在565名阿尔茨海默病患者的长期多尼佩西尔治疗 (AD2000):随机双盲试验
C Courtney1, D Farrell, R Gray
1Trials Unit, University of Birmingham, Birmingham, UK.
Lancet (London, England)
|June 29, 2004
概括
多尼西尔在阿尔茨海默病中提供了轻微的认知和功能改善,但并没有显著地延迟住院治疗或减缓残疾进展. 对阿尔茨海默病需要更有效的治疗方法.
科学领域:
- 神经学 神经学
- 老年学是一门学科.
- 药理学 药理学是指药理学的学科.
背景情况:
- 胆酶抑制剂在阿尔茨海默病 (AD) 中提供有限的认知益处.
- 这项研究研究了donepezil的疗效超越认知,专注于日常功能和患者的福祉.
研究的目的:
- 评估多内佩西尔是否在阿尔茨海默病患者的残疾,依赖和行为症状方面产生临床意义上的改善.
- 评估donepezil对护理人员福利和制度化延迟的影响.
- 为了确定患者子组,最佳剂量和治疗持续时间,以获得多尼利的益处.
主要方法:
- 经过12周的多内佩西尔 (每天5毫克) 或安慰剂的运行,随后随机选择多内佩西尔 (每天5或10毫克) 或安慰剂.
- 主要终点包括使用布里斯托尔日常生活活动量表 (BADLS) 的制度化和残疾进展.
- 对所有患者的结果评估使用logrank和多层模型进行了分析.
主要成果:
- 在2年内,多尼佩西尔在认知 (0.8MMSE点) 和功能 (1.0BADLS点) 中表现出适度的改善.
- 在多尼佩西尔和安慰剂组之间,没有观察到制度化率 (42% vs. 44% 在3年后) 或残疾进展率 (58% vs. 59% 在3年后) 的显著差异.
- 对于行为症状,护理人员精神病理,成本或不同剂量或安慰剂之间的不良事件,没有发现显著的益处.
结论:
- 多尼的益处低于最低相关值,表明它对阿尔茨海默病的治疗不具有成本效益.
- 目前的胆酶抑制剂,包括多内佩西尔,对于管理阿尔茨海默病的更广泛影响是不够的.
- 发展更有效的阿尔茨海默病治疗策略至关重要.
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