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Welche Glaukom-Operation bei fortgeschrittener Funktionsschädigung? 哪种青光眼手术可治疗晚期功能性损伤?
Pub Date : 2024-04-22 DOI: 10.1159/000538735
Klaus Rohrschneider
Ziel dieser Studie war es, die Ergebnisse chirurgischer Eingriffe bei neovaskulärem Glaukom (NVG) und schlechter Sehkraft zu analysieren. Dazu wurden NVG-Patienten mit einer Sehschärfe von 20/200 oder weniger verglichen, die entweder ein Ahmed-Glaukom-Ventil (AGV) oder eine Zyklophotokoagulation (CPC) erhalten hatten. Zu den Hauptergebnisgrößen zählten die chirurgische Erfolgsrate, Veränderungen des Augeninnendrucks (IOD), die Anzahl der Antiglaukom-Medikamente, die korrigierte Fernvisusschärfe und die Reoperationsrate bei Glaukom. 12 Monate nach Operation zeigten beide Verfahren gute Ergebnisse mit ähnlichen IOP-Werten. Im Vergleich zur CPC zeigte das AGV allerdings insgesamt eine höhere Erfolgsrate und einen geringeren Medikamentenbedarf.
本研究旨在分析新生血管性青光眼(NVG)和视力低下的手术干预结果。研究比较了视力在 20/200 或以下的新生血管性青光眼患者接受艾哈迈德青光眼瓣膜术(AGV)或环形光凝术(CPC)的情况。主要结果指标包括手术成功率、眼压(IOP)变化、抗青光眼药物使用次数、矫正远视力和青光眼再手术率。术后 12 个月,两种手术都取得了良好的效果,眼压值相似。不过,与 CPC 相比,AGV 显示出更高的总体成功率和更低的用药需求。
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引用次数: 0
Bowman-Layer-Onlay-Transplantation (BLOT) als minimal invasive Methode zur Therapie des fortgeschrittenen Keratokonus 鲍曼层嵌体移植术(BLOT)作为治疗晚期角膜病的微创方法
Pub Date : 2024-04-18 DOI: 10.1159/000538791
Mohamed Ghaly
Purpose: To analyze the clinical outcomes after Bowman layer (BL) onlay grafting for the treatment of progressive, advanced keratoconus. Design: Prospective, interventional case series. Methods: Twenty-one eyes underwent BL onlay grafting. After removing the epithelium, a single or double BL graft was «stretched» onto the corneal surface, allowed to dry-in, and a soft bandage lens was placed until the graft was re-epithelialized. Best spectacle- and/or best contact lens-corrected visual acuity (BSCVA/BCLVA), corneal tomography, and postoperative complication rates were analyzed for the total group and 2 subgroups (group 1: preoperative maximum keratometry [Kmax] <69 diopters [D; n = 7); group 2: preoperative Kmax ≥69 D [n = 14]). Follow-up ranged from 6 to 36 months (mean 21 ± 11 months). Results: All 21 surgeries were uneventful. Overall, Kmax changed from 76 ± 12 D preoperatively to 72 ± 9 D at 6 to 36 months postoperatively (P = .015). Kmax decreased by 6 D in group 2 (P = .002) but did not change in group 1. Average BSCVA remained stable for group 1 and improved from preoperatively 0.8 ± 0.4 to 0.4 ± 0.2 logarithm of the minimum angle of resolution postoperatively in group 2 (P = .032); BCLVA remained stable (P > .05). Within the first postoperative weeks, 2 eyes required BL graft repositioning after inadvertent bandage lens removal and 4 eyes underwent BL retransplantation for incomplete re-epithelialization. One eye underwent BL regrafting 12 months postoperatively after traumatic corneal erosion. All eyes showed a completely re-epithelialized graft at the last available follow-up. Conclusion: BL onlay grafting is a completely extraocular, minimally invasive surgical technique, providing up to 6 D of corneal flattening in eyes with advanced progressive keratoconus, allowing for continued (scleral) contact lens wear and therefore preserving the BCLVA.
