diabetic macular oedema

糖尿病性黄斑水肿
  • DOI:
    文章类型: Journal Article
    关于撒哈拉以南非洲(SSA)糖尿病性黄斑水肿(DMO)的治疗方法的信息很少。这项调查的主要目的是确定在SSA工作的眼科医生对DMO的“现实世界”管理。
    问卷分发给SSA视网膜和眼科协会成员。
    来自24个国家的93名眼科医生参加了会议,其中大多数在尼日利亚工作(51,55%)。大多数是视网膜专家(50,54%)和顾问(67,62%)。62(67%)眼科医生的临床显著黄斑水肿提示治疗,而视力(81,87%)和OCT改变(76,82%)是治疗DMO的更常见原因.治疗包括玻璃体内抗VEGF(91,98%),激光(70,75%),玻璃体内类固醇(57,61%),局部滴剂(52,56%),口服片剂(32,34%)和手术(20,22%)。使用的最常见的玻璃体内抗VEGF药物是贝伐单抗(89,96%)和雷珠单抗(71,76%)。69人(74%)使用玻璃体内注射曲安奈德,局部NSAIDs下降51(55%),和乙酰唑胺片剂由22(24%)眼科医生作为DMO的治疗。
    撒哈拉以南非洲眼科医生通常使用玻璃体内抗VEGF,激光,玻璃体内类固醇,和局部NSAIDs治疗DMO。经济限制和/或无法维持成功的玻璃体内抗VEGF治疗所需的强化方案可能会影响某些治疗选择。
    UNASSIGNED: There is minimal information about the availability of treatment for Diabetic macular oedema (DMO) in sub-Saharan Africa (SSA). The principal aim of this survey was to determine the \'real world\' management of DMO amongst ophthalmologists working in SSA.
    UNASSIGNED: Questionnaires were distributed to members of retinal and ophthalmological societies in SSA.
    UNASSIGNED: Ninety-Three ophthalmologists from 24 countries participated with the majority working in Nigeria (51, 55%). Most were retina specialists (50, 54%) and consultants (67, 62%). Clinically significant macular oedema prompted treatment for 62 (67%) ophthalmologists, whilst visual acuity (81, 87%) and OCT changes (76, 82%) were more common reasons to treat DMO. Treatment included intravitreal anti-VEGF (91, 98%), laser (70, 75%), intravitreal steroid (57, 61%), topical drops (52, 56%), oral tablets (32, 34%) and surgery (20, 22%). The commonest intravitreal anti-VEGF agents used were bevacizumab (89, 96%) and ranibizumab (71, 76%). Intravitreal triamcinolone was used by 69 (74%), topical NSAIDs by 51 (55%), and acetazolamide tablets by 22 (24%) ophthalmologists as a treatment for DMO.
    UNASSIGNED: Sub-Saharan African ophthalmologists commonly use intravitreal anti-VEGF, laser, intravitreal steroid, and topical NSAIDs to treat DMO. Economic constraints and/or the inability to maintain the intensive regimen required for successful intravitreal anti-VEGF therapy probably influence some treatment choices.
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  • 文章类型: Journal Article
    糖尿病视网膜病变(DR)是糖尿病最常见的微血管并发症,如果不及时治疗会导致视力障碍。本文讨论了使用光学相干断层扫描血管造影(OCTA)作为早期发现和管理DR的诊断工具。OCTA是一个快速的,非侵入性,非接触测试,使黄斑微血管在不同的丛详细可视化。OCTA比荧光素眼底血管造影术(FFA)有几个优点,特别是提供定量数据。OCTA并非没有限制,包括仔细解释文物的要求以及目前可以捕获的有限感兴趣区域。我们探讨了OCTA如何在检测DR临床体征之前的早期微血管变化中发挥作用。我们还讨论了OCTA在DR各个阶段的诊断和管理中的应用。包括非增生性糖尿病视网膜病变(NPDR),增殖性糖尿病视网膜病变(PDR),糖尿病性黄斑水肿(DMO),糖尿病性黄斑缺血和糖尿病前期。最后,我们讨论了OCTA的未来作用以及它如何用于提高DR的临床结局。
    Diabetic retinopathy (DR) is the most common microvascular complication of diabetes mellitus, leading to visual impairment if left untreated. This review discusses the use of optical coherence tomography angiography (OCTA) as a diagnostic tool for the early detection and management of DR. OCTA is a fast, non-invasive, non-contact test that enables the detailed visualisation of the macular microvasculature in different plexuses. OCTA offers several advantages over fundus fluorescein angiography (FFA), notably offering quantitative data. OCTA is not without limitations, including the requirement for careful interpretation of artefacts and the limited region of interest that can be captured currently. We explore how OCTA has been instrumental in detecting early microvascular changes that precede clinical signs of DR. We also discuss the application of OCTA in the diagnosis and management of various stages of DR, including non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), diabetic macular oedema (DMO), diabetic macular ischaemia (DMI), and pre-diabetes. Finally, we discuss the future role of OCTA and how it may be used to enhance the clinical outcomes of DR.
