Silicone Oils

硅油
  • 文章类型: Systematic Review
    目的:在临床实践中使用非批准的用于玻璃体腔给药的注射器,导致某些患者的玻璃体中检测到硅油滴。这种情况源于西班牙市场上缺乏批准的眼内使用的注射器。这项工作的目的是回顾使用注射器的眼内给药,以及寻找符合这些未满足需求的法律要求的替代品。
    方法:根据PRISMA2020指南,通过搜索PubMed的描述符:(硅胶)和(注射器)和((眼内)或(玻璃体内))并过滤所有现有出版物从2006年1月至2023年12月,包括所有有关玻璃体内注射中硅油释放的文章,并分析可能的后果。
    结果:共发现68个结果,其中23人被排除在外,因为他们没有处理正在研究的主题,共留下45篇文章供系统回顾。根据4组获得的结论将这些分类:有机硅产生的不良反应;给药技术;有机硅释放的物理化学方面;以及医疗器械的特性。在审查了目前商业化注射器的制造商和技术数据表后,已经收集了用于这种用途的现有注射器,发现2可能会在2024年初在西班牙商业化:零残留™0.2ml不含SiO和VitreJect®眼科。
    结论:从获得的结果来看,可以解释,由于患者可能产生的影响和后果,使用带有硅胶的注射器和针头进行玻璃体内使用是卫生专业人员关注的问题,最重要的是不良反应,因此,有必要在市场上有专门用于眼内使用的无硅胶注射器。使用眼内注射器和针头的安全性和合法性对于保证眼部完整性和患者健康至关重要。
    OBJECTIVE: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
    METHODS: A systematic review was performed following the PRISMA 2020 guidelines by searching PubMed with the descriptors: (silicone) AND (syringes) AND ((intraocular) OR (intravitreal)) and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
    RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone; the administration technique; the physicochemical aspects of silicone release; and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
    CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
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  • 文章类型: Systematic Review
    目的:在临床实践中使用非批准的用于玻璃体腔给药的注射器,导致某些患者的玻璃体中检测到硅油滴。这种情况源于西班牙市场上缺乏批准的眼内使用的注射器。这项工作的目的是回顾使用注射器的眼内给药,以及寻找符合这些未满足需求的法律要求的替代品。
    方法:根据PRISMA2020指南,通过搜索PubMed的描述符:“硅胶”和“注射器”和(“眼内”或“玻璃体内”)并过滤2006年1月至2023年12月的所有现有出版物,包括所有涉及玻璃体内注射硅油释放的文章,并分析可能的后果。
    结果:共发现68个结果,其中23人被排除在外,因为他们没有处理正在研究的主题,共留下45篇文章供系统回顾。这些根据获得的4组的结论进行分类:有机硅产生的不良反应,管理技术,有机硅释放的物理化学方面,以及医疗器械的特点。在审查了目前商业化注射器的制造商和技术数据表后,已经收集了用于这种用途的现有注射器,发现了两个可能在2024年初在西班牙商业化的产品:零残留™0.2ml不含SiO和VitreJect®眼科。
    结论:从获得的结果来看,可以解释,由于患者可能产生的影响和后果,使用带有硅胶的注射器和针头进行玻璃体内使用是卫生专业人员关注的问题,最重要的是不良反应,因此,有必要在市场上有专门用于眼内使用的无硅胶注射器。使用眼内注射器和针头的安全性和合法性对于保证眼部完整性和患者健康至关重要。
    OBJECTIVE: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
    METHODS: A systematic review was performed following the PRISMA 2020 Guidelines by searching PubMed with the descriptors: \"silicone\" AND \"syringes\" AND (\"intraocular\" OR \"intravitreal\") and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
    RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone, the administration technique, the physicochemical aspects of silicone release, and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialized syringes, the existing syringes for this use have been collected, finding two that will probably be commercialized in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
    CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
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  • 文章类型: Review
    巩膜破裂是一种罕见但重要的并发症,可能由于多种危险因素而发生。在这份报告中,我们讨论了在硅油注射期间和球周注射后发生的巩膜穿孔的两个实例。我们的研究表明,先前的眼科手术是术中巩膜破裂的另一个危险因素,需要更多的调查来确定削弱巩膜的其他相关风险因素。
    Scleral rupture is a rare but significant complication that can occur due to multiple risk factors. In this report, we discuss two instances of scleral perforation that happened during a silicone oil injection and after a peribulbar injection. Our study suggests that prior ocular surgery is a further risk factor for intraoperative scleral rupture, and more investigation is required to identify additional relevant risk factors that weaken the sclera.