目的:分析鲍曼层(Bowman layer,BL)镶嵌移植治疗进展性晚期角膜病的临床疗效。设计:前瞻性、介入性病例系列。方法:对 21 只眼睛进行 Bowman 层镶嵌移植术:21只眼睛接受了BL层镶嵌移植术。去除角膜上皮后,将单层或双层角膜基质移植片 "拉伸 "到角膜表面,待其干燥后戴上软绷带镜片,直至移植片重新上皮化。对全组和两个亚组(第 1 组:术前最大角膜度数 [Kmax] .05)的最佳眼镜和/或最佳隐形眼镜矫正视力(BSCVA/BCLVA)、角膜断层扫描和术后并发症发生率进行了分析。术后几周内,有两只眼因不慎摘除绷带镜片而需要重新定位BL移植片,有四只眼因再上皮不完全而接受了BL再移植手术。一只眼睛在术后 12 个月因外伤性角膜侵蚀而接受了角膜基质移植术。在最后一次随访时,所有眼睛都显示移植物完全再上皮化。结论:角膜上皮移植术是一种完全眼外微创的手术技术,可为晚期渐进性角膜炎患者提供多达 6 D 的角膜平整度,允许继续佩戴(巩膜)隐形眼镜,从而保留 BCLVA。
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引用次数: 0
Komplikationen nach Enukleation – das Post-Enucleation Socket Syndrome 去核术后并发症--去核术后凹陷综合征
Pub Date : 2024-04-15 DOI: 10.1159/000538408
Ira Seibel
Purpose: To evaluate socket outcomes of enucleation for uveal melanoma. Methods: This study was a retrospective chart review conducted in December 2022 of all patients who underwent enucleation surgery for uveal melanoma between 2010 and 2015 in the Royal Victoria Eye and Ear Hospital, to evaluate socket outcomes including completion of revision surgery, type of surgery, and completion of multiple revision surgeries, and potential associations. Results: Between June 2010 and December 2015, 72 patients underwent enucleation for uveal melanoma in the ocular oncology service, including 25 females and 47 males, mean age 65, range 11–91 years old. There were 68 primary enucleations and 4 secondary enucleations. Complete follow-up data was available for mean 4 years, range 1–11 years. Fourteen patients underwent further surgery, including one exenteration for local recurrence. Oculoplastic surgery (n = 6, 8%), implant exposure repair (n = 3, 6%), and orbit volume expanding surgery (n = 4, 6%) were also performed. Eight patients (11%) underwent one further surgery and five patients (7%) underwent a series of procedures. There was a significant association with younger age at enucleation (age <65) with undergoing further surgery (p = 0.03, Fisher’s Exact Test (FET)), and also an association of younger age with undergoing multiple further surgeries (p = 0.02, FET). There was no association found with other predictor variables, including primary versus secondary enucleation status. Most patients (75%) with PESS underwent more than one surgery. Conclusion: Post enucleation surgery 82% of patients did not undergo further surgery, but younger patients were more likely to undergo anophthalmic socket revision or oculoplastic surgery. Management of post enucleation socket syndrome was challenging and usually involved a series of procedures.
目的:评估葡萄膜黑色素瘤去核术的术后效果。方法:本研究于2022年12月对维多利亚皇家眼耳医院2010年至2015年期间接受葡萄膜黑色素瘤去核手术的所有患者进行了回顾性病历审查,以评估包括完成翻修手术、手术类型、完成多次翻修手术在内的套袋结果及其潜在关联。结果:2010年6月至2015年12月期间,眼部肿瘤科共有72名患者因葡萄膜黑色素瘤接受了去核手术,其中女性25人,男性47人,平均年龄65岁,年龄范围11-91岁。其中68例为原发性去核,4例为继发性去核。完整的随访数据平均为 4 年,1-11 年不等。14名患者接受了进一步手术,其中1名患者因局部复发而接受了外切手术。此外,还进行了眼部整形手术(6人,占8%)、植入物暴露修复手术(3人,占6%)和眼眶体积扩大手术(4人,占6%)。八名患者(11%)接受了一次进一步手术,五名患者(7%)接受了一系列手术。眼球摘除术时年龄较小(年龄小于 65 岁)与接受进一步手术有明显关系(费雪精确检验(FET),P = 0.03),年龄较小与接受多次进一步手术也有关系(费雪精确检验,P = 0.02)。与其他预测变量(包括原发性和继发性去核状态)没有关联。大多数 PESS 患者(75%)都接受了一次以上的手术。结论82%的患者在去核手术后没有接受进一步手术,但年轻患者更有可能接受眼窝整形或眼部整形手术。去核术后内眦赘皮综合征的治疗具有挑战性,通常需要进行一系列手术。
