Department of Ophthalmology, University Hospital of Larissa, Mezourlo Area, 41110, Larissa, Greece.
Department of Mathematics, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Int Ophthalmol. 2022 Sep;42(9):2673-2684. doi: 10.1007/s10792-022-02256-y. Epub 2022 Apr 13.
Neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME), and macular oedema due to central retinal vein occlusion (CRVO) are leading causes of vision loss, currently managed with anti-vascular endothelial growth factor injections (anti-VEGF). The aim of this study was to calculate QALYs in patients with nAMD, DME, and CRVO treated with anti-VEGF agents (QALYs) in a Greek tertiary hospital setting and compare them to theoretical QALYs that the patients would have without treatment (QALYs).
The study included 143 treatment-naive patients with macular oedema due to nAMD (n = 79), DME (n = 57), and CRVO (n = 7), who received anti-VEGF injections as monotherapy according to the Treat-and-Extend (T&E) protocol. The anti-VEGF agents were ranibizumab and aflibercept in equivalent fractions. QALYs where calculated by the formula QALY = Utility Value × Time, where "Time" refers to the follow-up period of the study. For QALYs, we assumed that visual acuity remained unchanged during this period.
Mean follow-up time was 1.3 ± 1.2 years in the nAMD group, 1 ± 1.3 years in the DME group, and 0.5 ± 1 years in the CRVO group. There was no statistically significant difference between QALYs and QALYs in all three ocular pathologies for the study period (p > 0.05 for each of the three statistical tests performed).
DISCUSSION/CONCLUSION: Possible explanations for the lack of significant difference between QALYs - and QALYs + in nAMD, DME, and CRVO groups, may be the short time horizon used in this analysis, the inclusion of data from the better-seeing eye (BSE) and the specific socio-economic, geographical and health care characteristics of this rural Greek area.
新生血管性年龄相关性黄斑变性(nAMD)、糖尿病性黄斑水肿(DME)和视网膜中央静脉阻塞(CRVO)引起的黄斑水肿是导致视力丧失的主要原因,目前采用抗血管内皮生长因子注射(anti-VEGF)进行治疗。本研究旨在计算在希腊一家三级医院接受抗血管内皮生长因子药物(anti-VEGF)治疗的 nAMD、DME 和 CRVO 患者的 QALY,并将其与未经治疗(QALYs)的患者的理论 QALY 进行比较。
本研究纳入了 143 名初次接受治疗的黄斑水肿患者,包括 nAMD(n=79)、DME(n=57)和 CRVO(n=7),他们根据“治疗和扩展(T&E)”方案接受了抗 VEGF 单药治疗。抗 VEGF 药物为雷珠单抗和阿柏西普,以等效分数给药。QALY 通过公式 QALY=效用值×时间计算,其中“时间”指的是研究的随访期。对于 QALY,我们假设在此期间视力保持不变。
nAMD 组的平均随访时间为 1.3±1.2 年,DME 组为 1.0±1.3 年,CRVO 组为 0.5±1.0 年。在所有三种眼部疾病中,研究期间 QALYs 和 QALYs 之间没有统计学上的显著差异(对于进行的三次统计学检验,p 值均>0.05)。
讨论/结论:在 nAMD、DME 和 CRVO 组中,QALYs 和 QALYs 之间没有显著差异的可能解释可能是由于本分析中使用的时间范围较短,包括了更好视力眼(BSE)的数据,以及这个希腊农村地区的特定社会经济、地理和医疗保健特征。