雷珠单抗治疗年龄相关性黄斑变性的临床安全性。

Clinical safety of ranibizumab in age-related macular degeneration.

机构信息

Medical University of Vienna, Department of Ophthalmology, Waehringer Guertel 18-20, A-1090 Vienna, Austria.

出版信息

Expert Opin Drug Saf. 2010 Jan;9(1):149-65. doi: 10.1517/14740330903418422.

DOI:10.1517/14740330903418422

PMID:20001757

Abstract

IMPORTANCE OF THE FIELD

Clinical safety of pharmaceutical products in the elderly is vital because of their increased risk of cardiac and other adverse events.

AREAS COVERED IN THIS REVIEW

Search of the Medline database, including articles and abstracts from 1984 to 2009.

WHAT THE READER WILL GAIN

Knowledge of ocular and systemic risks: The rate of endophthalmitis was 0.05% per injection (MARINA) and <0.1% per injection (ANCHOR), rates confirmed in a retrospective analysis of 14,320 injections. Moderate increases in intraocular pressure were transient, and incidences of intraocular inflammation were rarely serious. Systemic arterial thromboembolic events occurred in 4.6 and 0% of ranibizumab-treated patients and in 3.8 and 0% of sham-treated patients in MARINA (2 years) and PIER (1 year), respectively. In SAILOR, there was a numerically higher rate of cerebrovascular stroke with 0.5 mg ranibizumab compared with 0.3 mg ranibizumab (1.2 vs 0.7%), which was a non-statistically significant trend in patients with a history of stroke.

TAKE HOME MESSAGE

Although further studies to investigate the risk of stroke with ranibizumab therapy are required, repeated intravitreal ranibizumab was well tolerated and not associated with clinically significant safety risks during up to 2 years of treatment.

摘要

重要性的领域

药物产品在老年人的临床安全是至关重要的，因为他们的心脏和其他不良事件的风险增加。

涵盖的领域

搜索 Medline 数据库，包括文章和摘要从 1984 年到 2009 年。

读者将获得

知识的眼部和全身的风险：内眼炎的发生率为 0.05%每注射（MARINA）和<0.1%每注射（锚），率在回顾性分析中证实 14320 注射。中度增加眼压是短暂的，眼部炎症的发生率很少是严重的。全身动脉血栓栓塞事件发生在 4.6%和 0%的雷珠单抗治疗患者和 3.8%和 0%的假手术治疗患者在 MARINA（2 年）和 PIER（1 年），分别。在 SAILOR，有一个更高的数字率的脑血管中风与 0.5 毫克雷珠单抗相比，0.3 毫克雷珠单抗（1.2%对 0.7%），这是一个非统计学意义的趋势，在有中风史的患者。