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引用次数: 0
Systematische Übersicht über die Methoden und Qualität der Meldung von Komplikationen in Studien zur Beurteilung von innovativen glaukomchirurgischen Verfahren 对创新青光眼手术方法评估研究中并发症的报告方法和质量进行系统回顾
Pub Date : 2024-04-15 DOI: 10.1159/000538411
J. Bonnar, Augusto Azuara-Blanco
Das Ziel dieser systematischen Übersichtsarbeit ist die Ermittlung der Art der Meldung von Komplikationen bei der mikroinvasiven Glaukomchirurgie (MIGS) in randomisierten kontrollierten Studien (RCTs) und die Bestimmung der Qualität dieser Meldungen im Vergleich zur CONSORT-Erweiterung für Schäden. Aus einer Datenbank mit systematischen Übersichtsarbeiten und der aktuellen Literatur wurden MIGS-Verfahren bewertende RCTs ermittelt. Die Studien wurden im Vergleich zur CONSORT-Erweiterung für Schäden bewertet, um die Qualität der Berichterstattung über Schäden zu quantifizieren. Für die CONSORT-Checkliste wurden einfache deskriptive Statistiken berechnet. 21 Studien wurden als geeignet zur Einbeziehung ermittelt, davon untersuchten 14 Studien iStent, 1 Trabectome, 3 Hydrus, 1 Cypass, 1 PreserFlo MicroShunt und 1 Studie die Excimer-Laser-Trabekulotomie. Die durchschnittliche Anzahl der von den Studien erfüllten Punkte der CONSORT-Checkliste für Schäden betrug 10 von 16. Keine der Studien verwendete ein validiertes Instrument, um die Schwere der Schäden zu melden, und nur 4 hatten eine Liste oder Definition der unerwünschten Ereignisse. Eine Analyse der Schäden wurde in 19 von 21 Studien (90%) durchgeführt. In 19 von 21 Studien wurden geeignete Metriken für die Meldung von Raten unerwünschter Ereignisse verwendet, aber in nur 4 Studien wurde versucht, diesen unerwünschten Ereignissen einen Schweregrad zuzuordnen. Zusammenfassend lässt sich sagen, dass die meisten der die MIGS-Verfahren bewertenden Studien sich bemühen, Daten zu Schäden anzuerkennen, dies jedoch nicht einheitlich gut oder auf die gleiche Weise geschieht. Ein validiertes Instrument zur Meldung des Schweregrads und eine Standardliste der Komplikationen für die MIGS würden entscheidend zur Lösung dieses Problems beitragen.
本系统综述旨在确定随机对照试验(RCT)中微创青光眼手术(MIGS)并发症报告的性质,并确定这些报告与 CONSORT 危害性扩展标准相比的质量。从系统综述数据库和当前文献中确定了评估 MIGS 手术的 RCT。对照 CONSORT 危害性扩展条款对这些研究进行评估,以量化危害性报告的质量。对 CONSORT 核对表进行了简单的描述性统计计算。确定了 21 项适合纳入的研究,其中 14 项研究调查了 iStent、1 项 Trabectome、3 项 Hydrus、1 项 Cypass、1 项 PreserFlo MicroShunt,1 项研究调查了准分子激光小梁切开术。在 16 项研究中,平均有 10 项完成了 CONSORT 核对表中的危害项目,没有一项研究使用有效工具来报告危害的严重程度,只有 4 项研究列出了不良事件的清单或定义。21 项研究中有 19 项(90%)进行了危害分析。21 项研究中有 19 项使用了适当的指标来报告不良事件的发生率,但只有 4 项研究试图对这些不良事件的严重程度进行评估。总之,大多数对 MIGS 程序进行评估的研究都在努力确认伤害数据,但并没有做到始终如一,也没有采用相同的方法。有效的严重程度报告工具和标准的 MIGS 并发症清单将大大有助于解决这一问题。
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引用次数: 0
Schwere Proptose während einer Kataraktoperation 白内障手术中的严重眼球突出
Pub Date : 2024-04-11 DOI: 10.1159/000538412
Lauren Ton, Wanling Zhang, Murtaza Saifee, Anushka Walia, Julius Oatts, Ying Han
