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当前抗血管内皮生长因子给药方案:获益与负担。

Current anti-vascular endothelial growth factor dosing regimens: benefits and burden.

机构信息

Wills Eye Institute, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA.

出版信息

Ophthalmology. 2013 May;120(5 Suppl):S3-7. doi: 10.1016/j.ophtha.2013.01.057.

Abstract

TOPIC

To examine the outcomes of clinical trials and case studies that investigated the different dosing regimens used for the 3 intravitreal anti-vascular endothelial growth factor (VEGF) inhibitors that are available currently. The Comparisons of Age-Related Macular Degeneration (AMD) Treatments Trial (CATT) data are discussed briefly here and are reviewed in greater detail in a separate accompanying article.

CLINICAL RELEVANCE

Sustained improvement with the 2 most widely used anti-VEGF drugs, bevacizumab and ranibizumab, requires monthly visits, posing a difficulty for patients. Thus, there is a need to evaluate whether individualized treatment regimens may reduce patient burden and improve patient outcomes.

METHODS

Review of clinical trials and case studies presented at recent medical conferences and published in peer-reviewed literature.

RESULTS

Numerous trials, including the Efficacy and Safety of Ranibizumab in Patients with Subfoveal Choroidal Neovascularization (CNV) Secondary to AMD, Prospective Optical Coherence Tomography Imaging of Patients with Neovascular AMD Treated with Intraocular Ranibizumab, Study of Ranibizumab in Patients with Subfoveal CNV Secondary to AMD, Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects with CNV Secondary to AMD or Macular Edema Secondary to Retinal Vein Occlusion, Safety Assessment of Intravitreal Lucentis for AMD, and CATT, have evaluated alternatives to monthly dosing. Evidence suggests that either a treat-as-needed or, possibly, a treat-and-extend regimen provides a reasonable approach to monthly injections recommended for bevacizumab and ranibizumab, with the caveat that as yet, careful and ongoing surveillance remains a key feature of optical management.

CONCLUSIONS

Individualization of antiangiogenic treatment using data from clinical trials evaluating various dosing regimens against the patient's disease, lifestyle, and economic restrictions continues to evolve.

摘要

主题

研究目前可用的 3 种玻璃体内抗血管内皮生长因子 (VEGF) 抑制剂的不同给药方案的临床试验和病例研究结果。这里简要讨论了比较年龄相关性黄斑变性 (AMD) 治疗试验 (CATT) 的数据,并在另一篇单独的伴随文章中进行了更详细的回顾。

临床相关性

最广泛使用的两种抗 VEGF 药物贝伐单抗和雷珠单抗的持续改善需要每月就诊,这给患者带来了困难。因此,需要评估个体化治疗方案是否可以减轻患者负担并改善患者结局。

方法

回顾近期医学会议上提交的临床试验和病例研究,并查阅同行评议文献。

结果

许多试验,包括雷珠单抗治疗 AMD 相关脉络膜新生血管(subfoveal choroidal neovascularization,CNV)的疗效和安全性研究、玻璃体内雷珠单抗治疗新生血管 AMD 的前瞻性光学相干断层扫描成像研究、雷珠单抗治疗 AMD 相关脉络膜新生血管的研究、雷珠单抗治疗 AMD 或视网膜静脉阻塞相关黄斑水肿的 CNV 扩展研究、玻璃体内 Lucentis 治疗 AMD 的安全性评估和 CATT,都评估了替代每月给药的方案。有证据表明,按需治疗或可能的治疗和延长方案为贝伐单抗和雷珠单抗推荐的每月注射提供了一种合理的方法,但需要注意的是,谨慎和持续监测仍然是光学管理的关键特征。

结论

根据临床试验数据,针对患者的疾病、生活方式和经济限制,个体化抗血管生成治疗方案不断发展。

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