脑活素治疗Alzheimer病认知功能、非认知性精神症状和生活能力的多中心双盲随机对照研究

The efficacy of cerebrolysin in patients with Alzheimer disease

目的 验证脑活素治疗 Alzheimer病 (AD)的疗效。方法 脑活素 30ml，静脉滴注，每周 5次，共 4周。疗效评定量表包括：简明智力检查量表 (MMSE)，临床疗效总评量表 (CGI)，山道士老年评定量表 (SCAG)，日常生活能力量表 (ADL)，纽伦堡老年问卷 (NAI)，数字连线测验 (ZVT)。结果 治疗 4周后，脑活素组 MMSE平均总分、 CGI、 ZVT1、 NAI、 SCAG与对照组相比都具有显著性或极显著性差异。治疗期间两组病人不良反应的出现频率无显著性差异。结论 脑活素能改善轻中度 AD病人的认知功能、非认知性精神症状和生活功能。研究期间未观察到严重不良反应。

Objective To evaluate the efficacy and safety of cerebrolysin in patients with mild to moderately severe Alzheimer disease (AD)Method 30 ml cerebrolysin was injcted intravenous once daily from Monday to Friday for four weeks. The results were assessed with scales including the Mini Mental Status Examination (MMSE),the Clinical Global Impression (CGI),the Sandoz Clinical Assessmnt Geriatric (SCAG),the Nuremberg Activities Inventory (NAI), Activities of Daily Living (ADL)and the modified Trail Making Test (ZVT).Result Patients treated with cerebrolysin showed statistcally significant improvement in the MMSE, SCAG and NAI Scores and in the ZVT test at the end point of treatment compared with patients treated with placedb. The incidence of treatment emergent abverse events with cerebrolysin was very low and comparable to that observed with placebo .Conclusion Cerebrolysin leads to clinically relevant improvement including cognitive function, non cognitive psychiatric symptoms and daily activity in patients with.AD.NO significant side effects were observed during cerebrolysin treatment .