Ziel: Wir berichten über einen ungewöhnlichen Fall von schwerer Proptose während der Phakoemulsifikation bei einer 58-jährigen Frau mit Morbus Crohn, bilateraler chronischer Panuveitis, einem vorherigen bilateralen zentralen Netzhautvenenverschluss und unkontrollierter steroidassoziierter okularer Hypertonie, die die bilaterale Implantation eines Ahmed-Glaukom-Drainagegeräts (GDD) mit Pars-plana-Platzierung des Tubus erfordert. Beobachtungen: Während der Phakoemulsifikation des rechten Auges entwickelte die Patientin eine signifikante Proptose. Nach Entfernung des Lidspekulums und mechanischer Augenlidmanipulation löste sich die Proptose innerhalb von 20 Minuten auf, ohne dass eine laterale Kanthotomie erforderlich war. Die Patientin hatte keine dauerhaften visuellen Komplikationen. Schlussfolgerungen und Bedeutung: Die wahrscheinliche Pathophysiologie der intraoperativen Proptose war in diesem Fall die Ansammlung von Flüssigkeit im retrobulbären Raum aufgrund eines funktionierenden Ahmed-Tubus-Shunts mit dem in der Glaskörperhöhle platzierten Tubus. Um diese Komplikation zu vermeiden, kann bei Patienten mit Pars-plana-Tubusplatzierung beim GDD-Eingriff eine gleichzeitige Kataraktoperation in Betracht gezogen werden.
目的:我们报告了一例不寻常的病例,患者 58 岁,患有克罗恩病、双侧慢性泛眼炎、既往双侧视网膜中央静脉闭塞以及无法控制的类固醇相关性眼压,需要植入双侧 Ahmed 青光眼引流装置 (GDD),并在平面旁放置导管。观察结果:在右眼的乳化手术中,患者出现了明显的眼球突出。移除眼睑窥器并进行眼睑机械操作后,眼球突出在 20 分钟内缓解,无需进行外侧角膜切开术。患者没有出现永久性视力并发症。结论和意义:本例患者术中突眼的病理生理学原因可能是由于艾哈迈德管分流术在玻璃体腔内进行,导致球后间隙积液。为避免这一并发症,在进行 GDD 手术时,可考虑对在平面旁放置导管的患者同时进行白内障手术。
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引用次数: 0
Eine neue Plattform zum nicht invasiven Einbringen schlecht wasserlöslicher Substanzen ins Auge 将水溶性差的物质无创导入眼球的新平台
Pub Date : 2024-04-11 DOI: 10.1159/000538628
O. Strauss
To this day, the use of oily eye drops and non-invasive retinal delivery remain a major challenge. Oily eye drops usually cause ocular irritation and interfere with the normal functioning of the eye, while ocular injections for retinal drug delivery cause significant adverse effects and a high burden on the healthcare system. Here, the authors report a novel topical non-invasive ocular delivery platform (NIODP) through the periorbital skin for high-efficiency anterior and posterior ocular delivery in a non-human primate model (NHP). A single dose of about 7 mg JV-MD2 (omega 3 DHA) was delivered via the NIODP and reached the retina at a Cmax of 111 μg/g and the cornea at a Cmax of 66 μg/g. The NIODP also delivered JV-DE1, an anti-inflammatory agent in development for dry eye diseases, as efficiently as eye drops did to the anterior segments of the NHP. The topical NIODP seems to transport drug candidates through the corneal pathway to the anterior and via the conjunctiva/sclera pathway to the posterior segments of the eye. The novel NIODP method has the potential to reshape the landscape of ocular drug delivery. This is especially the case for oily eye drops and retinal delivery, where the success of the treatment lies in the ocular tolerability and bioavailability of drugs in the target tissue.
