Department of Neurology and Neurosurgery, Russian State Medical University, Moscow, Russia.
J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):310-8. doi: 10.1016/j.jstrokecerebrovasdis.2010.01.012. Epub 2010 Jul 24.
No drug to treat vascular dementia (VaD) has yet been approved by the American or European authorities, leaving a large population of patients without effective therapy. Cerebrolysin has a long record of safety and might be efficacious in this condition. We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD. The primary endpoint was the combined outcome of cognition (based on Alzheimer's Disease Assessment Scale Cognitive Subpart, Extended Version [ADAS-cog+] score) and overall clinical functioning (based on Clinician's Interview-Based Impression of Change plus Caregiver Input [CIBIC+] score) assessed after 24 weeks of treatment. Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid. The addition of Cerebrolysin was associated with significant improvement in both primary parameters. At week 24, ADAS-cog+ score improved by 10.6 points in the Cerebrolysin group, compared with 4.4 points in the placebo group (least squares mean difference, -6.17; P < .0001 vs placebo). CIBIC+ showed a mean improvement of 2.84 in the treatment arm and 3.68 in the placebo arm, a treatment difference of 0.84 (P < .0001 vs placebo). These findings were confirmed by responder analyses demonstrating higher rates in the Cerebrolysin group (ADAS-cog+ improvement of ≥4 points from baseline, 82.1% vs 52.2%; CIBIC+ score of <4 at week 24, 75.3% vs 37.4%; combined response in ADAS-cog+ and CIBIC+, 67.5% vs 27.0%). For Cerebrolysin, the odds ratio for achieving a favorable CIBIC+ response was 5.08 (P < .05), and that for achieving a favorable combined response was 5.63 (P < .05). Our data indicate that the addition of Cerebrolysin significantly improved clinical outcome, and that the benefits persisted for at least 24 weeks. Cerebrolysin was safe and well tolerated.
目前，美国和欧洲药政管理部门尚未批准任何用于治疗血管性痴呆（VaD）的药物，致使大量 VaD 患者无法获得有效治疗。脑活素（Cerebrolysin）在安全性方面具有长期记录，在 VaD 患者中可能有效。我们开展了一项针对 242 例符合 VaD 诊断标准患者的大型、多中心、双盲、安慰剂对照研究。主要终点是认知（根据阿尔茨海默病评估量表认知分量表，扩展版 [ADAS-cog+] 评分）和整体临床功能（根据临床医生访谈基于变化的印象加护理人员输入 [CIBIC+] 评分）的联合结局，在 24 周的治疗后进行评估。静脉注射脑活素 20mL，每日 1 次，连续 2 个疗程，作为乙酰水杨酸基础治疗的附加治疗。脑活素的添加与两个主要参数的显著改善相关。在第 24 周，脑活素组的 ADAS-cog+评分改善了 10.6 分，而安慰剂组仅改善了 4.4 分（最小二乘均数差，-6.17；P <.0001 与安慰剂相比）。CIBIC+在治疗组的平均改善为 2.84，在安慰剂组为 3.68，治疗差异为 0.84（P <.0001 与安慰剂相比）。通过应答者分析证实了这些发现，脑活素组的应答率更高（ADAS-cog+评分从基线改善≥4 分，82.1% vs 52.2%；第 24 周时 CIBIC+评分<4，75.3% vs 37.4%；ADAS-cog+和 CIBIC+联合应答，67.5% vs 27.0%）。对于脑活素，获得有利的 CIBIC+应答的优势比为 5.08（P <.05），获得有利的联合应答的优势比为 5.63（P <.05）。我们的数据表明，脑活素的添加显著改善了临床结局，且获益至少持续 24 周。脑活素安全且耐受良好。
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