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三种不同抗血管内皮生长因子治疗方案治疗新生血管性年龄相关性黄斑变性的有效性比较:两年真实世界临床结局

Comparing Effectiveness of Three Different Anti-VEGF Treatment Regimens for Neovascular Age-Related Macular Degeneration: Two Years' Real-World Clinical Outcomes.

作者信息

Horner Faye, Lip Peck Lin, Mohammed Bashar R, Fusi-Rubiano William, Gokhale Eesha, Mushtaq Bushra, Chavan Randhir

机构信息

Birmingham & Midland Eye Centre, Birmingham, UK.

出版信息

Clin Ophthalmol. 2021 Apr 23;15:1703-1713. doi: 10.2147/OPTH.S305141. eCollection 2021.

Abstract

PURPOSE

To compare and report the 2-year treatment outcomes from 3 different anti-VEGF treatment regimens in treating neovascular aged-related macular degeneration (nAMD): Ranibizumab pro re nata (Ranibizumab-PRN); Ranibizumab treat and extend (Ranibizumab-T&E); Aflibercept fixed first year dosing (7 injections) with treat and extend in subsequent year (Aflibercept-Fixed).

METHODS

All treatment-naïve nAMD patients who completed 24 months of monitoring from a single treatment center were included. Patients received the initial loading dose of three injections (4-weekly interval), followed by one of the 3 treatment regimens. Primary outcomes were changes in visual acuity (VA) and central retinal thickness (CRT). Secondary outcome was number of injections required in each year. Data analysis included last observation carried forward (LOCF) for patients with incomplete year-2 follow-up.

RESULTS

A total of 249 eyes (230 patients) were studied: 121 Ranibizumab-PRN; 65 Ranibizumab-T&E, and 63 Aflibercept-Fixed. Baseline median VA (ETDRS letters) for Ranibizumab-PRN, Ranibizumab-T&E, and Aflibercept-Fixed was 53.9, 61.1, and 54.9 letters, achieving final VA of 54.9, 65.1, and 65.1 letters, respectively. Hence, the number of letters increased at the end of 24 months for each group was +1.0 (Ranibizumab-PRN), +4.0 (Ranibizumab-T&E), highest +10.2 in Aflibercept-Fixed group. Median number of injections over 2 years (year-1/year-2) was 5/1 for Ranibizumab-PRN, 9/6 for Ranibizumab-T&E, and 7/5 for Aflibercept-Fixed. Both Ranibizumab-T&E and Aflibercept-Fixed also shared the same reduction of median CRT (115 µm), higher than Ranibizumab-PRN (83 µm).

CONCLUSION

We report VA improvement from all three different treatment regimens with both Aflibercept-Fixed and Ranibizumab-T&E regimens achieving the same higher final VA. Aflibercept-Fixed dosing may have more favorable efficacy with the highest VA gain and comparatively lower dosing frequency whereas Ranibizumab-T&E may be more efficient than Ranibizumab-PRN regimen, according to our study.

摘要

目的

比较并报告三种不同抗血管内皮生长因子(anti-VEGF)治疗方案治疗新生血管性年龄相关性黄斑变性(nAMD)的2年治疗结果:按需使用雷珠单抗(雷珠单抗-PRN);雷珠单抗治疗并延长给药间隔(雷珠单抗-T&E);阿柏西普第一年固定剂量给药(7次注射)并在随后年份延长给药间隔(阿柏西普-固定剂量组)。

方法

纳入所有来自单一治疗中心且完成24个月监测的初治nAMD患者。患者先接受3次初始负荷剂量注射(每4周一次),然后采用三种治疗方案之一进行治疗。主要结局指标为视力(VA)和中心视网膜厚度(CRT)的变化。次要结局指标为每年所需的注射次数。数据分析包括对2年随访不完整的患者采用末次观察结转(LOCF)法。

结果

共研究了249只眼(230例患者):121只眼采用雷珠单抗-PRN治疗;65只眼采用雷珠单抗-T&E治疗,63只眼采用阿柏西普-固定剂量组治疗。雷珠单抗-PRN组、雷珠单抗-T&E组和阿柏西普-固定剂量组的基线平均视力(ETDRS字母)分别为53.9、61.1和54.9个字母,最终视力分别达到54.9、65.1和65.1个字母。因此,每组在24个月结束时视力增加的字母数分别为:雷珠单抗-PRN组增加1.0个字母,雷珠单抗-T&E组增加4.0个字母,阿柏西普-固定剂量组增加最多,为10.2个字母。2年期间(第1年/第2年)的平均注射次数,雷珠单抗-PRN组为5/1次,雷珠单抗-T&E组为9/6次,阿柏西普-固定剂量组为7/5次。雷珠单抗-T&E组和阿柏西普-固定剂量组的平均CRT均降低了115 µm,高于雷珠单抗-PRN组(83 µm)。

结论

我们报告了所有三种不同治疗方案均能改善视力,阿柏西普-固定剂量组和雷珠单抗-T&E组均达到了相同的较高最终视力。根据我们的研究,阿柏西普固定剂量给药可能具有更优的疗效,视力提高幅度最大且给药频率相对较低,而雷珠单抗-T&E方案可能比雷珠单抗-PRN方案更有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b464/8080302/b0d4c4dd65f8/OPTH-15-1703-g0001.jpg

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