和苯二氮䓬类药物联合使用的FAERS报告有所增加。

结论

在2009年至2018年期间的NHANES调查参与者和FAERS报告中,发现了一小部分但值得注意的阿片类药物和苯二氮䓬类药物联合使用的情况。需要进一步研究阿片类药物、苯二氮䓬类药物与已确定的社会风险因素之间的因果关系,以便为处方提供信息,并最好地调整公共卫生干预措施,以安全有效地应对整个人口中的身体和精神疾病。