时至今日,使用油性眼药水和非侵入性视网膜给药仍是一项重大挑战。油性眼药水通常会对眼部造成刺激,影响眼睛的正常功能,而眼部注射视网膜给药会造成严重的不良反应,给医疗系统带来沉重负担。在此,作者报告了一种新型局部非侵入性眼部给药平台(NIODP),通过眶周皮肤在非人灵长类动物模型(NHP)中实现高效的眼部前后给药。通过 NIODP 输送单剂量约 7 毫克 JV-MD2(欧米茄 3 DHA),到达视网膜的 Cmax 为 111 微克/克,到达角膜的 Cmax 为 66 微克/克。NIODP 还能像眼药水一样有效地将正在开发的干眼病抗炎药 JV-DE1 输送到 NHP 的前段。局部 NIODP 似乎可以通过角膜途径将候选药物输送到眼球前段,并通过结膜/巩膜途径输送到眼球后段。新型 NIODP 方法有可能重塑眼部给药的格局。对于油性眼药水和视网膜给药来说尤其如此,因为治疗的成功与否取决于药物在目标组织中的眼部耐受性和生物利用度。
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引用次数: 0
Symptome des trockenen Auges bei Diabetes mellitus 糖尿病患者眼睛干涩的症状
Pub Date : 2024-01-30 DOI: 10.1159/000535686
A. Augustin
Dry eye disease is an umbrella term that includes a variety of symptoms and signs. A link between diabetes mellitus and dry eye disease exists, but the associated phenotype needs further examination. Thus, our aim was to determine how diabetes mellitus relates to the dry eye disease phenotype. A prospective, cross-sectional study was conducted at the Miami Veteran Affairs Medical Center ophthalmology clinic between October 2013 and September 2019. Participants included a volunteer sample of 366 South Florida veterans with one or more symptoms or signs of dry eye disease [Dry Eye Questionnaire-5 ≥ 6 OR tear break-up time ≤ 5 OR Schirmer’s test score ≤ 5 OR corneal fluorescein staining ≥ 2]. Participants were divided into three groups: (1) individuals without diabetes mellitus (controls); (2) individuals with diabetes mellitus but without end-organ complications; and (3) individuals with diabetes mellitus and end-organ complications. Dry eye metrics were compared across groups. The main outcome measures included ocular symptom questionnaires [e.g., 5-item Dry Eye Questionnaire, Ocular Surface Disease Index, and ocular pain assessment] and clinical parameters obtained from an ocular surface evaluation. A total of 366 individuals were included (mean age 59 ± 6 years; 89% males; 39% White; 11% diabetes mellitus and end-organ complications; 15% diabetes mellitus but without end-organ complications). Individuals with diabetes mellitus and end-organ complications had lower symptom scores on the dry eye disease and pain-specific questionnaires compared to individuals with diabetes mellitus but without end-organ complications and controls (Ocular Surface Disease Index: 42.1 ± 24.5 vs. 38.9 ± 25.1 vs. 23.6 ± 16.2; p < 0.001; numerical rating scale of ocular pain intensity: 4.9 ± 3.2 vs. 4.3 ± 2.7 vs. 3.5 ± 2.7; p = 0.02). Eyelid laxity was also more severe in the group with diabetes mellitus and end-organ complications (0.69 ± 0.64 vs. 0.73 ± 0.72 vs. 1.08 ± 0.77; p = 0.004) compared to the two other groups. The diabetic dry eye disease phenotype is driven by signs more so than by symptoms, with anatomic eyelid abnormalities being more frequent in individuals with diabetes mellitus and end-organ complications. Given this, ocular surface abnormalities in individuals with DM may be missed if screened by symptoms alone. As such, individuals with DM should undergo a slit lamp examination for signs of ocular surface disease, including anatomic abnormalities.
