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急性眼内毒性由全氟碳液体引起:医疗器械的安全控制系统。

Acute intraocular toxicity caused by perfluorocarbon liquids: safety control systems of medical devices.

机构信息

Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain.

Centro en Red de Medicina Regenerativa y Terapia Celular de Castilla Y León, Valladolid, Spain.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2022 Jul;260(7):2103-2110. doi: 10.1007/s00417-022-05578-w. Epub 2022 Feb 5.

DOI:10.1007/s00417-022-05578-w
PMID:35122500
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8817148/
Abstract

BACKGROUND

Acute retinal toxicity has been demonstrated to be associated with the intraoperative use of perfluorocarbon liquids (PFCLs), especially perfluorooctane (PFO). Recently, several cases of PFO-associated blindness have been reported in Spain, Holland, France, Italy, the Middle East, and South America.

METHODS

As a result, a new ISO guideline (ISO 16672:2020) was drafted, discussed, approved, and released in 2019. This recent ISO16672:2020 guideline recommends performing direct cytotoxicity tests as an option along with chemical analysis to measure PFCL quality (purity and safety).

RESULTS

In this review paper, it has been emphasized why an appropriate biological test, specifically direct exposure of PFCL to live cells, for measuring cytotoxicity must be performed with each PFCL batch along with chemical analysis.

CONCLUSIONS

The paper intends to compile all available information to discuss possible approaches for avoiding adverse clinical cases in future.

摘要

背景

术中使用全氟碳液体(PFCL),特别是全氟辛烷(PFO),已被证实会导致急性视网膜毒性。最近,西班牙、荷兰、法国、意大利、中东和南美洲都有几起因 PFO 导致失明的案例报告。

方法

因此,2019 年起草、讨论、批准并发布了一项新的 ISO 指南(ISO 16672:2020)。最近的 ISO16672:2020 指南建议将直接细胞毒性测试作为一种选择,与化学分析一起用于测量 PFCL 质量(纯度和安全性)。

结果

在这篇综述论文中,强调了为什么必须对每批 PFCL 进行适当的生物学测试,特别是将 PFCL 直接暴露于活细胞以测量细胞毒性,同时还要进行化学分析。

结论

本文旨在收集所有现有信息,讨论未来避免不良临床病例的可能方法。

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2
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3
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Chorioretinal Toxicity of Perfluorooctane (Ala Octa): Results From 48 Surgical Procedures in Geneva.全氟辛烷(Ala Octa)的眼脉络视网膜毒性:来自日内瓦 48 例手术的结果。
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