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

项目 3：新兴加热不燃烧烟草产品对心血管健康的影响

• 批准号: 10259838
• 负责人: MATTHEW Lawrence SPRINGER
• 金额: $ 35.17万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-19 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10259838
• 关键词: Acute; Acute myocardial infarction; Address; Aerosols; Behavior; Biochemical; Biological; Blood; Blood Vessels; Cardiac; Categories; Cessation of life; Chemicals; Chronic; Cigarette; Clinical Trials; Communication; Communities; Country; Data; Doctor of Philosophy; Electronic cigarette; Emerging Tobacco Products; Endothelium; Evaluation; Exposure to; Generations; Goals; Harm Reduction; Health; Heating; Human; Impairment; International; Lead; Legal; Manufacturer Name; Marketing; Modeling; Modified Risk Tobacco Product; Myocardial Infarction; Nicotine; Nitric Oxide; Peripheral; Physiological; Physiology; Plant Leaves; Policies; Production; Public Health; Rattus; Regulation; Research; System; Temperature; Testing; Time; Tissue Preservation; Tissues; Tobacco; Tobacco Industry; Tobacco smoke; Tobacco use; United States; Vaporizer; Vascular Endothelium; Work; behavioral economics; cardiovascular effects; cardiovascular health; cardiovascular risk factor; chemical property; cigarette smoke; e-cigarette aerosols; economic impact; electronic cigarette use; heart function; heated tobacco products; risk perception; tobacco products; tobacco smoke exposure; vapor

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.

项目概要/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以下温度 那些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溶胶。 尽管烟草业之前推出此类产品的尝试在很大程度上受到了阻碍 尽管不成功，菲利普莫里斯国际公司的 iQOS 已在多个国家成功试销。 此外，菲利普莫里斯产品公司已向 FDA 提交了修改风险烟草产品申请，以 允许在美国销售 iQOS 尽管声称可以减少危害，但 HNB 对健康的影响仍然存在。 该项目将在此之前向 FDA 通报这一新兴产品类别。 与电子烟相比，它得到了广泛的使用，在研究之前电子烟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。 HNB 产品对心血管的影响，从 iQOS 开始，包括对心脏和外周血管的影响 与烟草烟雾相关的急性心肌梗死后的血管功能和心脏组织保存 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）评估和理解 急性和反复接触 HNB 气溶胶对大鼠心血管健康的影响；以及 (3) 确定是否； 急性心肌梗死前急性和慢性暴露于 HNB 气溶胶会增加急性心肌梗死的程度 使用反映人类生理学的经过验证的大鼠模型来评估。 暴露的功能和生化后果将有助于评估潜在的不利健康 拟议的研究涉及 TCORS 的主题“理解组合”。 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沟通”不仅与其他产品相关 以生物学为导向的项目（研究电子烟和/或加热不燃烧气雾剂对健康的影响的项目 1 和 2），但是 此外，对与加热不燃烧产品相关的心血管风险的评估将为风险比较提供信息 项目 4 中的看法以及根据经验确定的有害影响的结果也将提供。 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 能够及时提供有关这一新兴产品类别的信息， 特别是通过该项目和项目 2 之间的集成，很难获得 TCORS 正在研究 iQOS 相对于电子烟使用对人类心血管的影响 将在 HNB 产品进入市场时向 FDA 提供有关这些产品的信息，而不是 事后几年。