Ranibizumab治疗湿性年龄相关性黄斑变性的安全性分析

湿性年龄相关性黄斑变性（AMD）的主要病理改变为脉络膜新生血管（CNV）的形成，血管内皮生长因子（VEGF）水平的升高是其重要的发病机制之一。Ranibizumab是一种重组人源化抗VEGF单克隆抗体片段，能够抑制新生血管形成，玻璃体腔内注射ranibizumab治疗湿性AMD的疗效已得到多项临床研究的证实。此外，玻璃体腔内注射ranibizumab的耐受性良好，眼内与全身不良反应的风险未显著增加。其主要眼内不良事件为眼部炎症和一过性眼压升高，但发生率较低。主要的严重眼内不良事件的发生率〈4％。Ranibizumab应用后心脑血管意外的发生风险无显著增加，采取在每月随访监测的基础上降低注射频率的方法可能得到最佳的风险获益比。就近年来湿性AMD患者应用ranibizumab治疗的临床试验为基础，从循证医学角度讨论其玻璃体腔内注射的安全性。

A safety evaluation of ranibizumab in patients with wet age-related macular degeneration

The main pathology of wet age-related macular degeneration (AMD) is the development of choroidal neovascularization( CNV),and the critical role of VEGF in the pathogenesis of CNV is well established.Ranibizumab is a fragment of a humanized and monoclonal antibody.It can binds to VEGF,thereby,inhibiting the angiogenesis.Some clinical trials have proved the clinical efficacy of ranibizumab via intravitreal injection for wet AMD.On the other hand,ranibizumab is well tolerated for wet AMD patients after administration and is not associated with a clinically significant risk of ocular or systemic adverse events.The large-scale clinical trials showed that its principal ocular adverse event occurred in ＜4％ of ranibizumab-treated patients,including the transient elevation of intraocular pressure and mild ocular inflammation.It appears unlikely that application of ranibizumab does not increase the risk of vascular event significantly.Less-frequent injections on an as-needed schedule based on monthly monitoring may have the most optimal risk/benefit ratio.This article summarized the recent clinical trials of ranibizumab and offered high-quality evidences for the safety evaluation of ranibizumab treating wet AMD.