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  • 文章类型: Journal Article
    黄斑水肿(ME)是眼内手术后视力下降的主要原因。尽管尚未完全了解ME的病理生理学,炎症介质起关键作用。使用硅油填塞的平坦部玻璃体切除术后ME的发生率在13%至27%之间变化。ME通常在硅油去除后自发分解,但耐药病例可能需要治疗。在这次审查中,平坦部玻璃体切除术后ME形成的机制,它的发病率,并讨论了其可能的治疗方法。
    Macular edema (ME) is a major cause of reduced vision following intraocular surgery. Although the pathophysiology of ME is not completely understood, inflammatory mediators play a key role. The incidence of ME following pars plana vitrectomy with silicone oil tamponade varies between 13% and 27%. ME usually resolves spontaneously following silicone oil removal, but treatment may be required for resistant cases. In this review, the mechanisms of ME formation after pars plana vitrectomy, its incidence, and its possible therapeutic approaches are discussed.
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  • 文章类型: Journal Article
    玻璃体代用品是玻璃体视网膜手术中不可或缺的工具。这些替代物的两个关键功能是它们从视网膜表面移位玻璃体内液体并允许视网膜粘附到视网膜色素上皮的能力。今天,玻璃体视网膜外科医生可以选择过多的玻璃体填塞剂,在不断扩大的有利结果的可能性范围内,选择填塞可能很难确定。目前可用的玻璃体代用品具有需要解决的缺点以改善当今可实现的手术结果。在这里,报告了所有玻璃体替代品的基本物理和化学特性,以及它们的使用和临床应用描述了一些术中操作的手术技术。广泛讨论了玻璃体替代品即将发生的主要发展,始终保持翻译视角。通过深入分析当前在预期结果和生物材料技术方面的不足,得出了有关未来观点的结论。
    Vitreous substitutes are indispensable tools in vitreoretinal surgery. The two crucial functions of these substitutes are their ability to displace intravitreal fluid from the retinal surface and to allow the retina to adhere to the retinal pigment epithelium. Today, vitreoretinal surgeons can choose among a plethora of vitreous tamponades, and the tamponade of choice might be difficult to determine in the ever-expanding range of possibilities for a favorable outcome. The currently available vitreous substitutes have disadvantages that need to be addressed to improve the surgical outcome achievable today. Herein, the fundamental physical and chemical proprieties of all vitreous substitutes are reported, and their use and clinical applications are described alongside some surgical techniques of intra-operative manipulation. The major upcoming developments in vitreous substitutes are extensively discussed, keeping a translational perspective throughout. Conclusions on future perspectives are derived through an in-depth analysis of what is lacking today in terms of desired outcomes and biomaterials technology.
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  • 文章类型: Review
    目的:描述一例并发的孔源性视网膜脱离,脉络膜脱离,1例单纯白内障摘除人工晶状体植入术(CEIOL)后形成黄斑裂孔(RRD-CD-MH)。此外,我们总结了文献中先前报道的RRD-CD-MH病例。
    方法:介入病例报告及文献复习。
    结果:一名没有相关既往病史或眼部病史的71岁白人男子接受了无并发症的CEIOL。三周后,他的手指视力和眼内压(IOP)为5mmHg。在扩张的眼底检查中,多个上泪液和总RRD与浆液性CD是明显的。术中,确定了全厚度MH。患者接受常规RRD和MH修复,滴注1000厘斯硅油(SiO)。视网膜成功地重新连接,CD解决了,和IOP正常化;然而,MH最初没有关闭。4个月后,SiO被移除,当MH保持开放时,患者的视力提高到20/80。手术修复后大约三年,MH自发关闭,视力保持在20/80。
    结论:我们的患者在无并发症CEIOL后出现RRD-CD-MH。MH显示延迟关闭。手术修复后视力改善,并长期保持稳定。
    OBJECTIVE: To describe a case of concurrent rhegmatogenous retinal detachment, choroidal detachment, and macular hole (RRD-CD-MH) formation in a patient after uncomplicated cataract extraction and intraocular lens implantation (CEIOL). In addition, we summarize the previously reported cases of RRD-CD-MH in the literature.
