Hwang Tae-Young, Ahn Inn-Sook, Kim Seonwoo, Kim Doh Kwan
Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.; Department of Psychiatry, Jeonbuk Provincial Maeumsarang Hospital, Wanju, Republic of Korea.
Center for Clinical Research, Samsung Biomedical Research Institute, Seoul, Republic of Korea.
Psychiatry Investig. 2016 May;13(3):341-8. doi: 10.4306/pi.2016.13.3.341. Epub 2016 May 18.
This study compares the efficacy of the cholinesterase inhibitor (ChEI) galantamine on cognition in patients with mild-to-moderate Alzheimer's dementia (AD) who were either naïve to ChEI drugs or who had failed a trial of the ChEI donepezil.
Outpatients with AD were sequentially referred for screening and enrollment. Current outpatients who had taken donepezil for at least 6 months without demonstrated efficacy on cognition were switched to galantamine (switched group). New outpatients with no ChEI prescription history were classified as the naïve group and were given galantamine. The primary outcome measures for the between-group comparison were response rate on cognition at 26 and 52 weeks (categorical) and change on the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale (dimensional). Secondary cognitive outcomes were measured using the subset of frontal executive function and the Korean Mini-Mental State Examination.
Seventy outpatients were enrolled and 66 were analyzed by Intent-to-treat (ITT). There were 42 cases in the naïve group and 24 in the switched group. Response rates did not differ at 26 weeks (71.4% naïve vs. 58.3% switched; p=0.277) or at 52 weeks (59.5% naïve vs. 41.6% switched; p=0.162). No significant differences were observed in the pattern of change over the 52 weeks on the primary and secondary cognitive scales.
As the efficacy of galantamine on cognition was not inferior in the switched group compared to that in the naïve group, switching ChEI drugs is clinically feasible for non-responding patients with mild-to-moderate AD.
本研究比较了胆碱酯酶抑制剂（ChEI）加兰他敏对轻度至中度阿尔茨海默病（AD）患者认知功能的疗效，这些患者要么未使用过ChEI药物，要么已停用ChEI药物多奈哌齐且试验失败。
对门诊AD患者进行连续筛查和入组。将目前服用多奈哌齐至少6个月但认知功能未显示疗效的门诊患者换用加兰他敏（换药组）。无ChEI用药史的新门诊患者分为初治组并给予加兰他敏。组间比较的主要结局指标为26周和52周时认知功能的反应率（分类指标）以及韩国版阿尔茨海默病评估量表认知子量表的变化（连续指标）。次要认知结局采用额叶执行功能子集和韩国简易精神状态检查表进行测量。
共纳入了70例门诊患者，66例按意向性分析（ITT）进行分析。初治组42例，换药组24例。26周时反应率无差异（初治组71.4% vs. 换药组58.3%；p = 0.277），52周时也无差异（初治组59.5% vs. 换药组41.6%；p = 0.162）。在主要和次要认知量表上，52周内的变化模式均未观察到显著差异。
由于加兰他敏对换药组认知功能的疗效不低于初治组，因此对于轻度至中度AD无反应患者，更换ChEI药物在临床上是可行的。
