Fluocinolone Acetonide

氟轻松
  • 文章类型: Practice Guideline
    这些指南是法国青光眼和视网膜专家对皮质类固醇植入物玻璃体内注射后三分之一病例中观察到的高眼压(OHT)管理的共识。他们更新了2017年发布的第一份指南。在法国销售两种植入物:地塞米松植入物(DEXi)和氟轻松缩内酯植入物(FAci)。在向患者注射皮质类固醇植入物之前,必须评估压力状态。在整个随访过程中和再次注射时,需要对眼内压进行分子特异性监测。现实生活中的研究已经允许通过显著提高这些植入物的安全性来优化管理算法。在切换到FAci之前,应使用DEXi进行皮质类固醇测试,以优化FAci的耐压性。除了局部降压治疗,选择性激光小梁成形术可考虑用于治疗类固醇诱导的OHT和随后的注射.
    These guidelines are a consensus of French glaucoma and retina experts on the management of ocular hypertension (OHT) observed in a third of the cases after corticosteroid implant intravitreal injections. They update the first guidelines published in 2017. Two implants are marketed in France: the dexamethasone implant (DEXi) and the fluocinolone acetonide implant (FAci). It is essential to assess the pressure status before injecting a patient with a corticosteroid implant. A molecule-specific monitoring of the intraocular pressure is needed throughout the follow-up and at the time of reinjections. Real-life studies have allowed optimizing the management algorithm by significantly increasing the safety of these implants. Corticosteroid testing with DEXi should be performed before switching to FAci to optimize pressure tolerance of FAci. Beyond topical hypotensive treatments, selective laser trabeculoplasty may be considered in the therapeutic arsenal for the management of steroid-induced OHT and subsequent injections.
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  • 文章类型: Journal Article
    目的:为了更好地了解视网膜专家对炎症在糖尿病性视网膜病变(DR)和糖尿病性黄斑水肿(DME)中的作用的共识水平,以及在DME治疗中使用0.19mg氟轻松(FAc)植入物,起草了一项共识调查,并分发给美国各地的视网膜专家.
    方法:使用改进的Delphi方法,共同作者基于对初始调查的简短回答,生成了12份共识声明.总的来说,56位视网膜专家完成了整个共识调查。除了两个选择题,有10个共识声明使用了修改后的李克特量表来表明他们对声明的同意程度:同意=3,大多数同意=2,大多数不同意=1,不同意=0。计算了一致性百分比和95%置信区间(CI),每个陈述的共识阈值设定为>80%。
    结果:使用改进的李克特量表的10份共识声明中有7份达成共识,包括炎症在DR/DME病理生理学中的作用,注射负担和患者依从性,FAc植入物的有效性和安全性。其余三个陈述显示出较高的一致性,平均得分>80%,但95%CI低于阈值。这些包括FAc植入物对DR进展的影响,FAc作为DME的基线治疗,以及使用FAc后,类固醇激发减轻眼压风险的有效性。两个多项选择题集中在临床情况下,皮质类固醇将被用作DME的基线治疗(假晶状体眼[73%],近期中风/心肌梗死[66%],和妊娠/母乳喂养[66%]),以及哪种分娩途径满足FAc植入物的类固醇挑战(玻璃体内[100%],下腱/眼周[73%],和局部[57%])。
    结论:医师高度认同炎症在DR/DME病理生理学中的作用,注射负担和患者依从性,FAc植入物的有效性和安全性。然而,对于FAc植入物对DR进展的影响未发现完全共识,FAc作为DME的基线治疗,以及使用FAc后,类固醇激发减轻眼压风险的有效性。[眼科手术激光成像视网膜。2023年;54(3):166-173。].
    To better understand the level of agreement among retina specialists on the role of inflammation in diabetic retinopathy (DR) and diabetic macular edema (DME), and the use of 0.19-mg fluocinolone acetonide (FAc) implant in DME treatment, a consensus survey was drafted and disseminated to retina specialists across the United States.
    Using the modified Delphi method, a list of 12 consensus statements were generated by the coauthors based on short-answer responses to an initial survey. In total, 56 retina specialists completed the entire consensus survey. Except for two multiple-choice questions, there were 10 consensus statements that used a modified Likert scale to indicate their level of agreement to the statement: Agree = 3, Mostly Agree = 2, Mostly Disagree = 1, Disagree = 0. Percentage agreement and 95% confidence intervals (CIs) were calculated, and a consensus threshold was set at > 80% agreement for each statement.
