Schwetz B A
FDA/National Center for Toxicological Research, Jefferson, Arkansas 72079-9502, USA.
Drug Metab Rev. 1996 Feb-May;28(1-2):77-84. doi: 10.3109/03602539608993992.
In summary, the concerns that environmental and other agents are causing adverse effects on reproductive function in humans are real, although the risk is not necessarily well characterized. The range of concerns for the types of effect that agents might have on reproduction span the full range of reproductive events. There is a fairly high background of reproductive disease in humans which decreases the sensitivity for identifying agents that have a subtle, but adverse, effect on reproductive performance of humans. Because our animal studies identify a large number of agents that cause some adverse reproductive effect at the dose levels tested, the concern is raised about the oversensitivity of animal models for predicting adverse effects in humans. Until we better understand the biology underlying the reproductive process of humans and animals, it will be difficult to make animal studies more specific in their predictiveness. Continued research to better understand the biology of reproduction in humans and animals should help to identify the types of data generated in animals that are most predictive of an adverse effect in humans.
总之，环境因素及其他因素正在对人类生殖功能产生不良影响，这种担忧是切实存在的，尽管风险未必得到充分界定。人们对这些因素可能对生殖产生的影响类型的担忧涵盖了整个生殖过程。人类存在相当高的生殖疾病背景，这降低了识别对人类生殖性能有微妙但不良影响的因素的敏感性。由于我们的动物研究确定了大量在测试剂量水平下会导致某种不良生殖影响的因素，因此有人对动物模型预测人类不良影响的过度敏感性提出了担忧。在我们更好地理解人类和动物生殖过程背后的生物学原理之前，很难使动物研究在预测方面更具针对性。持续开展研究以更好地理解人类和动物的生殖生物学，应有助于确定在动物身上生成的、最能预测对人类产生不良影响的数据类型。