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  • 文章类型: Review
    背景:关于同一主题的不同网络荟萃分析(NMA)导致发现的差异。在这次审查中,我们调查了NMA,比较了阿柏西普和雷珠单抗治疗糖尿病性黄斑水肿(DME)的疗效,以期阐明结果差异的原因.
    方法:在英文和中文电子数据库中搜索研究(PubMed,Embase,科克伦图书馆,WebofScience,CNKI,万方,VIP;详见正文中的详细搜索策略)。两名独立评审员系统地筛选了目标NMA,其中包括阿柏西普和雷珠单抗在DME患者中的比较。本综述感兴趣的关键结果是最佳矫正视力(BCVA)的变化,包括各种报告方式(例如在12个月时获得≥10个ETDRS字母的参与者比例;在12个月时BCVA的平均变化)。
    结果:对于BCVA的二元结果,不同的NMA都同意两种治疗方法之间没有明显差异,虽然连续结局都比雷珠单抗更有利于阿柏西普.我们讨论了五个类似的NMA所说明的四个特别关注的点,包括网络差异,PICO(参与者,干预措施,比较器,结果)差异,来自相同效果度量的不同数据,以及真正重要的差异。
    结论:仔细检查这些试验中的每一个,包括搜索和分析,都不同,但是发现,虽然呈现不同,有时解释不同,是相似的。
    Different network meta-analyses (NMAs) on the same topic result in differences in findings. In this review, we investigated NMAs comparing aflibercept with ranibizumab for diabetic macular oedema (DME) in the hope of illuminating why the differences in findings occurred.
    Studies were searched for in English and Chinese electronic databases (PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP; see detailed search strategy in the main body). Two independent reviewers systematically screened to identify target NMAs that included a comparison of aflibercept and ranibizumab in patients with DME. The key outcome of interest in this review is the change in best-corrected visual acuity (BCVA), including various ways of reporting (such as the proportion of participants who gain ≥ 10 ETDRS letters at 12 months; average change in BCVA at 12 months).
    For the binary outcome of BCVA, different NMAs all agreed that there is no clear difference between the two treatments, while continuous outcomes all favour aflibercept over ranibizumab. We discussed four points of particular concern that are illustrated by five similar NMAs, including network differences, PICO (participants, interventions, comparators, outcomes) differences, different data from the same measures of effect, and differences in what is truly significant.
    A closer inspection of each of these trials shows how the methods, including the searches and analyses, all differ, but the findings, although presented differently and sometimes interpreted differently, were similar.
