Philip Morris Products S.A., PMI Research and Development, Neuchâtel, Switzerland.
Nicotine Tob Res. 2018 Jan 5;20(2):161-172. doi: 10.1093/ntr/ntw287.
The menthol Tobacco Heating System 2.2 (mTHS) is a newly developed candidate modified-risk tobacco product intended to reduce exposure to the harmful and potentially harmful constituents (HPHCs) of conventional cigarette (CC) smoke. This study examined the impact of switching to mTHS on biomarkers of exposure to HPHCs relative to menthol CCs (mCCs) and smoking abstinence (SA).
In this three-arm, parallel-group study, 160 Japanese adult smokers (23-65 years; smoking ≥10 mCCs per day) were randomized to mTHS (n = 78), mCC (n = 42), or SA (n = 40) for 5 days in confinement and 85 days in ambulatory settings. Endpoints included biomarkers of exposure to HPHCs, human puffing topography, safety, and subjective effects of smoking measures.
After 5 days of product use, the concentrations of carboxyhemoglobin, 3-hydroxypropylmercapturic acid, monohydroxybutenyl mercapturic acid, and S-phenylmercapturic acid were 55%, 49%, 87%, and 89% lower (p < .001), respectively, in the mTHS group than in the mCC group. Other biomarkers of exposure (measured as secondary endpoints) were 50%-94% lower in the mTHS group than in the mCC group on day 5. These reductions in the mTHS group were maintained at day 90, similar to the SA group. Switching to mTHS was associated with changes in human puffing topography (shorter puff intervals and more frequent puffs). The urge-to-smoke and smoking satisfaction levels on day 90 were similar in the mTHS and the mCC groups.
Switching from mCCs to mTHS significantly reduced exposure to HPHCs relative to continuing smoking mCCs with concentrations similar to those observed following SA in Japanese adult smokers.
This randomized study compared the impact of switching to a modified-risk tobacco product candidate mTHS on biomarkers of exposure to HPHCs of cigarette smoke relative to continuing smoking cigarettes or abstaining from smoking in sequential confinement and ambulatory settings. The study showed that switching to mTHS was associated with significant biomarker reductions within 5 days in confinement, these reductions being maintained throughout the ambulatory setting up to day 90. The results provide evidence that switching to mTHS reduces real-life exposure to HPHCs in adult smokers.
薄荷醇加热烟草系统 2.2（mTHS）是一种新开发的候选改良风险烟草产品，旨在降低传统卷烟（CC）烟雾中有害和潜在有害成分（HPHCs）的暴露。本研究考察了与薄荷醇 CC（mCC）和戒烟（SA）相比，改用 mTHS 对 HPHCs 暴露生物标志物的影响。
在这项三臂平行组研究中，160 名日本成年吸烟者（23-65 岁；每天吸烟≥10 支 mCC）被随机分配至 mTHS（n=78）、mCC（n=42）或 SA（n=40）组，在禁闭期间使用 5 天，在流动环境中使用 85 天。终点包括 HPHCs 暴露生物标志物、人体吸烟模式、安全性和吸烟措施的主观效应。
在产品使用 5 天后，mTHS 组的碳氧血红蛋白、3-羟基丙基硫尿酸、单羟基丁烯基硫尿酸和 S-苯硫尿酸浓度分别降低了 55%、49%、87%和 89%（p<0.001），分别低于 mCC 组。其他暴露生物标志物（作为次要终点测量）在 mTHS 组的降低了 50%-94%，在第 5 天。在第 90 天，mTHS 组的这些减少与 SA 组相似。改用 mTHS 与人体吸烟模式的变化有关（吸烟间隔缩短，吸烟更频繁）。在第 90 天，mTHS 和 mCC 组的吸烟欲望和吸烟满意度水平相似。
与继续吸 mCC 相比，从 mCC 改用 mTHS 显著降低了对 HPHCs 的暴露，浓度与日本成年吸烟者戒烟后的浓度相似。
这项随机研究比较了改用候选改良风险烟草产品 mTHS 对暴露于 HPHCs 生物标志物的影响，与继续吸烟或在连续禁闭和流动环境中戒烟相比。研究表明，在禁闭期内，改用 mTHS 在 5 天内即可显著降低生物标志物水平，这些减少在流动环境中持续到第 90 天。研究结果表明，改用 mTHS 可降低成年吸烟者实际暴露于 HPHCs。
