Nanomedicinal products: a survey on specific toxicity and side effects.
Nanomedicinal products: a survey on specific toxicity and side effects.
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纳米医学产品：对特定毒性和副作用的调查。
DOI：
10.2147/ijn.s139687
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发表时间：
2017
影响因子：
8
通讯作者：
Geertsma RE
中科院分区：
文献类型：
--
作者：
Brand W;Noorlander CW;Giannakou C;De Jong WH;Kooi MW;Park MV;Vandebriel RJ;Bosselaers IE;Scholl JH;Geertsma RE
由于其特定的性质和药代动力学，纳米药物产品（NMP）与非纳米制剂的传统药物相比可能会出现不同的毒性和副作用。为了促进NMP的安全性评估，我们旨在通过系统分析欧盟批准的NMP的现有毒性数据，深入了解NMP的特定毒性作用。此外，通过比较五组具有相同活性药物成分（API）的常规制剂与纳米制剂的产品，我们旨在确定NMP纳米方面的任何特定副作用。目的是研究特定毒性是否与NMP的某些结构类型相关，以及与常规制剂相比，API的纳米制剂是否改变了产品在人体中的副作用性质。毒性数据的调查没有揭示可能与某些类型的NMP结构相关的纳米特异性毒性，除了先前报道的与铁纳米颗粒（NP）积累相关的那些。然而，鉴于分析中某些产品组或毒理学终点的数据有限，需要仔细考虑关于（缺乏）潜在纳米医学特异性效应的结论。五组药物（主要是脂质体和/或细胞抑制剂）的副作用比较结果证实，除了纳米制剂和常规制剂（例如，脂质体阿霉素和可能的脂质体柔红霉素）常见的副作用外，还诱导了文献中与特定NMP相关的假性过敏反应。根据现有数据，不能排除某些NMP的免疫毒理学效应，我们得出结论，这一终点需要进一步关注。
Due to their specific properties and pharmacokinetics, nanomedicinal products (NMPs) may present different toxicity and side effects compared to non-nanoformulated, conventional medicines. To facilitate the safety assessment of NMPs, we aimed to gain insight into toxic effects specific for NMPs by systematically analyzing the available toxicity data on approved NMPs in the European Union. In addition, by comparing five sets of products with the same active pharmaceutical ingredient (API) in a conventional formulation versus a nanoformulation, we aimed to identify any side effects specific for the nano aspect of NMPs. The objective was to investigate whether specific toxicity could be related to certain structural types of NMPs and whether a nanoformulation of an API altered the nature of side effects of the product in humans compared to a conventional formulation. The survey of toxicity data did not reveal nanospecific toxicity that could be related to certain types of structures of NMPs, other than those reported previously in relation to accumulation of iron nanoparticles (NPs). However, given the limited data for some of the product groups or toxicological end points in the analysis, conclusions with regard to (a lack of) potential nanomedicine-specific effects need to be considered carefully. Results from the comparison of side effects of five sets of drugs (mainly liposomes and/or cytostatics) confirmed the induction of pseudo-allergic responses associated with specific NMPs in the literature, in addition to the side effects common to both nanoformulations and regular formulations, eg, with liposomal doxorubicin, and possibly liposomal daunorubicin. Based on the available data, immunotoxicological effects of certain NMPs cannot be excluded, and we conclude that this end point requires further attention.