Ruzza Paolo, Gatto Claudio, Ragazzi Eugenio, Romano Mario R, Honisch Claudia, Tóthová Jana D'Amato
Institute of Biomolecular Chemistry of CNR, Padua Unit, via F. Marzolo 1, 35131 Padua, Italy.
Alchilife S.r.l., R&D, Viale Austria 14, 35020 Ponte San Nicolò, Padua, Italy.
ACS Omega. 2019 Aug 2;4(8):13481-13487. doi: 10.1021/acsomega.9b01793. eCollection 2019 Aug 20.
In recent years, cases of retinal toxicity occurred in some European, Middle Eastern, and South American countries following the use of perfluorocarbon liquids (PFCLs) on vitreoretinal surgeries owing to impurities in the product. Moreover, Spanish ophthalmologists reported several toxic cases on the use of perfluoro--octane Ala Octa (Alamedics, Dornstadt, Germany), raising the necessity of reviewing the current validated methods used for assessing the safety of PFCLs. We proved that in samples of PFCLs contaminated on purpose with impurities previously detected in Ala Octa devices, the determination of the so-called H-content using a H NMR quantitative assay implemented with the electronic reference to access in vivo concentrations 2 technology failed to demonstrate a correlation between the H-content and in vitro cytotoxicity test in ARPE-19 and BALB 3T3 cell lines. Therefore, direct information on the safety of PFCLs was provided only by the cytotoxicity test in vitro validated according to ISO 10993-5, and the H-content was not predictive of perfluorocarbon ocular endotamponade cytotoxicity in vitro.
近年来，在欧洲、中东和南美洲的一些国家，由于产品中存在杂质，在玻璃体视网膜手术中使用全氟碳液体（PFCLs）后出现了视网膜毒性病例。此外，西班牙眼科医生报告了几例使用全氟辛烷Ala Octa（德国多恩施塔特的阿拉梅迪克斯公司生产）的中毒病例，这就凸显了审查当前用于评估PFCLs安全性的经过验证的方法的必要性。我们证明，在故意用先前在Ala Octa装置中检测到的杂质污染的PFCLs样品中，使用通过电子参考获取体内浓度2技术实施的1H NMR定量测定法来测定所谓的H含量，未能证明ARPE-19和BALB 3T3细胞系中H含量与体外细胞毒性试验之间存在相关性。因此，只有根据ISO 10993-5进行体外验证的细胞毒性试验才能提供有关PFCLs安全性的直接信息，并且H含量不能预测全氟碳眼内填充剂的体外细胞毒性。
