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加热不燃烧烟草制品 THP1.0 评估. 第 9 部分:通过临床前评估研究,将一系列下一代产品相对于香烟在排放连续体上的定位。

Assessment of tobacco heating product THP1.0. Part 9: The placement of a range of next-generation products on an emissions continuum relative to cigarettes via pre-clinical assessment studies.

机构信息

British American Tobacco, R&D Centre, Southampton, SO15 8TL, United Kingdom.

British American Tobacco, R&D Centre, Southampton, SO15 8TL, United Kingdom.

出版信息

Regul Toxicol Pharmacol. 2018 Mar;93:92-104. doi: 10.1016/j.yrtph.2017.10.001. Epub 2017 Oct 25.

DOI:10.1016/j.yrtph.2017.10.001
PMID:29080852
Abstract

This series of nine papers described the operation and pre-clinical assessment of a tobacco heating product THP1.0. This last paper contextualises the pre-clinical assessment data on THP1.0 with data from other next generation products relative to cigarette smoke. The tobacco and nicotine risk continuum is a concept that ranks products according to their potential harm, with cigarettes at the highest risk extreme and Nicotine Replacement Therapy at the least risky extreme. Data generated in pre-clinical studies on THP1.0 and a range of Next Generation Products (NGPs) may provide some initial indication of potential ranking of these products, although importantly, data from such studies are limited and cannot take into consideration several important aspects for risk such as long term product use patterns. In each of the studies, the responses to the emissions from THP1.0 were substantially reduced relative to cigarette smoke. Additionally, responses from THP1.0 were very similar to those from the other NGP emissions. A comparison of the results clearly showed the emissions from all the NGPs were considerably lower than those from cigarettes and all in around the same emissions level. These results show that THP1.0 could have the potential to be a reduced risk product compared to cigarettes, though further studies assessing the exposure, individual and population risk reduction profile would be required to substantiate this potential.

摘要

本系列共九篇论文介绍了一款名为 THP1.0 的加热不燃烧烟草制品的操作和临床前评估。本文最后将 THP1.0 的临床前评估数据与其他新一代产品的香烟烟雾数据进行对比,以提供背景信息。烟草和尼古丁风险连续体是一个根据产品潜在危害程度对产品进行排序的概念,其中香烟处于风险最高的极端,尼古丁替代疗法处于风险最低的极端。THP1.0 和一系列新一代产品(NGP)的临床前研究中产生的数据可能为这些产品的潜在排名提供一些初步迹象,尽管重要的是,此类研究的数据有限,无法考虑到风险的几个重要方面,如长期产品使用模式。在每项研究中,THP1.0 排放物的反应明显低于香烟烟雾。此外,THP1.0 的反应与其他 NGP 排放物的反应非常相似。结果比较清楚地表明,所有 NGP 的排放物都明显低于香烟,而且排放水平大致相同。这些结果表明,与香烟相比,THP1.0 有可能成为一种降低风险的产品,但需要进一步评估暴露、个体和人群风险降低情况的研究来证实这一潜力。