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  • 文章类型: Journal Article
    背景:进行了系统文献综述(SLR)和网络荟萃分析(NMA)以评估比较疗效,faricimab的耐久性和安全性,用于治疗和延长(T&E)方案,间隔最多16周(Q16W),相对于目前用于治疗糖尿病性黄斑水肿(DME)的其他疗法。特别感兴趣的是在灵活的给药方案中应用的抗血管内皮生长因子(VEGF)疗法,例如Prorenata(PRN)和T&E,这是临床实践的支柱。
    方法:进行了一项在2021年8月之前发表的SLR识别随机对照试验(RCT),随后是贝叶斯NMA,将法利玛T&E治疗与阿柏西普进行了比较,雷珠单抗,贝伐单抗,地塞米松和激光治疗。分析中包括的结果是最佳矫正视力(BCVA)的变化,中心子场厚度(CST)的变化,注入频率,眼部不良事件(AE)和全因停药,所有这些都在12个月时进行评估.在可行的情况下进行亚组分析,包括未接受抗VEGF治疗的患者。
    结果:在SLR中确定的26项研究被纳入NMA。最重要的是临床实践中的决策,与所有其他灵活给药方案(视网膜干燥程度提高55-125微米)相比,faricimabT&E在视网膜厚度方面有统计学意义的降低(95%可信间隔排除零)和临床意义的降低.解剖学结果决定了患者的治疗效果和再治疗。NMA还显示,与FaricimabT&E相比,BCVA的平均变化在统计学上有更大的增加使用雷珠单抗和贝伐单抗的灵活方案(增加4.4-4.8个字母)以及数值改善与afliberceptPRN(两个字母,95%可信区间,包括零)。因此,与使用灵活给药方案的其他治疗相比,注射频率在数值上较低(减少0.92-1.43次注射).分析还表明,法利单抗T&E的安全性与雷珠单抗和阿柏西普相当,具有完善的安全特征,对于所有原因中止的数量也有类似的结果。
    结论:Faricimab为DME提供了一种新的治疗选择,具有VEGF和血管生成素-2(Ang-2)的双途径抑制作用。就作者所知,这是faricimabT&E在二甲醚中的首次间接比较。分析表明,与灵活给药方案中给出的所有其他治疗方法相比,法利单抗T&E与优越的视网膜干燥以及数字上较少的注射有关。与雷珠单抗和贝伐单抗相比,它还显示出更好的视力结果。
    A systematic literature review (SLR) and network meta-analysis (NMA) were conducted to evaluate the comparative efficacy, durability and safety of faricimab, used in a Treat & Extend (T&E) regime with intervals up to every 16 weeks (Q16W), relative to other therapies currently in use for treatment of diabetic macular oedema (DME). Of particular interest were anti-vascular endothelial growth factor (VEGF) therapies applied in flexible dosing regimens such as Pro re nata (PRN) and T&E, which are the mainstay in clinical practice.
    An SLR identifying randomised controlled trials (RCTs) published before August 2021 was conducted, followed by a Bayesian NMA comparing faricimab T&E treatment to aflibercept, ranibizumab, bevacizumab, dexamethasone and laser therapy. Outcomes included in the analysis were change in best-corrected visual acuity (BCVA), change in central subfield thickness (CST), injection frequency, ocular adverse events (AE) and all-cause discontinuation, all of which were evaluated at 12 months. Subgroup analyses including patients\' naïve to anti-VEGF were conducted where feasible.
    Twenty-six studies identified in the SLR were included in the NMA. Most importantly for decision making in clinical practise, faricimab T&E was associated with a statistically greater (95% credible intervals exclude zero) and clinically meaningful decrease in retinal thickness compared to all other flexible dosing regimens (greater retinal drying by 55-125 microns). Anatomical outcomes determine treatment efficacy and retreatment of patients. The NMA also showed a statistically greater increase in mean change in BCVA for faricimab T&E vs. flexible regimens using ranibizumab and bevacizumab (increase of 4.4-4.8 letters) as well as a numerical improvement vs. aflibercept PRN (two letters, 95% credible intervals including zero). Accordingly, the injection frequency was numerically lower versus other treatments using flexible dosing regimens (decrease by 0.92-1.43 injections). The analyses also indicated that the safety profile of faricimab T&E was comparable to those of ranibizumab and aflibercept, which have well-established safety profiles, with similar results for the number of all-cause discontinuations.
    Faricimab provides a new treatment option in DME with dual-pathway inhibition of VEGF and angiopoeitin-2 (Ang-2). To the authors\' knowledge, this is the first indirect comparison of faricimab T&E in DME. The analyses indicate that faricimab T&E is associated with superior retinal drying along with numerically fewer injections compared to all other treatments given in flexible dosing regimens. It also showed superior visual acuity outcomes compared to ranibizumab and bevacizumab.
