PROJECT 3: CARDIOVASCULAR HEALTH EFFECTS OF EMERGING HEAT-NOT-BURN TOBACCO PRODUCTS

项目摘要/摘要 不燃烧热(HNB)产品，将烟草和其他化合物的混合物加热到低于温度 在发生燃烧的地方，会释放出含有尼古丁和其他化学物质的可吸入气雾剂。 尽管烟草行业之前推出此类产品的尝试在很大程度上 不成功的是，菲利普莫里斯国际公司的iQOS正成功地在几个国家进行试销。在……里面 此外，菲利普莫里斯产品公司已向FDA提交了修改后的风险烟草产品申请，以 允许在美国销售iQOS。尽管声称减少危害，但HNB对健康的影响 人们对产品知之甚少。该项目将在此之前通知FDA有关这一新兴产品类别的信息 广泛使用，与电子烟形成对比，电子烟在研究之前赢得了相当大的市场份额 社区可以动员起来研究它们对健康的影响。建议的研究将评估 HNB产品的心血管效应，从IQOS开始，包括对心脏和外周的影响 与吸烟相关的急性心肌梗死后血管功能和心脏组织保存 还有电子烟喷雾剂。这些目标将通过以下具体目标来实现：(1)了解 HNB气溶胶的化学性质及其生成过程中的化学变化；(2)评估和了解 急性和反复暴露于HNB气雾剂对大鼠心血管健康的影响；以及(3)确定 急性心肌梗死前急性和长期暴露于HNB气雾剂会增加 导致心脏组织死亡。使用经过验证的反映人类生理的大鼠模型来评估 暴露的功能和生化后果将使评估潜在的有害健康成为可能 这些产品的效果。拟议的研究针对的是TCORS的主题，即 健康影响、行为和影响分析将为监管和公众提供可操作的信息 关于当前和新兴烟草产品的沟通“，不仅与其他产品相关 以生物为导向的项目(研究电子烟和/或HNB气雾剂对健康影响的项目1和2)，但 此外，对与HNB产品相关的心血管风险的评估将为风险的比较提供信息 项目4中的看法，以及经验确定的对该项目的有害影响。结果还将提供 用于评估项目5中使用这些新兴产品的经济影响的数据。 方法将使TCORS能够及时提供关于这一新兴产品类别的信息，这将 以其他方式很难获得。特别是，通过将该项目与项目2相结合， 该组织正在研究使用iQOS对心血管的影响与使用电子烟对人体的影响，这是一项TCORS 将在HNB产品进入市场时向FDA提供有关它们的信息，而不是 事实发生几年后。

PROJECT SUMMARY/ABSTRACT Heat-not-burn (HNB) products, which heat a mixture of tobacco and other compounds to temperatures below those at which combustion occurs, deliver an inhalable aerosol containing nicotine and other chemicals. Although previous attempts by the tobacco industry to introduce such products have been largely unsuccessful, Philip Morris International's iQOS is successfully being test marketed in several countries. In addition, Philip Morris Products S.A. has submitted modified risk tobacco product applications to the FDA to permit marketing iQOS in the United States. Despite harm reduction claims, the health effects of HNB products are poorly understood. This project will inform the FDA about this emerging product class before it reaches widespread use, in contrast to e-cigarettes, which won a substantial market share before the research community could mobilize to study their effects on health. The proposed studies will evaluate the cardiovascular effects of HNB products, beginning with iQOS, including effects on cardiac and peripheral vascular function, and cardiac tissue preservation after acute myocardial infarction, relative to tobacco smoke and e-cigarette aerosol. These goals will be accomplished with the following specific aims: (1) Understand chemical properties of HNB aerosol and chemical changes during its generation; (2) Evaluate and understand cardiovascular health effects of both acute and repeated exposure to HNB aerosol in rats; and (3) Determine if acute and chronic exposure to HNB aerosol prior to acute myocardial infarction increase the extent of the resulting cardiac tissue death. The use of validated rat models that reflect human physiology to evaluate functional and biochemical consequences of exposure will enable evaluation of the potential adverse health effects of these products. The proposed research addresses the TCORS theme that “understanding combined health effects, behavior, and impact analysis will provide actionable information for regulation of and public communications about current and emerging tobacco products” by being relevant not only to the other biologically-oriented projects (Projects 1 and 2 that study health effects of e-cigarette and/or HNB aerosol), but also the assessment of cardiovascular risks associated with HNB products will inform the comparison of risk perceptions in Project 4 with empirically determined harmful effects in this project. The results will also provide data for the assessments of economic impact of use of these emerging products in Project 5. This integrated approach will enable the TCORS to provide timely information about this emerging product category that would have been difficult to obtain otherwise. In particular, by integrating between this project and Project 2, which is studying cardiovascular effects of iQOS use relative to e-cigarette use in humans, this TCORS will supply the FDA with information about HNB products as they are entering the market, rather than several years after the fact.