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孔源性视网膜脱离硅油填充不同制剂眼内留存前后的污染情况

Contamination Profile of Different Formulations of Silicone Oil Tamponade Before and After Intraocular Permanence for Rhegmatogenous Retinal Detachment.

作者信息

Bellucci Carlo, Riboni Nicolò, Ricciotti Guido, Spadini Federico, Pasquali Andrea, Rossi Maurizio, Gandolfi Stefano, Ribezzi Erika, Marraffa Enrico, Bianchi Federica, Careri Maria, Mora Paolo

机构信息

Ophthalmology Unit, University Hospital of Parma, Parma, Italy.

Department of Chemistry, Life Sciences and Environmental Sustainability, University of Parma, Parma, Italy.

出版信息

Transl Vis Sci Technol. 2024 Mar 1;13(3):4. doi: 10.1167/tvst.13.3.4.

DOI:10.1167/tvst.13.3.4
PMID:38466299
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10929740/
Abstract

PURPOSE

The purpose of this study was to search for contaminants in silicone oil tamponades removed from eyes treated for retinal detachment, and to correlate chemical results with some clinical/functional parameters of the considered eyes.

METHODS

We examined a sequential cohort of eyes grouped according to the tamponade received: (1) Siluron2000 (S2), (2) RS-OIL ECS5000 (S5), and (3) Densiron Xtra (DX). Samples were collected at the beginning of the scheduled removal and analyzed by untargeted headspace gas-chromatography mass spectrometry (HS-GC-MS). Visual acuity and optic coherence tomography assessments were obtained before and after the tamponade removal.

RESULTS

Forty-one samples were analyzed: 22 belonging to the DX group, 13 to the S2 group, and 6 to the S5 group. For each group, a mixture of uninjected commercial preparation was analyzed as the reference. Different siloxanes and fluorinated compounds including perfluorodecalin (PFCL) were the most prevalent chemicals, found in 55% to 100% of the intraocular samples of the 3 groups. Some siloxanes were present also in the control matrices, whereas PFCL was only in the extracted tamponades. In the DX group, the concentration of hexamethylcyclotrisiloxane showed an inverse correlation trend with the duration of its permanence inside the eye (P = 0.054). Different alkanes, propanol, and acetaldehyde were identified only in the control matrices.

CONCLUSIONS

Several contaminants including siloxanes were identified in the intraocular samples and in the control matrices. A time-related ocular uptake of some of these is conceivable. PFCL was also highly present but only in intraocular samples.

TRANSLATIONAL RELEVANCE

After intraocular permanence silicone oils (SOs) have various unlabeled contaminants with some relevant differences with the commercial formulation chemical profile.

摘要

目的

本研究旨在寻找从接受视网膜脱离治疗的眼中取出的硅油填充剂中的污染物,并将化学分析结果与所研究眼睛的一些临床/功能参数相关联。

方法

我们检查了一组按所接受的填充剂分组的连续队列眼睛:(1)Siluron2000(S2),(2)RS - OIL ECS5000(S5),以及(3)Densiron Xtra(DX)。在预定取出开始时收集样本,并通过非靶向顶空气相色谱 - 质谱联用(HS - GC - MS)进行分析。在填充剂取出前后获得视力和光学相干断层扫描评估结果。

结果

共分析了41个样本:22个属于DX组,13个属于S2组,6个属于S5组。对于每组,分析了未注射的商业制剂混合物作为对照。不同的硅氧烷和含氟化合物(包括全氟萘烷(PFCL))是最常见的化学物质,在这3组的眼内样本中占比55%至100%。一些硅氧烷也存在于对照基质中,而PFCL仅存在于提取的填充剂中。在DX组中,六甲基环三硅氧烷的浓度与其在眼内停留时间呈负相关趋势(P = 0.054)。仅在对照基质中鉴定出不同的烷烃、丙醇和乙醛。

结论

在眼内样本和对照基质中鉴定出了包括硅氧烷在内的几种污染物。可以想象其中一些污染物存在与时间相关的眼内摄取情况。PFCL也大量存在,但仅存在于眼内样本中。

转化相关性

眼内留置硅油(SOs)后会有各种未标记的污染物,其化学特征与商业制剂存在一些相关差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f62/10929740/dcc950388d79/tvst-13-3-4-f001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f62/10929740/dcc950388d79/tvst-13-3-4-f001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f62/10929740/dcc950388d79/tvst-13-3-4-f001.jpg

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INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus.硅油眼内乳化(ITEM)分级系统:基于循证的专家共识。
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Acta Ophthalmol. 2022 Jun;100(4):e864-e880. doi: 10.1111/aos.15055. Epub 2021 Nov 29.
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