评价潜在减害产品的临床试验方法。
Clinical trials methods for evaluation of potential reduced exposure products.
机构信息
University of Minnesota Tobacco Use Research Center, Minneapolis, 55414, USA.
出版信息
Cancer Epidemiol Biomarkers Prev. 2009 Dec;18(12):3143-95. doi: 10.1158/1055-9965.EPI-09-0654.
Abstract
Potential reduced exposure products (PREPs) to tobacco toxicants may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Such an assessment involves determining the effects of these products on biomarkers of exposure and effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article identifies critical methodologic issues associated with PREP assessments, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations are provided for clinical trial PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop.
摘要
潜在减害产品（PREPs）可能有希望减少与烟草有关的发病率或死亡率，也可能对个人或人群造成更大的伤害。确定这些产品的风险或益处的关键是对其进行有效的人体临床试验 PREP 评估方法。这种评估涉及确定这些产品对暴露和效应生物标志物的影响，这些生物标志物可作为危害的替代物，并评估消费者对该产品的接受和滥用的可能性。本文确定了与 PREP 评估相关的关键方法学问题，回顾了用于评估 PREP 的方法，并描述了这些方法的优缺点。此外，根据此次审查和美国国立癌症研究所（National Cancer Institute）赞助的临床试验 PREP 方法研讨会的讨论，就临床试验 PREP 评估方法和该领域的未来研究方向提出了建议。
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