Panisset M, Gauthier S, Moessler H, Windisch M
McGill Centre for Studies in Ageing, Montreal, Quebec, Canada.
J Neural Transm (Vienna). 2002 Jul;109(7-8):1089-104. doi: 10.1007/s007020200092.
Cerebrolysin (Cere) is a compound with neurotrophic activity. It has been shown to be effective in the treatment of Alzheimer's disease (AD) in earlier trials. In this multicenter, randomized, double-blind, placebo-controlled, parallel-group study, patients were injected intravenously with placebo or 30 mL Cere five days per week for four weeks. Effects on cognition and global function were evaluated with the Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Clinicians Interview-based Impression of Change with Caregiver Input scale (CIBIC+) 4, 12, 24 weeks after the beginning of the injections. 192 patients were enrolled, 95 were randomized to placebo, and 97 to Cere. At baseline, there was a significant difference between groups for age, age of onset of dementia, and the number of patients with hallucinations. At week 12 there was a significant difference on the CIBIC+ (p = 0.033) in favor of Cere. The number of CIBIC+ responders (score < or = 4), was significantly higher (p = 0.007), with 68 (76%) in the Cere group and 51 (57%) in the placebo group. Trends were noted in the Disability Assessment in Dementia scale and the Cornell Depression Scale. Adverse events were recorded in 73% of placebo and 64% of Cere patients. Most common adverse events were headaches, dizziness, weight loss and anxiety.
Cere treatment was well tolerated and resulted in significant improvements in the global score two months after the end of active treatment.
脑蛋白水解物（Cere）是一种具有神经营养活性的化合物。早期试验表明它在治疗阿尔茨海默病（AD）方面有效。在这项多中心、随机、双盲、安慰剂对照、平行组研究中，患者每周五天静脉注射安慰剂或30毫升脑蛋白水解物，持续四周。在注射开始后的4周、12周和24周，使用阿尔茨海默病评估量表认知分量表（ADAS-Cog）和基于临床医生访谈的伴有照料者输入的变化印象量表（CIBIC+）评估对认知和整体功能的影响。共纳入192例患者，95例随机分配至安慰剂组，97例至脑蛋白水解物组。在基线时，两组在年龄、痴呆发病年龄和幻觉患者数量方面存在显著差异。在第12周时，CIBIC+评分存在显著差异（p = 0.033），脑蛋白水解物组更占优势。CIBIC+应答者（评分≤4）的数量显著更高（p = 0.007），脑蛋白水解物组为68例（76%），安慰剂组为51例（57%）。在痴呆残疾评估量表和康奈尔抑郁量表中也观察到了趋势。安慰剂组73%的患者和脑蛋白水解物组64%的患者记录到不良事件。最常见的不良事件是头痛、头晕、体重减轻和焦虑。
脑蛋白水解物治疗耐受性良好，在积极治疗结束两个月后整体评分有显著改善。
