Scientific & Regulatory Affairs, RAI Services Company, Winston-Salem, NC.
AbbVie, North Chicago, IL.
Nicotine Tob Res. 2019 Aug 19;21(9):1239-1247. doi: 10.1093/ntr/nty140.
The aerosol composition of electronic cigarettes (ECs) suggests that exposure to toxicants during use is greatly reduced compared to exposure from combustible cigarettes (CCs).
This randomized, parallel-group, clinical study enrolled smokers to switch to Vuse Solo (VS) Digital Vapor Cigarettes (Original or Menthol) or Nicorette 4 mg nicotine gum (NG) in a controlled setting. Subjects who smoked CCs ad libitum for 2 days during a baseline period were then randomized to ad libitum use of either VS or NG for 5 days. Biomarkers of 23 toxicants were measured in 24-hour urine samples and blood collected at baseline and following product switch.
A total of 153 subjects completed the study. Total nicotine equivalents decreased in all groups, but higher levels were observed in the VS groups compared to the NG groups, with decreases of 38% and 60%-67%, respectively. All other biomarkers were significantly decreased in subjects switched to VS, and the magnitude of biomarker decreases was similar to subjects switched to NG. Decreases ranged from 30% to greater than 85% for constituents such as benzene and acrylonitrile.
These results indicate that exposure to toxicants when using VS is significantly reduced compared to CC smoking, and these reductions are similar to those observed with use of NG. Although statistically significantly decreased, nicotine exposure is maintained closer to CC smoking with VS use compared to NG use. This research suggests that use of VS exposes consumers to fewer and lower levels of smoke toxicants than CCs while still providing nicotine to the consumer.
This is the first study to report changes in nicotine delivery and biomarkers of tobacco exposure following a short-term product switch from CCs to either an EC or NG in a controlled environment. The study shows that nicotine exposure decreased in both groups but was maintained closer to CC smoking with the EC groups. Biomarkers of tobacco combustion decreased to similar levels in both EC and gum groups.
电子烟（EC）的气溶胶成分表明，与可燃香烟（CC）相比，使用过程中接触到的有毒物质大大减少。
这项随机、平行组、临床研究招募吸烟者在受控环境下将 Vuse Solo（VS）数字蒸气香烟（原味或薄荷味）或 Nicorette 4 毫克尼古丁口香糖（NG）转换使用。在基线期间，受试者在 2 天内随意吸食 CC，然后随机随意使用 VS 或 NG 5 天。在基线和产品转换后，通过 24 小时尿液样本和血液收集来测量 23 种有毒物质的生物标志物。
共有 153 名受试者完成了研究。所有组别的总尼古丁当量均降低，但 VS 组的水平高于 NG 组，分别降低了 38%和 60%-67%。所有其他生物标志物在转换为 VS 的受试者中均显著降低，与转换为 NG 的受试者相比，生物标志物降低的幅度相似。从 30%到大于 85%不等，苯和丙烯腈等成分的降幅都很大。
这些结果表明，与吸食 CC 相比，使用 VS 时接触有毒物质的程度显著降低，与使用 NG 时观察到的结果相似。尽管统计学上有显著降低，但与使用 NG 相比，VS 的使用使尼古丁暴露量更接近 CC 吸烟。这项研究表明，与 CC 相比，使用 VS 使消费者接触到的烟雾有毒物质更少、水平更低，同时仍为消费者提供尼古丁。
这是第一项在受控环境下，对短期从 CC 转换为 EC 或 NG 后，报告尼古丁输送和烟草暴露生物标志物变化的研究。该研究表明，两组的尼古丁暴露量都有所下降，但与 EC 组相比，CC 吸烟时的尼古丁暴露量更接近。两组的烟草燃烧生物标志物都下降到相似水平。
