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玻璃体内注射布罗利尤单抗与阿柏西普治疗初治累及中心的糖尿病黄斑水肿的比较:一年真实世界病例系列。

Comparison between intravitreal brolucizumab and aflibercept in the treatment-naive central involved diabetic macular edema: One-year real-life case series.

机构信息

Department of Ophthalmology, Faculty of Medicine, Benha University, Benha, Egypt.

Department of Ophthalmology, Seha Emirates Hospital, Abu Dhabi, UAE.

出版信息

Eur J Ophthalmol. 2024 May;34(3):797-802. doi: 10.1177/11206721231207459. Epub 2023 Oct 10.

Abstract

PURPOSE

To evaluate the effectiveness and safety of intravitreal brolucizumab (IVB) and intravitreal aflibercept (IVA) injections in the management of naive central involved diabetic macular edema (CIDME).

METHODS

This study included 45 treatment-naive eyes with CIDME. A complete ophthalmic examination, including BCVA and SD-OCT was performed. Patients were randomized to (IVB) or (IVA) groups. All participants received a loading phase of three consecutive intravitreal injections, then followed by a personalized treat and extend (T&E) regimen.

RESULTS

At 12-month follow-up, the mean numbers of injections in IVA and IVB groups were 7.25  ±  0.53 and 6.3  ±  0.45, respectively (P < 0.0001). The IVA group showed a significant increase of the mean BCVA from 0.66  ±  0.15 logMAR (50.9  ±  7.7 letters) to 0.41  ±  0.19 logMAR (63.7  ±  10.8 letters). Mean CFT decreased significantly from 441.2  ±  35.7 μm to 281.3  ±  18.4 μm. The IVB group showed a significant increase of mean BCVA from 0.65  ±  0.16 logMAR (52.1  ±  7.9 letters) to 0.39  ±  0.17 logMAR (65.3  ±  8.7 letters). Mean CFT decreased significantly from 437.2  ±  41.9 μm to 275.5  ±  21.7 μm.No significant difference between both groups in terms of the vision improvement and the reduction of CFT was reported, whereas a statistical difference was observed in terms of intravitreal injections (IVI) numbers. No ocular complications were reported.

CONCLUSIONS

This case series highlights the effectiveness of both brolucizumab and aflibercept in the treatment of CIDME with a lower frequency of injection in brolucizumab group lowering the burden of IVI in this cohort.

摘要

目的

评估玻璃体内注射布罗鲁单抗(IVB)和玻璃体内注射阿柏西普(IVA)治疗初治中心性累及性糖尿病黄斑水肿(CIDME)的有效性和安全性。

方法

本研究纳入了 45 例初治 CIDME 患者。所有患者均进行全面眼科检查,包括视力和 SD-OCT。患者随机分为 IVB 组或 IVA 组。所有患者均接受 3 次连续玻璃体腔内注射负荷量治疗,然后进行个体化的治疗和扩展(T&E)方案。

结果

在 12 个月的随访中,IVA 组和 IVB 组的平均注射次数分别为 7.25±0.53 和 6.3±0.45(P<0.0001)。IVA 组患者的平均 BCVA 从 0.66±0.15 logMAR(50.9±7.7 个字母)显著增加到 0.41±0.19 logMAR(63.7±10.8 个字母)。平均 CFT 从 441.2±35.7 μm 显著降低至 281.3±18.4 μm。IVB 组患者的平均 BCVA 从 0.65±0.16 logMAR(52.1±7.9 个字母)显著增加到 0.39±0.17 logMAR(65.3±8.7 个字母)。平均 CFT 从 437.2±41.9 μm 显著降低至 275.5±21.7 μm。两组患者在视力改善和 CFT 降低方面无显著差异,但在玻璃体腔内注射次数方面存在统计学差异。未报告任何眼部并发症。

结论

本病例系列研究强调了布罗鲁单抗和阿柏西普治疗 CIDME 的有效性,布罗鲁单抗组的注射频率较低,降低了该队列中玻璃体腔内注射的负担。

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