目的:为了评估糖尿病性黄斑水肿(DME)的治疗效果,接受标准护理治疗的现实世界人口。
方法:在一项探索性研究中,我们纳入了先前发表的一项研究的32例患者的43只眼,以及38例标准治疗患者的46只眼.研究人群接受了三个月的阿柏西普注射的负荷剂量,然后进行局灶性/网格光凝和额外的阿柏西普治疗纳塔。12个月时的主要测量是玻璃体内注射的次数,最佳矫正视力(BCVA)和中央视网膜厚度(CRT)。
结果:在基线时,两组之间的年龄没有差异,性别,身体质量指数,血红蛋白A1C,收缩压或糖尿病类型,但是研究人群的舒张压较高(81.6对72.1mmHg,p=0.03)和较低的糖尿病持续时间(12.3年对23.2年,p=0.03)。在第12个月,研究组患者的视力较高(79.6对74.3个ETDRS字母,p=0.03),尽管接受了较少的阿柏西普注射(4.4对5.9,p<0.01),但在负荷阶段仅接受了三次强制性注射的可能性更高(39.5%对13.0%,p=0.01)。
结论:与匹配的,现实世界的DME人口,尽管接受了较少的玻璃体内注射,但接受玻璃体内阿柏西普和负荷后局灶性/网格光凝联合治疗的患者获得了更好的功能结局.未来的随机研究需要评估这种联合治疗方案的长期疗效。
OBJECTIVE: To evaluate treatment efficacy in diabetic macular oedema (DME) comparing a
study population receiving combined intravitreal vascular endothelial growth factor (VEGF) inhibition and focal/grid photocoagulation with a matched, real-world population receiving standard of care treatment.
METHODS: In an exploratory
study, we included 43 eyes from 32 patients from a previously published
study as well as 46 eyes from 38 standard-of-care patients. The
study population had received a loading dose of three monthly aflibercept injections followed by focal/grid photocoagulation and additional aflibercept pro re nata. Principal measurements at 12 months were numbers of intravitreal injections, best corrected visual acuity (BCVA) and central retinal thickness (CRT).
RESULTS: At baseline, there were no differences between groups regarding age, sex, body mass index, haemoglobin A1 C, systolic pressure or type of diabetes, but the study population had a higher diastolic pressure (81.6 versus 72.1 mmHg, p = 0.03) and a lower duration of diabetes (12.3 versus 23.2 years, p = 0.03). At month 12, patients in the
study group had a higher visual acuity (79.6 versus 74.3 ETDRS letters, p = 0.03), despite having received fewer aflibercept injections (4.4 versus 5.9, p < 0.01) with a higher likelihood of having only received the three mandatory injections in the loading phase (39.5% versus 13.0%, p = 0.01).
CONCLUSIONS: In comparison to a matched, real-world DME-population, patients in combined treatment with intravitreal aflibercept and postloading focal/grid photocoagulation obtained a better functional outcome despite having received fewer intravitreal injections. Future randomized studies are needed to evaluate the long-term efficacy of this combined treatment regimen.