    Seven of 10 consensus statements using the modified Likert scale reached consensus, including those on the role of inflammation in pathophysiology of DR/DME, injection burden and patient adherence, and efficacy and safety of the FAc implant. The remaining three statements displayed high agreement with average scores > 80%, but the 95% CIs were below threshold. These included the impact of the FAc implant on DR progression, FAc as baseline therapy for DME, and the effectiveness of the steroid challenge to mitigate intraocular pressure risk after FAc use. Two multiple-choice questions focused on clinical situations in which corticosteroids would be used as baseline therapy for DME (pseudophakic eye [73%], recent stroke/myocardial infarction [66%], and pregnancy/breastfeeding [66%]) and which delivery route satisfies the steroid challenge for the FAc implant (intravitreal [100%], sub-tenon/periocular [73%], and topical [57%]).
    Physicians highly agreed on the role of inflammation in pathophysiology of DR/DME, injection burden and patient adherence, and efficacy and safety of the FAc implant. However, full consensus was not found on the impact of the FAc implant on DR progression, FAc as baseline therapy for DME, and the effectiveness of the steroid challenge to mitigate intraocular pressure risk after FAc use. [Ophthalmic Surg Lasers Imaging Retina. 2023;54(3):166-173.].
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  • 文章类型: Journal Article
    中心累及的糖尿病性黄斑水肿(DME)是工作年龄成年人视力障碍的主要原因。虽然它的管理在依从性差的人群中尤其具有挑战性,不断创新和新分子的出现改善了其结果。控制血糖和全身加重因素对于减缓包括DME在内的疾病并发症的进展仍然至关重要。黄斑激光光凝的适应症已逐渐被逐步淘汰为护理标准,并由局部眼内抗VEGF生物制剂和糖皮质激素(GC)代替。控释药物递送系统中的玻璃体内GC已允许减少注射频率和治疗负担。不可生物降解的氟轻松(FAc)植入物允许功能和解剖改进的长期稳定。然而,适当的患者选择和通过定期随访进行监测对于获得最佳结果至关重要.根据他们的经验和最新的文献,本次审查的目的是就FAc植入物在DME治疗算法中的地位提供国际专家小组共识,以及它的安全性和如何管理它。
    Center-involving diabetic macular edema (DME) is a leading cause of vision impairment in working-age adults. While its management is particularly challenging in a poorly compliant population, continuous innovation and the advent of new molecules have improved its outcome. The control of glycemia and of systemic aggravating factors remain essential to slow down progression of disease complications including DME. The indications for macular laser photocoagulation has progressively been phased out as a standard of care and replaced by local intraocular anti-VEGFs biologics and glucocorticoids (GCs). Intravitreal GCs in controlled-release drug delivery systems have allowed to reduce injection frequency and treatment burden. The non biodegradable Fluocinolone Acetonide (FAc) implant allows a long-lasting stabilization of both functional and anatomic improvements. However, adequate patient selection and monitoring through regular follow-up are essential for optimal results. Based on their experience and the latest literature, the aim of the present review is to provide international expert panel consensus on the place of the FAc implant in the treatment algorithm of DME, as well as its safety profile and how to manage it.
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  • 文章类型: Journal Article
    玻璃体内治疗糖尿病性黄斑水肿,在易感患者中,增加眼内压(IOP)。由于不受控制的IOP可能会威胁视力,监测是患者管理的重要组成部分。对于视网膜专家来说,确保监测足够严格,以便尽早发现和解决任何潜在问题,而对于IOP升高风险最低的患者来说,这可能是一项挑战。我们开发了动态算法:(1)根据个体易感性和当前眼压调整监测的频率和程度;(2)协助视网膜专家决定何时应考虑转诊给青光眼专家。一种算法是针对对发生IOP升高的敏感性相对较低的患者(那些基线IOP<22mmHg并且没有IOP事件病史的患者)。根据他们的第一次植入后眼压检查,该算法将其分类为:如果IOP保持<22mmHg,则为低危;如果IOP为22~25mmHg,则为中危,且任何高于基线的升高均<10mmHg;如果IOP>25mmHg或高于基线的升高均为≥10mmHg,则为高危.此后,算法指导这些组中每个组所需的监测频率和程度,如果眼压在治疗期间上升或下降,患者可以相应地向上或向下移动风险组。为更容易发生IOP升高的患者(基线IOP≥22mmHg或先前有IOP事件史的患者)提供了不同的算法。这些患者需要更密切地监测,因此该算法仅具有中风险或高风险分类。这些算法更新了Goñi等人先前的监测指导。(戈尼等人。在OthalmorTher5:47-61,2016中)。
    一些糖尿病患者有黄斑水肿,这是视网膜中央部分(位于眼睛后部的组织)的肿胀。如果不治疗,这种肿胀会威胁视力。将诸如皮质类固醇之类的药物注入眼睛可以帮助治疗该病症。有时这具有增加眼内压(眼内压力)的副作用。小的或短暂的眼压上升应该没有理由担心,但是确保压力不会太高太长时间是非常重要的-因为这可能导致视力丧失。为了防止这种情况发生,眼科医生需要定期检查眼压。有些人更容易受到这个问题的影响-例如,过去有任何与眼压有关的问题的人,或者在治疗前眼睛压力已经高于正常水平的人。最易受影响的人可能需要更多类型的检查和更频繁的检查,以确保快速发现和治疗任何问题。我们开发了流程图,帮助眼科医生决定哪些检查是需要的,以及根据医生在治疗前对人的眼睛的了解以及他们在治疗后的每次检查中看到的情况而定的频率。他们帮助医生确保每个人都在正确的时间进行检查,并帮助医生及早发现任何问题,以便在长期损害发生之前解决这些问题。