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  • 文章类型: Journal Article
    退行性眼病,如年龄相关性黄斑变性(AMD),糖尿病视网膜病变,在发达国家,视网膜静脉阻塞是导致严重视力丧失的主要原因。控制与这些疾病相关的并发症的主要治疗方法包括玻璃体内递送抗血管内皮生长因子(VEGF)治疗。Faricimab是一部小说,人性化,同时结合所有VEGF-A亚型和血管生成素-2的双特异性抗体,已被监管机构批准,如美国食品和药物管理局(FDA),英国药品和保健品管理局(MHRA)和欧洲药品管理局(EMA),用于治疗新生血管性AMD和糖尿病性黄斑水肿(DMO)。玻璃体内法利单抗有望通过减少就诊次数来实现可比或优越的治疗结果,从而减轻患有这些疾病的患者的治疗负担。faricimab的应用范围包括解决复杂的黄斑疾病,如DMO。这篇综述旨在阐明法利单抗的独特药理学特征,并概述评估其治疗退行性黄斑疾病的有效性和安全性的关键临床试验和现实世界研究。
    Degenerative eye conditions such as age-related macular degeneration (AMD), diabetic retinopathy, and retinal vein occlusion are major contributors to significant vision loss in developed nations. The primary therapeutic approach for managing complications linked to these diseases involves the intravitreal delivery of anti-vascular endothelial growth factor (VEGF) treatments. Faricimab is a novel, humanised, bispecific antibody that simultaneously binds all VEGF-A isoforms and Angiopoietin-2, which has been approved by regulatory agencies, such as the US Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), for the treatment of neovascular AMD and diabetic macular oedema (DMO). Intravitreal faricimab holds the promise of reducing the treatment burden for patients with these conditions by achieving comparable or superior therapeutic outcomes with fewer clinic visits. The scope of faricimab\'s application includes addressing complex macular conditions such as DMO. This review intends to elucidate the distinctive pharmacological characteristics of faricimab and provide an overview of the key clinical trials and real-world studies that assess its effectiveness and safety in treating degenerative macular diseases.
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  • 文章类型: Journal Article
    背景:这篇综述旨在评估疗效,Faricimab-一种血管内皮生长因子和血管生成素2双重抑制剂-在新生血管性年龄相关性黄斑变性(nAMD)和糖尿病性黄斑水肿(DMO)患者中的耐久性和安全性。它总结了目前关于法利单抗的研究结果,并讨论了这种新药是否可以填补目前治疗方案的空白。
    方法:我们搜索了PubMed,科克伦,WebofScience和EMBASE数据库,用于2022年11月29日至2023年5月10日之间有关faricimab的出版物,并搜索ClinicalTrials.gov,以了解本次审查的临床试验方案。我们包括临床试验,病例对照研究和观察性研究。
    结果:在nAMD的3期试验中,法利单抗的疗效不劣于阿柏西普(5.8-6.6vs.+5.1-6.6早期治疗糖尿病视网膜病变研究[ETDRS]字母)。在研究结束时,80%的法利单抗治疗患者的给药间隔≥12周,44.9-45.7%的法利单抗治疗患者间隔给药16周。总不良事件,以及严重的眼部不良事件,组间具有可比性。在DMO的第三阶段试验中,法利单抗的疗效不劣于阿柏西普(10.7-11.8vs.+10.3-10.9ETDRS字母)。在研究结束时,>70%的患者在个性化治疗间隔法利单抗组≥12周的给药间隔,51-53%的患者间隔为16周。两组之间的总不良事件具有可比性,尽管法利单抗组的严重眼部不良事件发生率高于阿柏西普组(1.9-3.1%vs.0.6-1.9%,分别)。在对治疗抗性nAMD或DMO的实际研究中,与阿柏西普相比,法利克单抗表现出更好的疗效。在一项对大部分以前治疗过的nAMD的现实世界研究中,法利克单抗表现出一定的疗效。
    结论:Faricimab表现出不亚于优越的疗效,强大的耐久性和可接受的安全性在治疗-天真的nAMD和主要是治疗-天真的DMO,以及在治疗耐药nAMD和DMO中的优异疗效。然而,在现实世界中需要对faricimab进行进一步的研究。
    BACKGROUND: This review aims to assess the efficacy, durability and safety of faricimab-a dual vascular endothelial growth factor and angiopoietin 2 inhibitor-in patients with neovascular age-related macular degeneration (nAMD) and diabetic macula oedema (DMO). It summarises the findings of current studies on faricimab and discusses whether this new drug may fill a gap in current treatment options.
    METHODS: We performed a search of the PubMed, Cochrane, Web of Science and EMBASE databases for publications on faricimab between 29 November 2022 and 10 May 2023, and a search of ClinicalTrials.gov for the protocols on clinical trials for this review. We included clinical trials, case-control studies and observational studies.
