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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial.
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Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial.

机译：脑溶素在血管性痴呆中的作用：在一项随机，双盲，安慰剂对照的多中心试验中改善临床结果。

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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.
机译：美国或欧洲当局尚未批准用于治疗血管性痴呆（VaD）的药物，致使大量患者无法有效治疗。脑溶素有很长的安全记录，在这种情况下可能有效。我们对242名符合VaD标准的患者进行了一项大型，多中心，双盲，安慰剂对照研究。主要终点是认知结果（基于阿尔茨海默氏病评估量表认知子部分，扩展版[ADAS-cog +]得分）和整体临床功能（基于临床医生基于面试的变化印象加照顾者输入[CIBIC +]得分）治疗24周后评估。在两个治疗周期内，每天一次静脉注射20 mL静脉脑溶素，作为乙酰水杨酸基础治疗的附加治疗。脑溶素的添加与两个主要参数的显着改善有关。在第24周，脑溶素组的ADAS-cog +得分提高了10.6分，而安慰剂组为4.4分（最小二乘均方差-6.17;与安慰剂相比，P <.0001）。 CIBIC +显示治疗组平均改善2.84，安慰剂组平均改善3.68，治疗差异为0.84（与安慰剂相比，P <.0001）。这些发现得到了响应者分析的证实，这些分析表明脑溶素组的发病率更高（ADAS-cog +与基线相比提高了> / = 4点，分别为82.1％和52.2％; 24周时CIBIC +得分<4，分别为75.3％和37.4％;合计ADAS-cog +和CIBIC +中的应答率分别为67.5％和27.0％）。对于脑溶素，获得良好的CIBIC +响应的比值比为5.08（P <.05），而获得良好的组合响应的比值比为5.63（P <.05）。我们的数据表明，添加脑溶血素可显着改善临床结局，并且获益持续至少24周。脑溶素安全并且耐受良好。

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