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

项目总结/摘要 加热不燃烧（HNB）产品，将烟草和其他化合物的混合物加热到低于 燃烧发生的那些气体释放含有尼古丁和其它化学物质的可吸入气雾剂。 虽然烟草业以前尝试推出这类产品的努力在很大程度上失败了， 虽然没有成功，但菲利普莫里斯国际公司的iQOS在几个国家成功地进行了市场测试。在 菲利普莫里斯产品公司（Philip Morris Products S.A.）已向FDA提交了经修改的风险烟草产品申请， 在美国销售iQOS。尽管有减少伤害的说法，HNB对健康的影响 产品知之甚少。该项目将在其发布之前通知FDA有关这一新兴产品类别的信息。 与电子烟形成鲜明对比的是，电子烟在研究之前赢得了可观的市场份额。 社区可以动员起来研究它们对健康的影响。拟议的研究将评估 HNB产品的心血管效应，从iQOS开始，包括对心脏和外周血管的影响 与吸烟相关的急性心肌梗死后血管功能和心脏组织保护 和电子烟气雾剂。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 大鼠急性和重复暴露于HNB气溶胶对心血管健康的影响;以及（3）确定 急性心肌梗死前急性和慢性暴露于HNB气溶胶增加了心肌梗死的程度， 导致心脏组织死亡。使用经过验证的反映人体生理学的大鼠模型来评估 暴露的功能和生物化学后果将能够评估潜在的不利健康 这些产品的影响。拟议的研究解决了TCORS的主题，即“理解结合 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信息交流”，不仅与其他 生物导向的项目（研究电子烟和/或HNB气溶胶对健康影响的项目1和2），但 此外，与HNB产品相关的心血管风险评估将告知风险比较 项目4中的认知与经验确定的本项目中的有害影响。结果还将提供 项目5中使用这些新兴产品的经济影响评估数据。这一综合 这种方法将使TCORS能够及时提供有关这一新兴产品类别的信息， 否则很难获得。特别是，通过将该项目与项目2相结合， 该公司正在研究iQOS使用相对于电子烟使用对人类心血管的影响， 将向FDA提供有关HNB产品进入市场的信息，而不是 几年后的事实。

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.