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观察与计划方案中阿柏西普治疗新生血管性年龄相关性黄斑变性的注射负担和治疗间隔。

Injection burden and treatment intervals of aflibercept in observe-and-plan regimen for neovascular age-related macular degeneration.

机构信息

Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.

Department of Ophthalmology, Zealand University Hospital, Roskilde, Denmark.

出版信息

Acta Ophthalmol. 2024 Nov;102(7):821-827. doi: 10.1111/aos.16709. Epub 2024 May 11.

Abstract

PURPOSE

The Observe-and-Plan (O&P) regimen allows for individualised treatment. In this study, we evaluated injection burden and intervals using aflibercept in an O&P regimen for eyes with neovascular age-related macular degeneration (AMD).

METHODS

This was a retrospective registry-based study of treatment-naïve eyes with neovascular AMD. Treatment data were compiled for 3 years after commencement of intravitreal aflibercept therapy. We evaluated clinical consequences at the first follow-up after loading dose, the proportion of patients who obtained and kept dry macula after loading dose, number of injections and intervals between injections.

RESULTS

Data were obtained for 1103 eyes. After loading dose, 0.4% were lost to follow-up, 7.5% discontinued, 50.9% booked for further injections and 41.3% booked for monthly observations. After loading dose, the macula remained dry in 49.2% at 3 months, 34.0% at 6 months, 23.7% at 12 months and 15.2% at 24 months. For the entire population, median cumulative total number of injections was 7, 12 and 15, after 1, 2 and 3 years, respectively. After the 3rd year, the proportion of eyes in the short 4-6 weeks treatment interval was 51.1%, 8 weeks interval was kept in 14.4% and the extended treatment intervals of 10 and 12 weeks was possible in 34.4%.

CONCLUSION

After loading dose, one in two eyes required further injections. A large proportion required therapy with shorter intervals than the label-recommended 8 weeks. The large majority of those who obtained a dry macula after loading dose turned exudative again, mostly within the first 3 months.

摘要

目的

观察和计划(O&P)方案允许个体化治疗。本研究评估了接受贝伐单抗治疗的新生血管性年龄相关性黄斑变性(AMD)患者中,O&P 方案下的注射负担和间隔。

方法

这是一项回顾性基于注册的研究,纳入了新生血管性 AMD 的初治眼。在开始玻璃体内注射贝伐单抗治疗后,收集了 3 年的治疗数据。我们评估了负荷剂量后的首次随访时的临床后果、负荷剂量后获得并保持干性黄斑的患者比例、注射次数和注射间隔。

结果

共纳入 1103 只眼的数据。负荷剂量后,有 0.4%的患者失访,7.5%的患者停药,50.9%的患者预约进一步注射,41.3%的患者预约每月观察。负荷剂量后,3 个月时 49.2%的眼黄斑保持干性,6 个月时 34.0%,12 个月时 23.7%,24 个月时 15.2%。对于整个研究人群,在第 1、2 和 3 年时,累积总注射次数中位数分别为 7、12 和 15。第 3 年时,短至 4-6 周治疗间隔的眼比例为 51.1%,8 周间隔维持在 14.4%,10 和 12 周的延长治疗间隔分别有 34.4%的可能。

结论

负荷剂量后,约一半的眼需要进一步注射。很大一部分患者需要的治疗间隔比标签推荐的 8 周更短。负荷剂量后获得干性黄斑的患者中,很大一部分再次出现渗出,大多发生在第 3 个月内。

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