Department of Ophthalmology, University of Sydney, Sydney, Australia.
Curr Med Res Opin. 2011 Jul;27(7):1465-75. doi: 10.1185/03007995.2011.585394. Epub 2011 May 31.
To systematically review ocular and systemic events in treatment of wet age-related macular degeneration (AMD) with anti-vascular endothelial growth factor antibodies, ranibizumab and bevacizumab, and to provide a detailed perspective of their differences on clinical use, efficacy and safety.
This review was based on a 2010 PubMed literature search performed using two separate terms: 'lucentis' OR 'ranibizumab' AND 'age-related macular degeneration' OR 'AMD' or 'avastin' OR 'bevacizumab' AND 'age-related macular degeneration' OR 'AMD'. A clinical diagnosis of wet AMD was defined by the authors of the trial reports. Clinical studies that met Level I or Level II evidence criteria were considered for review.
Eight large, randomized, controlled trials of ranibizumab (Level I) included 1,485 patients (range 162-716) and four open-label studies of ranibizumab (Level II) included 4,484 patients (range 32-4,300). Six studies (one Level I, five Level II) of bevacizumab included 424 patients (range 28-165). All demonstrated improvements in visual acuity. Only one study (Level II) compared the efficacy of ranibizumab and bevacizumab. Adverse ocular and systemic safety events occurring during the study were prospectively recorded for ranibizumab, irrespective of their suspected relationship to study treatments. Only three of six bevacizumab studies reported details of adverse ocular or systemic events. There was extensive Level I and Level II evidence to support both the efficacy and safety of ranibizumab in wet AMD. Data suggest that bevacizumab provides efficacy in wet AMD, but the safety profile of intravitreal bevacizumab remains to be established.
In contrast to ranibizumab, current safety data for bevacizumab are incomplete and not yet robust. If the medical community remains committed to using intravitreal bevacizumab, it is critical to establish that it has an acceptable safety profile, supported by evidence-based medicine. Considerable further research is warranted to achieve this.
系统评价抗血管内皮生长因子抗体雷珠单抗和贝伐单抗治疗湿性年龄相关性黄斑变性（AMD）的眼部和全身事件，并详细比较其临床应用、疗效和安全性的差异。
本综述基于 2010 年在 PubMed 上进行的文献检索，使用了两个独立的术语：“Lucentis”或“雷珠单抗”和“年龄相关性黄斑变性”或“AMD”或“Avastin”或“贝伐单抗”和“年龄相关性黄斑变性”或“AMD”。试验报告的作者将湿性 AMD 的临床诊断定义为。考虑纳入符合 I 级或 II 级证据标准的临床研究。
共纳入 8 项大型随机对照雷珠单抗试验（I 级），共纳入 1485 例患者（范围 162-716 例），4 项雷珠单抗开放性研究（II 级）共纳入 4484 例患者（范围 32-4300 例）。6 项贝伐单抗研究（1 项 I 级，5 项 II 级）共纳入 424 例患者（范围 28-165 例）。所有研究均显示视力提高。只有一项研究（II 级）比较了雷珠单抗和贝伐单抗的疗效。雷珠单抗研究中无论疑似与治疗相关与否，均前瞻性记录眼部和全身不良安全事件。6 项贝伐单抗研究中仅有 3 项报告了眼部或全身不良事件的详细情况。大量 I 级和 II 级证据支持雷珠单抗治疗湿性 AMD 的疗效和安全性。数据表明，贝伐单抗治疗湿性 AMD 有效，但玻璃体内注射贝伐单抗的安全性尚待确定。
与雷珠单抗相比，目前贝伐单抗的安全性数据不完整且不充分。如果医学界仍致力于使用玻璃体内注射贝伐单抗，就必须基于循证医学，证明其具有可接受的安全性。为此，还需要进行大量进一步的研究。
