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[视网膜疾病抗血管内皮生长因子治疗的基线诊断与初始治疗决策:研究医师与阅片中心结果的比较(ORCA/OCEAN研究)]

[Baseline diagnostics and initial treatment decision for anti-vascular endothelial growth factor treatment in retinal diseases : Comparison between results by study physician and reading centers (ORCA/OCEAN study)].

作者信息

Brinkmann Christian K, Chang Petrus, Schick Tina, Heimes Britta, Vögeler Jessica, Haegele Birgit, Kirchhof Bernd, Holz Frank G, Pauleikhoff Daniel, Ziemssen Focke, Liakopoulos Sandra, Spital Georg, Schmitz-Valckenberg Steffen

机构信息

GRADE Reading Center, Universitäts-Augenklinik Bonn, Ernst-Abbe-Str. 2, 53127, Bonn, Deutschland.

Cologne Image Reading Center, Zentrum für Augenheilkunde, Uniklinik Köln, Köln, Deutschland.

出版信息

Ophthalmologe. 2019 Aug;116(8):753-765. doi: 10.1007/s00347-018-0805-y.

Abstract

BACKGROUND

The ORCA module of the non-interventional OCEAN study investigated the use of retinal imaging diagnostics in the clinical treatment of patients undergoing vascular endothelial growth factor (VEGF) inhibitor treatment as part of routine clinical care. This article analyzes the agreement between the diagnosis documented by the treating ophthalmologist and the evaluation of reading centers at baseline as well as the effect on the response to treatment during the course.

METHODS

A total of 396 patients (age 75.4 years) were enrolled in which ranibizumab treatment was indicated by the treating ophthalmologist due to either diabetic macular edema (DME), neovascular age-related macular degeneration (nvAMD) or retinal venous occlusion (RVO). Over a period of 24 months, patient and examination data, treatments and interpretation of retinal imaging data by the treating ophthalmologist were systematically recorded. Furthermore, retinal imaging data were also evaluated by three reading centers.

RESULTS

In 338 out of 396 (85.4%) study eyes, the baseline diagnosis of the treating ophthalmologist was confirmed by the reading centers (DME 87.5%, nvAMD 82.3%, RVO 94.9%). In 17 of the remaining 58 eyes with a discrepant diagnosis, there was at least a consensus with respect to the indications for VEGF inhibitor therapy. The differential diagnoses included a variety of different retinal diseases. During follow-up of up to 3 months, eyes with a consistent diagnosis showed a clear increase in visual acuity (6.4 versus 2.7 letters, p = 0.05) and greater decrease in central retinal thickness (-112.3 versus -24.4 μm, p < 0.0001).

DISCUSSION

The initial treatment decision for anti-VEGF therapy with consideration of the differential diagnoses can be challenging. Accurate evaluation of the clinical and imaging findings along with appropriate expertise appear to be important. The observation of superior initial response in eyes with a consensus of the diagnosis at baseline underlines the relevance of an adequate initial assessment for a successful treatment outcome.

摘要

背景

非介入性OCEAN研究的ORCA模块调查了视网膜成像诊断在接受血管内皮生长因子(VEGF)抑制剂治疗的患者临床治疗中的应用,这是常规临床护理的一部分。本文分析了治疗眼科医生记录的诊断与基线时阅读中心评估之间的一致性,以及在治疗过程中对治疗反应的影响。

方法

共纳入396例患者(年龄75.4岁),治疗眼科医生因糖尿病性黄斑水肿(DME)、新生血管性年龄相关性黄斑变性(nvAMD)或视网膜静脉阻塞(RVO)而指示进行雷珠单抗治疗。在24个月的时间里,系统记录了患者和检查数据、治疗情况以及治疗眼科医生对视网膜成像数据的解读。此外,三个阅读中心也对视网膜成像数据进行了评估。

结果

在396只研究眼中的338只(85.4%),阅读中心确认了治疗眼科医生的基线诊断(DME为87.5%,nvAMD为82.3%,RVO为94.9%)。在其余58只诊断不一致的眼中,有17只至少在VEGF抑制剂治疗指征方面达成了共识。鉴别诊断包括多种不同的视网膜疾病。在长达3个月的随访期间,诊断一致的眼睛视力明显提高(6.4对2.7字母,p = 0.05),中心视网膜厚度下降更大(-112.3对-24.4μm,p < 0.0001)。

讨论

考虑鉴别诊断进行抗VEGF治疗的初始治疗决策可能具有挑战性。准确评估临床和影像学表现以及适当的专业知识似乎很重要。在基线时诊断达成共识的眼睛中观察到更好的初始反应,这强调了充分的初始评估对成功治疗结果的相关性。

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