Matsunaga Shinji, Kishi Taro, Iwata Nakao
Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
PLoS One. 2015 Apr 10;10(4):e0123289. doi: 10.1371/journal.pone.0123289. eCollection 2015.
We performed an updated meta-analysis of randomized placebo-controlled trials testing memantine monotherapy for patients with Alzheimer's disease (AD).
The meta-analysis included randomized controlled trials of memantine monotherapy for AD, omitting those in which patients were also administered a cholinesterase inhibitor. Cognitive function, activities of daily living, behavioral disturbances, global function, stage of dementia, drug discontinuation rate, and individual side effects were compared between memantine monotherapy and placebo groups. The primary outcomes were cognitive function and behavioral disturbances; the others were secondary outcomes.
Nine studies including 2433 patients that met the study's inclusion criteria were identified. Memantine monotherapy significantly improved cognitive function [standardized mean difference (SMD)=-0.27, 95% confidence interval (CI)=-0.39 to -0.14, p=0.0001], behavioral disturbances (SMD=-0.12, 95% CI=-0.22 to -0.01, p=0.03), activities of daily living (SMD=-0.09, 95% CI=-0.19 to -0.00, p=0.05), global function assessment (SMD=-0.18, 95% CI=-0.27 to -0.09, p=0.0001), and stage of dementia (SMD=-0.23, 95% CI=-0.33 to -0.12, p=0.0001) scores. Memantine was superior to placebo in terms of discontinuation because of inefficacy [risk ratio (RR)=0.36, 95% CI=0.17¬ to 0.74, p=0.006, number needed to harm (NNH)=non significant]. Moreover, memantine was associated with less agitation compared with placebo (RR=0.68, 95% CI=0.49 to 0.94, p=0.02, NNH=non significant). There were no significant differences in the rate of discontinuation because of all causes, all adverse events, and individual side effects other than agitation between the memantine monotherapy and placebo groups.
Memantine monotherapy improved cognition, behavior, activities of daily living, global function, and stage of dementia and was well-tolerated by AD patients. However, the effect size in terms of efficacy outcomes was small and thus there is limited evidence of clinical benefit.
我们对测试美金刚单药治疗阿尔茨海默病（AD）患者的随机安慰剂对照试验进行了更新的荟萃分析。
该荟萃分析纳入了美金刚单药治疗AD的随机对照试验，排除了同时给予患者胆碱酯酶抑制剂的试验。比较了美金刚单药治疗组和安慰剂组之间的认知功能、日常生活活动能力、行为障碍、整体功能、痴呆阶段、药物停药率及个体副作用。主要结局为认知功能和行为障碍；其他为次要结局。
确定了9项研究，共2433例患者符合研究纳入标准。美金刚单药治疗显著改善了认知功能[标准化均数差（SMD）=-0.27，95%置信区间（CI）=-0.39至-0.14，p=0.0001]、行为障碍（SMD=-0.12，95%CI=-0.22至-0.01，p=0.03）、日常生活活动能力（SMD=-0.09，95%CI=-0.19至-0.00，p=0.05）、整体功能评估（SMD=-0.18，95%CI=-0.27至-0.09，p=0.0001）以及痴呆阶段（SMD=-0.23，95%CI=-0.33至-0.12，p=0.0001）评分。在因疗效不佳而停药方面，美金刚优于安慰剂[风险比（RR）=0.36，95%CI=0.17至0.74，p=0.006，伤害所需人数（NNH）=无显著意义]。此外，与安慰剂相比，美金刚引起的激越较少（RR=0.68，95%CI=0.49至0.94，p=0.02，NNH=无显著意义）。美金刚单药治疗组和安慰剂组在因各种原因停药率、所有不良事件以及除激越外的个体副作用方面无显著差异。
美金刚单药治疗改善了AD患者的认知、行为、日常生活活动能力、整体功能及痴呆阶段，且耐受性良好。然而，疗效结局方面的效应大小较小，因此临床获益的证据有限。
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