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电子烟的尼古丁含量、其在蒸汽中的释放情况以及不同批次间的一致性:监管意义

Nicotine content of electronic cigarettes, its release in vapour and its consistency across batches: regulatory implications.

作者信息

Goniewicz Maciej L, Hajek Peter, McRobbie Hayden

机构信息

Tobacco Dependence Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK; Department of Health Behavior, Division of Cancer Prevention and Population Sciences, Roswell Park Cancer Institute, Buffalo, NY, USA.

出版信息

Addiction. 2014 Mar;109(3):500-7. doi: 10.1111/add.12410. Epub 2013 Dec 18.

Abstract

BACKGROUND AND AIMS

Electronic cigarettes (EC) may have a potential for public health benefit as a safer alternative to smoking, but questions have been raised about whether EC should be licensed as a medicine, with accurate labelling of nicotine content. This study determined the nicotine content of the cartridges of the most popular EC brands in the United Kingdom and the nicotine levels they deliver in the vapour, and estimated the safety and consistency of nicotine delivery across batches of the same product as a proxy for quality control for individual brands and within the industry.

METHODS

We studied five UK brands (six products) with high internet popularity.

MEASUREMENTS

Two samples of each brand were purchased 4 weeks apart, and analysed for nicotine content in the cartridges and nicotine delivery in vapour.

RESULTS

The nicotine content of cartridges within the same batch varied by up to 12% relative standard deviation (RSD) and the mean difference between different batches of the same brand ranged from 1% [95% confidence interval (CI) = -5 to 7%] to 20% (95% CI=14-25%) for five brands and 31% (95% CI=21-39%) for the sixth. The puffing schedule used in this study vaporized 10-81% of the nicotine present in the cartridges. The nicotine delivery from 300 puffs ranged from ∼2 mg to ∼15 mg and was not related significantly to the variation of nicotine content in e-liquid (r=0.06, P=0.92). None of the tested products allowed access to e-liquid or produced vapour nicotine concentrations as high as conventional cigarettes.

CONCLUSIONS

There is very little risk of nicotine toxicity from major electronic cigarette (EC) brands in the United Kingdom. Variation in nicotine concentration in the vapour from a given brand is low. Nicotine concentration in e-liquid is not well related to nicotine in vapour. Other EC brands may be of lower quality and consumer protection regulation needs to be implemented, but in terms of accuracy of labelling of nicotine content and risks of nicotine overdose, regulation over and above such safeguards seems unnecessary.

摘要

背景与目的

电子烟作为一种比吸烟更安全的替代品,可能对公众健康有益,但对于电子烟是否应作为药品进行许可并准确标注尼古丁含量,人们提出了疑问。本研究测定了英国最受欢迎的电子烟品牌烟弹中的尼古丁含量及其产生的蒸汽中的尼古丁水平,并评估了同一产品不同批次间尼古丁输送的安全性和一致性,以此作为各品牌及整个行业质量控制的指标。

方法

我们研究了五个在互联网上知名度较高的英国品牌(六种产品)。

测量

每个品牌相隔4周购买两个样本,分析烟弹中的尼古丁含量以及蒸汽中的尼古丁输送量。

结果

同一批次烟弹中的尼古丁含量相对标准偏差(RSD)高达12%,五个品牌同一品牌不同批次之间的平均差异范围为1%[95%置信区间(CI)=-5至7%]至20%(95%CI=14-25%),第六个品牌为31%(95%CI=21-39%)。本研究中使用的抽吸方案使烟弹中10%-81%的尼古丁蒸发。300口的尼古丁输送量在约2毫克至约15毫克之间,与电子烟液中尼古丁含量的变化无显著相关性(r=0.06,P=0.92)。所测试的产品均未使电子烟液暴露,也未产生与传统香烟一样高的蒸汽尼古丁浓度。

结论

英国主要电子烟品牌导致尼古丁中毒的风险极低。特定品牌蒸汽中尼古丁浓度的变化较小。电子烟液中的尼古丁浓度与蒸汽中的尼古丁含量相关性不佳。其他电子烟品牌质量可能较低,需要实施消费者保护监管,但就尼古丁含量标注的准确性和尼古丁过量风险而言,除这些保障措施外的监管似乎并无必要。

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