日本患者静脉注射雷珠单抗生物类似物治疗近视性脉络膜新生血管的一年疗效

Mami Tomita, Manabu Yamamoto, K. Hirayama, Akika Kyo, N. Misawa, Gen Kinari, Takeya Kohno, Shigeru Honda
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摘要

目的评估日本患者接受雷尼珠单抗生物类似物(RBZ-BS)玻璃体内注射治疗近视脉络膜新生血管(mCNV)的一年疗效。研究方法对 21 例高度近视和 mCNV 患者(平均年龄 69.0 岁;男性 4 例,女性 17 例)进行回顾性研究。其中 12 名患者未接受过治疗,9 名患者曾接受过抗 VEGF 治疗。疗效指标包括最佳矫正视力(BCVA)和黄斑中心厚度(CMT)。结果:未接受治疗组的最佳矫正视力(BCVA)明显改善,从基线时的(0.55 ± 0.34)下降到 12 个月时(0.24 ± 0.28)。曾接受过治疗的组 BCVA 无明显变化。两组的CMT均明显下降:治疗无效组从295.3 ± 105.2 µm降至207.3 ± 63.0 µm,曾接受治疗组从196.1 ± 62.0 µm降至147.2 ± 50.1 µm。黄斑干涩率很高:治疗前未接受治疗组 3 个月和 12 个月的干涩率分别为 83% 和 83%,治疗前接受治疗组 3 个月和 12 个月的干涩率分别为 67% 和 89%。无不良反应报告。结论这些研究结果表明,RBZ-BS 是治疗 mCNV 的一种有效而安全的方法,尤其适用于治疗无效的患者。使用 RBZ-BS 可替代原来的雷尼珠单抗,在保持高疗效的同时减轻经济负担,是一种经济有效的选择。要证实这些结果并评估长期疗效和成本效益,还需要进行样本量更大、随访时间更长的进一步研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
One-Year Outcome of Intravitreal Injection of Ranibizumab Biosimilar for Myopic Choroidal Neovascularization in Japanese Patients
Objectives: To evaluate the one-year outcomes of intravitreal ranibizumab biosimilar (RBZ-BS) injections for myopic choroidal neovascularization (mCNV) in Japanese patients. Methods: Twenty-one patients (mean age 69.0 years; 4 males, 17 females) with high myopia and mCNV were retrospectively reviewed. Twelve were treatment-naïve, and nine had previous anti-VEGF treatments. Efficacy measures included best-corrected visual acuity (BCVA) and central macular thickness (CMT). Results: The treatment-naïve group showed significant BCVA improvement from 0.55 ± 0.34 at baseline to 0.24 ± 0.28 at 12 months. The previously treated group had no significant BCVA changes. CMT significantly decreased in both groups: from 295.3 ± 105.2 µm to 207.3 ± 63.0 µm in the treatment-naïve group, and from 196.1 ± 62.0 µm to 147.2 ± 50.1 µm in the previously treated group. Dry macula rates were high: 83% at 3 months and 83% at 12 months in the treatment-naïve group, and 67% at 3 months and 89% at 12 months in the previously treated group. No adverse events were reported. Conclusions: These findings indicate that RBZ-BS is an effective and safe treatment for mCNV, particularly in treatment-naïve patients. The use of RBZ-BS offers a cost-effective alternative to original ranibizumab, reducing financial burdens while maintaining high therapeutic efficacy. Further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and evaluate long-term outcomes and cost-effectiveness.
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