Antineoplastic compounds in the environment-substances of special concern
Antineoplastic compounds in the environment-substances of special concern
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DOI：
10.1007/s11356-014-3902-8
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发表时间：
2016-08-01
影响因子：
5.8
通讯作者：
Ebert, Ina
中科院分区：
文献类型：
--
作者：
Kuemmerer, Klaus;Haiss, Annette;Ebert, Ina
抗肿瘤药物在癌症的治疗中很重要。有些直接与脱氧核糖核酸 (DNA) 相互作用，就风险而言至关重要。作为高活性化合物，抗肿瘤药物及其代谢物大部分被排泄到废水中，并且在水生环境中的存在量达到较低的μg/L范围。它们的预测环境浓度通常低于欧洲药品管理局 (EMA) 指南中规定的行动限值。关于它们在水生环境中的存在和影响的深入风险评估往往没有进行，而且缺乏知识。这项研究考虑了 EMA 和 FDA 指南中规定的触发值是否低估了与抗肿瘤药物的存在相关的可能风险。经过权衡，我们总共确定了 102 种与环境相关的 ATC L01 组（抗肿瘤药）活性药物成分。在德国，2012 年消耗了 20.7 吨抗肿瘤药物。过去 6 年间，具有 DNA 损伤特性的药物比例从 24% 增加到 67%。仅卡培他滨和 5-氟尿嘧啶的用量就达到 8 吨，相当于抗肿瘤药物总消耗量的 39%。大约 80% 的总消耗量可归因于办公室医生开出的处方，并且大部分在家里排出。根据不同的行动模式，建议对与其在环境中存在相关的风险进行逐案评估。 DNA 损伤药物应独立评估，因为不能假定任何作用限制。
Antineoplastic drugs are important in the treatment of cancer. Some interact directly with the deoxyribonucleic acid (DNA) and are of utmost importance in terms of risk. As highly active compounds, antineoplastics and their metabolites are largely excreted into wastewater and are found in the aquatic environment up to the lower mu g/L range. Their predicted environmental concentrations are often below the action limit set in the European Medicines Agency (EMA) guideline. An in-depth risk assessment regarding their presence and effects in the aquatic environment is often not performed, and there is a lack of knowledge. This study considered whether there is an underestimation of possible risks associated with the presence of antineoplastic drugs with regard to trigger value stated in the EMA and FDA guidelines. In a balance, we identified a total of 102 active pharmaceutical ingredients of the ATC-group L01 (antineoplastic agents), which are environmentally relevant. In Germany, 20.7 t of antineoplastic agents was consumed in 2012. The share of drugs with DNA-damaging properties increased within the last 6 years from 24 up to 67 %. Solely, capecitabine and 5-fluorouracil amount together 8 t-which corresponds to 39 % of the total antineoplastic consumption. Around 80 % of the total mass consumed could be attributed to prescriptions issued by office-based practitioners and is mostly excreted at home. Based on the different mode of actions, a case-by-case evaluation of the risk connected to their presence in the environment is recommended. DNA-damaging drugs should be assessed independently as no action limit can be assumed.