俄罗斯首个新生血管性老年黄斑变性患者登记册:一项真实世界临床研究

V. Neroev, O. V. Zaytseva, V. A. Petrakovskaya, M. A. Trifonova, E. I. Ganeeva
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摘要

目的: 对俄罗斯首个新生血管性老年黄斑变性(nAMD)登记册进行数据分析--该登记册是一个基于网络的 nAMD 患者临床监测系统,旨在收集和积累有关此类患者、其人口、社会和临床特征、治疗 nAMD 的现行做法、抗 VEGF 治疗效果评估以及疾病造成的负担的数据。材料与方法开展了一项非干预性、多中心前瞻性研究(CRTH258ARU01),其中包括数据的初步收集和再利用。该研究被称为 "俄罗斯新生血管性老年黄斑变性患者登记"。病人的病历是主要的信息来源,其中包含的数据由医生输入个人电子登记卡(eIRC)。电子个人登记卡用于远程动态临床观察和数据分析。来自俄罗斯 34 家科研或医疗机构的 61 名眼科医生参与了 nAMD 患者的诊断、跟踪和治疗。登记册的数据收集时间为 2020 年 12 月 20 日至 2022 年 12 月 5 日。登记册中有 2665 名患者(3460 只眼睛)的数据。结果纳入登记册时患者的平均年龄(± 标准差)为 73.0 ± 8.8 岁;大多数患者(66.2%)为女性。每位患者每年的平均复诊次数为(3.4 ± 2.7)次,每只眼睛每年的平均抗血管内皮生长因子药物注射次数为(2.0 ± 1.7)次。结论随着登记册的建立,研究的主要目标已经实现。另一方面,登记册显示,有相当一部分 nAMD 患者/眼逃避了医学观察,患者对治疗的依从性不足,这对实际临床实践中的治疗效果产生了明显的负面影响
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The first Russian register of patients with neovascular age-related macular degeneration: a real-world clinical study
Purpose: data analysis of Russia’s first register of neovascular age-related macular degeneration (nAMD) — a web-based system for clinical monitoring of nAMD patients designed to collect and accumulate the data on such patients, their demographic, social and clinical characteristics, on the existing practice of treating nAMD, assessing the effectiveness of anti-VEGF therapy and the burden inflicted by the disease. Material and methods. A non-interventional, multicenter prospective study (CRTH258ARU01) was undertaken, which involved primary collection and reuse of data. The study is referred to as “the Russian register of patients with neovascular age-related macular degeneration”. The patients’ case histories served as the primary source of information as the data contained therein were entered by the doctors into electronic individual registration cards (eIRC). The eIRC were used remotely for dynamic clinical observations and data analysis. 61 ophthalmologists from 34 Russia’s scientific or medical organizations engaged in diagnosing, follow-up and treatment of nAMD patients contributed to the register. The data for the register were collected from December 20, 2020 to December 5, 2022. The register has data on 2665 patients (3460 eyes). Results. The mean age (± standard deviation) of patients at the time of inclusion in the registry was 73.0 ± 8.8 years; the majority of patients (66.2%) were female. The average yearly number of follow-up visits per patient was 3.4 ± 2.7, while the average yearly number of injections of anti-VEGF drugs per eye was 2.0 ± 1.7. Conclusion. With the creation of the register, the main goals of the study have been achieved. On the other hand, the register showed that a significant share of nAMD patients/eyes evaded medical observation, and that the patients’ adherence to treatment was insufficient, which had a notable negative impact on the results of therapy in real clinical practice
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