    RESULTS: In phase 3 trials of nAMD, the efficacy of faricimab was non-inferior to aflibercept (+ 5.8-6.6 vs. + 5.1-6.6 Early Treatment Diabetic Retinopathy Study [ETDRS] letters). At study end, 80% of faricimab-treated patients were on ≥ 12-week dosing intervals, and 44.9-45.7% of faricimab-treated patients were on 16-week dosing intervals. Total adverse events, as well as serious ocular adverse events, were comparable between groups. In phase 3 trials of DMO, efficacy of faricimab was non-inferior to aflibercept (+ 10.7-11.8 vs. + 10.3-10.9 ETDRS letters). At study end, > 70% of patients in the personalised treatment interval faricimab group were on ≥ 12-week dosing intervals, and 51-53% were on 16-week dosing intervals. Total adverse events were comparable between groups, although the rate of serious ocular adverse events was higher in the faricimab groups than in the aflibercept groups (1.9-3.1% vs. 0.6-1.9%, respectively). In real-world studies of treatment-resistant nAMD or DMO, faricimab demonstrated superior efficacy compared to aflibercept. In a real-world study of mostly previously treated nAMD, faricimab demonstrated some efficacy.
    CONCLUSIONS: Faricimab demonstrated non-inferior to superior efficacy, strong durability and acceptable safety in treatment-naïve nAMD and mostly treatment-naïve DMO, as well as superior efficacy in treatment-resistant nAMD and DMO. However, further research is needed on faricimab in real-world settings.
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  • 文章类型: Journal Article
    背景:本研究的目的是评估在慢性糖尿病性黄斑水肿(DME)患者最后一次玻璃体内植入地塞米松(DEXi)1个月后注射醋酸氟轻松(FAci)的疗效和安全性。
    方法:在经常接受地塞米松玻璃体内植入物治疗的慢性DME假晶状体患者中进行的回顾性多中心研究(DEXi;DME复发时间≤6个月),在上次DEXi后1个月收到FAci,至少6个月的随访。最佳矫正视力(BCVA),光学相干断层扫描的中央黄斑厚度(CMT),在注射FAci(M0)当天评估眼内压(IOP)和其他治疗,1(M1)和3个月(M3)后,然后每3个月。
    结果:共纳入34例患者的41只眼。在M0时,患者的平均年龄为68.7±9.8岁,DME的平均持续时间为63.9±22.9个月,两次DEXi之间的平均间隔为14.2±3.3周.71%的患者可获得M12数据。在基线,平均BCVA,CMT和IOP为63.2±16.6个字母,299.4±103.3µm,16.2±4.5mmHg,分别,并在随访期间保持稳定。在M12时,14%的患者需要额外的玻璃体内治疗。
    结论:慢性DME患者对DEXi反应良好,但需要每6个月重复注射一次,在上次DEXi有效且安全的1个月后切换到FAci。需要进一步的前瞻性随机对照研究来证实这些发现,并确定最后一个DEXi和第一个FAci之间的最佳间隔。
    BACKGROUND: The aim of this study was to assess the efficacy and safety of fluocinolone acetonide implant (FAci) injected 1 month after the last dexamethasone intravitreal implant (DEXi) in chronic diabetic macular oedema (DME) patients.
    METHODS: Retrospective multicentric study conducted in pseudophakic patients with chronic DME frequently treated with dexamethasone intravitreal implant (DEXi; time to DME recurrence ≤ 6 months), receiving FAci 1 month after the last DEXi, with at least a 6-month follow-up. Best-corrected visual acuity (BCVA), central macular thickness (CMT) on optical coherence tomography, intraocular pressure (IOP) and additional treatments were assessed on the day of FAci injection (M0), 1 (M1) and 3 months (M3) later and then every 3 months.
    RESULTS: A total of 41 eyes from 34 patients were included. At M0, patients\' mean age was 68.7 ± 9.8 years, the mean DME duration was 63.9 ± 22.9 months, the mean interval between two DEXi was 14.2 ± 3.3 weeks. M12 data were available for 71% of patients. At baseline, the mean BCVA, CMT and IOP were 63.2 ± 16.6 letters, 299.4 ± 103.3 µm, and 16.2 ± 4.5 mmHg, respectively, and remained stable during the follow-up. At M12, 14% of patients required additional intravitreal treatments.
    CONCLUSIONS: In pseudophakic patients with chronic DME showing good response to DEXi but requiring repeated injections every < 6 months, switching to FAci 1 month after the last DEXi was effective and safe. Further prospective randomized controlled studies are needed to confirm these findings, and to determine the best interval between the last DEXi and the first FAci.
