Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong, China.
Clinical Trial Center of Dongguan KangHua Hospital, Dongguan, Guangdong, China.
Nicotine Tob Res. 2022 Nov 12;24(12):1881-1888. doi: 10.1093/ntr/ntac143.
To evaluate the nicotine pharmacokinetics of a commercial electronic cigarette (e-cigarette) relative to conventional cigarettes in Chinese adult smokers.
A randomized, open-label, crossover clinical study was conducted on 23 healthy adult Chinese smokers. In two sessions, subjects used either the e-cigarettes with 30 mg/g nicotine in e-liquid or conventional cigarettes of a given brand, at one puff every 30 seconds for a total of 10 puffs. Blood samples were collected at specified time points for 4 hours after the first puff. Subjective effects on desire-to-smoke and physiological parameters such as heart rate and oxyhemoglobin saturation levels were also examined before and after using the two products.
The baseline-adjusted maximum nicotine concentration (Cmax-BL), time-to-peak nicotine concentration (Tmax), and nicotine absorption rate (Cmax-BL divided by Tmax) were found to be similar for the e-cigarette versus those of conventional cigarettes (p > .05). Total nicotine exposure measured as the area-under-curve (AUC0-t-BL) was significantly lower for the e-cigarette relative to that of conventional cigarettes. In addition, the subjects found that e-cigarettes were well tolerated under controlled puffing conditions.
The test e-cigarettes achieved similar nicotine delivery and pharmacokinetic profiles to those of the comparator cigarettes, indicating that this e-cigarette could be a potential alternative to conventional cigarettes for those adult smokers.
There are no data in the published literature on the nicotine pharmacokinetics of e-cigarettes in Chinese smokers. To the best of our knowledge, this is the first study to evaluate the nicotine delivery and pharmacokinetic profile of a commercial e-cigarette brand compared with conventional cigarettes in Chinese adult smokers. After the use of test e-cigarettes, nicotine delivery and pharmacokinetic profile were similar to those of conventional cigarettes in Chinese adult smokers.
评估一种商业电子烟（电子烟）相对于中国成年吸烟者常规香烟的尼古丁药代动力学。
对 23 名健康的成年中国吸烟者进行了一项随机、开放标签、交叉临床试验。在两个阶段，受试者分别使用含有 30mg/g 尼古丁的电子烟或特定品牌的常规香烟，每 30 秒吸一口，总共吸 10 口。在第一口吸烟后 4 小时内，按规定时间点采集血样。在使用两种产品前后，还检查了吸烟欲望和心率、氧合血红蛋白饱和度等生理参数的主观影响。
电子烟与常规香烟相比，调整基线后的最大尼古丁浓度（Cmax-BL）、达峰时间（Tmax）和尼古丁吸收速率（Cmax-BL 除以 Tmax）相似（p>.05）。电子烟的尼古丁总暴露量（AUC0-t-BL）明显低于常规香烟。此外，在受控吸烟条件下，受试者发现电子烟耐受性良好。
测试电子烟的尼古丁输送和药代动力学特征与比较香烟相似，表明该电子烟可能成为成年吸烟者替代常规香烟的潜在选择。
目前还没有关于中国吸烟者电子烟尼古丁药代动力学的已发表文献数据。据我们所知，这是第一项评估商业电子烟品牌与中国成年吸烟者常规香烟相比的尼古丁输送和药代动力学特征的研究。使用测试电子烟后，尼古丁输送和药代动力学特征与中国成年吸烟者常规香烟相似。
