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基于流行病学的风险评估使用基准剂量/暴露边际方法:以乙醇和肝硬化为例。

Epidemiology-based risk assessment using the benchmark dose/margin of exposure approach: the example of ethanol and liver cirrhosis.

机构信息

Chemisches und Veterinäruntersuchungsamt Karlsruhe, Karlsruhe, Germany.

出版信息

Int J Epidemiol. 2011 Feb;40(1):210-8. doi: 10.1093/ije/dyq150. Epub 2010 Sep 6.

DOI:10.1093/ije/dyq150
PMID:20819784
Abstract

BACKGROUND

A novel approach to derive a threshold dose with respect to alcohol-related harm, the benchmark dose (BMD) methodology, is introduced to provide a basis for evidence-based drinking guidelines. This study is the first to calculate a BMD for alcohol exposure using epidemiological cohort data. With this BMD we will be able to calculate the margin of exposure (MOE) for alcohol consumption, which can be used for comparative risk assessment and applied to setting public health policy.

METHODS

Benchmark dose-response modelling of epidemiological data gathered during a recent systematic review and meta-analysis of alcohol consumption as a risk factor for liver cirrhosis morbidity and mortality.

RESULTS

For a benchmark response (BMR) of 1.5%, the resulting BMD values were 30.9 g/day for males and 29.7 g/day for females; the corresponding lower one-sided confidence values were 25.7 and 27.2 g/day, respectively. The intake scenario for the Canadian population resulted in an MOE of 1.23. Intake scenarios for individuals as based on the Canadian drinking guidelines led to MOE values between 0.96 and 1.91. Using an uncertainty factor of 10, the acceptable daily intake for alcohol would be 2.6 g/day.

CONCLUSIONS

The BMD approach was feasible in developing evidence-based guidelines for low-risk drinking. As our calculated MOEs result around unity (i.e. 1) for moderate drinking, it is evident that the current guidelines correspond very well to low risk on the dose-response curve. The BMD methodology therefore validates current guidelines. The results again highlight the health risk associated with alcohol consumption.

摘要

背景

一种新的方法,即基准剂量(BMD)方法,用于确定与酒精相关伤害的阈值剂量,为循证饮酒指南提供了依据。本研究首次使用流行病学队列数据计算酒精暴露的 BMD。有了这个 BMD,我们将能够计算酒精摄入量的暴露边际(MOE),可用于比较风险评估,并应用于制定公共卫生政策。

方法

对最近一项关于饮酒作为肝硬化发病率和死亡率危险因素的系统性综述和荟萃分析中收集的流行病学数据进行基准剂量反应建模。

结果

对于基准反应(BMR)为 1.5%,得出的 BMD 值分别为男性 30.9 g/天和女性 29.7 g/天;相应的单侧置信下限值分别为 25.7 和 27.2 g/天。加拿大人群的摄入量情景导致 MOE 为 1.23。根据加拿大饮酒指南得出的个人摄入量情景导致 MOE 值在 0.96 至 1.91 之间。使用不确定因素 10,酒精的可接受日摄入量将为 2.6 g/天。

结论

BMD 方法在制定低风险饮酒的循证指南方面是可行的。由于我们计算的 MOE 值在适度饮酒时约为 1(即 1),因此当前指南与剂量-反应曲线上的低风险非常吻合。BMD 方法因此验证了当前的指南。结果再次强调了饮酒带来的健康风险。

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