    Intravitreal therapy for diabetic macular edema can, in susceptible patients, increase intraocular pressure (IOP). As uncontrolled IOP can potentially be sight threatening, monitoring is an essential component of patient management. It can be challenging for retina specialists to ensure that monitoring is rigorous enough to detect and resolve any potential problems at the earliest opportunity without it also being overburdensome for patients who have the lowest risk of developing an IOP rise. We have developed dynamic algorithms that: (1) tailor the frequency and extent of monitoring according to individual susceptibility and current IOP and (2) assist retina specialists in deciding when they should consider a referral to a glaucoma specialist. One algorithm is for patients with a relatively low susceptibility to developing an IOP rise (those whose baseline IOP is < 22 mmHg and who do not have a history of IOP events). Depending on their first post-implantation IOP check, the algorithm classifies them as: low risk if IOP remains < 22 mmHg; medium risk if IOP is 22-25 mmHg and any rise from baseline is < 10 mmHg; or high risk if IOP is > 25 mmHg or any rise from baseline is ≥ 10 mmHg. Thereafter, the algorithm guides on the frequency and extent of monitoring required in each of these groups and, if IOP rises or falls during treatment, patients may move up or down the risk groups accordingly. A different algorithm is provided for patients who are more susceptible to developing an IOP rise (those with a baseline IOP of ≥ 22 mmHg or a prior history of an IOP event). These patients need monitoring more closely so this algorithm has only medium- or high-risk classifications. These algorithms update the previous monitoring guidance by Goñi et al. (Goñi et al. in Ophthalmol Ther 5:47-61, 2016).
    Some people with diabetes have macular edema, which is a swelling of the central part of the retina (the tissue that lines the back of the eye). This swelling can threaten eyesight if untreated.Injecting a drug such as a corticosteroid into the eye can help treat the condition. Sometimes this has a side effect of increasing intraocular pressure (pressure within the eye). A small or short-lived rise in eye pressure should be no cause for concern, but it is very important to ensure the pressure is not too high for too long—because this could lead to the loss of eyesight. To prevent this happening, an eye doctor needs to check the eye pressure regularly.Some people are more susceptible to this problem—for example, people who have had any problems related to eye pressure in the past or people whose eyes already have a higher than normal pressure even before treatment. People who are most susceptible may need more types of checks and more frequent checks to ensure that any problems are found and treated quickly.We have developed flowcharts that help eye doctors decide which checks are needed and how often based on what the doctor knows about the person’s eye before treatment and what they see at each check-up after treatment. They help doctors make sure that everyone has check-ups at the right time and they help doctors spot any problems early so that they can be resolved before long-lasting damage can occur.
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  • 文章类型: Consensus Development Conference
    The diabetic macular edema (DME) treatment paradigm has evolved as the understanding of the disease pathology has grown. Since 2012, four pharmacotherapies have been approved by the U.S. Food and Drug Administration for the treatment of DME. First-line treatment of DME with anti-vascular endothelial growth factor [VEGF] agents has become the gold standard; however, an appreciable percentage of patients do not respond to anti-VEGF therapies. In patients who inadequately respond to anti-VEGF therapies, the underlying disease pathology may be mediated by a multitude of growth factors and inflammatory cytokines. For these patients, corticosteroids are an attractive treatment option because they not only downregulate VEGF, but also an array of cytokines. The phase 3 MEAD and FAME trials demonstrated significant visual acuity improvements associated with dexamethasone and fluocinolone acetonide, respectively, in patients with DME; however, class-specific adverse events, including increased intraocular pressure and cataract development, must be considered before use. A panel of experts gathered during the 2015 annual meeting of the American Academy of Ophthalmology for a roundtable discussion focused on patient selection and adverse event management associated with the use of the 0.19 mg fluocinolone acetonide intravitreal implant.
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