Ogawa A, Yoshimoto T, Kikuchi H, Sano K, Saito I, Yamaguchi T, Yasuhara H
Iwate Medical University, Morioka, Japan.
Cerebrovasc Dis. 1999 Mar-Apr;9(2):112-8. doi: 10.1159/000015908.
A randomized, double-blind, placebo-controlled trial of ebselen was conducted in patients with complete occlusion of the middle cerebral artery. Ebselen or placebo granules suspended in water (150 mg b.i.d. ) were orally administered within 12 h of onset and continued for 2 weeks. The major end points were the maximum volume of cerebral infarct measured on follow-up computed tomography and the Glasgow Outcome Scale score at 1 month. One hundred and five patients were enrolled in this trial. Although the intent-to-treat analysis of 99 patients (43 given ebselen and 56 given placebo) did not reach statistical significance in reduction of the infarct volume (p = 0. 099), the protocol-compatible analysis of 83 patients with complete occlusion of the middle cerebral artery (34 given ebselen and 49 given placebo) determined a significant reduction using ebselen treatment (p = 0.034). A good outcome was seen in approximately 15% more patients from the ebselen group, but the difference between the 2 groups was not significant (p = 0.129). There was a corresponding significant reduction in the volume of cerebral infarct and an improvement in the outcome of patients who started treatment within 6 h of onset. These findings may suggest that ebselen protected the brain from ischemic damage in the acute stage.
在大脑中动脉完全闭塞的患者中进行了一项关于依布硒啉的随机、双盲、安慰剂对照试验。将依布硒啉或安慰剂颗粒悬浮于水中（150毫克，每日两次），在发病后12小时内口服给药，并持续2周。主要终点为随访计算机断层扫描测得的脑梗死最大体积以及1个月时的格拉斯哥预后评分。105名患者参与了该试验。虽然对99名患者（43名给予依布硒啉，56名给予安慰剂）的意向性分析在梗死体积减少方面未达到统计学显著性（p = 0.099），但对83名大脑中动脉完全闭塞的患者（34名给予依布硒啉，49名给予安慰剂）进行的符合方案分析确定依布硒啉治疗有显著的梗死体积减少（p = 0.034）。依布硒啉组约多15%的患者获得了良好预后，但两组之间的差异不显著（p = 0.129）。发病后6小时内开始治疗的患者，其脑梗死体积相应显著减少，预后有所改善。这些发现可能提示依布硒啉在急性期可保护大脑免受缺血性损伤。
