亚洲急性缺血性脑卒中患者的脑活素治疗：一项双盲、安慰剂对照的随机临床试验结果。
Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial.
机构信息
Max-Planck Institut für Neurologie, Gleueler Strasse 50, 50931 Koeln, Germany.
出版信息
Stroke. 2012 Mar;43(3):630-6. doi: 10.1161/STROKEAHA.111.628537. Epub 2012 Jan 26.
BACKGROUND AND PURPOSE
Cerebrolysin showed neuroprotective and neurotrophic properties in various preclinical models of ischemia and small clinical trials. The aim of this large double-blind, placebo-controlled randomized clinical trial was to test its efficacy and safety in patients with acute ischemic stroke.
METHODS
Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily). The patients were followed up to 90 days. The primary end point was the result of a combined global directional test of modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale. Adverse events were documented to assess safety.
RESULTS
A total of 1070 patients were enrolled in this study. Five hundred twenty-nine patients were assigned to Cerebrolysin and 541 to placebo. The confirmatory end point showed no significant difference between the treatment groups. When stratified by severity however, a post hoc analysis of National Institutes of Health Stroke Scale and modified Rankin Scale showed a trend in favor of Cerebrolysin in patients with National Institutes of Health Stroke Scale >12 (National Institutes of Health Stroke Scale: OR, 1.27; CI lower bound, 0.97; modified Rankin Scale: OR, 1.27; CI lower bound, 0.90). In this subgroup, the cumulative mortality by 90 days was 20.2% in the placebo and 10.5% in the Cerebrolysin group (hazard ratio, 1.9661; CI lower bound, 1.0013).
CONCLUSIONS
In this study, the confirmatory end point showed neutral results between the treatment groups. However, a favorable outcome trend was seen in the severely affected patients with ischemic stroke treated with Cerebrolysin. This observation should be confirmed by a further clinical trial.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00868283.
背景与目的
Cerebrolysin 在各种缺血性疾病的临床前模型和小型临床试验中表现出神经保护和神经营养特性。本项大型双盲、安慰剂对照随机临床试验的目的是在急性缺血性脑卒中患者中测试其疗效和安全性。
方法
患者在症状发作后 12 小时内随机分为活性治疗组（每日 30ml Cerebrolysin）或安慰剂组（生理盐水溶液），除了阿司匹林（每日 100mg）外，还接受 10 天的静脉输注。患者随访 90 天。主要终点是改良 Rankin 量表、巴氏量表和国立卫生研究院卒中量表的联合综合定向测试结果。记录不良事件以评估安全性。
结果
这项研究共纳入了 1070 名患者。529 名患者被分配到 Cerebrolysin 组，541 名患者被分配到安慰剂组。确认性终点表明治疗组之间没有显著差异。然而，按照严重程度分层后，对国立卫生研究院卒中量表和改良 Rankin 量表的事后分析显示，Cerebrolysin 治疗组的国立卫生研究院卒中量表>12 的患者有治疗趋势（国立卫生研究院卒中量表：比值比，1.27；置信区间下限，0.97；改良 Rankin 量表：比值比，1.27；置信区间下限，0.90）。在该亚组中，90 天累积死亡率安慰剂组为 20.2%，Cerebrolysin 组为 10.5%（风险比，1.9661；置信区间下限，1.0013）。
结论
在这项研究中，治疗组之间的确认性终点显示出中性结果。然而，在接受 Cerebrolysin 治疗的严重缺血性脑卒中患者中，观察到了有利的结果趋势。这一观察结果需要进一步的临床试验来证实。
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