A Randomized Trial of Tenecteplase in Acute Central Retinal Artery Occlusion.

Effective treatment is lacking.

目前缺乏有效的治疗方法。

Methods

We conducted a phase 3, double-blind, double-dummy, randomized, controlled trial involving adults with acute, nonarteritic central retinal artery occlusion who had symptom onset within 4.5 hours before treatment.

我们开展了一项3期、双盲、双模拟、随机对照试验，对象为急性非动脉炎性视网膜中央动脉阻塞的成人患者，这些患者在治疗前4.5小时内出现症状。

Patients were assigned, in a 1:1 ratio, to receive intravenous tenecteplase (at a dose of 0.25 mg per kilogram of body weight) and oral placebo or intravenous placebo and oral aspirin (at a dose of 300 mg).

患者按1:1的比例分配，接受静脉注射替奈普酶（按每公斤体重0.25毫克的剂量）和口服安慰剂，或静脉注射安慰剂和口服阿司匹林（按300毫克的剂量）。

The primary end point was vision recovery, defined as a best corrected visual acuity (BCVA) in the affected eye at 30 days of up to 0.7 logMAR (logarithm of the minimum angle of resolution; equivalent to ≥20/100).

主要终点是视力恢复，定义为受影响眼在30天时的最佳矫正视力（BCVA）达到0.7 logMAR（最小角度分辨率的对数；相当于≥20/100）。

Key secondary visual end points were a BCVA of up to 0.5 logMAR (equivalent to ≥20/63), mean improvement in BCVA, and perimetry score at 30 days.

关键的次要视觉终点是30天时BCVA达到0.5 logMAR（相当于≥20/63），BCVA的平均改善，以及视野评分。

Key safety end points included symptomatic intracranial hemorrhage, major bleeding, and death.

关键的安全性终点包括症状性颅内出血、主要出血和死亡。

Results

A total of 78 patients at 16 sites in six countries underwent randomization, with 40 assigned to receive tenecteplase and 38 to receive aspirin.

共有来自六个国家的16个地点的78名患者进行了随机分组，其中40名被分配接受替奈普酶治疗，38名被分配接受阿司匹林治疗。

At 30 days, 8 patients (20%) in the tenecteplase group and 9 patients (24%) in the aspirin group had vision recovery (risk difference, -3.7 percentage points; 95% confidence interval, -22.0 to 14.7; P = 0.69).

在30天时，接受替奈普酶治疗的患者中有8名（20%）和接受阿司匹林治疗的患者中有9名（24%）视力恢复（风险差异，-3.7个百分点；95%置信区间，-22.0至14.7；P = 0.69）。

The outcomes with regard to the secondary visual end points did not differ substantially between the groups.

关于次要视力终点的结果，在两组之间没有显著差异。

There was a greater incidenceof adverse events in the tenecteplase group, including one fatal intracranial hemorrhage.

在使用替奈普酶的组别中，不良事件的发生率更高，包括一例致命的颅内出血。

Conclusions

Intravenous tenecteplase administered within 4.5 hours after onset of central retinal artery occlusion did not result in significantly greater vision recovery at 30 days than oral aspirin but was associated with serious safety concerns.

在中央视网膜动脉阻塞发作后4.5小时内静脉给予替奈普酶，并未在30天时显著提高视力恢复率，与口服阿司匹林相比，但与严重的安全问题相关。

(Funded by Oslo University Hospital and others; TenCRAOS ClinicalTrials.gov number, NCT04526951; EU Clinical Trials number, 2024-517606-29-00.).

(由奥斯陆大学医院和其他机构资助；TenCRAOS临床试验注册号，NCT04526951；欧盟临床试验注册号，2024-517606-29-00。)