干眼症是一个统称,包括各种症状和体征。糖尿病与干眼症之间存在联系,但相关表型需要进一步研究。因此,我们的目的是确定糖尿病与干眼症表型之间的关系。2013 年 10 月至 2019 年 9 月期间,我们在迈阿密退伍军人事务医疗中心眼科诊所进行了一项前瞻性横断面研究。参与者包括366名南佛罗里达州退伍军人志愿者样本,他们都有一种或多种干眼症症状或体征[干眼症问卷-5≥6或泪液破裂时间≤5或Schirmer测试评分≤5或角膜荧光素染色≥2]。参与者分为三组:(1) 无糖尿病者(对照组);(2) 有糖尿病但无内脏器官并发症者;(3) 有糖尿病和内脏器官并发症者。对各组的干眼症指标进行了比较。主要结果测量包括眼部症状问卷(如 5 项干眼症问卷、眼表疾病指数和眼痛评估)和眼表评估获得的临床参数。共纳入了 366 人(平均年龄为 59 ± 6 岁;89% 为男性;39% 为白人;11% 患有糖尿病和内脏并发症;15% 患有糖尿病但无内脏并发症)。与患有糖尿病但无内脏器官并发症的患者和对照组相比,患有糖尿病且有内脏器官并发症的患者在干眼症和疼痛特异性问卷中的症状评分较低(眼表疾病指数:42.1 ± 24.5 vs. 42.1 ± 24.5):42.1 ± 24.5 vs. 38.9 ± 25.1 vs. 23.6 ± 16.2;p < 0.001;眼部疼痛强度数字评分表:4.9 ± 3.2 vs. 23.6 ± 16.2;p < 0.001;p < 0.001:4.9 ± 3.2 vs. 4.3 ± 2.7 vs. 3.5 ± 2.7;p = 0.02)。与其他两组相比,糖尿病和内脏并发症组的眼睑松弛程度也更严重(0.69 ± 0.64 vs. 0.73 ± 0.72 vs. 1.08 ± 0.77;P = 0.004)。糖尿病干眼症的表型是由体征而非症状驱动的,眼睑解剖异常在糖尿病和内脏器官并发症患者中更为常见。因此,如果仅凭症状进行筛查,可能会漏掉糖尿病患者的眼表异常。因此,糖尿病患者应接受裂隙灯检查,以发现眼表疾病的迹象,包括眼表解剖异常。
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引用次数: 0
Wirksamkeit von Teprotumumab bei der chronischen endokrinen Orbitopathie 替普鲁单抗对慢性内分泌性眼眶病的疗效
Pub Date : 2024-01-08 DOI: 10.1159/000535780
E. Bertelmann
Context: Early inflammatory thyroid eye disease (TED) can lead to symptomatic chronic disease including disabling proptosis. Teprotumumab, an IGF-1 receptor inhibitor, previously demonstrated efficacy in acute, high-inflammation TED trials. Objective: We present data from the first placebo-controlled trial with teprotumumab in chronic/low disease activity TED. Design: This was a randomized double-masked, placebo-controlled trial. Setting: The study was conducted in 11 US centers. Participants: Adults with TED duration 2–10 years, Clinical Activity Score (CAS) ≤ 1 or no additional inflammation or progression in proptosis/diplopia for ≥ 1 year, proptosis ≥ 3 mm from before TED/from normal, euthyroid/mildly hypo/hyperthyroid, no prior teprotumumab, and no steroids within 3 weeks of baseline participated. Intervention: Patients received (2:1) intravenous teprotumumab or placebo once every 3 weeks (total 8 infusions). Main outcome measures: The primary endpoint was proptosis (millimeter) improvement at Week-24. Adverse events (AEs) were assessed. Results: 42 teprotumumab and 20 placebo patients were randomized. At Week-24, mean (SD) proptosis improvement was greater with teprotumumab (-2.41 [0.228]) than placebo (-0.92 [0.323]), difference -1.48, 95%CI -2.28, -0.69, P = .0004. Proportions of patients with AEs were similar between groups. Hyperglycemia was reported in 6(15%) vs 2(10%) and hearing impairment in 9(22%) vs 2(10%) with teprotumumab and placebo respectively. AEs led to discontinuation in one teprotumumab (left ear conductive hearing loss with congenital anomaly) and one placebo patient (infusion-related). There were no deaths.