    METHODS: Interventional case report and literature review.
    RESULTS: A 71-year-old white man without relevant medical or ocular history underwent an uncomplicated CEIOL. He presented with counting fingers vision and intraocular pressure of 5 mmHg after 3 weeks. On dilated fundus examination, multiple superior tears and total RRD with a serous CD was evident. Intraoperatively, a full-thickness MH was identified. The patient underwent routine RRD and MH repair, with instillation of 1,000 centistoke silicone oil (SiO). The retina successfully re-attached, the CD resolved, and the intraocular pressure normalized; however, the MH did not initially close. The SiO was removed approximately 4 months later and, while the MH remained open, the patient\'s vision improved to 20/80. Approximately three years after the surgical repair, the MH closed spontaneously, and the vision remained at 20/80.
    CONCLUSIONS: Our patient developed an RRD-CD-MH after uncomplicated CEIOL. The MH displayed delayed closure. The vision improved after surgical repair, and remained stable in the long term.
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  • 文章类型: Journal Article
    本文介绍了有关纺织工业中使用的各种化学添加剂的一般信息。综述了有机官能硅烷和聚硅氧烷(有机硅)在纺织材料的化学和物理改性中的性能和应用,专注于硅胶柔软剂,硅烷,以及基于有机硅的超疏水整理剂和由有机硅弹性体和橡胶组成的纺织品上的涂层。硅烷和有机硅改性纺织材料的性能及其实际和潜在应用,主要在纺织业,已经讨论过了。
    General information concerning different kinds of chemical additives used in the textile industry has been described in this paper. The properties and applications of organofunctional silanes and polysiloxanes (silicones) for chemical and physical modifications of textile materials have been reviewed, with a focus on silicone softeners, silane, and silicones-based superhydrophobic finishes and coatings on textiles composed of silicone elastomers and rubbers. The properties of textile materials modified with silanes and silicones and their practical and potential applications, mainly in the textile industry, have been discussed.
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  • 文章类型: Case Reports
    背景:仰卧位观察到的脑室内硅油的运动极为罕见。在这里,我们描述了一名患者在改变位置时出现心室中动态移动的硅油颗粒,并提供了对这一现象的最新综述。
    方法:我们报告了一例70岁的女性,其表现为脑计算机断层扫描(CT)偶尔发现的脑室内高密度。最初的非增强脑CT显示侧脑室双侧前角的非依赖性高密度,第三脑室,和右侧的鞍上水箱,模仿脑室内出血.仰卧位进一步脑部磁共振成像(MRI)显示侧脑室双侧前角异常信号,右心室的后角,第三脑室,右边的上层水箱,和双侧眼球,等信号强度在T1加权成像上被低信号化学位移伪影包围,在T2加权成像上被可变信号(低强度或高强度)包围。右心室前角的病变大部分移至同侧心室的后角。最终的颅颈CT血管造影显示,后角的病变已移回右心室的前角。这些特征与脑室内硅油迁移一致。最终的脊柱MRI未显示硅油迁移到脊髓蛛网膜下腔。
    结论:该病例报告描述了仰卧位硅油驱替的动态过程,并提供了全面的影像学表现。MRI上的运动模式和特征性化学位移伪影是诊断的关键,可能有助于防止不必要的检查或干预。
    BACKGROUND: The movement of intraventricular silicone oil observed in the supine position is extremely rare. Herein, we describe a patient who presented with dynamically moving silicone oil particles in the ventricle when changing position and provide an updated review of this phenomenon.
