上海交通大学学报（医学版）

上海交通大学学报（医学版） ›› 2026, Vol. 46 ›› Issue (2): 227-234.doi: 10.3969/j.issn.1674-8115.2026.02.012

• 综述 • 上一篇    

雷珠单抗治疗早产儿视网膜病变的临床研究进展

陈致君, 彭婕, 张雪蕊, 赵培泉()   

  1. 上海交通大学医学院附属新华医院眼科，上海 200092
  • 收稿日期:2025-03-12 接受日期:2025-05-21 出版日期:2026-01-29 发布日期:2026-01-29
  • 通讯作者: 赵培泉，教授，主任医师，博士；电子信箱：zhaopeiquan@xinhuamed.com.cn。
  • 基金资助:
    国家自然科学基金(82201201);上海市卫生健康委员会卫生行业临床研究专项(20224Y0108);上海交通大学医学院附属新华医院临床研究基金(24XHCR04A);上海市第二轮《促进市级医院临床技能与临床创新三年行动计划（2023—2025年）》眼底病临床研究数据共享和模拟RCT研究项目(SHDC2024CRI011)

Clinical research progress on ranibizumab in the treatment of retinopathy of prematurity

Chen Zhijun, Peng Jie, Zhang Xuerui, Zhao Peiquan()   

  1. Department of Ophthalmology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
  • Received:2025-03-12 Accepted:2025-05-21 Online:2026-01-29 Published:2026-01-29
  • Contact: Zhao Peiquan, E-mail: zhaopeiquan@xinhuamed.com.cn.
  • Supported by:
    National Natural Science Foundation of China(82201201);Special Project of Shanghai Municipal Health Commission for Clinical Research(20224Y0108);Clinical Research Fund of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine(24XHCR04A);Project of Data Sharing and Emulation of Clinical Trials (CCS-DASET) for Ocular Fundus Diseases, Shanghai Second Round of "Three-Year Plan for Promoting Clinical Skills and Innovation in Municipal Hospitals (2023?2025)"(SHDC2024CRI011)

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摘要：

早产儿视网膜病变（retinopathy of prematurity，ROP）是一种视网膜血管增生性眼底病，常见于早产儿与出生体质量较低的新生儿。目前主要治疗方法为玻璃体腔注射抗血管内皮生长因子（vascular endothelial growth factor，VEGF）药物治疗，雷珠单抗（ranibizumab）是目前我国唯一获得国家药品监督管理局批准用于治疗ROP的抗VEGF药物。雷珠单抗是一种人源化重组的单克隆抗体Fab片段，可以有效抑制视网膜病理性新生血管的形成。单次注射雷珠单抗治疗ROP活动性病变的效果很好，但存在较高的ROP复发风险，通常需要多次重复注射。雷珠单抗在长期疗效方面可以促进视网膜血管发育，但可能会对视网膜结构产生一定的影响。低剂量的雷珠单抗也能获得很好的疗效，且可能有利于提高药物的安全性。在安全性方面，雷珠单抗与激光光凝治疗相比，导致高度近视和眼部结构异常的概率较低，而对于全身系统的安全性和长期影响还有待进一步深入研究。雷珠单抗联合激光光凝补充治疗、ROP的个体化治疗策略、标准化随访体系的建立，以及探索新型给药途径是未来临床实践的重点。该文对雷珠单抗治疗ROP的临床研究进展进行总结，为临床实践提供借鉴。

关键词: 早产儿视网膜病变, 雷珠单抗, 抗血管内皮生长因子药物

Abstract:

Retinopathy of prematurity (ROP) is a retinal vascular proliferative fundus disease that occurs in premature infants with low birth weight. Currently, a widely used treatment is intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs. Ranibizumab is the only anti-VEGF drug approved by the National Medical Products Administration for the treatment of ROP in China. Ranibizumab is a humanized recombinant monoclonal antibody Fab fragment that can inhibit pathological neovascularization. A single intravitreal injection of ranibizumab is effective for active ROP lesions; but there is a high risk of recurrence, which usually requires multiple repeated injections. The long-term efficacy of ranibizumab can promote the development of retinal vascularization, but it may have certain effects on the retinal structure. Low-dose ranibizumab has been shown to achieve favorable therapeutic outcomes, which may be beneficial in improving the safety of the drug. For the safety of ranibizumab, compared with laser photocoagulation treatment, ranibizumab has a lower incidence of high myopia and structural abnormalities. However, further research is needed to evaluate its long-term systemic effects. Combination therapy with ranibizumab and supplementary laser photocoagulation, individualized treatment strategies, standardized follow-up systems, and the exploration of novel drug delivery routes are the future research directions. This article reviews the latest research on the treatment of ROP with ranibizumab, providing reference for clinical practice.

Key words: retinopathy of prematurity (ROP), ranibizumab, anti-vascular endothelial growth factor drug

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