相似文献

1
Assessment of tobacco heating product THP1.0. Part 9: The placement of a range of next-generation products on an emissions continuum relative to cigarettes via pre-clinical assessment studies.加热不燃烧烟草制品 THP1.0 评估. 第 9 部分:通过临床前评估研究,将一系列下一代产品相对于香烟在排放连续体上的定位。
Regul Toxicol Pharmacol. 2018 Mar;93:92-104. doi: 10.1016/j.yrtph.2017.10.001. Epub 2017 Oct 25.
2
Assessment of novel tobacco heating product THP1.0. Part 3: Comprehensive chemical characterisation of harmful and potentially harmful aerosol emissions.新型烟草加热产品 THP1.0 的评估。第 3 部分:有害和潜在有害气溶胶排放物的综合化学特征。
Regul Toxicol Pharmacol. 2018 Mar;93:14-33. doi: 10.1016/j.yrtph.2017.10.006. Epub 2017 Oct 25.
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Assessment of tobacco heating product THP1.0. Part 8: Study to determine puffing topography, mouth level exposure and consumption among Japanese users.加热不燃烧烟草制品 THP1.0 评估。第 8 部分:日本使用者的抽吸模式、口腔暴露水平和消费情况研究。
Regul Toxicol Pharmacol. 2018 Mar;93:84-91. doi: 10.1016/j.yrtph.2017.08.005. Epub 2017 Aug 16.
4
Assessment of tobacco heating product THP1.0. Part 5: In vitro dosimetric and cytotoxic assessment.加热不燃烧烟草制品 THP1.0 评估. 第 5 部分:体外剂量学和细胞毒性评估。
Regul Toxicol Pharmacol. 2018 Mar;93:52-61. doi: 10.1016/j.yrtph.2017.09.016. Epub 2017 Oct 1.
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Assessment of tobacco heating product THP1.0. Part 4: Characterisation of indoor air quality and odour.加热不燃烧烟草制品 THP1.0 评估. 第 4 部分: 室内空气质量和气味特性.
Regul Toxicol Pharmacol. 2018 Mar;93:34-51. doi: 10.1016/j.yrtph.2017.09.017. Epub 2017 Oct 1.
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Assessment of tobacco heating product THP1.0. Part 2: Product design, operation and thermophysical characterisation.加热不燃烧烟草制品 THP1.0 评估。第 2 部分:产品设计、操作和热物理特性。
Regul Toxicol Pharmacol. 2018 Mar;93:4-13. doi: 10.1016/j.yrtph.2017.09.009. Epub 2017 Oct 25.
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Assessment of enamel discoloration in vitro following exposure to cigarette smoke and emissions from novel vapor and tobacco heating products.体外评估暴露于香烟烟雾以及新型电子烟和烟草加热产品的烟雾后牙釉质变色情况。
Am J Dent. 2018 Oct;31(5):227-233.
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Assessment of tobacco heating product THP1.0. Part 1: Series introduction.加热不燃烧烟草制品 THP1.0 评估。第一部分:系列介绍。
Regul Toxicol Pharmacol. 2018 Mar;93:1-3. doi: 10.1016/j.yrtph.2017.09.010. Epub 2017 Oct 1.
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Nicotine Delivery to the Aerosol of a Heat-Not-Burn Tobacco Product: Comparison With a Tobacco Cigarette and E-Cigarettes.加热不燃烧烟草制品气溶胶中尼古丁的传递:与传统卷烟和电子烟的比较。
Nicotine Tob Res. 2018 Jul 9;20(8):1004-1009. doi: 10.1093/ntr/ntx138.
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Assessment of novel tobacco heating product THP1.0. Part 6: A comparative in vitro study using contemporary screening approaches.新型烟草加热产品 THP1.0 的评估。第 6 部分:使用当代筛选方法的体外比较研究。
Regul Toxicol Pharmacol. 2018 Mar;93:62-70. doi: 10.1016/j.yrtph.2017.08.016. Epub 2017 Oct 25.

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Chem Res Toxicol. 2020 Jul 20;33(7):1882-1887. doi: 10.1021/acs.chemrestox.0c00088. Epub 2020 Jun 2.
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A cross-category puffing topography, mouth level exposure and consumption study among Italian users of tobacco and nicotine products.意大利烟草和尼古丁制品使用者的跨品类抽吸特征、口腔水平暴露和消费研究。
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Evaluating the effects of switching from cigarette smoking to using a heated tobacco product on health effect indicators in healthy subjects: study protocol for a randomized controlled trial.评估健康受试者由吸烟转为使用加热烟草制品对健康效应指标影响的随机对照试验研究方案。
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A Meta-Analysis of the Performance of a Blood-Based Exposure Response Gene Signature Across Clinical Studies on the Tobacco Heating System 2.2 (THS 2.2).一项关于基于血液的暴露反应基因特征在烟草加热系统2.2(THS 2.2)临床研究中的表现的荟萃分析。
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