Weitkunat Rolf, Lee Peter N, Baker Gizelle, Sponsiello-Wang Zheng, González-Zuloeta Ladd Angela M, Lüdicke Frank
Philip Morris International Research & Development, Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland.
P N Lee Statistics and Computing Ltd, 17 Cedar Road, Sutton, Surrey SM2 5DA, United Kingdom.
Regul Toxicol Pharmacol. 2015 Jun;72(1):87-93. doi: 10.1016/j.yrtph.2015.03.011. Epub 2015 Mar 27.
Based on the Food and Drug Administration's Modified Risk Tobacco Product (MRTP) Application draft guideline, Philip Morris International (PMI) has developed a Population Health Impact Model to estimate the reduction in the number of deaths over a period following the introduction of an MRTP. Such a model is necessary to assess the effect that its introduction would have on population health, given the lack of epidemiological data available prior to marketing authorization on any risks from MRTPs. The model is based on publicly available data on smoking prevalence and on the relationships between smoking-related disease-specific mortality and various aspects of the smoking of conventional cigarettes (CCs), together with an estimate of exposure from the MRTP relative to that from CCs, and allows the exploration of possible scenarios regarding the effect of MRTP introduction on the prevalence of CC and MRTP use, individually and in combination. By comparing mortality attributable in a scenario where the MRTP is introduced with one where it is not, the model can estimate the mortality attributable to CCs and the MRTP, as well as the reduction in the deaths attributable to the introduction of the MRTP.
根据美国食品药品监督管理局的改良风险烟草产品（MRTP）申请草案指南，菲利普·莫里斯国际公司（PMI）开发了一种人群健康影响模型，以估计在引入MRTP后的一段时间内死亡人数的减少情况。鉴于在获得市场授权之前缺乏关于MRTP任何风险的流行病学数据，这样的模型对于评估其引入对人群健康的影响是必要的。该模型基于关于吸烟流行率的公开数据、吸烟相关疾病特异性死亡率与传统卷烟（CC）吸烟各方面之间的关系，以及相对于CC的MRTP暴露估计，并允许探索关于引入MRTP对CC和MRTP使用流行率单独及综合影响的可能情景。通过比较引入MRTP的情景与未引入MRTP的情景下的归因死亡率，该模型可以估计CC和MRTP的归因死亡率，以及引入MRTP导致的死亡减少情况。
