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硅化和无油注射器和针头在同一批次中存在高颗粒变异性。

High particle variability across siliconized and oil-free syringes and needles from the same lots.

机构信息

Hospital de Olhos de Sergipe, Rua Campo do Brito, 995, Aracaju, SE, Brazil.

Federal University of Sergipe, Av Marechal Rondon, s/n, São Cristovão, SE, Brazil.

出版信息

Sci Rep. 2021 Feb 25;11(1):4645. doi: 10.1038/s41598-021-84158-0.

DOI:10.1038/s41598-021-84158-0
PMID:33633285
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7907352/
Abstract

Previous studies have reported silicone oil (SO) applied to needles and syringes in the vitreous of patients after intravitreal injections. We evaluated four syringes (SR 1-mL insulin, Saldanha-Rodrigues; BD 1-mL Tuberculin Slip Tip, Becton-Dickinson; BD Ultra-Fine 0.3 mL, HSW Norm-Ject Tuberculin, Henke Sass Wolf) and 10 needles (BD PrecisionGlide 27- and 30-gauge (G); BD Eclipse and JBP Nanoneedle 27-, 30-, 33- and 34-G; TSK Invisible Needle and 27 and 30-G Steriject Control Hub). The protein-free buffer samples injected into the syringes and needles under study were collected in an Eppendorf tube and taken to Flow imaging microscopy, that characterized the concentration and morphology of the microsized particles. The number of particles was analyzed. The coefficients of variation (CV) were the primary outcome. The Feltz and Miller test compared the CVs. The significance level was 5%. Numerous particles and high CVs were associated with both devices, needles and syringes; the comparisons among them did not reach significance. The BD Ultrafine 0.3 mL syringe (149.7%) had the highest CV and the SO-free HSW Norm-Ject (66.4%) syringe the lowest, and the TSK Invisible needle (149.5%) had the highest and the BD Precision Glide 30G needle (35.9%) needle the lowest. In conclusion, particle release, including those with SO morphology, varied greatly among instruments, even from the same lots, which is relevant considering that fewer particles are injected into some eyes compared with others.

摘要

先前的研究已经报道了硅油(SO)在玻璃体腔注射后应用于针和注射器。我们评估了四种注射器(SR 1 毫升胰岛素,Saldanha-Rodrigues;BD 1 毫升结核菌素滑尖,Becton-Dickinson;BD Ultra-Fine 0.3 毫升,HSW Norm-Ject 结核菌素,Henke Sass Wolf)和 10 根针(BD PrecisionGlide 27 和 30 号(G);BD Eclipse 和 JBP Nanoneedle 27、30、33 和 34-G;TSK Invisible Needle 和 27 和 30-G Steriject Control Hub)。将无蛋白缓冲液样品注入研究中的注射器和针中,收集到 Eppendorf 管中,并进行流成像显微镜检查,以表征微尺度颗粒的浓度和形态。分析了颗粒数量。变异系数(CV)是主要结果。Feltz 和 Miller 检验比较了 CV。显著性水平为 5%。大量的颗粒和高 CV 与两种设备(针和注射器)都有关;它们之间的比较没有达到显著性。BD Ultrafine 0.3 毫升注射器(149.7%)的 CV 最高,SO 自由的 HSW Norm-Ject(66.4%)注射器的 CV 最低,TSK Invisible 针(149.5%)的 CV 最高,BD Precision Glide 30G 针(35.9%)的 CV 最低。总之,颗粒释放,包括 SO 形态的颗粒,在仪器之间差异很大,即使是来自同一批次的仪器也是如此,这在考虑到与其他眼睛相比,一些眼睛中注射的颗粒较少时是相关的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba2b/7907352/8151761e6071/41598_2021_84158_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba2b/7907352/79d423bc771d/41598_2021_84158_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba2b/7907352/0a05423edcba/41598_2021_84158_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba2b/7907352/8151761e6071/41598_2021_84158_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba2b/7907352/79d423bc771d/41598_2021_84158_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba2b/7907352/0a05423edcba/41598_2021_84158_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba2b/7907352/8151761e6071/41598_2021_84158_Fig3_HTML.jpg

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本文引用的文献

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Critical analysis of techniques and materials used in devices, syringes, and needles used for intravitreal injections.眼内注射用装置、注射器和针头中使用的技术和材料的批判性分析。
Prog Retin Eye Res. 2021 Jan;80:100862. doi: 10.1016/j.preteyeres.2020.100862. Epub 2020 Apr 18.
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Prevalence of silicone oil droplets in eyes treated with intravitreal injection.玻璃体腔内注射治疗的眼睛中硅油滴的患病率。
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Silicone oil found in syringes commonly used for intravitreal injections.
在常用于玻璃体内注射的注射器中发现了硅油。
Arq Bras Oftalmol. 2019 Aug 19;82(4):354-355. doi: 10.5935/0004-2749.20190080.
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Inflammatory Reaction After Aflibercept Intravitreal Injections Associated With Silicone Oil Droplets Released From Syringes: A Case-Control Study.阿柏西普玻璃体内注射后与注射器释放的硅油滴相关的炎症反应:一项病例对照研究。
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Needles as a source of silicone oil during intravitreal injection.玻璃体内注射时针头作为硅油来源的情况。
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Silicone oil droplets following intravitreal bevacizumab injections.玻璃体内注射贝伐单抗后的硅油滴
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Incidence of Presumed Silicone Oil Droplets in the Vitreous Cavity After Intravitreal Bevacizumab Injection With Insulin Syringes.使用胰岛素注射器玻璃体内注射贝伐单抗后玻璃体内假定硅油滴的发生率。
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