Christensen F M
Danish Toxicology Centre (DTC), 2 Kogle Allé, Horsholm, 2970, Denmark.
Regul Toxicol Pharmacol. 1998 Dec;28(3):212-21. doi: 10.1006/rtph.1998.1253.
Pharmaceuticals in the environment and their potential toxic effects are emerging research areas, which is also reflected in the drug approval regulation. This far, focus has mainly been directed toward potential effects on nature and wildlife. In this paper, human risk as a consequence of exposure via the environment has been addressed and assessed. The synthetic estrogen 17alpha-ethinylestradiol (EE2), the antibiotic phenoxymethylpenicillin (Pen V), and the antineoplastic drug cyclophosphamide (CP) were chosen as modeling substances based on criteria of receptor specificity, elevated risk for human population groups for which the pharmaceuticals are not therapeutically intended, different modes of action, and prescription frequency. Attention has been focused on emissions from the use phase and subsequent diffuse release via the sewer systems. A reasonable worst-case environmental fate and human exposure were estimated using the software EUSES on worst-case emission quantities. The results indicate a negligible human risk connected to the environmental exposure for these substances. Danish conditions have been used as the modeling area, but the results are assumed to be valid for regions with similar drug consumption profiles.
环境中的药物及其潜在毒性影响是新兴的研究领域，这也反映在药品审批法规中。到目前为止，重点主要集中在对自然和野生动物的潜在影响上。本文探讨并评估了因通过环境接触而导致的人类风险。基于受体特异性、药物并非用于治疗的人群组风险升高、不同作用模式以及处方频率等标准，选择了合成雌激素17α-乙炔雌二醇（EE2）、抗生素苯氧甲基青霉素（青霉素V）和抗肿瘤药物环磷酰胺（CP）作为模拟物质。重点关注了使用阶段的排放以及随后通过下水道系统的扩散释放。使用软件EUSES对最坏情况排放量估算了合理的最坏情况环境归宿和人类接触情况。结果表明，这些物质因环境接触而导致的人类风险可忽略不计。以丹麦的情况作为建模区域，但假定结果对具有相似药物消费概况的地区有效。
