尼古丁袋独家使用者以及当前吸烟者、既往吸烟者和从不吸烟者的暴露生物标志物与潜在危害：一项横断面临床研究方案

Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study.

作者信息

Azzopardi David, Haswell Linsey Ellen, Frosina Justin, McEwan Michael, Gale Nathan, Thissen Jesse, Meichanetzidis Filimon, Hardie George

机构信息

British American Tobacco (Investments) Limited, Southampton, United Kingdom.

出版信息

JMIR Res Protoc. 2022 Oct 6;11(10):e39785. doi: 10.2196/39785.

DOI:10.2196/39785

PMID:36201395

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9585440/

Abstract

BACKGROUND

Tobacco harm reduction (THR) aims to reduce the health burden of cigarettes by encouraging smokers to switch to using alternative tobacco or nicotine products. Nicotine pouches (NPs) are smokeless, tobacco-free, oral products that may be beneficial as part of a THR strategy.

OBJECTIVE

This 2-center, cross-sectional confinement study conducted in Denmark and Sweden aimed to determine whether biomarkers of exposure (BoEs) to tobacco toxicants and biomarkers of potential harm (BoPHs) in exclusive users of NPs show favorable differences compared with current smokers.

METHODS

Participants were healthy NP users (target n=100) and current, former, or never smokers (target n=40 each), as confirmed by urinary cotinine and exhaled carbon monoxide concentrations. During a 24-hour confinement period, participants were asked to use their usual product (NP or cigarette) as normal, and BoEs and BoPHs were measured in blood and 24-hour urine samples, with compliance determined using anabasine, anatabine, and N-(2-cyanoethyl)valine. BoEs and BoPHs were compared between NP users and current, former, and never smokers. Urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (BoE to nicotine-derived nitrosamine ketone) and urinary 8-epi-prostaglandin F2α type III, exhaled nitric oxide, blood carboxyhemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein cholesterol (BoPHs) were evaluated as primary outcomes. Other measures included urinary 11-dehydrothromboxane B2, forced expiratory volume, carotid intima-media thickness, self-reported quality of life, and oral health.

RESULTS

The results of this study were received in mid-2022 and will be published in late 2022 to early 2023.

CONCLUSIONS

The results of this study will provide information on toxicant exposure and biomarkers associated with the development of smoking-related diseases among users of NPs compared with smokers, as well as on the potential role of NPs in THR.

TRIAL REGISTRATION

International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN16988167; https://www.isrctn.com/ISRCTN16988167.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39785.

摘要

背景

烟草危害降低（THR）旨在通过鼓励吸烟者改用其他烟草或尼古丁产品来减轻香烟对健康的负担。尼古丁袋（NPs）是无烟、无烟草的口服产品，作为THR策略的一部分可能有益。

目的

这项在丹麦和瑞典进行的2中心横断面限制研究旨在确定，与当前吸烟者相比，NPs唯一使用者中烟草毒物暴露生物标志物（BoEs）和潜在危害生物标志物（BoPHs）是否显示出有利差异。

方法

参与者为健康的NPs使用者（目标人数 = 100）以及当前吸烟者、既往吸烟者或从不吸烟者（各目标人数 = 40），通过尿可替宁和呼出一氧化碳浓度确认。在24小时的限制期内，要求参与者像往常一样使用他们常用的产品（NPs或香烟），并在血液和24小时尿液样本中测量BoEs和BoPHs，使用新烟草碱、降烟碱和N -（2 - 氰基乙基）缬氨酸确定依从性。比较NPs使用者与当前吸烟者、既往吸烟者和从不吸烟者之间的BoEs和BoPHs。评估尿中总4 -（甲基亚硝胺基）- 1 -（3 - 吡啶基）- 1 - 丁醇（尼古丁衍生的亚硝胺酮的BoE）以及尿中8 - 表 - 前列腺素F2α III型、呼出一氧化氮、血液碳氧血红蛋白、白细胞计数、可溶性细胞间黏附分子 - 1和高密度脂蛋白胆固醇（BoPHs）作为主要结果。其他测量指标包括尿中11 - 脱氢血栓素B2、用力呼气量、颈动脉内膜中层厚度、自我报告的生活质量和口腔健康。