Swaen G M H
Department of Epidemiology, Maastricht University, The Netherlands.
Hum Exp Toxicol. 2006 Mar;25(3):147-55. doi: 10.1191/0960327106ht600oa.
Data on health effects from human exposure to chemicals provide the most direct information for risk assessment. Despite their clear relevance for risk assessment and despite the frequently made statements by regulatory bodies to use epidemiological data whenever deemed appropriate, they are not always optimally used. In this article, a framework for using epidemiological data in risk assessment is presented. Before using an epidemiologic study as the basis for risk assessment, its quality must be evaluated. The quality criteria for such a study strongly depends on the type of association between the chemical and health effect in terms of its specificity and latency period. The framework is built on the type of health effect under consideration, whether it is a specific or non-specific effect and time window of the effect, whether it is an acute, sub-acute or long-term effect. Specificity and latency are aspects that have a great impact on the choice of research design and quality criteria that must be met in order to produce reliable results appropriate for risk assessment purposes. Although expert judgement will always play an important role, the framework can help to assess if a set of epidemiological data are sufficiently reliable to serve as the basis for the derivation of health-based exposure limits. The limitations and suitability to use for risk assessment of epidemiologic studies is more likely to be the result of poor or insufficient exposure data than of poor or unreliable health effect information. It is concluded that the value of epidemiologic data not only depends on its intrinsic quality, but also on the type of health effects under consideration. In this respect, the specificity and latency play an important role.
关于人类接触化学物质对健康影响的数据为风险评估提供了最直接的信息。尽管这些数据与风险评估明显相关，尽管监管机构经常声明在认为适当时使用流行病学数据，但它们并未总是得到最佳利用。本文提出了一个在风险评估中使用流行病学数据的框架。在将一项流行病学研究用作风险评估的基础之前，必须对其质量进行评估。此类研究的质量标准在很大程度上取决于化学物质与健康影响之间关联的类型，包括其特异性和潜伏期。该框架基于所考虑的健康影响类型构建，即它是特定影响还是非特定影响，以及影响的时间窗，是急性、亚急性还是长期影响。特异性和潜伏期是对研究设计选择以及为得出适用于风险评估目的的可靠结果必须满足的质量标准有重大影响的方面。尽管专家判断始终会发挥重要作用，但该框架有助于评估一组流行病学数据是否足够可靠，从而作为推导基于健康的接触限值的基础。流行病学研究用于风险评估的局限性和适用性更可能是接触数据不佳或不足的结果，而非健康影响信息不佳或不可靠的结果。得出的结论是，流行病学数据的价值不仅取决于其内在质量，还取决于所考虑的健康影响类型。在这方面，特异性和潜伏期起着重要作用。