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  • 文章类型: Journal Article
    眼部血管疾病是视力障碍和失明的常见原因,抗血管内皮生长因子(抗VEGF)是一线治疗。目前的研究描述了接受玻璃体内注射抗VEGF(IVI)的患者的概况,不丹的性别差异。该研究旨在为国家卫生政策提供信息。
    回顾性横断面研究。
    我们回顾了三年来不丹玻璃体视网膜(VR)单位的手术记录。患者人口统计学,临床发现,进行的诊断测试,并记录IVI的诊断或适应症。进行了描述性分析。
    尽管抗VEGF的应用有限,根据国家指南的规定,共有381例患者在手术室接受了IVI.大多数患者是男性(230,60.4%,p=0.004)。平均年龄为65.2±13.5岁(13岁至90岁),中位数为69岁。大多数治疗的眼睛(117,30.7%)的BCVA<3/60的光感知(PL),另外51只眼(13.4%)<6/60至3/60。IVI最常见的指征是新生血管性年龄相关性黄斑变性(nAMD)(168例,42.2%),其次是视网膜静脉阻塞(RVO)(132例,34.6%),糖尿病性黄斑水肿(DMO)和视网膜病变(DR)(50例,13.1%),和近视脉络膜新生血管膜(11例,0.03%)。
    不丹管理VR疾病的人力资源有限,加上经济和地理挑战。随着nAMD、近视等VR疾病和DR等全身性疾病并发症的增多,DMO和RVO,需要改进VR服务。目前,抗VEGF仅适用于需要IVI的合并患者,和病人失去了由于较长的等待时间。不丹需要评估女性是否因文化障碍和社会耻辱而报告较少或没有接受治疗。
    UNASSIGNED: Ocular vascular diseases are common causes of visual impairment and blindness, for which anti-vascular endothelial growth factor (anti-VEGF) is the first-line therapy. Current study describes the profile of patients receiving intravitreal anti-VEGF injections (IVI), and gender variation in Bhutan. The study was designed to inform national health policy.
    UNASSIGNED: Retrospective cross-sectional study.
    UNASSIGNED: We reviewed the surgical registers of the vitreoretinal (VR) units across Bhutan over three years. Patient demography, clinical findings, diagnostic tests performed, and diagnoses or indications for IVI were logged. A descriptive analysis was performed.
    UNASSIGNED: Despite limited availability of anti-VEGF, a total of 381 patients received IVI in operating theatres as mandated by the national guidelines. The majority of patients were males (230, 60.4%, p = 0.004). The mean age was 65.2 ± 13.5 years (range 13 years to 90 years), and a median of 69 years. The majority of the treated eyes (117, 30.7%) had BCVA <3/60 to light perception (PL), and another 51 eyes (13.4%) had < 6/60 to 3/60. The most common indication for IVI was neovascular age-related macular degeneration (nAMD) (168 cases, 42.2%), followed by retinal vein occlusion (RVO) (132 cases, 34.6%), diabetic macular oedema (DMO) and retinopathy (DR) (50 cases, 13.1%), and myopic choroidal neovascular membrane (11 cases, 0.03%).
    UNASSIGNED: Limited human resources for managing VR diseases in Bhutan are compounded by economic and geographic challenges. With increasing VR diseases such as nAMD and myopia and complications of systemic diseases such as DR, DMO and RVO, there is a need to improve VR services. Currently, anti-VEGF is procured only for a pooled patients requiring IVI, and patients are lost due to longer waiting periods. Bhutan needs to assess if females are reporting less or are not receiving treatment due to cultural barriers and social stigma.
