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用于治疗新生血管性年龄相关性黄斑变性的抗血管内皮生长因子给药方案

[Anti-VEGF dosing regimen for neovascular age-related macular degeneration treatment].

作者信息

Fayzrakhmanov R R

机构信息

National Medical and Surgical Center named after N.I. Pirogov, 70 Nizhnyaya Pervomayskaya St., Moscow, Russian Federation, 105203.

出版信息

Vestn Oftalmol. 2018;134(6):107-115. doi: 10.17116/oftalma2018134061107.

Abstract

antivasoproliferative therapy is a revolutionary option in the therapy of Neovascular Age-related Macular Degeneration (nAMD). In addition to the problem of choosing an anti-VEGF drug, it is equally important to choose the mode of its intravitreal administration. The basic dosing regimen is fixed monthly intravitreal injections. The effectiveness of monthly intravitreal injections has been demonstrated in randomized clinical trials; however, this regimen is associated with heavy workload on the healthcare system and patients. This fact leads to the constant search of the optimal administration mode for anti-VEGF drugs, which would reduce the number of injections by increasing the interval between them. VIEW1 and VIEW2 randomized clinical trials showed that the optimal dosing regimen for aflibercept is 1 injection every other month after 3 initial monthly doses, and that it reduces the burden of treatment. The Pro Re Nata (PRN) and Observe-and-Plan (O&P) regimens also reduce the number of injections, but the antivasoproliferative effect of the therapy with these regimens may be decreased. In addition, when using the PRN regimen, patients need regular monitoring visits and examinations between injections. The basis of another Treat and Extend (T&E) regimen is the principle of achieving the maximum possible interval between injections while preserving the achieved anatomical and functional results of the treatment. The individualized approach implemented in T&E results in pronounced functional improvements avoiding negative effect onits efficiency. However, the rapid, steady and unpredictable course of nAMD imposes certain restrictions on its implementation of T&E in clinical practice, especially in the first year of treatment. Therefore, when choosing the optimal regimen for anti-VEGF therapy, in addition to the criteria for the duration and mechanism of action of the corresponding anti-VEGF drug, the individual characteristics of the course of the disease should also be considered.

摘要

抗血管生成疗法是治疗新生血管性年龄相关性黄斑变性(nAMD)的一种革命性选择。除了选择抗VEGF药物的问题外,选择其玻璃体内给药方式同样重要。基本给药方案是每月进行一次固定的玻璃体内注射。每月玻璃体内注射的有效性已在随机临床试验中得到证实;然而,这种方案给医疗系统和患者带来了沉重的负担。这一事实导致人们不断寻找抗VEGF药物的最佳给药方式,即通过延长注射间隔来减少注射次数。VIEW1和VIEW2随机临床试验表明,阿柏西普的最佳给药方案是在最初3次每月注射后,每隔一个月注射1次,这减轻了治疗负担。按需(PRN)和观察与计划(O&P)方案也减少了注射次数,但这些方案治疗的抗血管生成效果可能会降低。此外,使用PRN方案时,患者在两次注射之间需要定期进行监测和检查。另一种治疗并延长(T&E)方案的基础是在保持已取得的治疗解剖学和功能结果的同时,尽可能延长注射间隔的原则。T&E中实施的个体化方法可带来显著的功能改善,同时避免对其疗效产生负面影响。然而,nAMD快速、稳定且不可预测的病程在临床实践中对T&E方案的实施施加了一定限制,尤其是在治疗的第一年。因此,在选择抗VEGF治疗的最佳方案时,除了考虑相应抗VEGF药物的作用持续时间和机制标准外,还应考虑疾病病程的个体特征。

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