Wu Lihteh, Martínez-Castellanos María A, Quiroz-Mercado Hugo, Arevalo J Fernando, Berrocal María H, Farah Michel E, Maia Mauricio, Roca José A, Rodriguez Francisco J
Instituto de Cirugía Ocular, San José, Costa Rica.
Graefes Arch Clin Exp Ophthalmol. 2008 Jan;246(1):81-7. doi: 10.1007/s00417-007-0660-z. Epub 2007 Aug 3.
Vascular endothelial growth factor (VEGF) plays an important role in many diseases of the posterior pole that are characterized by macular edema and/or intraocular neovascularization. Recently anti-VEGF agents such as ranibizumab and pegaptanib sodium have been shown to be beneficial in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (ARMD). However in most parts of the world, both pegaptanib sodium and ranibizumab are not readily available. Bevacizumab, a humanized recombinant monoclonal IgG antibody that binds and inhibits all VEGF isoforms, has been proposed as an alternative treatment option.
A total of 1,265 consecutive patients were injected with bevacizumab for diseases such as proliferative diabetic retinopathy, diabetic macular edema, retinal vein occlusions, and CNV of several etiologies including ARMD at eight Latin American institutions from 1 September 2005 to 31 January 2006. Of these 1,265, 92 were excluded because they were injected once and lost to follow-up. The remaining 1,173 patients constitute the subjects of this retrospective, multicenter, open label, uncontrolled interventional case series that reports the cumulative systemic and ocular adverse events following intravitreal bevacizumab during 12 months of follow-up. Patients were examined at baseline and then monthly. If the patients were unable to attend the 12-month visit, a telephone interview was conducted to assess for possible systemic complications.
A total of 4,303 intravitreal injections of bevacizumab on 1,310 eyes was reported. All 1,173 patients were accounted for at the 12-month visit. Systemic adverse events were reported in 18 (1.5%) patients. These included seven (0.59%) cases of an acute elevation of systemic blood pressure, six (0.5%) cerebrovascular accidents, five (0.4%) myocardial infarctions, two (0.17%) iliac artery aneurysms, two (0.17%) toe amputations and five (0.4%) deaths. Ocular complications included seven (0.16%) bacterial endophthalmitis, seven (0.16%) tractional retinal detachments, four (0.09%) uveitis, and a case (0.02%) each of rhegmatogenous retinal detachment and vitreous hemorrhage.
Despite the limited follow-up, repeated intravitreal injections of either 1.25 mg or 2.5 mg of bevacizumab appears to be safe and well tolerated during the 1st year.
血管内皮生长因子（VEGF）在许多以黄斑水肿和/或眼内新生血管形成为特征的后极部疾病中起重要作用。最近，诸如雷珠单抗和聚乙二醇化重组人血管内皮生长因子受体拮抗剂等抗VEGF药物已被证明在治疗年龄相关性黄斑变性（ARMD）继发的脉络膜新生血管（CNV）方面有益。然而，在世界大部分地区，聚乙二醇化重组人血管内皮生长因子受体拮抗剂和雷珠单抗都不容易获得。贝伐单抗是一种能结合并抑制所有VEGF异构体的人源化重组单克隆IgG抗体，已被提议作为一种替代治疗选择。
2005年9月1日至2006年1月31日期间，在八个拉丁美洲机构，共有1265例连续患者接受了贝伐单抗注射，用于治疗增殖性糖尿病视网膜病变、糖尿病性黄斑水肿、视网膜静脉阻塞以及包括ARMD在内的多种病因引起的CNV等疾病。在这1265例患者中，92例被排除，因为他们只接受了一次注射且失访。其余1173例患者构成了这个回顾性、多中心、开放标签、非对照干预病例系列的研究对象，该研究报告了玻璃体内注射贝伐单抗后12个月随访期间累积的全身和眼部不良事件。患者在基线时接受检查，然后每月检查一次。如果患者无法参加12个月的随访，则通过电话访谈评估可能的全身并发症。
共报告了1310只眼接受了4303次玻璃体内注射贝伐单抗。在12个月随访时，所有1173例患者均有记录。18例（1.5%）患者报告了全身不良事件。其中包括7例（0.59%）系统性血压急性升高、6例（0.5%）脑血管意外、5例（0.4%）心肌梗死、2例（0.17%）髂动脉瘤、2例（0.17%）脚趾截肢和5例（0.4%）死亡。眼部并发症包括7例（0.16%）细菌性眼内炎、7例（0.16%）牵拉性视网膜脱离、4例（0.09%）葡萄膜炎，以及各1例（0.02%）孔源性视网膜脱离和玻璃体积血。
尽管随访有限，但在第一年期间，重复玻璃体内注射1.25mg或2.5mg贝伐单抗似乎是安全的且耐受性良好。
