欧洲治疗阿尔茨海默病药物指导原则(译文)  

European Guidance on Clinical Investgation of Medical Products for the Treatment of Alzheimer's Disease

作　　者：卓宏[1] 赵德恒[1] 

机构地区：[1]国家药品监督管理局药品审评中心,北京100050

出　　处：《中国临床药理学杂志》2000年第1期69-72,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：本文介绍了阿尔茨海默病痴呆的定义及诊断标准。确定了ＡＤ疗效评价的主要目标是：症状改善；减慢或阻止症状的发展；初级预防。目前在后两个方面还缺乏经验，所以对症状改善的评价应为重点，包括认知功能测试、日常生活能力量表及临床总体评价。建议用多种适当的测试工具对不同方面进行评价。为确定短期疗效，设有对照的Ⅲ期临床试验应持续６个月，停药后应随访２个月。These notes introduce the definition, criteria of diagnosis and selection for Alzheimer's Disease. The main goals of AD treatment are established : symptomatic improvement; slowing or arrest; primary prevention. This guideline concentrates on assessment of symptomatic improvement in so far as, for the time being, experience is lacking in either slowing or arresting of symptom progression or in the primary prevention of disease. Improvement of symptoms should be assessed in three areas : 1. cognition; 2. activities of daily living; 3. overall clinical response. It suggests making assessment in various areas by many kinds of instrument. Phase III controlled clinical trials aimed at demonstrating short term improvement should last 6 months. After the end of the treatment administration, the state of the patient should be observed for at least 2 months.

关 键 词：欧洲 阿尔茨海默病 药物治疗 指导原则 诊断标准 AD 疗效评价 

分 类 号：R749.16[医药卫生—神经病学与精神病学]