Charité Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie, Berlin, Germany.
Int J Geriatr Psychiatry. 2012 Jun;27(6):651-6. doi: 10.1002/gps.2766. Epub 2011 Aug 25.
Responder analyses are of relevance to evaluate the benefits of a medical treatment. The aim of the current paper is to analyse the response of patients with moderate to severe Alzheimer's disease (AD) to memantine, and clinical relevant response is defined as a delay of clinical worsening.
Post hoc analyses were performed over the results of nine individual clinical trials including 2506 study patients. Overall, estimates of the odds ratio (OR) and corresponding confidence intervals were based upon a random-effect model for three individual domains (cognition, activities of daily living and clinical global impression). In addition, a combined responder criterion (triple response) includes all three individual domains.
Responder analyses have shown that AD patients treated with memantine benefited from a significant delay of clinical worsening compared with placebo-treated patients, and fewer patients faced clinical worsening in the relevant domains cognition (24.6% vs 36.2%, p < 0.001), activities of daily living (56.2% vs 61.6%, p < 0.05) and global impression of change (40.9% vs 49.8, p < 0.001). In addition, response to treatment on the combined domains (triple response) was significantly in favour of memantine compared with placebo, with fewer patients showing clinical worsening (11.0% vs 20.4%, p < 0.001).
Treatment with memantine delays clinical worsening in patients with moderate to severe AD when compared with placebo. This effect was seen in single domains (cognition, functional abilities and clinical global impression) as well as in the combination of these domains. The consistent results prove the beneficial effects of memantine in moderate to severe AD patients.
应答者分析对于评估医疗效果具有重要意义。本文旨在分析中重度阿尔茨海默病（AD）患者接受美金刚的应答情况，临床相关应答定义为临床恶化的延迟。
对包括 2506 例研究患者在内的 9 项单独临床试验的结果进行了事后分析。总体而言，基于随机效应模型，对三个单独的领域（认知、日常生活活动和临床总体印象）的优势比（OR）和相应的置信区间进行了估计。此外，一个联合应答标准（三重应答）包括所有三个单独的领域。
应答者分析表明，与安慰剂治疗的患者相比，接受美金刚治疗的 AD 患者从临床恶化的显著延迟中获益，并且在相关认知领域（24.6%对 36.2%，p<0.001）、日常生活活动（56.2%对 61.6%，p<0.05）和临床总体印象变化（40.9%对 49.8%，p<0.001）方面，出现临床恶化的患者较少。此外，与安慰剂相比，联合应答（三重应答）在治疗上有明显的优势，显示临床恶化的患者较少（11.0%对 20.4%，p<0.001）。
与安慰剂相比，美金刚治疗可延缓中重度 AD 患者的临床恶化。这种效果在单个领域（认知、功能能力和临床总体印象）以及这些领域的组合中都有体现。一致的结果证明了美金刚在中重度 AD 患者中的有益作用。
