抗VEGF治疗CRVO黄斑水肿的疗效及安全性的meta分析评估

发布时间：2018-07-21 21:50

【摘要】：背景视网膜中央静脉阻塞(central retinal vein occlusion, CRVO)是常见的视网膜血管病变,其引起的黄斑水肿是造成视力损害的严重并发症之一。眼内注射抗血管内皮生长因子(vascular endothelial growth factor, VEGF)可以有效地缓解黄斑水肿,提高患者视力,显示出巨大的临床应用前景。目前在安全性及疗效方面尚缺乏足够的循证医学证据。实验设计Meta分析。研究对象目前己报道的随机对照双盲临床试验中使用抗VEGF玻璃体腔内注射治疗继发黄斑水肿的CRVO患者。实验方法在MEDLINE, CENTRAL及EMBASE数据库中,对2013年4月前发表的文献进行系统而全面的检索,使用RevMan5.2软件对数据进行meta分析评估。评估内容选取治疗前后最佳矫正视力(best-corrected visual acuity, BCVA)及视网膜中央厚度(central retinal thickness, CRT)的变化量作为主要评估指标。次要评估指标为：视力改变15个及以上ETDRS字符的患者比例,视力优于20/40Snellen视力或劣于20/200Snellen视力的患者比例,黄斑水肿的消退率,发生新生血管性并发症的患者比例,及治疗前后NEI VFQ-25评分的变化。眼内或全身的严重不良事件(severe adverse events, SAEs)作为安全性评价指标。实验结果共6组临床随机双盲对照试验纳入分析,包含940例患眼。抗VEGF治疗组中,患者视力的提高及黄斑水肿的缓解迅速且显著。在治疗6个月后,两组间BCVA及CRT变化量的均数差分别为15.2个ETDRS字符(95%CI=12.0-18.5,P0.00001)及-242.2μm(95%CI=-312.6—-171.8,P0.00001)。两组间不良事件的发生率没有显著差异。结论玻璃体腔内注射抗VEGF药物治疗继发于CRVO的黄斑水肿是安全、有效的,其疗效均有迅速、显著及稳定的特点。具体的适应证及治疗方案有待进步的试验以完善。
[Abstract]:Background: central retinal vein occlusion (central retinal vein occlusion, CRVO) is a common retinal vascular disease. Macular edema caused by it is one of the serious complications of visual impairment. Intraocular injection of anti vascular endothelial growth factor (vascular endothelial growth factor,) can effectively relieve macular edema and improve the visual acuity of patients. At present, there is a lack of evidence-based medical evidence in terms of safety and efficacy. Experimental design Meta analysis. Participants in randomized controlled double-blind clinical trials, anti VEGF intravitreal injection was used to treat CRVO patients with secondary macular edema. Methods in MEDLINE, central and EMBASE databases, the literatures published before April 2013 were searched systematically and comprehensively, and the data were analyzed and evaluated by meta with Revman 5.2 software. The changes of best-corrected visual acuteness (BCVA) and central retinal thickness (central retinal thickness,) before and after treatment were selected as the main evaluation indexes. The secondary evaluation measures were as follows: the proportion of patients with 15 or more ETDRS characters, the proportion of patients with visual acuity better than 20 / 40 Snellen vision or less than 20 / 200 Snellen vision, the regression rate of macular edema, and the proportion of patients with neovascular complications. And the changes of NEI VFQ-25 score before and after treatment. Severe intraocular or systemic adverse events (severe adverse events, SAEs) were used to evaluate safety. Results six groups of randomized double-blind controlled trials were included in the analysis, including 940 eyes. In the anti-VEGF treatment group, the improvement of visual acuity and the relief of macular edema were rapid and significant. After 6 months of treatment, the mean differences of BCVA and CRT between the two groups were 15.2 ETDRS characters (95CI12.0-18.5 P0.00001) and -242.2 渭 m (95CI-312.6-171.8 P0.00001), respectively. There was no significant difference in the incidence of adverse events between the two groups. Conclusion intravitreal injection of anti-VEGF drugs in the treatment of secondary macular edema secondary to CRVO is safe and effective, and its curative effect is rapid, significant and stable. The indication and treatment plan need to be improved.
【学位授予单位】：上海交通大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：R774.5

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