摘要
目的系统评价雷珠单抗治疗视网膜静脉阻塞继发黄斑水肿的效果及安全性。方法计算机检索MEDLINE、EMbase、Cochrane协作网眼和视力组数据库、CNKI、VIP、万方数据库及中国生物医学文献数据库中关于雷珠单抗治疗视网膜静脉阻塞继发黄斑水肿的随机对照试验,同时追索纳入文献的参考文献。检索时限均为从建库至2012年12月。在评价纳入研究由两人独立进行随机对照试验(RCT)的筛选、资料提取和质量评价后,采用RevMan 5.1软件进行Meta分析。结果共纳入4个RCT。共1674只患眼。Meta分析结果显示:随访结束时,0.5 mg雷珠单抗组与安慰剂组比较,在最佳矫正视力和黄斑中心凹厚度方面,差异均有统计学意义[OR=12.21,95%CI:10.41～14.01;OR=223.93,95%CI:186.22～261.63;均P<0.000 01];0.5 mg雷珠单抗组发生白内障的人数高于安慰剂组,但两组在发生眼内的炎症反应(虹膜睫状体炎、虹膜炎、玻璃体炎)、各种原因引起的青光眼、玻璃体积血和视网膜裂孔方面,差异无统计学意义(P>0.05)。结论现有临床研究证据提示,0.5 mg雷珠单抗组较安慰剂组治疗视网膜静脉阻塞继发黄斑水肿,更能有效地提高视力,减轻黄斑水肿,但雷珠单抗的使用也会增加白内障等并发症的发生率,但仍需更多高质量、大样本、长期的随机对照试验来验证其最佳剂量。
Objective To evaluate the efficacy and safety of Ranibizumab for macular edema due to retinal vein oc- clusion. Methods Such databases as The Cochrane Library, Medline, Embase, CNKI, VIP, Wanfang Data and CBM were searched from the date of their establishment to December 2012, and the references of all included studies were also traced. After study selection, assessment, data collection, and analysis were undertaken by two reviewers inde- pendently, Meta-analyses was performed by the RevMan 5.1 software. Results 4 RCTs involving 1674 ill eyes were includes. Results of Meta-analysis showed that： at the end of follow-up, there were significant differences between 0.5 mg Ranibizumab group and placebo group in the best-corrected visual acuity （OR = 12.21, 95%CI： 10.41-14.01, P 〈 0.000 01）, and central macular thickness （OR = 223.93, 95%CI： 186.22-261.63, P 〈 0.000 01）. In comparison with the plaeebo group, there were more people in the 0.5 mg Ranibizumab group who needed to be treated for cataract. But no significant difference was found between the two groups in intraoeular inflammation reaction （iridocyclitis, iritis, hyalitis hyaloiditis）, all kinds of causes of glaucoma, vitreous hemorrhage and retinal tear （P 〉 0.05）. Conclusion Cur- rent clinical research evidence shows that 0.5 mg Ranibizumab is superior to placebo in improving eyesight and reduc- ing the macular edema, but the use of Ranibizumab will also increase the incidence of complications such as cataract. However, more high quality, large sample and long-term randomized controlled trial are needed to confirm this.
出处
《中国医药导报》
CAS
2013年第27期62-64,67,共4页
China Medical Herald
