Central Retinal Artery Occlusion: Local Intra-arterial Fibrinolysis versus Conservative Treatment, a Multicenter Randomized Trial
Central Retinal Artery Occlusion: Local Intra-arterial Fibrinolysis versus Conservative Treatment, a Multicenter Randomized Trial
复制标题
DOI：
10.1016/j.ophtha.2010.03.061
复制
发表时间：
2010-07-01
期刊：
影响因子：
13.7
通讯作者：
Feltgen, Nicolas
中科院分区：
文献类型：
--
作者：
Schumacher, Martin;Schmidt, Dieter;Feltgen, Nicolas
目的：报道的视网膜中央动脉闭塞（CRAO）治疗或不治疗的结果差异很大。虽然使用重组组织型纤溶酶原激活剂（rtPA）进行局部动脉内纤溶（LIF）治疗是一种很有前景的治疗方法，但在随机试验中还没有比较结果。设计：前瞻性随机多中心临床试验（欧洲眼科松解研究评估小组），比较急性非动脉性CRAO保守标准治疗（CST）和LIF治疗后的治疗结果。参与者：2002年至2007年间，奥地利和德国的9个中心招募了84名患者（40名接受CST， 44名接受LIF），并对82名患者的数据进行了分析。方法：年龄18-75岁的CRAO患者，症状持续时间不超过20小时，最佳矫正视力(BCVA) <最小分辨角（logMAR）的0.5对数随机分为CST组或LIF组。主要观察指标：主要终点为1个月后BCVA；次要终点是安全性。结果：首次出现症状到治疗的平均时间间隔为10.99 +/- 5.49小时（CST）和12.78 +/- 5.77小时（LIF）。两组患者的平均BCVA （logMAR）均显著改善（CST: -0.44[标准差0.55];LIF: -0.45[标准差0.55]；均P < 0.0001），两组间无差异（P=0.69）。60.0% （CST）和57.1% （LIF）患者的临床视力显著改善（>= 0.3 logMAR）。CST组2例（4.3%）、LIF组13例（37.1%）出现不良反应。由于LIF组明显相似的疗效和更高的不良反应发生率，在数据和安全监测委员会的建议下，该研究在第一次中期分析后停止。结论：鉴于这两种治疗方法的预后相似，且与LIF相关的不良反应发生率较高，我们不能推荐使用LIF治疗急性CRAO。财务披露：作者在本文中讨论的任何材料中没有专有或商业利益。眼科2010;117: 1367-1375 (C) 2010由美国眼科学会。
Purpose: The reported outcomes of central retinal artery occlusion (CRAO) with or without treatment vary considerably. Although local intra-arterial fibrinolysis (LIF) using recombinant tissue plasminogen activator (rtPA) is a promising treatment, outcomes have not been compared in randomized trials.Design: Prospective randomized multicenter clinical trial (the European Assessment Group for Lysis in the Eye Study) to compare treatment outcome after conservative standard treatment (CST) and LIF for acute nonarteritic CRAO.Participants: Between 2002 and 2007, 9 centers in Austria and Germany recruited 84 patients (40 received CST, 44 received LIF), and data for 82 patients were analyzed.Methods: Patients (age 18-75 years) with CRAO, symptoms for 20 hours or less, and best-corrected visual acuity (BCVA) < 0.5 logarithm of the minimum angle of resolution (logMAR) were randomized to the CST or LIF group.Main Outcome Measures: The primary end point was BCVA after 1 month; the secondary end point was safety.Results: The mean interval between first symptoms and therapy was 10.99 +/- 5.49 hours (CST) and 12.78 +/- 5.77 hours (LIF). The mean BCVA (logMAR) improved significantly in both groups (CST: -0.44 [standard deviation 0.55]; LIF: -0.45 [standard deviation 0.55]; both P < 0.0001) and did not differ between groups (P=0.69). Clinically significant visual improvement (>= 0.3 logMAR) was noted in 60.0% (CST) and 57.1% (LIF) of patients. Two patients in the CST group (4.3%) and 13 patients in the LIF group (37.1%) had adverse reactions. Because of apparently similar efficacy and the higher rate of adverse reactions in the LIF group, the study was stopped after the first interim analysis at the recommendation of the data and safety monitoring committee.Conclusions: In light of these 2 therapies' similar outcomes and the higher rate of adverse reactions associated with LIF, we cannot recommend LIF for the management of acute CRAO.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2010; 117: 1367-1375 (C) 2010 by the American Academy of Ophthalmology.