背景:美国食品和药物管理局批准的药物疗法在达到临床相关改善方面的有效性尚不清楚。
目的:回顾胆碱酯酶抑制剂(多奈哌齐,加兰他敏,利伐斯的明,和他克林)和神经肽修饰剂美金刚在实现临床相关改善方面,主要是在认知方面,全局函数,行为,和生活质量,痴呆症患者。
方法:Cochrane中央对照试验登记册,MEDLINE,PREMEDLINE,EMBASE,联合和补充医学数据库,CINAHL,AgeLine,和PsycINFO从1986年1月到2006年11月。
方法:英语随机,如果对照试验评估了诊断为痴呆的成年人的药物,没有使用交叉设计,在Jadad量表上的质量得分为至少3分。
方法:提取研究特征和结果的数据,包括不良事件。计算效应大小,并在适当时合并数据。
结果:代表59项独特研究的96篇出版物符合本综述的条件。胆碱酯酶抑制剂和美金刚在认知和全球评估领域具有一致的作用,但汇总估计显示效应大小较小。对行为和生活质量领域的结果进行评估的频率较低,并且显示出不那么一致的效果。大多数研究持续时间短(6个月),这限制了他们检测痴呆症发作或进展延迟的能力。三项研究直接比较了不同的胆碱酯酶抑制剂,发现认知和行为没有差异。
结论:现有研究的局限性包括持续时间短,仅包括轻度至中度阿尔茨海默病患者,不良事件报告,缺乏对统计意义的明确定义,对行为和生活质量结果的有限评估,和有限的不同治疗方法的直接比较。
结论:使用胆碱酯酶抑制剂和美金刚治疗痴呆可在认知测量和痴呆的总体评估方面产生统计学上显著的但临床上微不足道的改善。
BACKGROUND: The effectiveness of the 5 U.S. Food and Drug Administration-approved pharmacologic therapies for dementias in achieving clinically relevant improvements is unclear.
OBJECTIVE: To review the evidence for the effectiveness of cholinesterase inhibitors (donepezil, galantamine, rivastigmine, and tacrine) and the neuropeptide-modifying agent memantine in achieving clinically relevant improvements, primarily in cognition, global function, behavior, and quality of life, for patients with dementia.
METHODS: Cochrane Central Register of Controlled Trials, MEDLINE, PREMEDLINE, EMBASE, Allied and Complementary Medicine Database, CINAHL, AgeLine, and PsycINFO from January 1986 through November 2006.
METHODS: English-language randomized, controlled trials were included in the review if they evaluated pharmacologic agents for adults with a diagnosis of dementia, did not use a crossover design, and had a quality score of at least 3 on the Jadad scale.
METHODS: Data were extracted on study characteristics and outcomes, including adverse events. Effect sizes were calculated and data were combined when appropriate.
RESULTS: 96 publications representing 59 unique studies were eligible for this review. Both cholinesterase inhibitors and memantine had consistent effects in the domains of cognition and global assessment, but summary estimates showed small effect sizes. Outcomes in the domains of behavior and quality of life were evaluated less frequently and showed less consistent effects. Most studies were of short duration (6 months), which limited their ability to detect delay in onset or progression of dementia. Three studies directly compared different cholinesterase inhibitors and found no differences in cognition and behavior.
CONCLUSIONS: Limitations of available studies included short duration, inclusion of only patients with mild to moderate Alzheimer disease, poor reporting of adverse events, lack of clear definitions for statistical significance, limited evaluation of behavior and quality-of-life outcomes, and limited direct comparison of different treatments.
CONCLUSIONS: Treatment of dementia with cholinesterase inhibitors and memantine can result in statistically significant but clinically marginal improvement in measures of cognition and global assessment of dementia.