《不败者》：玻璃体内抗血管内皮生长因子药物与地塞米松植入物治疗糖尿病黄斑水肿的疗效比较：一项 12 个月随访研究。
INVICTUS: Intravitreal anti-VEGF and dexamethasone implant comparison for the treatment of diabetic macular edema: A 12 months follow-up study.
机构信息
Ophthalmology Department, Hôpital Nord, Aix-Marseille University, Chemin des Bourrely, Marseille, France.
Institut de Neurosciences de la Timone, Aix-Marseille University, Marseille, France.
出版信息
Eur J Ophthalmol. 2021 Mar;31(2):754-758. doi: 10.1177/1120672120930603. Epub 2020 Jun 8.
PURPOSE
To compare the efficacy of intravitreal injections (IVI) of ranibizumab (Lucentis, Novartis, Basel, Switzerland; RAN), aflibercept (Eylea, Bayer, Leverkusen, Germany; AFL) and dexamethasone implant (Ozurdex, Allergan, Irvine, California; DXI) in the treatment of naive diabetic macular oedema (DME) during a 12-month follow-up, in real life.
METHODS
Nineteen eyes treated with RAN, 20 with AFL and 21 with DXI were analysed from inclusion up to 12 months (M12) with intermediate analysis at M6. Best corrected visual acuity (BCVA), fundus and central retinal thickness (CRT) using spectral-domain optical coherence tomography (SD-OCT; Spectralis/HRA, Heidelberg Engineering, Germany) were performed at inclusion, M3, M6 and M12.
RESULTS
BCVA improved until 67.9 letters ±13.3 SD (+5.5 letters) at M6 and 69.6 letters ±12 SD (+7.2 letters) at 12 months for RAN group ( = 0.036). For the AFL group it improved until 63.6 letters ±15.2 SD (+6.6 letters) at M6 and 67.5 letters ±12.2 SD (+8.5 letters) at 12 months ( = 0.014). Lastly DXI group improved by 66.9 letters ±15.1 SD (+7.9 letters) at M6 and 68.4 letters ±11.2 SD (+9.4 letters) at 12 months ( = 0.0023). CRT decreased by 124.4 µm at M6 and 99.3 µm at M12 in RAN group, 144.3 µm and 101.5 µm in AFL group and finally 95.6 µm and 162.7 µm in DXI group.
CONCLUSION
In summary, these three drugs provide an efficient treatment option with an acceptable benefit-risk ratio for the treatment of naive patients with DME, whether on BCVA or CRT on the first year of treatment.
目的
在 12 个月的随访中，比较玻璃体内注射雷珠单抗（诺华制药，瑞士巴塞尔；RAN）、阿柏西普（拜耳制药，德国勒沃库森；AFL）和地塞米松植入剂（艾尔建，加利福尼亚欧文；DXI）治疗初发糖尿病性黄斑水肿（DME）的疗效。
方法
纳入 19 只眼接受 RAN 治疗，20 只眼接受 AFL 治疗，21 只眼接受 DXI 治疗。从中纳入患者进行分析，直至 12 个月（M12）时进行中间分析。最佳矫正视力（BCVA）、眼底和中心视网膜厚度（CRT）采用频域光学相干断层扫描（SD-OCT；Spectralis/HRA，德国海德堡工程公司）在纳入时、M3、M6 和 M12 时进行测量。
结果
RAN 组在 M6 时改善至 67.9 个字母±13.3 个标准差（+5.5 个字母），在 12 个月时改善至 69.6 个字母±12 个标准差（+7.2 个字母）（ = 0.036）。AFL 组在 M6 时改善至 63.6 个字母±15.2 个标准差（+6.6 个字母），在 12 个月时改善至 67.5 个字母±12.2 个标准差（+8.5 个字母）（ = 0.014）。最后，DXI 组在 M6 时改善至 66.9 个字母±15.1 个标准差（+7.9 个字母），在 12 个月时改善至 68.4 个字母±11.2 个标准差（+9.4 个字母）（ = 0.0023）。RAN 组 CRT 在 M6 时下降 124.4μm，在 M12 时下降 99.3μm；AFL 组 CRT 在 M6 时下降 144.3μm，在 M12 时下降 101.5μm；最后 DXI 组 CRT 在 M6 时下降 95.6μm，在 M12 时下降 162.7μm。
结论
综上所述，这三种药物在治疗初发 DME 患者时，在第一年的治疗中，无论在 BCVA 还是 CRT 方面，均提供了一种有效的治疗选择，具有可接受的收益风险比。
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