背景:早期炎症性甲状腺眼病(TED)可导致有症状的慢性疾病,包括致残性突眼。特普鲁单抗是一种 IGF-1 受体抑制剂,曾在急性、高炎症性 TED 试验中显示出疗效。目的:我们展示了泰普单抗治疗慢性/低疾病活动性TED的首个安慰剂对照试验的数据。设计:这是一项随机双掩蔽、安慰剂对照试验。研究地点研究在美国的 11 个中心进行。参与者:TED病程为2-10年,临床活动评分(CAS)≤1或≥1年内无其他炎症或突眼/斜视进展,突眼距TED前≥3毫米/距正常值≥3毫米,甲状腺功能正常/轻度低下/甲状腺功能亢进,既往未使用过替普鲁单抗,基线后3周内未使用过类固醇药物的成年人。干预措施患者接受(2:1)特普鲁单抗或安慰剂静脉注射,每3周一次(共8次)。主要结局指标:主要终点是第24周时突眼(毫米)的改善情况。对不良事件(AEs)进行评估。结果42名泰普鲁单抗患者和20名安慰剂患者被随机分配。第24周时,特普鲁单抗(-2.41 [0.228])比安慰剂(-0.92 [0.323])改善的眼球突出平均(标度)更大,差异为-1.48,95%CI为-2.28,-0.69,P = 0.0004。两组患者出现 AEs 的比例相似。特普鲁单抗和安慰剂组分别有6例(15%)和2例(10%)出现高血糖,9例(22%)和2例(10%)出现听力障碍。一名特普鲁单抗患者(左耳传导性听力损失伴先天性异常)和一名安慰剂患者(输液相关)因AE导致停药。无死亡病例。
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引用次数: 0
Trockenes Auge bei Typ-2-Diabetikern: GLP-1-Agonisten scheinen einen protektiven Effekt zu haben 2 型糖尿病患者的干眼症:GLP-1 促效剂似乎具有保护作用
Pub Date : 2024-01-04 DOI: 10.1159/000535820
Björn Bachmann
The glucagon-like peptide 1 (GLP-1) agonist showed anti-hyperglycemic and anti-inflammatory effects, which may retard the risk of external eye disease. The protective effect of GLP-1 agonist and dry eye disease (DED) was found, while the relationship between GLP-1 agonist and other corneal diseases was not clear. Herein, we aim to evaluate the association between the usage of GLP-1 agonists and the development of the following external eye disease in type 2 diabetes mellitus (T2DM) patients. A retrospective cohort study using the National Health Insurance Research Database (NHIRD) of Taiwan was conducted. The T2DM patients were divided into those with GLP-1 treatment and those without GLP-1 treatment and matched with a 1:2 ratio. The main outcomes were the development of dry eye disease (DED), superficial keratitis, and infectious keratitis. The Cox proportional hazard regression was adopted to produce the adjusted hazard ratio (aHR) with a 95% confidence interval (CI) of external eye diseases between groups. There were 115, 54, and 11 episodes of DED, superficial keratitis, and infectious keratitis in the GLP-1 group. Another 280, 168, and 31 events of DED, superficial keratitis, and infectious keratitis were recorded in the control group. The GLP-1 group demonstrated a significantly lower incidence of DED (aHR: 0.853, 95% CI: 0.668–0.989, p = 0.0356) and superficial keratitis (aHR: 0.670, 95% CI: 0.475–0.945, p = 0.0107) compared to the control group. In the subgroup analyses, the correlation of GLP-1 agonist and DED development was more prominent in patients younger than 60 years old (p = 0.0018). In conclusion, the GLP-1 agonist treatments are significantly associated with a lower incidence of subsequent DED and superficial keratitis, while the relationship was not significant between GLP-1 agonist usage and infectious keratitis.
胰高血糖素样肽 1(GLP-1)激动剂具有抗高血糖和抗炎作用,可延缓外眼病的风险。研究发现,GLP-1 促效剂对干眼症(DED)有保护作用,但 GLP-1 促效剂与其他角膜疾病的关系尚不明确。在此,我们旨在评估 GLP-1 激动剂的使用与 2 型糖尿病(T2DM)患者以下外眼病的发生之间的关系。我们利用台湾国民健康保险研究数据库(NHIRD)进行了一项回顾性队列研究。研究人员将 T2DM 患者分为接受 GLP-1 治疗和未接受 GLP-1 治疗的两组,并按 1:2 的比例进行配对。主要结果为干眼症(DED)、浅表性角膜炎和感染性角膜炎的发生。采用 Cox 比例危险度回归法得出组间外眼病的调整危险度比(aHR)和 95% 置信区间(CI)。GLP-1组的DED、浅表性角膜炎和感染性角膜炎发病次数分别为115次、54次和11次。对照组分别发生了 280 次、168 次和 31 次 DED、浅表角膜炎和感染性角膜炎。与对照组相比,GLP-1 组的 DED(aHR:0.853,95% CI:0.668-0.989,p = 0.0356)和浅表角膜炎(aHR:0.670,95% CI:0.475-0.945,p = 0.0107)发病率明显较低。在亚组分析中,GLP-1 激动剂与 DED 发展的相关性在 60 岁以下的患者中更为突出(p = 0.0018)。总之,GLP-1 促效剂治疗与较低的后续 DED 和浅表角膜炎发病率有显著相关性,而 GLP-1 促效剂的使用与感染性角膜炎之间的关系并不明显。
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Kompass Ophthalmologie
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