    METHODS: We report a case of a 70-year-old woman who presented with intraventricular hyperdensities that were occasionally found on brain computed tomography (CT). Initial nonenhanced brain CT demonstrated nondependent hyperdensities in the bilateral anterior horns of the lateral ventricles, the third ventricle, and the right suprasellar cistern, mimicking an intraventricular hemorrhage. Further brain magnetic resonance imaging (MRI) in the supine position revealed abnormal signals in the bilateral anterior horns of the lateral ventricles, the posterior horn of the right lateral ventricle, the third ventricle, the right suprasellar cistern, and the bilateral eyeballs, with isosignal intensities surrounded by low-signal chemical shift artifacts on T1-weighted imaging and variable signals (hypo- or hyperintensity) on T2-weighted imaging. The lesion in the anterior horn of the right ventricle largely moved to the posterior horn of the ipsilateral ventricle. The final craniocervical CT angiography showed that the lesion in the posterior horn had moved back to the anterior horn of the right lateral ventricle. These features were consistent with intraventricular silicone oil migration. The final spinal MRI did not demonstrate a migration of silicone oil into the spinal subarachnoid space.
    CONCLUSIONS: This case report describes a dynamic process of silicone oil displacement in the supine position and provides a comprehensive imaging presentation. The moving pattern and a characteristic chemical shift artifact on MRI are key to the diagnosis and may help prevent unnecessary examinations or intervention.
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  • 文章类型: Journal Article
    各种不同的填塞剂与玻璃体切除术结合内界膜(ILM)剥离用于治疗特发性黄斑裂孔。这些代理包括空气,气体(六氟化硫[SF6],六氟乙烷[C2F6],和全氟丙烷[C3F8]),和硅油。最佳填塞剂是不确定的,我们旨在回顾填塞剂的选择对孔闭合和视觉结果的影响。
    尽管大多数外科医生最初选择使用长效气体(C3F8),在实践中逐渐改变了介质(C2F6)和短效气体(SF6)甚至空气的使用。然而,关于它们的相对效力没有共识。
    系统评价和荟萃分析随机对照试验(RCT)和前瞻性和回顾性比较队列研究,比较不同填塞剂在接受玻璃体切除术和ILM剥离治疗原发性特发性黄斑裂孔患者中的应用。对于RCT,使用随机对照试验的Cochrane偏差风险工具评估偏差风险,而对于非随机研究,使用非随机干预研究中的偏倚风险工具。
    13种出版物,包括2个RCT,已确定。总的来说,与C3F8或C2F6相比,使用SF6的研究之间的解剖闭合率没有显著差异(比值比[OR]=0.74;95%置信区间[CI]=0.51-1.08).亚组分析显示,在没有术后姿势的患者中,使用SF6的闭合率显着提高(OR=0.49;95%CI=0.30-0.79),而在建议采取姿势的患者中却没有。视觉结果和不良事件没有显着差异。用气体填塞与治疗的患者的解剖闭合率的比较硅油和空气vs.SF6无明显差别。纳入的研究有许多方法学上的局限性和异质性,使结论不精确,推荐等级的确定性较低或非常低,评估,开发和评估方法。
    目前用于全厚度黄斑裂孔的玻璃体切除术和ILM剥离的填塞选择的证据基础有几个主要的局限性。需要进一步适当设计的研究来指导填塞剂的选择。
    A variety of different tamponade agents are used with vitrectomy combined with internal limiting membrane (ILM) peeling for the treatment of idiopathic macular holes. These agents include air, gas (sulfur hexafluoride [SF6], hexafluoroethane [C2F6], and perfluoropropane [C3F8]), and silicone oil. The optimal tamponade agent is uncertain, and we aimed to review the effect of tamponade choice on hole closure and visual outcomes.
    Although most surgeons initially chose to use long-acting gas (C3F8), there has been a gradual change in practice to the increasing use of the medium- (C2F6) and short-acting gases (SF6) or even air. However, there is no consensus regarding their relative efficacies.
