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烟草和尼古丁产品的不良健康事件:来自美国食品药品监督管理局安全报告门户网站的调查结果

Tobacco and Nicotine Products Adverse Health Events: Findings From the FDA Safety Reporting Portal.

作者信息

Barrientos Steven Alec, Dabroy Danny, Ebrahimi Kalan Mohammad, Laestadius Linnea Irina, Ben Taleb Ziyad

机构信息

Department of Kinesiology, College of Nursing and Health Innovation, The University of Texas at Arlington, Arlington, TX, USA.

School of Health Professions, Eastern Virginia Medical School, Norfolk, VA, USA.

出版信息

Tob Use Insights. 2024 Aug 28;17:1179173X241279674. doi: 10.1177/1179173X241279674. eCollection 2024.

DOI:10.1177/1179173X241279674
PMID:39220628
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11363042/
Abstract

INTRODUCTION

The FDA oversees regulatory aspects of all U.S. tobacco products. Understanding the impact of emerging health trends and incidents associated with various tobacco and nicotine products is vital for public health. This study utilizes the FDA's Tobacco Product Problem Reports (TPPRs) to characterize and track adverse health events (AHEs) associated with tobacco and nicotine products over time, considering the impact of EVALI and the COVID-19 pandemic.

METHODS

FDA TPPRs from 2017-2022 provided information on AHEs related to various tobacco products. After data cleaning, 839 reports were categorized by two independent coders based on affected health category, frequency of AHEs reports, and proportion of AHEs per each health category. Additionally, variations in AHEs over time were assessed, considering major health events like EVALI and the COVID-19 pandemic.

RESULTS

Among the 839 reports, electronic cigarettes (e-cigarettes) were the primary product of concern, comprising 90.6% (n = 760) of all reports, surpassing traditional cigarettes (5.1%; n = 43) and other products. Notably, 45.6% of reports (n = 383) identified the neurological system as the most frequently mentioned health category, each reporting at least one AHE. This was followed by the respiratory (39.1%; n = 328) and digestive (10.7%; n = 90) systems. Among all reported AHEs, respiratory system issues were most frequent (25.9%; n = 512), closely followed by neurological (25.2%; n = 499) and digestive (6.6%; n = 131) concerns. Most reports occurred in 2019 (65.7%; n = 551), coinciding with the EVALI outbreak, with a subsequent decline post-Q3 2019, highlighting the potential impact of specific health crises on reporting trends.

CONCLUSION

E-cigarettes dominated adverse health reports, particularly affecting the neurological and respiratory systems, with a peak in 2019. Our findings provide insights to regulatory entities and future research, enhancing understanding of AHEs in lesser-explored bodily systems, such as the neurological and digestive systems. This study emphasizes the need for ongoing and improved surveillance of emerging tobacco products to protect public health.

摘要

引言

美国食品药品监督管理局(FDA)负责监管美国所有烟草产品的相关事宜。了解与各类烟草及尼古丁产品相关的新出现的健康趋势和事件对公众健康至关重要。本研究利用FDA的烟草产品问题报告(TPPR)来描述和追踪随时间推移与烟草及尼古丁产品相关的不良健康事件(AHE),同时考虑电子烟相关肺损伤(EVALI)和新冠疫情的影响。

方法

2017年至2022年的FDA TPPR提供了与各类烟草产品相关的AHE信息。在数据清理后,两名独立编码员根据受影响的健康类别、AHE报告频率以及每个健康类别中AHE的比例对839份报告进行了分类。此外,考虑到EVALI和新冠疫情等重大健康事件,评估了AHE随时间的变化情况。

结果

在839份报告中,电子烟是主要关注的产品,占所有报告的90.6%(n = 760),超过传统香烟(5.1%;n = 43)和其他产品。值得注意的是,45.6%的报告(n = 383)将神经系统确定为最常提及的健康类别,每份报告至少提及一起AHE。其次是呼吸系统(39.1%;n = 328)和消化系统(10.7%;n = 90)。在所有报告的AHE中,呼吸系统问题最为常见(25.9%;n = 512),其次是神经系统(25.2%;n = 499)和消化系统(6.6%;n = 131)问题。大多数报告发生在2019年(65.7%;n = 551),与EVALI疫情爆发时间一致,在2019年第三季度之后报告数量有所下降,这突出了特定健康危机对报告趋势的潜在影响。

结论

电子烟在不良健康报告中占主导地位,尤其影响神经系统和呼吸系统,在2019年达到峰值。我们的研究结果为监管机构和未来研究提供了见解,增进了对较少研究的身体系统(如神经系统和消化系统)中AHE的理解。本研究强调需要持续加强对新兴烟草产品的监测以保护公众健康。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/b1ea91a51a16/10.1177_1179173X241279674-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/fa0b29cbdcd3/10.1177_1179173X241279674-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/c8eb9a2eeb69/10.1177_1179173X241279674-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/4df801108ab9/10.1177_1179173X241279674-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/b1ea91a51a16/10.1177_1179173X241279674-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/fa0b29cbdcd3/10.1177_1179173X241279674-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/c8eb9a2eeb69/10.1177_1179173X241279674-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/4df801108ab9/10.1177_1179173X241279674-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a1b/11363042/b1ea91a51a16/10.1177_1179173X241279674-fig4.jpg

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