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  • 文章类型: Journal Article
    背景:主要临床指南推荐抗血管内皮生长因子(VEGF)治疗作为糖尿病性黄斑水肿(DMO)所致视力损害的一线治疗。进行了系统文献综述(SLR)和网络荟萃分析(NMA),比较了抗VEGF布鲁单抗与美国以外国家批准的最相关的比较给药方案的聚焦网络的相对疗效(阿柏西普,雷珠单抗)。还评估了brolucizumab的安全性和耐受性。
    方法:进行广泛的SLR以确定随机对照试验,以确保捕获所有相关的潜在比较者。已确定的研究被细化为适合纳入NMA的研究。进行了贝叶斯NMA,比较了6mg的brolucizumab(每12[Q12W]/每8周[Q8W])与相关的阿柏西普2mg和雷珠单抗0.5mg方案。
    结果:14项研究纳入了NMA。在1年的随访中,各种阿柏西普2mg和雷珠单抗0.5mg方案在主要视觉和解剖学结局方面与布罗珠单抗6mgQ12W/Q8W相当,除了在最佳矫正视力(BCVA)中相对于基线(CFB)的变化方面,每4周(Q4W)6mg的brolucizumab优于0.5mg的雷珠单抗,和BCVA预先指定的字母数的损失/收益,在糖尿病视网膜病变严重程度量表中,超过雷珠单抗0.5mg前再纳塔用于CFB,和视网膜厚度。在第二年,有数据的地方,与所有其他抗VEGF相比,布罗珠单抗6mg在疗效结局中显示相似的结果。在大多数情况下,停药率(所有原因,并且由于不良事件[AE]),并且不包括眼部炎症事件的AE的严重和总体发生率(在未合并和合并治疗分析中)与比较者相似。
    结论:Brolucizumab6mgQ12W/Q8W在各种视觉和解剖学疗效结果和停药率方面与阿柏西普2mg和雷珠单抗0.5mg方案相当或更好。
    BACKGROUND: Key clinical guidelines recommend anti-vascular endothelial growth factor (VEGF) therapy as first-line treatment for visual impairment due to diabetic macular oedema (DMO). A systematic literature review (SLR) and network meta-analysis (NMA) were conducted comparing the relative efficacy of the anti-VEGF brolucizumab with a focused network of the most relevant comparator dosing regimens approved in countries other than the USA (aflibercept, ranibizumab). The safety and tolerability of brolucizumab were also assessed.
    METHODS: A broad SLR was conducted to identify randomised controlled trials to ensure all relevant potential comparators were captured. Identified studies were refined to those appropriate for inclusion in the NMA. A Bayesian NMA was conducted comparing brolucizumab 6 mg (every 12 [Q12W]/every 8 weeks [Q8W]) with relevant aflibercept 2 mg and ranibizumab 0.5 mg regimens.
    RESULTS: Fourteen studies were included in the NMA. At 1-year follow-up, the various aflibercept 2 mg and ranibizumab 0.5 mg regimens were mostly comparable with brolucizumab 6 mg Q12W/Q8W across key visual and anatomical outcomes, except brolucizumab 6 mg was favoured over ranibizumab 0.5 mg every 4 weeks (Q4W) for the change from baseline (CFB) in best-corrected visual acuity (BCVA), and BCVA loss/gain of pre-specified numbers of letters, and over ranibizumab 0.5 mg pro re nata for CFB in diabetic retinopathy severity scale, and retinal thickness. At year 2, where data were available, brolucizumab 6 mg showed similar results across efficacy outcomes versus all other anti-VEGFs. In most cases, discontinuation rates (all cause, and due to adverse events [AE]) and serious and overall rates of AEs excluding ocular inflammatory events were similar (in unpooled and pooled-treatment analyses) versus comparators.
    CONCLUSIONS: Brolucizumab 6 mg Q12W/Q8W was comparable or superior to aflibercept 2 mg and ranibizumab 0.5 mg regimens for various visual and anatomical efficacy outcomes and discontinuation rates.
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  • 文章类型: Journal Article
    氟轻松(FAc)玻璃体内植入物(Iluvien®)是一种皮质类固醇植入物,适用于先前接受常规治疗但没有良好反应的患者的糖尿病性黄斑水肿(DMO)的治疗,非感染性后葡萄膜炎,并作为视网膜静脉阻塞继发的黄斑水肿的标签外治疗。FAc是不可生物降解的0.19mg玻璃体内植入物,其被设计为以每天约0.2mcg的速率在3年内释放FAc。这篇综述的目的是描述Iluvien的特殊药理特性,并显示有关其治疗上述视网膜疾病的有效性和安全性的最重要的临床试验和现实世界研究的结果。
    Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) is a corticosteroid implant indicated for the treatment of diabetic macular oedema (DMO) in patients who have previously received conventional treatment without good response, non-infectious posterior uveitis, and as an off-label treatment of the macular oedema secondary to retinal vein occlusion. FAc is a non-biodegradable 0.19 mg intravitreal implant which is designed to release FAc over 3 years at a rate of approximately 0.2 mcg per day. The aim of this review is to describe the special pharmacological properties of Iluvien and display the outcomes of the most important clinical trials and real-world studies regarding its efficacy and safety for the management of the above retinal disorders.
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