    Systematic review and meta-analysis of randomized controlled trials (RCTs) and prospective and retrospective comparative cohort studies comparing different tamponade agents in patients undergoing vitrectomy and ILM peeling for primary idiopathic macular holes. For RCTs, the risk of bias was assessed using the Cochrane Risk of Bias tool for RCTs, whereas for nonrandomized studies, the Risk of Bias in Nonrandomized Studies of Interventions tool was used.
    Thirteen publications, including 2 RCTs, were identified. Overall, there was no significant difference in the anatomic closure rates between studies using SF6 compared with either C3F8 or C2F6 (odds ratio [OR] = 0.74; 95% confidence interval [CI] = 0.51-1.08). A subgroup analysis showed a significantly higher closure rate using SF6 (OR = 0.49; 95% CI = 0.30-0.79) in patients without postoperative posturing but not in those who were advised to posture facedown. The visual outcomes and adverse events were not significantly different. The comparisons of anatomic closure rates of patients treated with gas tamponade vs. silicone oil and with air vs. SF6 showed no significant differences. The included studies had a number of methodological limitations and heterogeneities, making conclusions imprecise, with low or very low certainty by the Grades of Recommendation, Assessment, Development and Evaluation approach.
    The current evidence base for tamponade selection with vitrectomy and ILM peeling for full-thickness macular hole has several major limitations. Further appropriately designed studies are needed to guide tamponade selection.
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  • 文章类型: Journal Article
    孔源性视网膜脱离(RRD)修复后的视网膜移位是评估再附着完整性的重要考虑因素。对功能结果有潜在影响。比较各种手术技术的数据有限。我们对RRD修复后的视网膜位移进行了回顾,直到2021年10月,发现21项研究涵盖了1,258只独特的眼睛。结果测量包括视网膜移位的频率,视敏度,变态,和位移方向。使用报告为风险比(RR)或平均差和95%置信区间的数据进行荟萃分析。在35±20%的RRD修复中发现视网膜移位。没有填塞的巩膜扣(SB)的视网膜移位率最低,然后是气动视网膜固定术(PnR),最后是平坦部玻璃体切除术(PPV)(PPV的RR与SB:9.60[2.01-45.95],P=0.005)。与气体相比,硅油可降低PPV后的置换风险(气体中的RR与SO:2.16[1.22-3.83],P=0.009),可以立即面朝下定位2小时。在92±14%的病例中,PPV后的视网膜移位发生在向下方向,并且似乎没有显着影响视力(0.05[-0.21至0.31],P=0.70),虽然它可能会增加失真。SB,PnR,含硅油的PPV,和立即面朝下定位可能与较少的视网膜位移有关。需要额外的前瞻性研究来增加这些发现的确定性。
    Retinal displacement following rhegmatogenous retinal detachment (RRD) repair is an important consideration when assessing the integrity of reattachment, with potential implications on functional outcomes. There are limited data comparing various surgical techniques. We conducted a review of retinal displacement following RRD repair through October 2021, finding 21 studies encompassing 1,258 unique eyes. Outcome measures included the frequency of retinal displacement, visual acuity, metamorphopsia, and displacement direction. A meta-analysis was performed with data reported as risk ratios (RR) or mean difference and 95% confidence intervals. Retinal displacement was found in 35 ± 20% of RRD repairs. Scleral buckle (SB) without tamponade had the lowest rate of retinal displacement, followed by pneumatic retinopexy (PnR) and finally pars plana vitrectomy (PPV) (RR in PPV vs SB: 9.60 [2.01-45.95], P = 0.005). Silicone oil may reduce risk of displacement following PPV compared to gas (RR in gas vs SO: 2.16 [1.22-3.83], P = 0.009), as may immediate face-down positioning for 2 hours. Retinal displacement following PPV occurred in the downward direction in 92 ± 14% of cases and does not appear to significantly impact visual acuity (0.05 [-0.21 to 0.31], P = 0.70), although it may increase distortion. SB, PnR, PPV with silicone oil, and immediate face-down positioning are likely associated with less retinal displacement. Additional prospective studies are required to increase the certainty of these findings.
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